## Protocol Section
### Identification Module
**NCT ID:** NCT02195479

**Brief Title:** A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma

**Official Title:** A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy

#### Organization Study ID Info
**ID:** CR104761
#### Organization
**Class:** INDUSTRY
**Full Name:** Janssen Research & Development, LLC
#### Secondary ID Infos
**Domain:** Janssen Research and Development, LLC
**ID:** 54767414MMY3007
**Type:** OTHER
**ID:** 2014-002272-88
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2017-11-21

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-12-17

**Type:** ACTUAL

**Results First Submit Date:** 2018-11-21

**Results First Submit QC Date:** 2018-11-21

#### Start Date
**Date:** 2014-12-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2014-07-21
**Type:** ESTIMATED
**Study First Submit Date:** 2014-07-18
**Study First Submit QC Date:** 2014-07-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Janssen Research & Development, LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).

**Detailed Description:** The study consists of 3 phases: Screening Phase (within 21 days prior to randomization), Treatment Phase (Cycle 1 Day 1 to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, withdrawal of consent, or the study ends, whichever occurs first). Treatment phase will include 2 treatments (Treatment A: participants will receive Velcade MelphalanPrednisone (VMP) alone and Treatment B: participants will receive daratumumab in combination with VMP).Two interim analyses are planned. The first will be to evaluate safety after a total of approximately 100 participants have been treated for at least 2 cycles or discontinued the study treatment. The second will be to evaluate cumulative interim safety and efficacy data, and will be performed when approximately 216 PFS events have been accumulated. The final OS analysis will occur when approximately 382 deaths have occurred. Efficacy will be primarily measured by comparison of PFS between the two treatment arms. Participants' safety will be monitored throughout the study.

### Conditions Module

**Conditions:**

- Multiple Myeloma

**Keywords:**

- Multiple Myeloma

- Bortezomib

- Velcade

- Melphalan

- Prednisone

- Daratumumab

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 706

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 , orally, once daily (on Days 1-4) and prednisone 60 mg/m\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.

**Intervention Names:**

- Drug: Velcade

- Drug: Melphalan

- Drug: Prednisone

**Label:** Treatment Arm A (VMP Alone)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Participants will receive velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally, once daily (on Days 1-4) and prednisone 60 mg/m\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 mg/kg as IV infusion, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. On days when daratumumab is given, dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute, and prednisone 60 mg/m2 once daily will be given on Days 2-4. Following amendment 7, participants will have the option to switch to daratumumab subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.

**Intervention Names:**

- Drug: Velcade

- Drug: Melphalan

- Drug: Prednisone

- Drug: Daratumumab IV

- Drug: Dexamethasone

- Drug: Daratumumab SC

**Label:** Treatment Arm B (D-VMP)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment Arm A (VMP Alone)

- Treatment Arm B (D-VMP)

**Description:** Participants will receive velcade 1.3 mg/m\^2, as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9.

**Name:** Velcade

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Treatment Arm A (VMP Alone)

- Treatment Arm B (D-VMP)

**Description:** Participants will receive melphalan 9 mg/m\^2, orally, once daily on Days 1 to 4 of each cycle up to Cycle 9.

**Name:** Melphalan

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Treatment Arm A (VMP Alone)

- Treatment Arm B (D-VMP)

**Description:** Participants will receive prednisone 60 mg/m\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.

**Name:** Prednisone

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Treatment Arm B (D-VMP)

**Description:** Participants will receive daratumumab 16 mg/kg as intravenous infusion, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study .

**Name:** Daratumumab IV

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Treatment Arm B (D-VMP)

**Description:** Participants administered with dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute.

**Name:** Dexamethasone

**Type:** DRUG

#### Intervention 6

**Arm Group Labels:**

- Treatment Arm B (D-VMP)

**Description:** Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. Following amendment 7, participants can switch from daratumumab IV to daratumumab SC.

**Name:** Daratumumab SC

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase \>=0.5 gram per deciliter \[g/dL\] and \>=200 milligram \[mg\]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase\>10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % \>=10%);Bone marrow PC%: absolute% \>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.

**Measure:** Progression Free Survival (PFS)

**Time Frame:** From randomization to either disease progression or death whichever occurs first (up to 2.4 years)

#### Secondary Outcomes

**Description:** The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (\>=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by \>=90% or to \<200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.

**Measure:** Overall Response Rate (ORR)

**Time Frame:** From randomization to disease progression (up to 2.4 years)

**Description:** VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response\[sCR\]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein level less than (\<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and \< 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.

**Measure:** Percentage of Participants With Very Good Partial Response (VGPR) or Better

**Time Frame:** From randomization to disease progression (up to 2.4 years)

**Description:** CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.

**Measure:** Percentage of Participants With Complete Response (CR) or Better

**Time Frame:** From randomization to disease progression (up to 2.4 years)

**Description:** The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10\^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR).

**Measure:** Percentage of Participants With Negative Minimal Residual Disease (MRD)

**Time Frame:** From randomization to disease progression (up to 2.4 years)

**Description:** Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.

**Measure:** Overall Survival (OS)

**Time Frame:** From randomization to death (up to approximately 2.4 years)

**Description:** Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.

**Measure:** Progression Free Survival on Next Line of Therapy (PFS2)

**Time Frame:** From randomization to either disease progression or death whichever occurs first (up to 2.4 years)

**Description:** sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; \<5% plasma cells (PCs) in bone marrow.

**Measure:** Percentage of Participants With Stringent Complete Response (sCR)

**Time Frame:** From randomization to disease progression (up to 2.4 years)

**Description:** TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase \>=0.5 gram per deciliter \[g/dL\] and \>=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % \>=10%); Bone marrow PC %: absolute % \>10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.

**Measure:** Time to Disease Progression (TTP)

**Time Frame:** From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)

**Description:** Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%.

**Measure:** Time to Response

**Time Frame:** From randomization to first documented PR or better (up to 2.4 years)

**Description:** DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase\>=0.5 g/dL); Urine M-component (absolute increase\>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%\>=10%); Bone marrow PC's %: absolute%\>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

**Measure:** Duration of Response (DOR)

**Time Frame:** Up to 2.4 years

**Description:** Time to next treatment is defined as the time from randomization to the start of the next-line treatment.

**Measure:** Time to Next Treatment (TNT)

**Time Frame:** Approximately up to 2.4 years

**Description:** Percentage of participants with Best M- protein response of 100% reduction and \>=90% to \< 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).

**Measure:** Percentage of Participants With Best M-protein Response

**Time Frame:** Approximately up to 2.4 years

**Description:** The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement.

**Measure:** Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score

**Time Frame:** Baseline, Months 3, 6, 9, 12 and 18

**Description:** EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.

**Measure:** Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)

**Time Frame:** Baseline, Months 3, 6, 9, 12 and 18

**Description:** EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.

**Measure:** Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score

**Time Frame:** Baseline, Months 3, 6, 9, 12 and 18

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participant must have documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria, monoclonal plasma cells in the bone marrow greater than or equal to 10 percent (%) or presence of a biopsy proven plasmacytoma, and measurable secretory disease, as assessed by the central laboratory, and defined in protocol
* Participants who are newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age \>=65 years, or in participants \<65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Meet the clinical laboratory criteria as specified in the protocol
* A woman of childbearing potential must have a negative serum pregnancy test at screening within 14 days prior to randomization
* Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal \[birth control pills, injections, hormonal patches, vaginal rings or implants\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy

Exclusion Criteria:

* Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
* Participant has a diagnosis of Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
* Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment
* Participant has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 4
* Participant has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
* Participant has had radiation therapy within 14 days of randomization
* Participant has had plasmapheresis within 28 days of randomization
* Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \[FEV1\] \<50% of predicted normal), known moderate or severe persistent asthma within the last 2 years or currently has uncontrolled asthma of any classification (controlled intermittent asthma or controlled mild persistent asthma is allowed)
* Participants with known or suspected COPD must have a FEV1 test during screening
* Participant is known to be seropositive for human immunodeficiency virus (HIV), known to have hepatitis B surface antigen positivity, or history of to have a history of hepatitis C
* Participant has any concurrent medical or psychiatric condition or disease (example active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** California City

**Country:** United States

**State:** California

**Location 2:**

**City:** Corona

**Country:** United States

**State:** California

**Location 3:**

**City:** Fountain Valley

**Country:** United States

**State:** California

**Location 4:**

**City:** Los Angeles

**Country:** United States

**State:** California

**Location 5:**

**City:** Hialeah

**Country:** United States

**State:** Florida

**Location 6:**

**City:** Orange Park

**Country:** United States

**State:** Florida

**Location 7:**

**City:** Chicago

**Country:** United States

**State:** Illinois

**Location 8:**

**City:** Springfield

**Country:** United States

**State:** Missouri

**Location 9:**

**City:** Cleveland

**Country:** United States

**State:** Ohio

**Location 10:**

**City:** Fredericksburg

**Country:** United States

**State:** Virginia

**Location 11:**

**City:** Buenos Aires

**Country:** Argentina

**Location 12:**

**City:** Ciudad Autonoma Buenos Aires

**Country:** Argentina

**Location 13:**

**City:** Córdoba

**Country:** Argentina

**Location 14:**

**City:** Santa Fe

**Country:** Argentina

**Location 15:**

**City:** Adelaide

**Country:** Australia

**Location 16:**

**City:** Bendigo

**Country:** Australia

**Location 17:**

**City:** Camperdown N/a

**Country:** Australia

**Location 18:**

**City:** Geelong

**Country:** Australia

**Location 19:**

**City:** Gosford

**Country:** Australia

**Location 20:**

**City:** Greenslopes

**Country:** Australia

**Location 21:**

**City:** Hobart

**Country:** Australia

**Location 22:**

**City:** North Adelaide

**Country:** Australia

**Location 23:**

**City:** Parkville

**Country:** Australia

**Location 24:**

**City:** Antwerpen

**Country:** Belgium

**Location 25:**

**City:** Antwerp

**Country:** Belgium

**Location 26:**

**City:** Brussel

**Country:** Belgium

**Location 27:**

**City:** Charleroi

**Country:** Belgium

**Location 28:**

**City:** Gent

**Country:** Belgium

**Location 29:**

**City:** Kortrijk

**Country:** Belgium

**Location 30:**

**City:** Roeselare

**Country:** Belgium

**Location 31:**

**City:** Turnhout

**Country:** Belgium

**Location 32:**

**City:** Yvoir

**Country:** Belgium

**Location 33:**

**City:** Barretos

**Country:** Brazil

**Location 34:**

**City:** Cuiaba - Mount

**Country:** Brazil

**Location 35:**

**City:** Fortaleza

**Country:** Brazil

**Location 36:**

**City:** Goiania

**Country:** Brazil

**Location 37:**

**City:** Natal

**Country:** Brazil

**Location 38:**

**City:** Porto Alegre

**Country:** Brazil

**Location 39:**

**City:** Ribeirao Preto

**Country:** Brazil

**Location 40:**

**City:** Rio de Janeiro

**Country:** Brazil

**Location 41:**

**City:** Sao Paulo

**Country:** Brazil

**Location 42:**

**City:** São Paulo

**Country:** Brazil

**Location 43:**

**City:** Pleven

**Country:** Bulgaria

**Location 44:**

**City:** Plovdiv

**Country:** Bulgaria

**Location 45:**

**City:** Sofia

**Country:** Bulgaria

**Location 46:**

**City:** Varna

**Country:** Bulgaria

**Location 47:**

**City:** Vratsa

**Country:** Bulgaria

**Location 48:**

**City:** Zadar

**Country:** Croatia

**Location 49:**

**City:** Zagreb

**Country:** Croatia

**Location 50:**

**City:** Brno

**Country:** Czechia

**Location 51:**

**City:** Hradec Kralove

**Country:** Czechia

**Location 52:**

**City:** Olomouc

**Country:** Czechia

**Location 53:**

**City:** Ostrava-Poruba

**Country:** Czechia

**Location 54:**

**City:** Praha 10

**Country:** Czechia

**Location 55:**

**City:** Praha 2

**Country:** Czechia

**Location 56:**

**City:** Tbilisi

**Country:** Georgia

**Location 57:**

**City:** Berlin

**Country:** Germany

**Location 58:**

**City:** Dortmund

**Country:** Germany

**Location 59:**

**City:** Karlsruhe

**Country:** Germany

**Location 60:**

**City:** Potsdam

**Country:** Germany

**Location 61:**

**City:** Saarbrücken

**Country:** Germany

**Location 62:**

**City:** Stuttgart

**Country:** Germany

**Location 63:**

**City:** Würzburg

**Country:** Germany

**Location 64:**

**City:** Athens Attica

**Country:** Greece

**Location 65:**

**City:** Athens

**Country:** Greece

**Location 66:**

**City:** Patra

**Country:** Greece

**Location 67:**

**City:** Thessaloniki

**Country:** Greece

**Location 68:**

**City:** Budapest

**Country:** Hungary

**Location 69:**

**City:** Debrecen

**Country:** Hungary

**Location 70:**

**City:** Kaposvar

**Country:** Hungary

**Location 71:**

**City:** Pecs N/a

**Country:** Hungary

**Location 72:**

**City:** Chiba

**Country:** Japan

**Location 73:**

**City:** Hitachi

**Country:** Japan

**Location 74:**

**City:** Kanazawa

**Country:** Japan

**Location 75:**

**City:** Kawasaki

**Country:** Japan

**Location 76:**

**City:** Kobe

**Country:** Japan

**Location 77:**

**City:** Kurume

**Country:** Japan

**Location 78:**

**City:** Matsuyama

**Country:** Japan

**Location 79:**

**City:** Nagoya

**Country:** Japan

**Location 80:**

**City:** Narita

**Country:** Japan

**Location 81:**

**City:** Ohgaki

**Country:** Japan

**Location 82:**

**City:** Okayama

**Country:** Japan

**Location 83:**

**City:** Osaka

**Country:** Japan

**Location 84:**

**City:** Sendai-shi

**Country:** Japan

**Location 85:**

**City:** Shibukawa

**Country:** Japan

**Location 86:**

**City:** Shibuya

**Country:** Japan

**Location 87:**

**City:** Tachikawa

**Country:** Japan

**Location 88:**

**City:** Toyohashi

**Country:** Japan

**Location 89:**

**City:** Busan

**Country:** Korea, Republic of

**Location 90:**

**City:** Gyeonggi-do

**Country:** Korea, Republic of

**Location 91:**

**City:** Hwasun

**Country:** Korea, Republic of

**Location 92:**

**City:** Incheon

**Country:** Korea, Republic of

**Location 93:**

**City:** Seongnam

**Country:** Korea, Republic of

**Location 94:**

**City:** Seoul

**Country:** Korea, Republic of

**Location 95:**

**City:** Skopje

**Country:** North Macedonia

**Location 96:**

**City:** Bialystok

**Country:** Poland

**Location 97:**

**City:** Bydgoszcz

**Country:** Poland

**Location 98:**

**City:** Chorzow

**Country:** Poland

**Location 99:**

**City:** Gdansk

**Country:** Poland

**Location 100:**

**City:** Legnica

**Country:** Poland

**Location 101:**

**City:** Lublin

**Country:** Poland

**Location 102:**

**City:** Opole

**Country:** Poland

**Location 103:**

**City:** Slupsk

**Country:** Poland

**Location 104:**

**City:** Warszawa Ul

**Country:** Poland

**Location 105:**

**City:** Warszawa

**Country:** Poland

**Location 106:**

**City:** Wroclaw

**Country:** Poland

**Location 107:**

**City:** Lisboa

**Country:** Portugal

**Location 108:**

**City:** Lisbon

**Country:** Portugal

**Location 109:**

**City:** Porto

**Country:** Portugal

**Location 110:**

**City:** Brasov

**Country:** Romania

**Location 111:**

**City:** Bucharest

**Country:** Romania

**Location 112:**

**City:** Iasi

**Country:** Romania

**Location 113:**

**City:** Arkhangelsk

**Country:** Russian Federation

**Location 114:**

**City:** Dzerzhinsk

**Country:** Russian Federation

**Location 115:**

**City:** Ekaterinbourg

**Country:** Russian Federation

**Location 116:**

**City:** Nizhny Novgorod

**Country:** Russian Federation

**Location 117:**

**City:** Ryazan

**Country:** Russian Federation

**Location 118:**

**City:** Saint-Petersburg

**Country:** Russian Federation

**Location 119:**

**City:** Saratov

**Country:** Russian Federation

**Location 120:**

**City:** Sochi

**Country:** Russian Federation

**Location 121:**

**City:** St Petersburg

**Country:** Russian Federation

**Location 122:**

**City:** Volgograd

**Country:** Russian Federation

**Location 123:**

**City:** Belgrade

**Country:** Serbia

**Location 124:**

**City:** Nis

**Country:** Serbia

**Location 125:**

**City:** Novi Sad

**Country:** Serbia

**Location 126:**

**City:** Sremska Kamenica

**Country:** Serbia

**Location 127:**

**City:** Zemun

**Country:** Serbia

**Location 128:**

**City:** Andalucía

**Country:** Spain

**Location 129:**

**City:** Badalona

**Country:** Spain

**Location 130:**

**City:** Barcelona

**Country:** Spain

**Location 131:**

**City:** Córdoba

**Country:** Spain

**Location 132:**

**City:** Girona

**Country:** Spain

**Location 133:**

**City:** La Laguna

**Country:** Spain

**Location 134:**

**City:** Madrid

**Country:** Spain

**Location 135:**

**City:** Maranon

**Country:** Spain

**Location 136:**

**City:** Murcia N/a

**Country:** Spain

**Location 137:**

**City:** Ourense

**Country:** Spain

**Location 138:**

**City:** Pamplona

**Country:** Spain

**Location 139:**

**City:** Salamanca

**Country:** Spain

**Location 140:**

**City:** Sevilla

**Country:** Spain

**Location 141:**

**City:** Toledo

**Country:** Spain

**Location 142:**

**City:** Valencia

**Country:** Spain

**Location 143:**

**City:** Zaragoza

**Country:** Spain

**Location 144:**

**City:** Altindag

**Country:** Turkey

**Location 145:**

**City:** Ankara

**Country:** Turkey

**Location 146:**

**City:** Aydin

**Country:** Turkey

**Location 147:**

**City:** Izmir

**Country:** Turkey

**Location 148:**

**City:** Kayseri

**Country:** Turkey

**Location 149:**

**City:** Samsun

**Country:** Turkey

**Location 150:**

**City:** Tekirdag

**Country:** Turkey

**Location 151:**

**City:** Cherkassy

**Country:** Ukraine

**Location 152:**

**City:** Dnepropetrovsk

**Country:** Ukraine

**Location 153:**

**City:** Ivano-Frankivsk

**Country:** Ukraine

**Location 154:**

**City:** Kharkov

**Country:** Ukraine

**Location 155:**

**City:** Khmelnitskiy

**Country:** Ukraine

**Location 156:**

**City:** Lviv

**Country:** Ukraine

**Location 157:**

**City:** Zaporizhzhia

**Country:** Ukraine

**Location 158:**

**City:** Birmingham

**Country:** United Kingdom

**Location 159:**

**City:** Cambridge

**Country:** United Kingdom

**Location 160:**

**City:** Colchester

**Country:** United Kingdom

**Location 161:**

**City:** Harlow

**Country:** United Kingdom

**Location 162:**

**City:** Leicester

**Country:** United Kingdom

**Location 163:**

**City:** London

**Country:** United Kingdom

**Location 164:**

**City:** Manchester

**Country:** United Kingdom

**Location 165:**

**City:** Woolwich

**Country:** United Kingdom

#### Overall Officials

**Official 1:**

**Affiliation:** Janssen Research & Development, LLC

**Name:** Janssen Research & Development, LLC Clinical Trial

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Yoon SS, Iosava G, Fujisaki T, Garg M, Iida S, Blade J, Ukropec J, Pei H, Van Rampelbergh R, Kudva A, Qi M, San-Miguel J. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):785-798. doi: 10.1016/j.clml.2021.06.005. Epub 2021 Jun 18.

**PMID:** 34344638

**Citation:** Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.

**PMID:** 34289038

**Citation:** San-Miguel J, Avet-Loiseau H, Paiva B, Kumar S, Dimopoulos MA, Facon T, Mateos MV, Touzeau C, Jakubowiak A, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE. Blood. 2022 Jan 27;139(4):492-501. doi: 10.1182/blood.2020010439.

**PMID:** 34269818

**Citation:** Knop S, Mateos MV, Dimopoulos MA, Suzuki K, Jakubowiak A, Doyen C, Lucio P, Nagy Z, Usenko G, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Losava G, Fujisaki T, Garg M, Wang J, Wroblewski S, Kudva A, Gries KS, Fastenau J, San-Miguel J, Cavo M. Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial. BMC Cancer. 2021 Jun 2;21(1):659. doi: 10.1186/s12885-021-08325-2.

**PMID:** 34078314

**Citation:** Mateos MV, Cavo M, Blade J, Dimopoulos MA, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Krevvata M, Chen Y, Wang J, Kudva A, Ukropec J, Wroblewski S, Qi M, Kobos R, San-Miguel J. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. Lancet. 2020 Jan 11;395(10218):132-141. doi: 10.1016/S0140-6736(19)32956-3. Epub 2019 Dec 10.

**PMID:** 31836199

**Citation:** Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Kaplan P, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Chiu C, Wang J, Carson R, Crist W, Deraedt W, Nguyen H, Qi M, San-Miguel J; ALCYONE Trial Investigators. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018 Feb 8;378(6):518-528. doi: 10.1056/NEJMoa1714678. Epub 2017 Dec 12.

**PMID:** 29231133

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-02-14

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 2416702

- Type Abbrev: Prot

- Upload Date: 2018-11-21T07:08

- Date: 2017-07-19

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 860873

- Type Abbrev: SAP

- Upload Date: 2018-11-21T07:08

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000020141

- Term: Hemostatic Disorders

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010265

- Term: Paraproteinemias

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006474

- Term: Hemorrhagic Disorders

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12058

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: M27588

- Name: Neoplasms, Plasma Cell

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13178

- Name: Paraproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3947

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

### Condition Browse Module - Meshes

- ID: D000009101

- Term: Multiple Myeloma

- ID: D000054219

- Term: Neoplasms, Plasma Cell

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000019653

- Term: Myeloablative Agonists

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M14121

- Name: Prednisone

- Relevance: HIGH

- As Found: Min

- ID: M11541

- Name: Melphalan

- Relevance: HIGH

- As Found: Modified

- ID: M376

- Name: Bortezomib

- Relevance: HIGH

- As Found: Old

- ID: M272211

- Name: Daratumumab

- Relevance: HIGH

- As Found: National

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: HIGH

- As Found: National

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003907

- Term: Dexamethasone

- ID: D000011241

- Term: Prednisone

- ID: D000008558

- Term: Melphalan

- ID: D000069286

- Term: Bortezomib

- ID: C000556306

- Term: Daratumumab

- ID: D000000911

- Term: Antibodies, Monoclonal

### Misc Info Module

#### Removed Countries

- Country: Czech Republic

- Country: Macedonia, The Former Yugoslav Republic of

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety population defined as participants who have received at least 1 administration of any study drug.

#### Event Groups

**Group ID:** EG000

**Title:** Velcade, Melphalan and Prednisone (VMP)

**Deaths Num Affected:** 48

**Deaths Num At Risk:** 354

**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.

**ID:** EG000

**Other Num Affected:** 331

**Other Num at Risk:** 354

**Serious Number Affected:** 115

**Serious Number At Risk:** 354

**Title:** Velcade, Melphalan and Prednisone (VMP)

**Group ID:** EG001

**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)

**Deaths Num Affected:** 45

**Deaths Num At Risk:** 346

**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.

**ID:** EG001

**Other Num Affected:** 324

**Other Num at Risk:** 346

**Serious Number Affected:** 144

**Serious Number At Risk:** 346

**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Lymphopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Abdominal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Dyspepsia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Chills

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Injection Site Erythema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Oedema Peripheral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Bronchitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Nasopharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Upper Respiratory Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Urinary Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Decreased Appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Hyperglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Hypocalcaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Hypokalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Back Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Bone Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Pain in Extremity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Neuralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Paraesthesia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Peripheral Sensory Neuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 20.0

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 20.0

#### Serious Events

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 346

**Term:** Febrile Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 346

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 346

**Term:** Acute Coronary Syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Acute Myocardial Infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Angina Unstable

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Atrial Fibrillation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 346

**Term:** Cardiac Arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Cardiac Failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Cardiac Failure Acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Cardiac Failure Chronic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Cardiac Failure Congestive

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Cardio-Respiratory Arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Cardiovascular Insufficiency

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Sinus Bradycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Stress Cardiomyopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Supraventricular Tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Conjunctival Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Retinal Detachment

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Abdominal Adhesions

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Abdominal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Abdominal Pain Upper

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Anal Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Colitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Diverticular Perforation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Enterocolitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Gastric Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Gastritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Gastrointestinal Disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Gastrointestinal Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Haematemesis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Haemorrhoidal Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Ileus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Ileus Paralytic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Inguinal Hernia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Large Intestine Perforation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Oesophageal Rupture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Oesophagitis Haemorrhagic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Rectal Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Chest Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Generalised Oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Hyperthermia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Malaise

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Multiple Organ Dysfunction Syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Non-Cardiac Chest Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 346

**Term:** Cholelithiasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Abdominal Abscess

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Bacteraemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Bronchitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 346

**Term:** Candida Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Cellulitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Clostridium Colitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Clostridium Difficile Colitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Clostridium Difficile Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Cytomegalovirus Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Device Related Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Diverticulitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Enterococcal Bacteraemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Epiglottitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Gastroenteritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** H1n1 Influenza

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Herpes Zoster

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Herpes Zoster Disseminated

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 346

**Term:** Infective Exacerbation of Chronic Obstructive Airways Disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Infective Myositis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Influenza

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 346

**Term:** Lower Respiratory Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 346

**Term:** Lower Respiratory Tract Infection Bacterial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Lung Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Meningitis Pneumococcal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Neutropenic Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pelvic Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Peritonitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pneumococcal Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 11

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 35

**Num At Risk:** 346

**Term:** Pneumonia Bacterial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Pneumonia Pneumococcal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Pneumonia Streptococcal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Pneumonia Viral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pseudomembranous Colitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pulmonary Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Respiratory Syncytial Virus Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Respiratory Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 346

**Term:** Septic Shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Staphylococcal Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Tuberculosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Tuberculous Pleurisy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Upper Respiratory Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 346

**Term:** Urinary Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 346

**Term:** Urinary Tract Infection Bacterial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Urosepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Wound Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Chest Injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Femoral Neck Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Femur Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 346

**Term:** Foot Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Humerus Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Infusion Related Reaction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Skeletal Injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Spinal Compression Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 346

**Term:** Subarachnoid Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Toxicity to Various Agents

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Traumatic Shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Upper Limb Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Wrist Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Alanine Aminotransferase Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Aspartate Aminotransferase Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Blood Creatinine Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** C-Reactive Protein Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Oxygen Saturation Decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Troponin Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Decreased Appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Hyperkalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Hypophagia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Tumour Lysis Syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Back Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 346

**Term:** Bone Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Dactylitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Neck Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Osteonecrosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Spinal Column Stenosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Acute Myeloid Leukaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Adenocarcinoma of Colon

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Bile Duct Cancer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Breast Cancer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Meningioma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Oesophageal Adenocarcinoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Plasmacytoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Rectal Adenocarcinoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Renal Cell Carcinoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Autonomic Nervous System Imbalance

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Cerebral Infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Cerebral Ischaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Cerebrovascular Accident

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Epilepsy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Haemorrhage Intracranial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Ischaemic Stroke

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Neuralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Neurotoxicity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Paraesthesia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Paraparesis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Parkinson's Disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Peripheral Motor Neuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Peripheral Sensorimotor Neuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Peripheral Sensory Neuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Sciatica

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Somnolence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Spinal Cord Compression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Syncope

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Agitation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Delirium

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Depression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Psychotic Disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Acute Kidney Injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 346

**Term:** Anuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Chronic Kidney Disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Haematuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Prerenal Failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Renal Failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Urinary Retention

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Acute Respiratory Distress Syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Acute Respiratory Failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Bronchiectasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Bronchospasm

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Chronic Obstructive Pulmonary Disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 346

**Term:** Haemoptysis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Hypoxia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Interstitial Lung Disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Laryngeal Oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Obstructive Airways Disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Pneumonitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Pneumothorax Spontaneous

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Pulmonary Embolism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Pulmonary Oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 346

**Term:** Tachypnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Wheezing

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Decubitus Ulcer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Erythema Multiforme

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Rash Erythematous

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Rash Vesicular

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 346

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Hypovolaemic Shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Orthostatic Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 354

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 346

**Term:** Thrombophlebitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 20.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 354

**Group ID:** EG001

**Num At Risk:** 346

**Time Frame:** Up to 2.4 years

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Units:** Participants

### Group

**ID:** BG000

**Title:** Velcade, Melphalan and Prednisone (VMP)

**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.

### Group

**ID:** BG001

**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)

**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 5.82

**Value:** 71.5

#### Measurement

**Group ID:** BG001

**Spread:** 6.66

**Value:** 71.3

#### Measurement

**Group ID:** BG002

**Spread:** 6.25

**Value:** 71.4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 189

#### Measurement

**Group ID:** BG001

**Value:** 190

#### Measurement

**Group ID:** BG002

**Value:** 379

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 167

#### Measurement

**Group ID:** BG001

**Value:** 160

#### Measurement

**Group ID:** BG002

**Value:** 327

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 40

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 332

#### Measurement

**Group ID:** BG001

**Value:** 320

#### Measurement

**Group ID:** BG002

**Value:** 652

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 45

#### Measurement

**Group ID:** BG001

**Value:** 47

#### Measurement

**Group ID:** BG002

**Value:** 92

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 304

#### Measurement

**Group ID:** BG001

**Value:** 297

#### Measurement

**Group ID:** BG002

**Value:** 601

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Argentina

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 15

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Australia

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Belgium

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Brazil

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 23

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Bulgaria

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Croatia

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 50

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Czech Republic

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 22

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Georgia

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 7

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Germany

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 29

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Greece

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 26

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Hungary

#### Measurement

**Group ID:** BG000

**Value:** 26

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 54

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Italy

#### Measurement

**Group ID:** BG000

**Value:** 26

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 50

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Japan

#### Measurement

**Group ID:** BG000

**Value:** 27

#### Measurement

**Group ID:** BG001

**Value:** 39

#### Measurement

**Group ID:** BG002

**Value:** 66

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Poland

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 7

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Portugal

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 11

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Macedonia

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 28

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Romania

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 43

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Russia

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 10

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Serbia

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 23

#### Measurement

**Group ID:** BG002

**Value:** 41

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Korea, Democratic People'S Republic Of

#### Measurement

**Group ID:** BG000

**Value:** 47

#### Measurement

**Group ID:** BG001

**Value:** 56

#### Measurement

**Group ID:** BG002

**Value:** 103

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Spain

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 15

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Turkey

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 48

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** Ukraine

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 24

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** United Kingdom

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 38

#### Measurement

**Group ID:** BG001

**Value:** 47

#### Measurement

**Group ID:** BG002

**Value:** 85

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 331

**Group ID:** BG001

**Value:** 333

**Group ID:** BG002

**Value:** 664

**Class Title:** I

#### Measurement

**Group ID:** BG000

**Value:** 247

#### Measurement

**Group ID:** BG001

**Value:** 226

#### Measurement

**Group ID:** BG002

**Value:** 473

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 331

**Group ID:** BG001

**Value:** 333

**Group ID:** BG002

**Value:** 664

**Class Title:** II

#### Measurement

**Group ID:** BG000

**Value:** 46

#### Measurement

**Group ID:** BG001

**Value:** 60

#### Measurement

**Group ID:** BG002

**Value:** 106

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 331

**Group ID:** BG001

**Value:** 333

**Group ID:** BG002

**Value:** 664

**Class Title:** III

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.737

**Value:** 1.27

#### Measurement

**Group ID:** BG001

**Spread:** 1.056

**Value:** 1.09

#### Measurement

**Group ID:** BG002

**Spread:** 1.442

**Value:** 1.18

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 356

**Group ID:** BG001

**Value:** 350

**Group ID:** BG002

**Value:** 706

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 6
**Description:** The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (\<)3.5 milligram per liter (mg/L) and albumin greater than or equal to (\>=) 3.5 gram per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin \>= 5.5 mg/L.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this study specific characteristic.
**Title:** Stage of Disease (ISS)
**Unit of Measure:** Participants
### Measure 7
**Description:** Time from multiple myeloma (MM) diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Time from multiple myeloma (MM) diagnosis
**Unit of Measure:** Months
## Results Section - More Information Module
### Certain Agreement
**Other Details:** A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialDisclosure@its.jnj.com
**Organization:** Janssen Research and Development, LLC
**Phone:** 844-434-4210
**Title:** Executive Medical Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.53
- **Spread:** 
- **Upper Limit:** 19.91
- **Value:** 18.14
- **Comment:** Median and 95% confidence interval (CI) was not estimable due to insufficient number of events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90.9
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71.1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42.6
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.3
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** Median and 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Median and 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** Median and 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Median and 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20.3
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 17.38
- **Spread:** 
- **Upper Limit:** 22.67
- **Value:** 19.35
- **Comment:** Median and 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.7
- **Spread:** 
- **Upper Limit:** 12.6
- **Value:** 0.82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.4
- **Spread:** 
- **Upper Limit:** 15.5
- **Value:** 0.79
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** Upper limit of 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG000
- **Lower Limit:** 18.4
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 21.3
- **Comment:** Median and 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** Median and upper limit of 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG000
- **Lower Limit:** 21.4
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Median and 95% CI was not estimable due to insufficient number of events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 287
- **Group ID:** OG001
- **Value:** 277
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 287
- **Group ID:** OG001
- **Value:** 277
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 36
- **Group ID:** OG001
- **Value:** 42
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 36
- **Group ID:** OG001
- **Value:** 42
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 18
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 18
**Units:** Participants
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.1
- **Spread:** 
- **Upper Limit:** 11.7
- **Value:** 9.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.6
- **Spread:** 
- **Upper Limit:** 11.1
- **Value:** 8.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 244
- **Group ID:** OG001
- **Value:** 261
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.1
- **Spread:** 
- **Upper Limit:** 12.9
- **Value:** 10.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 8.3
- **Spread:** 
- **Upper Limit:** 12.9
- **Value:** 10.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 212
- **Group ID:** OG001
- **Value:** 233
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.4
- **Spread:** 
- **Upper Limit:** 14.4
- **Value:** 11.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 8.8
- **Spread:** 
- **Upper Limit:** 13.5
- **Value:** 11.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 189
- **Group ID:** OG001
- **Value:** 226
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.4
- **Spread:** 
- **Upper Limit:** 13.6
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10.2
- **Spread:** 
- **Upper Limit:** 14.9
- **Value:** 12.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 179
- **Group ID:** OG001
- **Value:** 220
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.5
- **Spread:** 
- **Upper Limit:** 16.9
- **Value:** 12.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.9
- **Spread:** 
- **Upper Limit:** 14.9
- **Value:** 11.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 52
- **Group ID:** OG001
- **Value:** 78
**Units:** Participants
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 20.610
- **Upper Limit:** 
- **Value:** 60.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.190
- **Upper Limit:** 
- **Value:** 57.90
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 325
- **Group ID:** OG001
- **Value:** 315
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.417
- **Upper Limit:** 
- **Value:** 4.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.195
- **Upper Limit:** 
- **Value:** 9.28
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 241
- **Group ID:** OG001
- **Value:** 258
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.002
- **Upper Limit:** 
- **Value:** 7.40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.123
- **Upper Limit:** 
- **Value:** 10.83
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 209
- **Group ID:** OG001
- **Value:** 229
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 19.516
- **Upper Limit:** 
- **Value:** 9.89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.616
- **Upper Limit:** 
- **Value:** 12.50
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 186
- **Group ID:** OG001
- **Value:** 225
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 19.386
- **Upper Limit:** 
- **Value:** 10.80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.271
- **Upper Limit:** 
- **Value:** 10.79
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 179
- **Group ID:** OG001
- **Value:** 216
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 19.284
- **Upper Limit:** 
- **Value:** 7.65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.126
- **Upper Limit:** 
- **Value:** 12.04
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 51
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.301
- **Upper Limit:** 
- **Value:** 0.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.292
- **Upper Limit:** 
- **Value:** 0.57
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 325
- **Group ID:** OG001
- **Value:** 315
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.312
- **Upper Limit:** 
- **Value:** 0.09
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.265
- **Upper Limit:** 
- **Value:** 0.12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 241
- **Group ID:** OG001
- **Value:** 258
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.270
- **Upper Limit:** 
- **Value:** 0.12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.271
- **Upper Limit:** 
- **Value:** 0.13
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 209
- **Group ID:** OG001
- **Value:** 229
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.270
- **Upper Limit:** 
- **Value:** 0.16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.270
- **Upper Limit:** 
- **Value:** 0.16
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 186
- **Group ID:** OG001
- **Value:** 225
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.278
- **Upper Limit:** 
- **Value:** 0.15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.287
- **Upper Limit:** 
- **Value:** 0.17
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 179
- **Group ID:** OG001
- **Value:** 216
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.247
- **Upper Limit:** 
- **Value:** 0.13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.314
- **Upper Limit:** 
- **Value:** 0.13
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 51
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase \>=0.5 gram per deciliter \[g/dL\] and \>=200 milligram \[mg\]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase\>10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % \>=10%);Bone marrow PC%: absolute% \>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Intent-to-treat (ITT) population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
**Title:** Progression Free Survival (PFS)
**Type:** PRIMARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 2
**Description:** The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (\>=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by \>=90% or to \<200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.
**Parameter Type:** NUMBER
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to disease progression (up to 2.4 years)
**Title:** Overall Response Rate (ORR)
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 3
**Description:** VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response\[sCR\]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein level less than (\<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and \< 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.
**Parameter Type:** NUMBER
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to disease progression (up to 2.4 years)
**Title:** Percentage of Participants With Very Good Partial Response (VGPR) or Better
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 4
**Description:** CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
**Parameter Type:** NUMBER
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to disease progression (up to 2.4 years)
**Title:** Percentage of Participants With Complete Response (CR) or Better
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 5
**Description:** The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10\^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR).
**Parameter Type:** NUMBER
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to disease progression (up to 2.4 years)
**Title:** Percentage of Participants With Negative Minimal Residual Disease (MRD)
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 6
**Description:** Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to death (up to approximately 2.4 years)
**Title:** Overall Survival (OS)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 7
**Description:** Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
**Title:** Progression Free Survival on Next Line of Therapy (PFS2)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 8
**Description:** sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; \<5% plasma cells (PCs) in bone marrow.
**Parameter Type:** NUMBER
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to disease progression (up to 2.4 years)
**Title:** Percentage of Participants With Stringent Complete Response (sCR)
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 9
**Description:** TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase \>=0.5 gram per deciliter \[g/dL\] and \>=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % \>=10%); Bone marrow PC %: absolute % \>10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)
**Title:** Time to Disease Progression (TTP)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 10
**Description:** Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Response-evaluable population: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening, must receive at least one component of study treatment and have adequate post-baseline disease assessments. "N" (number of participants analyzed) signifies number of participants evaluable for this endpoint.
**Reporting Status:** POSTED
**Time Frame:** From randomization to first documented PR or better (up to 2.4 years)
**Title:** Time to Response
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 11
**Description:** DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase\>=0.5 g/dL); Urine M-component (absolute increase\>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%\>=10%); Bone marrow PC's %: absolute%\>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Response-evaluable set: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must have received at least one component of study treatment and have adequate post-baseline disease assessments. "N"(number of participants analyzed) signifies number of participants evaluable for this endpoint.
**Reporting Status:** POSTED
**Time Frame:** Up to 2.4 years
**Title:** Duration of Response (DOR)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 12
**Description:** Time to next treatment is defined as the time from randomization to the start of the next-line treatment.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** Approximately up to 2.4 years
**Title:** Time to Next Treatment (TNT)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 13
**Description:** Percentage of participants with Best M- protein response of 100% reduction and \>=90% to \< 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).
**Parameter Type:** NUMBER
**Population Description:** Response-evaluable set: participants have confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must receive at least one component of study treatment, have adequate post-baseline disease assessments. 'n' (number of participants analyzed) signifies number of participants analyzed for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Approximately up to 2.4 years
**Title:** Percentage of Participants With Best M-protein Response
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 14
**Description:** The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Months 3, 6, 9, 12 and 18
**Title:** Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 15
**Description:** EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Months 3, 6, 9, 12 and 18
**Title:** Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Outcome Measure 16
**Description:** EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Months 3, 6, 9, 12 and 18
**Title:** Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** OG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
##### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** OG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
### Participant Flow Module
#### Group
**Description:** Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
**ID:** FG000
**Title:** Velcade, Melphalan and Prednisone (VMP)
#### Group
**Description:** Participants received velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
**ID:** FG001
**Title:** Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 48
###### Reason
**Group ID:** FG001
**Number of Subjects:** 45
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Ongoing
###### Reason
**Group ID:** FG000
**Number of Subjects:** 291
###### Reason
**Group ID:** FG001
**Number of Subjects:** 297
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 356
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 350
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 354
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 346
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 356
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 350
**Pre-Assignment Details:** Results are reported up to second interim analysis (up to 2.4 years). Complete data through 6.4 years will be reported within 1 year of end of study trial date when final data based on study completion date will be available.
**Has Results:** True