## Protocol Section
### Identification Module
**NCT ID:** NCT00400179

**Brief Title:** A Safety and Efficacy Study in Patients With Gastric Cancer

**Official Title:** An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease

**NCT ID Aliases:**
- NCT00128609
#### Organization Study ID Info
**ID:** TPU S-1301
#### Organization
**Class:** INDUSTRY
**Full Name:** Taiho Oncology, Inc.
### Status Module
#### Completion Date
**Date:** 2008-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-08-14

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-04-23

**Type:** ESTIMATED

**Results First Submit Date:** 2012-01-06

**Results First Submit QC Date:** 2012-03-28

#### Start Date
**Date:** 2005-05

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2006-11-16
**Type:** ESTIMATED
**Study First Submit Date:** 2005-06-30
**Study First Submit QC Date:** 2006-11-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Quintiles, Inc.

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Taiho Oncology, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm). Patients will be stratified by number of metastatic sites (one vs. more than one), locally advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or non-measurable disease, and center.

### Conditions Module

**Conditions:**

- Gastric Cancer

**Keywords:**

- Gastric Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1053

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In Arm A, S-1 25 mg/m² was administered orally BID from Day 1 through Day 21 followed by a recovery period from Days 22 through Day 28. On Day 1, the morning dose of S-1 was administered before cisplatin 75 mg/m2 administration as a 1- to 3-hour IV infusion. This regimen was repeated every 4 weeks. S-1 was administered one hour before or one hour after a meal with a glass of water (approximately 100 mL).

**Intervention Names:**

- Drug: S-1/Cisplatin

**Label:** A

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** In Arm B, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion (CIV) over 120 hours (on Days 1 through 5). This regimen was repeated every 4 weeks. 5-FU CIV followed cisplatin infusion on Day 1. All 5-FU used in this study was commercially available product.

**Intervention Names:**

- Drug: 5-FU/cisplatin

**Label:** B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

**Description:** In Arm A, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth (NPO 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with approximately 8 ounces of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour IV infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin.

**Name:** S-1/Cisplatin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- B

**Description:** In Arm B, 5-FU 1000 mg/m2/24 hours was administered CIV on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin.

**Name:** 5-FU/cisplatin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.

**Measure:** Median Survival

**Time Frame:** The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).

#### Secondary Outcomes

**Description:** The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions.

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

**Time Frame:** Data cutoff was 07 March 2008 (12 months after last patient randomized).

**Description:** Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions.

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

**Time Frame:** Data cutoff was 07 March 2008 (12 months after last patient was randomized).

**Description:** The time from randomization to date of first documented PD or date of death, whichever occurred first.

**Measure:** Progression-free Survival (PFS)

**Time Frame:** From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.

**Description:** The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first.

**Measure:** Time to Treatment Failure (TTF)

**Time Frame:** From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:

* Has given written informed consent
* Has histologically confirmed, unresectable, locally advanced (Stage IV) or metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction
* Has measurable or evaluable but non-measurable disease, defined as follows:

  * Measurable Disease - Patients with measurable disease as defined by RECIST criteria, i.e., the presence of at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter \>_ 20 mm using conventional techniques or \>_ 10 mm using spiral Computed Tomography (CT)scan. Locally recurrent disease (other than primary) is accepted if there is at least one measurable lesion (i.e. peritoneal mass, lymph node, etc.)
  * Evaluable but Non-measurable Disease - Patients with all lesions below the limits defined above for measureable disease (i.e., longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT) excluding those patients with only a primary lesion and/or with only non-evaluable cancer such as bone metastases, ascites, pleural or pericardia effusions, lymphangitic carcinomatosis of the skin or lung, previously irradiated lesions not in progression, or peritoneal carcinomatosis \< 10 mm in diameter with conventional imaging techniques.
* No prior palliative chemotherapy is permitted. Adjuvant and /or neo-adjuvant chemotherapy is permitted if more than 12 months have elapsed between the end of adjuvant or neo-adjuvant therapy and first recurrence. This does not qualify as 1st line therapy.
* Is able to take medications orally
* Is \>_ 18 years of age
* Is at least 3 weeks from prior major surgery
* Is at least 4 weeks from prior radiotherapy
* Has a ECOG performance status 0 to 1
* Has adequate organ function as defined by the following criteria:

  * AST (SGOT) and ALT (SGPT) \<_ 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) \<_ 5 x ULN
  * Total serum bilirubin of \<_ 1.5 x ULN
  * Absolute granulocyte count of \>_ 1,500/mm (i.e. \>_ 1.5 x 10/L by International Units (IU)
  * Platelet count \>_ 100,000/mm (IU: \>_ 100 x 10/L
  * Hemoglobin value of \>_ 9.0 g/dL
  * Calculated creatinine clearance \>_ 60 mL/min (Cockcroft-Gault formula)
* Is willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

Exclusion Criteria:

Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed:

* Has had a treatment with any of the following within the specified timeframe prior to study drug administration:

  * Any prior palliative chemotherapy or any previous therapy for malignancy, including any chemotherapy, immunotherapy, biologic or hormonal therapy, within the past 5 years.
  * Adjuvant or neo-adjuvant therapy within the past 12 months
  * Concurrent treatment with any investigational anti-cancer agent
  * Prior cisplatin as neo-adjuvant and /or adjuvant chemotherapy with cumulative dose \> 300 mg/m
  * \> 25% of marrow-bearing bone radiated
  * Concurrent treatment with an investigational agent or within 30 days from randomization
  * Concurrent enrollment in another clinical study
* Has a serious illness or medical condition(s) including, but not limited to the following:

  * Known brain or leptomeningeal metastases
  * Uncontrolled ascites requiring drainage at least twice a week
  * Other malignancies within the past 5 years, except adequately treated carcinoma-in-situ of the cervix or non-melanoma skin cancer
  * Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV
  * Chronic nausea, vomiting or diarrhea
  * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS-related illness
  * Psychiatric disorder that may interfere with consent and/or protocol compliance
  * Known neuropathy, Grade 2 or higher
  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgement of the Investigator would make the patient inappropriate for entry into this study
* Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:

  * Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity)
  * Allopurinol (may diminish S-1 activity
  * Phenytoin (S-1 may enhance phenytoin activity)
  * Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity)
* Is receiving concomitant treatment with drugs interacting with 5-FU:

  * Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole(may enhance 5-FU activity)
  * Allopurinol (may diminish 5-FU activity)
  * Phenytoin (5-FU may enhance phenytoin activity)
* Is receiving concomitant treatment with drugs interacting with cisplatin:

  * Phenytoin (cisplatin may diminish phenytoin activity)
  * Aminoglycosides (should be avoided within 8 days after cisplatin administration)
  * Ethyol (may diminish cisplatin activity
* Is a pregnant or lactating female
* Has known hypersensitivity to 5-FU or cisplatin
* Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Huntsville

**Country:** United States

**Facility:** Clearview Cancer Center

**State:** Alabama

**Zip:** 35801

**Location 2:**

**City:** Burbank

**Country:** United States

**Facility:** Saint Joseph Medical Center

**State:** California

**Zip:** 91505

**Location 3:**

**City:** Gilroy

**Country:** United States

**Facility:** Dr. Ronald Yanagihara

**State:** California

**Zip:** 95020

**Location 4:**

**City:** Los Angeles

**Country:** United States

**Facility:** Norris Cancer Center

**State:** California

**Zip:** 90033

**Location 5:**

**City:** Palm Springs

**Country:** United States

**Facility:** Comprehensive Cancer Center

**State:** California

**Zip:** 92262

**Location 6:**

**City:** San Francisco

**Country:** United States

**Facility:** Saint Francis Memorial Hospital

**State:** California

**Zip:** 94109

**Location 7:**

**City:** Santa Monica

**Country:** United States

**Facility:** Premiere Oncology

**State:** California

**Zip:** 90404

**Location 8:**

**City:** Lakewood

**Country:** United States

**Facility:** Western Hematology/Oncology

**State:** Colorado

**Zip:** 80215

**Location 9:**

**City:** Fort Lauderdale

**Country:** United States

**Facility:** Broward Oncology Associates

**State:** Florida

**Zip:** 33308

**Location 10:**

**City:** Tampa

**Country:** United States

**Facility:** Alexandar Rosemurgy

**State:** Florida

**Zip:** 33606

**Location 11:**

**City:** West Palm Beach

**Country:** United States

**Facility:** Palm Beach Cancer Institute

**State:** Florida

**Zip:** 33401

**Location 12:**

**City:** Honolulu

**Country:** United States

**Facility:** Straub Clinic and Hospital

**State:** Hawaii

**Zip:** 96813

**Location 13:**

**City:** Chicago

**Country:** United States

**Facility:** Robert H. Lurie Comprehensive Cancer Center

**State:** Illinois

**Zip:** 60611

**Location 14:**

**City:** Chicago

**Country:** United States

**Facility:** University of Chicago Medical Center

**State:** Illinois

**Zip:** 60637-1470

**Location 15:**

**City:** Metairie

**Country:** United States

**Facility:** Oncology and Hematology

**State:** Louisiana

**Zip:** 70006

**Location 16:**

**City:** Duluth

**Country:** United States

**Facility:** St. Lukes Cancer Care Center

**State:** Minnesota

**Zip:** 55802

**Location 17:**

**City:** Saint Louis

**Country:** United States

**Facility:** Neuroscience Center

**State:** Missouri

**Zip:** 63110

**Location 18:**

**City:** Saint Louis

**Country:** United States

**Facility:** St. Louis University Cancer Center

**State:** Missouri

**Zip:** 63110

**Location 19:**

**City:** Las Vegas

**Country:** United States

**Facility:** Southern Nevada Cancer Research Foundation

**State:** Nevada

**Zip:** 89106

**Location 20:**

**City:** Albuquerque

**Country:** United States

**Facility:** AHS Lovelace Medical Group,LLC

**State:** New Mexico

**Zip:** 87102

**Location 21:**

**City:** Albuquerque

**Country:** United States

**Facility:** New Mexico Cancer Center Associates

**State:** New Mexico

**Zip:** 87106

**Location 22:**

**City:** Albuquerque

**Country:** United States

**Facility:** University of New Mexico

**State:** New Mexico

**Zip:** 87106

**Location 23:**

**City:** Hawthorne

**Country:** United States

**Facility:** Hoo Chun, MD

**State:** New York

**Zip:** 10532

**Location 24:**

**City:** New City

**Country:** United States

**Facility:** Hematology/Oncology Associates of Rockland

**State:** New York

**Zip:** 10956

**Location 25:**

**City:** New Bern

**Country:** United States

**Facility:** New Bern Cancer Care

**State:** North Carolina

**Zip:** 28560

**Location 26:**

**City:** Philadelphia

**Country:** United States

**Facility:** Abramson Cancer Center

**State:** Pennsylvania

**Zip:** 19104

**Location 27:**

**City:** Philadelphia

**Country:** United States

**Facility:** Thomas Jefferson University

**State:** Pennsylvania

**Zip:** 19107

**Location 28:**

**City:** Charleston

**Country:** United States

**Facility:** Charleston Cancer Center

**State:** South Carolina

**Zip:** 29406

**Location 29:**

**City:** Chattanooga

**Country:** United States

**Facility:** Associates in Oncology and Hematology

**State:** Tennessee

**Zip:** 37404

**Location 30:**

**City:** Chattanooga

**Country:** United States

**Facility:** Lexington Oncology Associates

**State:** Tennessee

**Zip:** 37404

**Location 31:**

**City:** Houston

**Country:** United States

**Facility:** MD Anderson Cancer Center

**State:** Texas

**Zip:** 77030

**Location 32:**

**City:** Madison

**Country:** United States

**Facility:** University of Wisconsin Comprehensive Cancer Center

**State:** Wisconsin

**Zip:** 53792

**Location 33:**

**City:** Montreal

**Country:** Canada

**Facility:** CHUM Hopital Saint-Luc

**State:** Quebec

**Zip:** H2X3J4

#### Overall Officials

**Official 1:**

**Affiliation:** Taiho Oncology, Inc.

**Name:** Fabio Benedetti, MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Bodoky G, Scheulen ME, Rivera F, Jassem J, Carrato A, Moiseyenko V, Vynnychenko I, Prausova J, Van Laethem JL, Cascinu S, Ajani JA. Clinical Benefit and Health-Related Quality of Life Assessment in Patients Treated with Cisplatin/S-1 Versus Cisplatin/5-FU: Secondary End Point Results From the First-Line Advanced Gastric Cancer Study (FLAGS). J Gastrointest Cancer. 2015 Jun;46(2):109-17. doi: 10.1007/s12029-014-9680-1.

**PMID:** 25707610

**Citation:** Ajani JA, Buyse M, Lichinitser M, Gorbunova V, Bodoky G, Douillard JY, Cascinu S, Heinemann V, Zaucha R, Carrato A, Ferry D, Moiseyenko V. Combination of cisplatin/S-1 in the treatment of patients with advanced gastric or gastroesophageal adenocarcinoma: Results of noninferiority and safety analyses compared with cisplatin/5-fluorouracil in the First-Line Advanced Gastric Cancer Study. Eur J Cancer. 2013 Nov;49(17):3616-24. doi: 10.1016/j.ejca.2013.07.003. Epub 2013 Jul 27.

**PMID:** 23899532

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: HIGH

- As Found: Gastric Cancer

### Condition Browse Module - Meshes

- ID: D000013274

- Term: Stomach Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M8600

- Name: Fluorouracil

- Relevance: LOW

- As Found: Unknown

- ID: M6182

- Name: Cisplatin

- Relevance: HIGH

- As Found: High

### Intervention Browse Module - Meshes

- ID: D000002945

- Term: Cisplatin

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** S-1/Cisplatin

**Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment.

**ID:** EG000

**Other Num Affected:** 514

**Other Num at Risk:** 521

**Serious Number Affected:** 257

**Serious Number At Risk:** 521

**Title:** S-1/Cisplatin

**Group ID:** EG001

**Title:** 5-FU/Cisplatin

**Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.

**ID:** EG001

**Other Num Affected:** 504

**Other Num at Risk:** 508

**Serious Number Affected:** 248

**Serious Number At Risk:** 508

**Title:** 5-FU/Cisplatin

**Frequency Threshold:** 3

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Granulocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Leukocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Tinnitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Deafness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Lacrimation increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Vision blurred

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Gastrooesophageal reflux disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Disease progression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Performance status decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Mucosal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Injection site reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hyperbilirubinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

**Term:** Oral candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Creatinine renal clearance decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Haemoglobin decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Blood LDH increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Blood urea increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Glomerular filtration rate decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hypomagnesaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hypocalcaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hyperkalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hypophosphataemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Peripheral sensory neuropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Neuropathy peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hiccups

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Palmar-plantar erythrodysaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Skin hyperpigmentation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Deep vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** Phlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 33

**Num At Risk:** 521

**Num Events:** 37

**Group ID:** EG001

**Num Affected:** 31

**Num At Risk:** 508

**Num Events:** 38

**Term:** Anaemia megaloblastic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Bone marrow failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Disseminated intravascular coagulation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 521

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 31

**Num At Risk:** 508

**Num Events:** 34

**Term:** Haemorrhagic anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Haemorrhagic diathesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 508

**Num Events:** 5

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 521

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 31

**Num At Risk:** 508

**Num Events:** 34

**Term:** Pancytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 11

**Num At Risk:** 521

**Num Events:** 11

**Group ID:** EG001

**Num Affected:** 17

**Num At Risk:** 508

**Num Events:** 18

**Term:** Acute left ventricular failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Angina pectoris

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Cardiac Arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Cardiopulmonary failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Myocardial ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pericardial effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Ventricular fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Ventricular tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Deafness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hypoacusis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Adrenal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Visual acuity reduced

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Vitreious floaters

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 12

**Num At Risk:** 521

**Num Events:** 13

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 508

**Num Events:** 7

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 521

**Num Events:** 9

**Group ID:** EG001

**Num Affected:** 13

**Num At Risk:** 508

**Num Events:** 13

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Enteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Gastric haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Gastric perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Gastric stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Gastric ulcer haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 13

**Num At Risk:** 521

**Num Events:** 13

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 508

**Num Events:** 8

**Term:** Gastrointestinal hypomotility

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Gastrointestinal motility disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Gastrointestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Gastrointestinal perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Haematemesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 521

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Ileus paralytic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Intestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Intestinal ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 521

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Mechanical ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Melaena

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 17

**Num At Risk:** 521

**Num Events:** 18

**Group ID:** EG001

**Num Affected:** 10

**Num At Risk:** 508

**Num Events:** 13

**Term:** Obstruction gastric

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 521

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Odynophagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Oesophageal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Oesophageal spasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Oesophagitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pancreatitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 4

**Term:** Periproctitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Peritonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Prepyloric stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Retroperitoneal fibrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Small intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 4

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 24

**Num At Risk:** 508

**Num Events:** 30

**Term:** Subileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Thrombosis mesenteric vessel

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Upper gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 521

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 23

**Num At Risk:** 521

**Num Events:** 23

**Group ID:** EG001

**Num Affected:** 17

**Num At Risk:** 508

**Num Events:** 21

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Catheter site pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Catheter thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 521

**Num Events:** 9

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Disease progression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 53

**Num At Risk:** 521

**Num Events:** 53

**Group ID:** EG001

**Num Affected:** 34

**Num At Risk:** 508

**Num Events:** 34

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 521

**Num Events:** 10

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 508

**Num Events:** 7

**Term:** Generalised Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hyperthermia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Mucosal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 10

**Num At Risk:** 508

**Num Events:** 11

**Term:** Multi-organ failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Performance status decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 10

**Num At Risk:** 521

**Num Events:** 10

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Sudden death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Bile duct obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Bile duct stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Cholangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hepatic failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Hepatic function abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Hyperbilirubinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Jaundice cholestatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Anal abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Appendicitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Broncopneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Catheter related infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Catheter sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Catheter site cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Central line infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Clostridium difficile colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Enterocolitis infectious

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Gastrointestinal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Genital candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Lobar pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Neutropenic sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 508

**Num Events:** 5

**Term:** Oesophageal candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Oral candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Oral herpes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Parotitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Peritonitis bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pharyngitis streptococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pharyngotonsillitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 521

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 508

**Num Events:** 6

**Term:** Pneumonia bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Postoperative wound infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pyelonephritis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pyothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 10

**Num At Risk:** 508

**Num Events:** 10

**Term:** Staphylococcal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Tooth infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Urosepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Vaginal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Wound abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Anastomotic complication

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Confusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Device migration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Drug toxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Femoral neck fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Femur fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Head Injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Humerus fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Incorrect dose administered

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Stent occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Traumatic brain injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Blood potassium decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Creatinine renal clearance decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Glomerular filtration rate decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Haemoglobin decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Urine electrolytes increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Alkalosis hypochloraemic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 521

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Cachexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 21

**Num At Risk:** 521

**Num Events:** 21

**Group ID:** EG001

**Num Affected:** 32

**Num At Risk:** 508

**Num Events:** 41

**Term:** Diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Diabetic ketoacidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Failure to thrive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Hyperkalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Hyperuricaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Hypocalcaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 508

**Num Events:** 8

**Term:** Hypomagnesaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 508

**Num Events:** 6

**Term:** Hypophosphataemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Hypovolaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Malnutrition

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Metabolic acidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 521

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Bone pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Musculoskeletal chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Pathological fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Malignant ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Malignant pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Metastases to bladder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Metastases to central nervous system

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Metastases to liver

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Metastases to ovary

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Metastases to spine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Tumour associated fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 2

**Term:** Tumour haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 521

**Num Events:** 9

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 4

**Term:** Tumour lysis syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Tumour pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Tumour perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Acoustic neuritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Cerebellar infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Cerebral infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Cerebral ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Cerebral thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 4

**Term:** Cerebrovascular disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Convulsion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 521

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Grand mal convulsion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hypotonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Ischaemic cerebral infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Ischaemic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Metabolic encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Neuropathy peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Peripheral sensory neuropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Speech disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Spinal cord compression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 521

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Syncope vasovagal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Disorientation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Psychotic disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Calculus urinary

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hydronephrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Renal colic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Renal disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Renal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 9

**Num At Risk:** 508

**Num Events:** 9

**Term:** Renal failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 11

**Num At Risk:** 508

**Num Events:** 11

**Term:** Renal failure chronic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Renal impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 3

**Term:** Renal tubular disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Ureteric stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Chronic Obstructive Pulmonary Disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hydrothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Pharyngeal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 508

**Num Events:** 4

**Term:** Pneumonia aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Pneumothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Pulmonary artery thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 12

**Num At Risk:** 521

**Num Events:** 12

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 508

**Num Events:** 8

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Aortic thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Arterial thrombosis limb

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Circulatory collapse

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Deep vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 521

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 17

**Num At Risk:** 508

**Num Events:** 18

**Term:** Haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 508

**Num Events:** 2

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Hypertensive crisis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 508

**Num Events:** 4

**Term:** Hypovolaemic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 521

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Iliac artery thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Pelvis venous thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Peripheral embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Subclavian vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 521

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Thrombophlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Term:** Vena cava thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 521

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 508

**Term:** Venous thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 521

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 508

**Num Events:** 1

**Time Frame:** From the start of study drug administration until 12 months after last patient randomized

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 521

**Group ID:** BG001

**Value:** 508

**Group ID:** BG002

**Value:** 1029

**Units:** Participants

### Group

**ID:** BG000

**Title:** S-1/Cisplatin

**Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment.

### Group

**ID:** BG001

**Title:** 5-FU/Cisplatin

**Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 18

**Upper Limit:** 83

**Value:** 59.0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 18

**Upper Limit:** 85

**Value:** 59.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 18

**Upper Limit:** 85

**Value:** 59.0

**Class Title:** Baseline Measure Data (descriptive stats, median)

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 139

#### Measurement

**Group ID:** BG001

**Value:** 161

#### Measurement

**Group ID:** BG002

**Value:** 300

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 382

#### Measurement

**Group ID:** BG001

**Value:** 347

#### Measurement

**Group ID:** BG002

**Value:** 729

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 10

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

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 447

#### Measurement

**Group ID:** BG001

**Value:** 438

#### Measurement

**Group ID:** BG002

**Value:** 885

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 61

#### Measurement

**Group ID:** BG001

**Value:** 53

#### Measurement

**Group ID:** BG002

**Value:** 114

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 9

**Class Title:** </=1.29 m2

#### Measurement

**Group ID:** BG000

**Value:** 46

#### Measurement

**Group ID:** BG001

**Value:** 44

#### Measurement

**Group ID:** BG002

**Value:** 90

**Class Title:** 1.30-1.49 m2

#### Measurement

**Group ID:** BG000

**Value:** 118

#### Measurement

**Group ID:** BG001

**Value:** 147

#### Measurement

**Group ID:** BG002

**Value:** 265

**Class Title:** 1.50-1.69 m2

#### Measurement

**Group ID:** BG000

**Value:** 208

#### Measurement

**Group ID:** BG001

**Value:** 181

#### Measurement

**Group ID:** BG002

**Value:** 389

**Class Title:** 1.70-1.89 m2

#### Measurement

**Group ID:** BG000

**Value:** 114

#### Measurement

**Group ID:** BG001

**Value:** 93

#### Measurement

**Group ID:** BG002

**Value:** 207

**Class Title:** 1.90-2.09 m2

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 63

**Class Title:** 2.10-2.29 m2

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 6

**Class Title:** >/=2.30 m2

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 226

#### Measurement

**Group ID:** BG001

**Value:** 200

#### Measurement

**Group ID:** BG002

**Value:** 426

**Class Title:** 0

#### Measurement

**Group ID:** BG000

**Value:** 295

#### Measurement

**Group ID:** BG001

**Value:** 308

#### Measurement

**Group ID:** BG002

**Value:** 603

**Class Title:** 1

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 30

**Class Title:** Papillary adenocarcinoma

#### Measurement

**Group ID:** BG000

**Value:** 132

#### Measurement

**Group ID:** BG001

**Value:** 113

#### Measurement

**Group ID:** BG002

**Value:** 245

**Class Title:** Tubular adenocarcinoma

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 37

**Class Title:** Well-differentiated

#### Measurement

**Group ID:** BG000

**Value:** 105

#### Measurement

**Group ID:** BG001

**Value:** 91

#### Measurement

**Group ID:** BG002

**Value:** 196

**Class Title:** Moderately-differentiated

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 12

**Class Title:** Unknown

#### Measurement

**Group ID:** BG000

**Value:** 210

#### Measurement

**Group ID:** BG001

**Value:** 189

#### Measurement

**Group ID:** BG002

**Value:** 399

**Class Title:** Poorly differentiated adenocarcinoma

#### Measurement

**Group ID:** BG000

**Value:** 75

#### Measurement

**Group ID:** BG001

**Value:** 95

#### Measurement

**Group ID:** BG002

**Value:** 170

**Class Title:** Signet-ring cell carcinoma

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 32

#### Measurement

**Group ID:** BG002

**Value:** 60

**Class Title:** Mucinous adenocarcinoma

#### Measurement

**Group ID:** BG000

**Value:** 97

#### Measurement

**Group ID:** BG001

**Value:** 94

#### Measurement

**Group ID:** BG002

**Value:** 191

**Class Title:** Other

#### Measurement

**Group ID:** BG000

**Value:** 87

#### Measurement

**Group ID:** BG001

**Value:** 87

#### Measurement

**Group ID:** BG002

**Value:** 174

**Class Title:** Adenocarcinoma NOS

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 9

**Class Title:** Poorly differentiated cancer

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Class Title:** Unknown/not specified

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 6

**Class Title:** Other types

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 438

#### Measurement

**Group ID:** BG001

**Value:** 417

#### Measurement

**Group ID:** BG002

**Value:** 855

**Class Title:** Stomach

#### Measurement

**Group ID:** BG000

**Value:** 82

#### Measurement

**Group ID:** BG001

**Value:** 88

#### Measurement

**Group ID:** BG002

**Value:** 170

**Class Title:** Gastroesophageal junction

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 4

**Class Title:** Stomach and gastroesophageal junction

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 43

**Class Title:** Locally advanced

#### Measurement

**Group ID:** BG000

**Value:** 157

#### Measurement

**Group ID:** BG001

**Value:** 161

#### Measurement

**Group ID:** BG002

**Value:** 318

**Class Title:** 1 metastatic site

#### Measurement

**Group ID:** BG000

**Value:** 340

#### Measurement

**Group ID:** BG001

**Value:** 327

#### Measurement

**Group ID:** BG002

**Value:** 667

**Class Title:** >/=2 metastatic sites

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** Not assessed

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 499

#### Measurement

**Group ID:** BG001

**Value:** 485

#### Measurement

**Group ID:** BG002

**Value:** 984

**Class Title:** Measureable disease

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 43

**Class Title:** Non-measurable disease

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** Nonevaluable disease

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** No disease present

**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:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Body surface area (BSA) Categories
**Unit of Measure:** Participants
### Measure 5
**Description:** 0=Fully active, able to carry on all pre-disease performance without restriction

1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
**Parameter Type:** NUMBER
**Title:** Eastern Cooperative Oncology Group (ECOG) Performance Status
**Unit of Measure:** Participants
### Measure 6
**Description:** Patients can have more than one tissue type and are included under each type.
**Parameter Type:** NUMBER
**Title:** Tissue Type
**Unit of Measure:** Participants
### Measure 7
**Parameter Type:** NUMBER
**Title:** Anatomical Location of Primary Lesion
**Unit of Measure:** Participants
### Measure 8
**Parameter Type:** NUMBER
**Title:** Extent of Disease
**Unit of Measure:** Participants
### Measure 9
**Parameter Type:** NUMBER
**Title:** Disease Measurability
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Taiho agreements vary with individual investigators, but do not prohibit any from publishing. Taiho is provided time to review material discussing trial results (generally 30 to 120 days with possible extension), and can remove undisclosed confidential, proprietary and intellectual property rights-related information. Authors have final control and approval of publication content of final study results. The investigator agrees not to publish any results before the first multicenter publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** benedetti@taihopui.com
**Organization:** Taiho Pharma USA, Inc.
**Phone:** 609-750-5300
**Title:** Fabio Benedetti, MD, Chief Medical Officer
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.3952
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Fisher Exact
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.57
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.03
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.0808
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.77
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.86
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.14
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.9158
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.99
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.77
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.99
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.0320
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.87
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 0.80
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.05
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.1983
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.92
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.7
- **Spread:** 
- **Upper Limit:** 33.8
- **Value:** 29.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 27.3
- **Spread:** 
- **Upper Limit:** 36.9
- **Value:** 31.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.8
- **Spread:** 
- **Upper Limit:** 7.4
- **Value:** 6.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.5
- **Spread:** 
- **Upper Limit:** 6.1
- **Value:** 5.8
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.0
- **Spread:** 
- **Upper Limit:** 5.5
- **Value:** 4.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.4
- **Spread:** 
- **Upper Limit:** 5.8
- **Value:** 5.5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.7
- **Spread:** 
- **Upper Limit:** 4.0
- **Value:** 3.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.7
- **Spread:** 
- **Upper Limit:** 4.4
- **Value:** 3.8
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.9
- **Spread:** 
- **Upper Limit:** 9.5
- **Value:** 8.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.2
- **Spread:** 
- **Upper Limit:** 8.5
- **Value:** 7.9
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Data cutoff was 07 March 2008 (12 months after last patient randomized).
**Title:** Overall Response Rate (ORR)
**Type:** SECONDARY
**Unit of Measure:** Percentage of patients in each group
##### Group
**Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment.
**ID:** OG000
**Title:** S-1/Cisplatin
##### Group
**Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
**ID:** OG001
**Title:** 5-FU/Cisplatin
#### Outcome Measure 2
**Description:** Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Data cutoff was 07 March 2008 (12 months after last patient was randomized).
**Title:** Duration of Response (DR)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment.
**ID:** OG000
**Title:** S-1/Cisplatin
##### Group
**Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
**ID:** OG001
**Title:** 5-FU/Cisplatin
#### Outcome Measure 3
**Description:** The time from randomization to date of first documented PD or date of death, whichever occurred first.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.
**Title:** Progression-free Survival (PFS)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment.
**ID:** OG000
**Title:** S-1/Cisplatin
##### Group
**Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
**ID:** OG001
**Title:** 5-FU/Cisplatin
#### Outcome Measure 4
**Description:** The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.
**Title:** Time to Treatment Failure (TTF)
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment.
**ID:** OG000
**Title:** S-1/Cisplatin
##### Group
**Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
**ID:** OG001
**Title:** 5-FU/Cisplatin
#### Outcome Measure 5
**Description:** Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).
**Title:** Median Survival
**Type:** PRIMARY
**Unit of Measure:** Months
##### Group
**Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment.
**ID:** OG000
**Title:** S-1/Cisplatin
##### Group
**Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
**ID:** OG001
**Title:** 5-FU/Cisplatin
### Participant Flow Module
#### Group
**Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.

Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment.
**ID:** FG000
**Title:** S-1/Cisplatin
#### Group
**Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
**ID:** FG001
**Title:** 5-FU/Cisplatin
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrew Consent
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Withdraw
**Type:** Disease progression
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Intercurrent illness
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Investigator judgment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Randomization error/patient ineligible
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 527
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 526
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 521
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 508
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 18
**Recruitment Details:** This multicenter study was conducted between May 18, 2005 and March 7, 2008 in 24 countries including the United States. Study centers were also located in Canada, Eastern and Western Europe, South America, Australia, and ex-Soviet Union block of nations.
**Has Results:** True