## Protocol Section
### Identification Module
**NCT ID:** NCT01466179

**Brief Title:** Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

**Official Title:** An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE® Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

#### Organization Study ID Info
**ID:** MT103-211
#### Organization
**Class:** INDUSTRY
**Full Name:** Amgen Research (Munich) GmbH
#### Secondary ID Infos
**ID:** 2011-002257-61
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-18

**Type:** ACTUAL

**Last Update Submit Date:** 2017-07-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-01-22

**Type:** ESTIMATED

**Results First Submit Date:** 2014-12-21

**Results First Submit QC Date:** 2015-01-20

#### Start Date
**Date:** 2011-12

**Status Verified Date:** 2017-07

#### Study First Post Date
**Date:** 2011-11-06
**Type:** ESTIMATED
**Study First Submit Date:** 2011-10-28
**Study First Submit QC Date:** 2011-11-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Amgen Research (Munich) GmbH

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to confirm whether the bispecific T cell engager antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).

**Detailed Description:** Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prognosis. Several studies have reported long term survival to be below 10%. Major prognostic factors are duration of first complete remission (CR1) and age. With current salvage chemotherapy, complete remission (CR) rate is low (20 to 30%) in patients in first salvage with short duration (\< one year) of first remission, patients relapsed after first salvage, or patients aged 60 years and older. Duration of CR is usually very short (median disease free survival \[DFS\]: 2.0-7.5 months). Allogeneic hematopoietic stem cell transplantation (HSCT) may provide a curative treatment option for patients in CR with a satisfactory donor and appropriate clinical status including age, organ function, and remission status. Allogeneic HSCT is not an option in most elderly patients with relapsed ALL. Additional therapeutic approaches are urgently needed.

Blinatumomab is a bispecific single-chain antibody derivative against CD (cluster of differentiation)19 and CD3, designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19-expressing cells. In vitro data indicate CD19+ lymphoma and leukemia cell lines to be extremely sensitive to blinatumomab-mediated cytotoxicity. Blinatumomab has the potential to provide meaningful therapeutic benefits to patients compared with existing treatments for this patient population.

This study consists of a screening period, a treatment period and a follow-up period. Participants receive one to five treatment cycles of blinatumomab at a target dose of 28 μg/day. In the first cycle, the initial dose is 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.

Participants who achieve remission within two cycles of treatment can receive up to three additional cycles of consolidation treatment or proceed to allogeneic HSCT. In the event of progression or relapse within the treatment period, treatment will be terminated. Participants with hematological relapse during the efficacy or safety follow-up period may receive up to three additional cycles of blinatumomab (retreatment) for a maximal total of eight cycles at the investigator´s discretion.

Thirty days after end of the last treatment, participants have an end-of-core-study visit. Following this, there are efficacy follow-up visits at 3, 6, 9, 12, 18 and 24 months at the most after treatment start. Once efficacy follow-up is complete, information on survival collected at least every six months until death or at least until three years after treatment start, whichever occurs earlier (survival follow-up).

### Conditions Module

**Conditions:**

- Acute Lymphoblastic Leukemia

**Keywords:**

- B-ALL

- relapsed ALL

- refractory ALL

- adult ALL

- Leukemia

- Leukemia, Lymphoid

- precursor cell lymphoblastic leukemia-lymphoma

- Lymphatic diseases

- Lymphoproliferative disorders

- bispecific antibody

- anti-CD19

- Immunotherapeutic treatment

- immunoproliferative disorders

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 225

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.

**Intervention Names:**

- Biological: Blinatumomab

**Label:** Blinatumomab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Blinatumomab

**Description:** Continuous intravenous infusion over four weeks per treatment cycle

**Name:** Blinatumomab

**Other Names:**

- AMG103

- MT103

- BLINCYTO™

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.

Hematological remissions were defined by the following criteria:

Complete Remission (CR):

* bone marrow blasts ≤ 5%
* no evidence of disease
* full recovery of peripheral blood counts:

  * platelets \> 100,000/μL, and
  * absolute neutrophil count (ANC) \> 1,000/μL

Complete Remission With Partial Hematological Recovery (CRh\*):

* bone marrow blasts ≤ 5%
* no evidence of disease
* partial recovery of peripheral blood counts:

  * platelets \> 50,000/μL, and
  * ANC \> 500/μL.

**Measure:** Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment

**Time Frame:** Within the first 2 cycles of treatment, 12 weeks

#### Secondary Outcomes

**Description:** Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.

Hematological relapse is defined as:

* proportion of blasts in bone marrow \> 5% after documented CR/CRh\* or
* blasts in peripheral blood after documented CR/CRh\*.

Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.

**Measure:** Time to Hematological Relapse (Duration of Response)

**Time Frame:** Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.

**Description:** Participants who were eligible for allogeneic HSCT were those who achieved remission (complete response or complete response with partial recovery of peripheral blood counts) after 2 cycles of blinatumomab treatment, and no further anti-leukemic medication was given before HSCT.

**Measure:** Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission

**Time Frame:** Up to the data cut-off date of 10 October 2013. Maximum duration on study was 17.8 months.

**Description:** Complete Remission was defined by the following criteria:

* bone marrow blasts ≤ 5%
* no evidence of disease
* full recovery of peripheral blood counts:

  * platelets \> 100,000/μL, and
  * absolute neutrophil count (ANC) \> 1,000/μL

**Measure:** Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment

**Time Frame:** Within the first 2 cycles of treatment, 12 weeks

**Description:** Complete Remission With Partial Hematological Recovery was defined by the following criteria:

* bone marrow blasts ≤ 5%
* no evidence of disease
* partial recovery of peripheral blood counts:

  * platelets \> 50,000/μL, and
  * ANC \> 500/μL.

**Measure:** Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment

**Time Frame:** Within the first 2 cycles of treatment, 12 weeks

**Description:** Partial Remission is defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.

**Measure:** Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment

**Time Frame:** Within the first 2 cycles of treatment, 12 weeks

**Description:** Relapse-free survival was assessed for participants who achieved a complete remission or complete remission with partial hematological recovery during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.

Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.

**Measure:** Relapse-free Survival

**Time Frame:** Up to the data cut-off date of 10 October 2013; median observation time was 8.9 months.

**Description:** Event-free survival was calculated from the start date of blinatumomab infusion until the date of bone marrow aspiration at which hematological relapse was first detected, or the date of diagnosis on which the hematological or extramedullary relapse was documented or the date of start of any new therapy for ALL (excluding HSCT), or the date of death, whichever was earlier. Participants who did not achieve complete remission or complete remission with partial hematological recovery during the core study were evaluated as having an event on Day 1. Participants in remission who did not experience hematological relapse, did not receive a new therapy for ALL (excluding HSCT), and did not die were censored on the date of the last available bone marrow aspiration or on the last date of survival follow-up visit, whichever was later.

Event free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.

**Measure:** Event-free Survival

**Time Frame:** Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.

**Description:** Overall survival was measured for all participants from the time the participant received the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan Meier method.

**Measure:** Overall Survival

**Time Frame:** Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.

**Description:** Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.

The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.

An AE was considered "serious" if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition.

Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events.

**Measure:** Number of Participants With Treatment-emergent Adverse Events

**Time Frame:** From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 42.2 days.

**Description:** The analysis of 100-day mortality after allogeneic HSCT was assessed for all participants who received an allogeneic HSCT while in remission (CR/CRh\*) following treatment with blinatumomab. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.

Patients alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive.

The 100-day mortality rate after allogeneic HSCT was defined as the percentage of patients having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods.

**Measure:** 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant

**Time Frame:** From the date of allogeneic HSCT until the data cut-off date of 10 October 2013; median observation time was 7.4 months.

**Description:** The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.

**Measure:** Serum Blinatumomab Concentration at Steady State

**Time Frame:** Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.

**Description:** The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data \< LOQ and \> LOD were reported as measured.

Serum IL-4 levels were below detection limit (\< 20 pg/mL) at all time points in all participants studied.

**Measure:** Serum Cytokine Peak Levels

**Time Frame:** Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.

**Description:** Blast Free Hypoplastic or Aplastic Bone Marrow was defined as:

* bone marrow blasts ≤ 5%
* no evidence of disease
* insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or absolute neutrophil count (ANC) ≤ 500/μL

**Measure:** Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment

**Time Frame:** Within the first 2 cycles of treatment, 12 weeks

**Description:** Complete Remission (CR):

* bone marrow blasts ≤ 5%
* no evidence of disease
* full recovery of peripheral blood counts:

  * platelets \> 100,000/μL, and
  * absolute neutrophil count (ANC) \> 1,000/μL

Complete Remission With Partial Hematological Recovery (CRh\*):

* bone marrow blasts ≤ 5%
* no evidence of disease
* partial recovery of peripheral blood counts:

  * platelets \> 50,000/μL, and
  * ANC \> 500/μL

Blast Free Hypoplastic or Aplastic Bone Marrow:

* bone marrow blasts ≤ 5%
* no evidence of disease
* insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL

Partial Remission:

• bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline.

**Measure:** Best Response During the Core Study

**Time Frame:** From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with Philadelphia chromosome (Ph)-negative B-precursor ALL, with any of the following:

  * relapsed or refractory with first remission duration less than or equal to 12 months in first salvage or
  * relapsed or refractory after first salvage therapy or
  * relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT)
* 10% or more blasts in bone marrow
* In case of clinical signs of additional extramedullary disease: measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Age ≥ 18 years

Exclusion Criteria:

* Patients with Ph-positive ALL
* Patients with Burkitt's Leukemia according to World Health organization (WHO) classification
* History or presence of clinically relevant central nervous system (CNS) pathology
* Active ALL in the CNS or testes
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement
* Autologous HSCT within six weeks prior to start of blinatumomab treatment
* Allogeneic HSCT within three months prior to start of blinatumomab treatment
* Any active acute graft versus-host disease (GvHD), or active chronic GvHD Grade 2 - 4
* Any systemic therapy against GvHD within two weeks prior to start of blinatumomab treatment
* Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
* Radiotherapy within two weeks prior to start of blinatumomab treatment
* Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treat-ment
* Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
* Treatment with any other investigational medicinal product (IMP) after signature of informed consent
* Eligibility for allogeneic HSCT at the time of enrollment
* Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation
* Abnormal laboratory values indicative of inadequate renal or liver function
* History of malignancy requiring treatment other than ALL within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
* Any concurrent disease or medical condition that is deemed to interfere with the conduct of the study
* Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus
* Pregnant or nursing women
* Women of childbearing potential not willing to use an effective form of contraception. Male patients not willing to ensure not to beget a child
* Previous treatment with blinatumomab

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Duarte

**Country:** United States

**Facility:** City of Hope

**State:** California

**Zip:** 91010-3000

**Location 2:**

**City:** Los Angeles

**Country:** United States

**Facility:** University of California Los Angeles

**State:** California

**Zip:** 90095-1678

**Location 3:**

**City:** Atlanta

**Country:** United States

**Facility:** Winship Cancer Institute of Emory University

**State:** Georgia

**Zip:** 30322

**Location 4:**

**City:** Chicago

**Country:** United States

**Facility:** Rush University Medical Center

**State:** Illinois

**Zip:** 60612

**Location 5:**

**City:** Chicago

**Country:** United States

**Facility:** University of Chicago

**State:** Illinois

**Zip:** 60637

**Location 6:**

**City:** Boston

**Country:** United States

**Facility:** Dana Farber Institute

**State:** Massachusetts

**Zip:** 02215

**Location 7:**

**City:** Detroit

**Country:** United States

**Facility:** Barbara Ann Karmanos Cancer Institute

**State:** Michigan

**Zip:** 48201

**Location 8:**

**City:** Rochester

**Country:** United States

**Facility:** Mayo Clinic

**State:** Minnesota

**Zip:** 55905

**Location 9:**

**City:** Saint Louis

**Country:** United States

**Facility:** Washington University School of Medicine

**State:** Missouri

**Zip:** 63110

**Location 10:**

**City:** Buffalo

**Country:** United States

**Facility:** Roswell Park Cancer Streets

**State:** New York

**Zip:** 14263

**Location 11:**

**City:** Philadelphia

**Country:** United States

**Facility:** University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

**Location 12:**

**City:** Houston

**Country:** United States

**Facility:** University of Texas MD Anderson Cancer Center

**State:** Texas

**Zip:** 77030

**Location 13:**

**City:** Angers

**Country:** France

**Facility:** CHU d'Angers

**Zip:** 49933

**Location 14:**

**City:** Nantes

**Country:** France

**Facility:** Hôpital de l'hôtel Dieu

**Zip:** 44000

**Location 15:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Saint Louis

**Zip:** 75475

**Location 16:**

**City:** Toulouse

**Country:** France

**Facility:** CHU de Purpan

**Zip:** 31059

**Location 17:**

**City:** Berlin

**Country:** Germany

**Facility:** Charité - Campus Benjamin Franklin

**Zip:** 12200

**Location 18:**

**City:** Frankfurt

**Country:** Germany

**Facility:** Klinikum der Goethe Universität, Medizinische Klinik II

**Zip:** 60590

**Location 19:**

**City:** Freiburg

**Country:** Germany

**Facility:** Universitätsklinikum Freiburg

**Zip:** 79106

**Location 20:**

**City:** Hannover

**Country:** Germany

**Facility:** Medizinische Hochschule Hannover

**Zip:** 30625

**Location 21:**

**City:** Kiel

**Country:** Germany

**Facility:** Universitätsklinikum Schleswig-Holstein

**Zip:** 24116

**Location 22:**

**City:** Münster

**Country:** Germany

**Facility:** Universitätsklinikum Münster

**Zip:** 48149

**Location 23:**

**City:** Tübingen

**Country:** Germany

**Facility:** Universitätsklinikum Tübingen

**Zip:** 72076

**Location 24:**

**City:** Ulm

**Country:** Germany

**Facility:** Universitätsklinikum Ulm

**Zip:** 89081

**Location 25:**

**City:** Würzburg

**Country:** Germany

**Facility:** Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II

**Zip:** 97080

**Location 26:**

**City:** Bergamo

**Country:** Italy

**Facility:** Ospedali Riuniti di Bergamo

**Zip:** 24128

**Location 27:**

**City:** Naples

**Country:** Italy

**Facility:** Azienda Ospedaliera Antonio Cardarelli

**Zip:** 80131

**Location 28:**

**City:** Palermo

**Country:** Italy

**Facility:** Ospedali Riuniti "Villa Sofia-Cervello"

**Zip:** 90146

**Location 29:**

**City:** Rome

**Country:** Italy

**Facility:** Università La Sapienza di Roma

**Zip:** 00161

**Location 30:**

**City:** Turin

**Country:** Italy

**Facility:** Azienda Ospedaliero-Universitaria

**Zip:** 10126

**Location 31:**

**City:** Verona

**Country:** Italy

**Facility:** Azienda Ospedaliera di Verona

**Zip:** 37134

**Location 32:**

**City:** Badalona

**Country:** Spain

**Facility:** ICO Hospital Germans Trias I Pujol

**Zip:** 08916

**Location 33:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Clínic Servei d´Hematologia

**Zip:** 08036

**Location 34:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital 12 de Octubre

**Zip:** 28041

**Location 35:**

**City:** Salamanca

**Country:** Spain

**Facility:** Hospital universitario de Salamanca

**Zip:** 37007

**Location 36:**

**City:** Sevilla

**Country:** Spain

**Facility:** Hospital Universitario Virgen Del Rocio

**Zip:** 41013

**Location 37:**

**City:** Bristol

**Country:** United Kingdom

**Facility:** University Hospitals Bristol NHS

**Zip:** BS2 8ED

**Location 38:**

**City:** London

**Country:** United Kingdom

**Facility:** Royal Free Hampstead NHS Trust

**Zip:** NW3 2QG

**Location 39:**

**City:** Manchester

**Country:** United Kingdom

**Facility:** The Christie NHS Foundation Trust

**Zip:** M20 4BX

#### Overall Officials

**Official 1:**

**Affiliation:** Klinikum der Goethe Universität Frankfurt

**Name:** Nicola Gökbuget, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II, Würzburg

**Name:** Max Topp, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** MD Anderson Cancer Center, Houston, Texas

**Name:** Hagop Kantarjian, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

**PMID:** 35622074

**Citation:** Gokbuget N, Kantarjian HM, Bruggemann M, Stein AS, Bargou RC, Dombret H, Fielding AK, Heffner L, Rigal-Huguet F, Litzow M, O'Brien S, Zugmaier G, Gao S, Nagorsen D, Forman SJ, Topp MS. Molecular response with blinatumomab in relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Blood Adv. 2019 Oct 22;3(20):3033-3037. doi: 10.1182/bloodadvances.2019000457.

**PMID:** 31648325

**Citation:** Zhu M, Kratzer A, Johnson J, Holland C, Brandl C, Singh I, Wolf A, Doshi S. Blinatumomab Pharmacodynamics and Exposure-Response Relationships in Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Pharmacol. 2018 Feb;58(2):168-179. doi: 10.1002/jcph.1006. Epub 2017 Sep 18.

**PMID:** 28922466

**Citation:** Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21.

**PMID:** 27873237

**Citation:** Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.

**PMID:** 27209293

**Citation:** Topp MS, Gokbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, Dombret H, Fielding AK, Heffner L, Larson RA, Neumann S, Foa R, Litzow M, Ribera JM, Rambaldi A, Schiller G, Bruggemann M, Horst HA, Holland C, Jia C, Maniar T, Huber B, Nagorsen D, Forman SJ, Kantarjian HM. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015 Jan;16(1):57-66. doi: 10.1016/S1470-2045(14)71170-2. Epub 2014 Dec 16. Erratum In: Lancet Oncol. 2015 Apr;16(4):e158.

**PMID:** 25524800

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10951

- Name: Leukemia, Lymphoid

- Relevance: HIGH

- As Found: Lymphoblastic Leukemia

- ID: M27585

- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: M11220

- Name: Lymphoma

- 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: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T175

- Name: Acute Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: T3533

- Name: Lymphoblastic Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000054198

- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- ID: D000007945

- Term: Leukemia, Lymphoid

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M20194

- Name: Antibodies, Bispecific

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M287547

- Name: Blinatumomab

- Relevance: HIGH

- As Found: Inguinal Hernia

### Intervention Browse Module - Meshes

- ID: C000510808

- Term: Blinatumomab

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

#### Event Groups

**Group ID:** EG000

**Title:** Blinatumomab

**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The the initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.

**ID:** EG000

**Other Num Affected:** 186

**Other Num at Risk:** 189

**Serious Number Affected:** 121

**Serious Number At Risk:** 189

**Title:** Blinatumomab

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Sinus tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Vision blurred

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Cytokine release syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

**Term:** Immunoglobulins decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

**Term:** Weight increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Hypomagnesaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Hypophosphataemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Bone pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Petechiae

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 16.1

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 16.1

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Disseminated intravascular coagulation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 16

**Num At Risk:** 189

**Term:** Leukocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 189

**Term:** Pancytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Cardiac failure congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Sinus bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Supraventricular tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Ventricular fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Aplasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Diplopia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Enteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Device occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Disease progression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 189

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Hypothermia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Medical device complication

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 189

**Term:** Mucosal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Multi-organ failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 11

**Num At Risk:** 189

**Term:** Cytokine release syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Hypersensitivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Abdominal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Aspergillus infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** BK virus infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Bacterial sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Bronchopneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Bronchopulmonary aspergillosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Candida infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Cholecystitis infective

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Device related infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 189

**Term:** Enterobacter infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Enterococcal bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Enterococcal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Enterococcal sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Epididymal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Erysipelas

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Escherichia sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Fungal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Fusarium infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Gastrointestinal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Herpes zoster

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 189

**Term:** Kidney infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Klebsiella infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Leuconostoc infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Lower respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Lung infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Neutropenic sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Pathogen resistance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Pilonidal cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 189

**Term:** Pneumonia fungal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Pneumonia klebsiella

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Pneumonia respiratory syncytial viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Pseudomonal bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Pseudomonas infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Pulmonary sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Rhinitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Rhinovirus infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 189

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 189

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Sinusitis fungal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Staphylococcal bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 189

**Term:** Staphylococcal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Staphylococcal sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Streptococcal sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Urosepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Viral haemorrhagic cystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Viral infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Accidental overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Femoral neck fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Hip fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 189

**Term:** Post lumbar puncture syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Subdural haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Toxicity to various agents

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 189

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Blood lactate dehydrogenase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** C-reactive protein increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Fluid overload

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Tumour lysis syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Bone pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Fistula

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Myopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Acute leukaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Acute lymphocytic leukaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** B precursor type acute leukaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Chloroma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Lymphoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Aphasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Ataxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 189

**Term:** Cerebral haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Cognitive disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 189

**Term:** Convulsion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Dysaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Dysarthria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 189

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 189

**Term:** Hemiparesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Nervous system disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Neurological symptom

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Neurotoxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 189

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Poor quality sleep

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 189

**Term:** Trigeminal nerve disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Agitation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 189

**Term:** Delirium febrile

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Mental status changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Restlessness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Bladder perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Renal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Renal failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Scrotal oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Respiratory distress

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 189

**Term:** Erythema multiforme

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Rash vesicular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Skin lesion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Catheter placement

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Central venous catheter removal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Resuscitation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Capillary leak syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Femoral artery occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 189

**Term:** Hypovolaemic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Term:** Subclavian vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 189

**Time Frame:** From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 42.2 days.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 189

**Units:** Participants

### Group

**ID:** BG000

**Title:** Blinatumomab

**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 18

**Upper Limit:** 79

**Value:** 39.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 90

**Class Title:** 18 to < 35 years

#### Measurement

**Group ID:** BG000

**Value:** 46

**Class Title:** 35 to < 55 years

#### Measurement

**Group ID:** BG000

**Value:** 28

**Class Title:** 55 to < 65 years

#### Measurement

**Group ID:** BG000

**Value:** 25

**Class Title:** ≥ 65 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 70

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 119

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 145

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 7

**Class Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** American Indian or Alaska native

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** Native Hawaiian or other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 9

**Class Title:** Other

#### Measurement

**Group ID:** BG000

**Value:** 20

**Class Title:** Not recorded

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

**Class Title:** Primary refractory

#### Measurement

**Group ID:** BG000

**Value:** 39

**Class Title:** Relapse ≤ 12 months of allogeneic HSCT

#### Measurement

**Group ID:** BG000

**Value:** 23

**Class Title:** Entering first salvage; first remission ≤ 12 mo

#### Measurement

**Group ID:** BG000

**Value:** 108

**Class Title:** Entering second or greater salvage therapies

#### Measurement

**Group ID:** BG000

**Value:** 3

**Class Title:** No criteria met

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

**Class Title:** 0

#### Measurement

**Group ID:** BG000

**Value:** 107

**Class Title:** 1

#### Measurement

**Group ID:** BG000

**Value:** 46

**Class Title:** 2

#### Measurement

**Group ID:** BG000

**Value:** 20

**Class Title:** >2

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 64

**Class Title:** Prior allogeneic HSCT

#### Measurement

**Group ID:** BG000

**Value:** 16

**Class Title:** No prior alloHSCT, no prior relapse

#### Measurement

**Group ID:** BG000

**Value:** 84

**Class Title:** No prior alloHSCT, 1 prior relapse

#### Measurement

**Group ID:** BG000

**Value:** 22

**Class Title:** No prior alloHSCT, 2 prior relapses

#### Measurement

**Group ID:** BG000

**Value:** 3

**Class Title:** No prior alloHSCT, > 2 prior relapses

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 38

**Class Title:** No prior salvage therapy

#### Measurement

**Group ID:** BG000

**Value:** 77

**Class Title:** 1 prior salvage therapy

#### Measurement

**Group ID:** BG000

**Value:** 42

**Class Title:** 2 prior salvage therapies

#### Measurement

**Group ID:** BG000

**Value:** 32

**Class Title:** > 2 prior salvage therapies

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 1.9

**Upper Limit:** 249.0

**Value:** 16.59

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 0.1

**Upper Limit:** 56.8

**Value:** 1.38

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** < 10%

#### Measurement

**Group ID:** BG000

**Value:** 43

**Class Title:** 10% - < 50%

#### Measurement

**Group ID:** BG000

**Value:** 145

**Class Title:** ≥ 50%

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Description:** Race was not permitted to be collected in France
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 5
**Description:** HSCT = hematopoietic stem cell transplantation
**Parameter Type:** NUMBER
**Title:** Disease stage entry criteria met
**Unit of Measure:** participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Number of prior relapses
**Unit of Measure:** participants
### Measure 7
**Description:** alloHSCT = allogeneic hematopoietic stem cell transplantation
**Parameter Type:** NUMBER
**Title:** Prior allogeneic HSCT and prior relapses
**Unit of Measure:** participants
### Measure 8
**Parameter Type:** NUMBER
**Title:** Number of prior salvage therapies
**Unit of Measure:** participants
### Measure 9
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Time since initial diagnosis
**Unit of Measure:** months
### Measure 10
**Description:** Reported for 173 participants with a prior relapse (the other16 participants were primary refractory with no prior relapses).
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Time since last relapse
**Unit of Measure:** months
### Measure 11
**Description:** Bone marrow blasts were assessed by local and central laboratories; reported data are based on maximum central and local laboratory assessments.
**Parameter Type:** NUMBER
**Title:** Baseline bone marrow blast category
**Unit of Measure:** participants
**Population Description:** Primary Analysis Set
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Organization:** Amgen Inc.
**Phone:** 866-572-6436
**Title:** Study 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
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 35.7
- **Spread:** 
- **Upper Limit:** 50.2
- **Value:** 42.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** Not estimable due to the number of events during the observation period.
- **Group ID:** OG000
- **Lower Limit:** 5.1
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 6.7
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 28.8
- **Spread:** 
- **Upper Limit:** 51.0
- **Value:** 39.5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 26.7
- **Spread:** 
- **Upper Limit:** 40.5
- **Value:** 33.3
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.7
- **Spread:** 
- **Upper Limit:** 14.6
- **Value:** 9.5
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.9
- **Spread:** 
- **Upper Limit:** 6.1
- **Value:** 2.6
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.8
- **Spread:** 
- **Upper Limit:** 8.3
- **Value:** 5.9
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 1.0
- **Value:** 0.0
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.2
- **Spread:** 
- **Upper Limit:** 7.5
- **Value:** 6.1
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 188
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 155
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 166
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 105
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 121
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 105
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 23.4
- **Value:** 11.3
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 258
- **Upper Limit:** 
- **Value:** 211
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 502
- **Upper Limit:** 
- **Value:** 621
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 444
- **Upper Limit:** 
- **Value:** 731
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 409
- **Upper Limit:** 
- **Value:** 93.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 83.1
- **Upper Limit:** 
- **Value:** 27.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 45.8
- **Upper Limit:** 
- **Value:** 22.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27.6
- **Upper Limit:** 
- **Value:** 21.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 822
- **Upper Limit:** 
- **Value:** 589
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 136
- **Upper Limit:** 
- **Value:** 95.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 633
- **Upper Limit:** 
- **Value:** 397
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 941
- **Upper Limit:** 
- **Value:** 428
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 44.6
- **Upper Limit:** 
- **Value:** 24.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.21
- **Upper Limit:** 
- **Value:** 10.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.17
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.03
- **Upper Limit:** 
- **Value:** 10.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2390
- **Upper Limit:** 
- **Value:** 826
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 681
- **Upper Limit:** 
- **Value:** 234
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 952
- **Upper Limit:** 
- **Value:** 315
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 114
- **Upper Limit:** 
- **Value:** 69.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 125
- **Upper Limit:** 
- **Value:** 30
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.33
- **Upper Limit:** 
- **Value:** 10.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15
- **Upper Limit:** 
- **Value:** 12.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.79
- **Upper Limit:** 
- **Value:** 12
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.3
- **Spread:** 
- **Upper Limit:** 14.0
- **Value:** 9.0
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 36.2
- **Spread:** 
- **Upper Limit:** 50.8
- **Value:** 43.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 28.6
- **Spread:** 
- **Upper Limit:** 42.7
- **Value:** 35.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.5
- **Spread:** 
- **Upper Limit:** 12.8
- **Value:** 7.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.3
- **Spread:** 
- **Upper Limit:** 14.0
- **Value:** 9.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.9
- **Spread:** 
- **Upper Limit:** 6.1
- **Value:** 2.6
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.

Hematological remissions were defined by the following criteria:

Complete Remission (CR):

* bone marrow blasts ≤ 5%
* no evidence of disease
* full recovery of peripheral blood counts:

  * platelets \> 100,000/μL, and
  * absolute neutrophil count (ANC) \> 1,000/μL

Complete Remission With Partial Hematological Recovery (CRh\*):

* bone marrow blasts ≤ 5%
* no evidence of disease
* partial recovery of peripheral blood counts:

  * platelets \> 50,000/μL, and
  * ANC \> 500/μL.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The Primary Analysis Set (PAS), defined as participants from the first 3 stages of the study who received any infusion of blinatumomab.
**Reporting Status:** POSTED
**Time Frame:** Within the first 2 cycles of treatment, 12 weeks
**Title:** Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 2
**Description:** Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.

Hematological relapse is defined as:

* proportion of blasts in bone marrow \> 5% after documented CR/CRh\* or
* blasts in peripheral blood after documented CR/CRh\*.

Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Participants who reached complete remission or complete remission with partial hematological recovery during the core study.
**Reporting Status:** POSTED
**Time Frame:** Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.
**Title:** Time to Hematological Relapse (Duration of Response)
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 3
**Description:** Participants who were eligible for allogeneic HSCT were those who achieved remission (complete response or complete response with partial recovery of peripheral blood counts) after 2 cycles of blinatumomab treatment, and no further anti-leukemic medication was given before HSCT.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Participants who reached complete remission or complete remission with partial hematological recovery during the first 2 cycles of treatment.
**Reporting Status:** POSTED
**Time Frame:** Up to the data cut-off date of 10 October 2013. Maximum duration on study was 17.8 months.
**Title:** Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 4
**Description:** Complete Remission was defined by the following criteria:

* bone marrow blasts ≤ 5%
* no evidence of disease
* full recovery of peripheral blood counts:

  * platelets \> 100,000/μL, and
  * absolute neutrophil count (ANC) \> 1,000/μL
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Primary analysis set
**Reporting Status:** POSTED
**Time Frame:** Within the first 2 cycles of treatment, 12 weeks
**Title:** Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 5
**Description:** Complete Remission With Partial Hematological Recovery was defined by the following criteria:

* bone marrow blasts ≤ 5%
* no evidence of disease
* partial recovery of peripheral blood counts:

  * platelets \> 50,000/μL, and
  * ANC \> 500/μL.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Primary analysis set
**Reporting Status:** POSTED
**Time Frame:** Within the first 2 cycles of treatment, 12 weeks
**Title:** Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 6
**Description:** Partial Remission is defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Primary analysis set
**Reporting Status:** POSTED
**Time Frame:** Within the first 2 cycles of treatment, 12 weeks
**Title:** Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 7
**Description:** Relapse-free survival was assessed for participants who achieved a complete remission or complete remission with partial hematological recovery during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.

Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Participants who reached complete remission or complete remission with partial hematological recovery during the core study
**Reporting Status:** POSTED
**Time Frame:** Up to the data cut-off date of 10 October 2013; median observation time was 8.9 months.
**Title:** Relapse-free Survival
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 8
**Description:** Event-free survival was calculated from the start date of blinatumomab infusion until the date of bone marrow aspiration at which hematological relapse was first detected, or the date of diagnosis on which the hematological or extramedullary relapse was documented or the date of start of any new therapy for ALL (excluding HSCT), or the date of death, whichever was earlier. Participants who did not achieve complete remission or complete remission with partial hematological recovery during the core study were evaluated as having an event on Day 1. Participants in remission who did not experience hematological relapse, did not receive a new therapy for ALL (excluding HSCT), and did not die were censored on the date of the last available bone marrow aspiration or on the last date of survival follow-up visit, whichever was later.

Event free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Primary analysis set
**Reporting Status:** POSTED
**Time Frame:** Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.
**Title:** Event-free Survival
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 9
**Description:** Overall survival was measured for all participants from the time the participant received the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan Meier method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Primary analysis set
**Reporting Status:** POSTED
**Time Frame:** Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.
**Title:** Overall Survival
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 10
**Description:** Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.

The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.

An AE was considered "serious" if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition.

Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events.
**Parameter Type:** NUMBER
**Population Description:** Full analysis set (FAS), defined as all patients who received any infusion of blinatumomab.
**Reporting Status:** POSTED
**Time Frame:** From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 42.2 days.
**Title:** Number of Participants With Treatment-emergent Adverse Events
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 11
**Description:** The analysis of 100-day mortality after allogeneic HSCT was assessed for all participants who received an allogeneic HSCT while in remission (CR/CRh\*) following treatment with blinatumomab. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.

Patients alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive.

The 100-day mortality rate after allogeneic HSCT was defined as the percentage of patients having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Participants who received an allogeneic HSCT while in remission induced by blinatumomab treatment.
**Reporting Status:** POSTED
**Time Frame:** From the date of allogeneic HSCT until the data cut-off date of 10 October 2013; median observation time was 7.4 months.
**Title:** 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 12
**Description:** The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Data Set (PKS) defined as all patients who received any infusion of blinatumomab and had at least one PK sample collected unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption or sampling information was missing.
**Reporting Status:** POSTED
**Time Frame:** Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.
**Title:** Serum Blinatumomab Concentration at Steady State
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Participants receiving 9 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
**ID:** OG000
**Title:** Cycle 1: Blinatumomab 9 μg/Day
##### Group
**Description:** Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
**ID:** OG001
**Title:** Cycle 1: Blinatumomab 28 μg/Day
##### Group
**Description:** Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 2.
**ID:** OG002
**Title:** Cycle 2: Blinatumomab 28 μg/Day
#### Outcome Measure 13
**Description:** The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data \< LOQ and \> LOD were reported as measured.

Serum IL-4 levels were below detection limit (\< 20 pg/mL) at all time points in all participants studied.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacodynamic Data Set (PDS): All patients who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected. N indicates the number of participants with available data at each time point.
**Reporting Status:** POSTED
**Time Frame:** Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.
**Title:** Serum Cytokine Peak Levels
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 14
**Description:** Blast Free Hypoplastic or Aplastic Bone Marrow was defined as:

* bone marrow blasts ≤ 5%
* no evidence of disease
* insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or absolute neutrophil count (ANC) ≤ 500/μL
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Primary analysis set
**Reporting Status:** POSTED
**Time Frame:** Within the first 2 cycles of treatment, 12 weeks
**Title:** Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
#### Outcome Measure 15
**Description:** Complete Remission (CR):

* bone marrow blasts ≤ 5%
* no evidence of disease
* full recovery of peripheral blood counts:

  * platelets \> 100,000/μL, and
  * absolute neutrophil count (ANC) \> 1,000/μL

Complete Remission With Partial Hematological Recovery (CRh\*):

* bone marrow blasts ≤ 5%
* no evidence of disease
* partial recovery of peripheral blood counts:

  * platelets \> 50,000/μL, and
  * ANC \> 500/μL

Blast Free Hypoplastic or Aplastic Bone Marrow:

* bone marrow blasts ≤ 5%
* no evidence of disease
* insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL

Partial Remission:

• bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Primary analysis set
**Reporting Status:** POSTED
**Time Frame:** From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.
**Title:** Best Response During the Core Study
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** OG000
**Title:** Blinatumomab
### Participant Flow Module
#### Group
**Description:** Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
**ID:** FG000
**Title:** Blinatumomab
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Ongoing in core study
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 46
##### Withdraw
**Type:** Progressive disease
###### Reason
**Group ID:** FG000
**Number of Subjects:** 43
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 32
##### Withdraw
**Type:** Disease relapse
###### Reason
**Group ID:** FG000
**Number of Subjects:** 23
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 14
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 189
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 179
**Pre-Assignment Details:** Two hundred twenty-five participants enrolled in the study overall. Results below include data for 189 participants enrolled in the first 3 stages of the study (the primary analysis set). An additional 36 participants enrolled in the Additional Evaluation Cohort are not reported here as the study is ongoing and data collection has not completed.
**Recruitment Details:** This study was open to adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia (ALL).

The study protocol originally used a Simon 2-stage design and was subsequently expanded to include a third stage. Protocol amendment 4 added an additional cohort of participants for central nervous system evaluations.
**Has Results:** True