## Protocol Section
### Identification Module
**NCT ID:** NCT01746979

**Acronym:** MAESTRO

**Brief Title:** Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

**Official Title:** A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

#### Organization Study ID Info
**ID:** EMR 200592-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Threshold Pharmaceuticals
#### Secondary ID Infos
**ID:** 2012-002957-42
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-12-02

**Type:** ACTUAL

**Last Update Submit Date:** 2017-10-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-12-02

**Type:** ACTUAL

**Results First Submit Date:** 2017-07-18

**Results First Submit QC Date:** 2017-10-26

#### Start Date
**Date:** 2012-12

**Status Verified Date:** 2017-10

#### Study First Post Date
**Date:** 2012-12-11
**Type:** ESTIMATED
**Study First Submit Date:** 2012-12-07
**Study First Submit QC Date:** 2012-12-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Threshold Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled.

### Conditions Module

**Conditions:**

- Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

**Keywords:**

- TH-302

- Evofosfamide

- Pancreatic Cancer

- EMR200592-001

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 693

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: TH-302

- Drug: Gemcitabine

**Label:** Gemcitabine plus TH-302

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Gemcitabine

- Drug: Placebo (5 percent dextrose - D5W)

**Label:** Gemcitabine plus placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Gemcitabine plus TH-302

**Description:** TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

**Name:** TH-302

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Gemcitabine plus TH-302

- Gemcitabine plus placebo

**Description:** Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

**Name:** Gemcitabine

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Gemcitabine plus placebo

**Description:** TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

**Name:** Placebo (5 percent dextrose - D5W)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Overall survival is defined as time from randomization to death or last day known to be alive.

**Measure:** Overall Survival

**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

#### Secondary Outcomes

**Description:** Progression Free Survival is defined as the time from randomization to either first observation of progressive disease or occurrence of death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

**Measure:** Progression Free Survival

**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* At least 18 years of age
* Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:

  * Radiosensitizing doses of 5-fluorouracil;
  * Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
  * Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
  * Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
* Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria
* Documentation of disease progression since any prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 month
* Acceptable liver, renal function and acceptable hematological status
* Other protocol defined inclusion criteria may apply

Exclusion Criteria:

* New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within 6 months prior to the date of randomization, unstable arrhythmia or symptomatic peripheral arterial vascular disease
* Symptomatic ischemic heart disease
* Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
* Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately treated non-melanoma skin cancer or pre-invasive cancer of the cervix
* Severe chronic obstructive or other pulmonary disease with hypoxemia
* Major surgery, other than diagnostic surgery, less than or equal to 28 days prior to the date of randomization. Subject must have completely recovered from surgery
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Treatment of pancreatic cancer with radiation therapy or surgery less than or equal to 28 days prior to the date of randomization
* Prior therapy with a hypoxic cytotoxin
* Subjects who participated in an investigational drug or device trial less than or equal to 28 days prior to Day 1 of the first cycle
* Known infection with Human Immunodeficiency Virus (HIV), or an active infection with Hepatitis B or Hepatitis C
* Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients or to gemcitabine or its excipients
* Other protocol defined exclusion criteria may apply

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rockland

**Country:** United States

**Facility:** Please Contact U.S. Medical Information

**State:** Massachusetts

**Location 2:**

**City:** Darmstadt

**Country:** Germany

**Facility:** Please Contact Merck Communication Center

#### Overall Officials

**Official 1:**

**Affiliation:** EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany

**Name:** Antonio Gualberto, MD, PhD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: HIGH

- As Found: Adenocarcinoma

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000230

- Term: Adenocarcinoma

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- 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: M2985

- Name: Gemcitabine

- Relevance: HIGH

- As Found: Activity

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000093542

- Term: Gemcitabine

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** TH-302

**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

**ID:** EG000

**Other Num Affected:** 341

**Other Num at Risk:** 341

**Serious Number Affected:** 341

**Serious Number At Risk:** 341

**Title:** TH-302

**Group ID:** EG001

**Title:** Placebo

**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

**ID:** EG001

**Other Num Affected:** 338

**Other Num at Risk:** 338

**Serious Number Affected:** 338

**Serious Number At Risk:** 338

**Title:** Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

#### Serious Events

**Term:** Appendicitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 3

**Term:** Bacterial infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Bacterial prostatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Biliary sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Biliary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Bronchopneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Clostridium difficile colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Cystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Device related infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 341

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Device related sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Diabetic gangrene

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Diverticulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Enterococcal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Enterocolitis infectious

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Erysipelas

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Escherichia infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Escherichia sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Febrile infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Fungal oesophagitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Herpes zoster

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Infusion site infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Klebsiella bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Klebsiella sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Lower respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Meningoencephalitis herpetic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Oesophageal candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Oropharyngeal candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Pancreatic abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Penile infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Peritonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 341

**Num Events:** 11

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 338

**Num Events:** 8

**Term:** Respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 341

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 338

**Num Events:** 5

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Splenic abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Subcutaneous abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 341

**Num Events:** 4

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Urosepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Vaginal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Cancer pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Malignant ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Paraneoplastic syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 15

**Num At Risk:** 341

**Num Events:** 18

**Group ID:** EG001

**Num Affected:** 16

**Num At Risk:** 338

**Num Events:** 18

**Term:** Bone marrow failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 338

**Num Events:** 7

**Term:** Leukocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 9

**Num At Risk:** 338

**Num Events:** 13

**Term:** Pancytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Splenic infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Splenic vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 19

**Num At Risk:** 338

**Num Events:** 25

**Term:** Anaphylactic reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Drug hypersensitivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Hypersensitivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Cachexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Hypovolaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Metabolic disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Type 2 diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Mental status changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Suicide attempt

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Amnesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Balance disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Cerebral artery stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Cerebral infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Coma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Convulsion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Hemianopia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Ischaemic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Spinal cord compression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Transient ischaemic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Macular hole

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Acute coronary syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Aortic valve disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Atrial tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Cardiac failure congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Cardio-respiratory arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Aortic dissection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Arterial occlusive disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Arterial thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Axillary vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Circulatory collapse

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Deep vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 341

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 338

**Num Events:** 7

**Term:** Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Peripheral ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Phlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Shock haemorrhagic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Thrombophlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Venous thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Venous thrombosis limb

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Acute interstitial pneumonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Acute pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Chronic obstructive pulmonary disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Dyspnoea exertional

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Hiccups

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Interstitial lung disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Pneumonia aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Pneumonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 10

**Num At Risk:** 341

**Num Events:** 10

**Group ID:** EG001

**Num Affected:** 11

**Num At Risk:** 338

**Num Events:** 11

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 341

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 10

**Num At Risk:** 338

**Num Events:** 10

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 341

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Colitis ischaemic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 338

**Num Events:** 11

**Term:** Duodenal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 341

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Duodenal perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Duodenal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 341

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Duodenal ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Duodenal ulcer haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Gastric haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Gastric perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Gastric ulcer haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Gastric ulcer perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Gastrointestinal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Gastrointestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Gastrointestinal perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Gastrooesophageal reflux disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Haematemesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Impaired gastric emptying

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Intestinal ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Intestinal perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Intra-abdominal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Large intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Large intestine perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 341

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 4

**Term:** Obstruction gastric

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Oedematous pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Oesophageal ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Oesophageal varices haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Pancreatitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Proctalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Small intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Subileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Upper gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 13

**Num At Risk:** 341

**Num Events:** 13

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 338

**Num Events:** 8

**Term:** Bile duct obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 341

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Bile duct stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 341

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 338

**Num Events:** 5

**Term:** Bile duct stone

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Biliary dilatation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Cholangiectasis acquired

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Cholangiolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Cholangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 15

**Num At Risk:** 341

**Num Events:** 21

**Group ID:** EG001

**Num Affected:** 12

**Num At Risk:** 338

**Num Events:** 12

**Term:** Cholangitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 341

**Num Events:** 10

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Cholecystitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Cholestasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Gallbladder obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Hepatic failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Hepatic function abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 338

**Num Events:** 4

**Term:** Hepatorenal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Hyperbilirubinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Jaundice

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 341

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Jaundice cholestatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 341

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Portal hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Dermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Diabetic foot

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Skin maceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Yellow skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Flank pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Gouty arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Dysuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Haematuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Hydronephrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Proteinuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Renal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Renal failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Renal impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Urinary retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Urinary tract obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Pyloric stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 338

**Num Events:** 4

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Device malfunction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Device occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Disease progression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 338

**Num Events:** 4

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** General physical health deterioration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 14

**Num At Risk:** 341

**Num Events:** 15

**Group ID:** EG001

**Num Affected:** 11

**Num At Risk:** 338

**Num Events:** 12

**Term:** Generalised oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Infusion site extravasation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Injection site extravasation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Local swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Multi-organ failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 11

**Num At Risk:** 341

**Num Events:** 12

**Group ID:** EG001

**Num Affected:** 14

**Num At Risk:** 338

**Num Events:** 15

**Term:** Stent malfunction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Sudden death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 341

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 338

**Num Events:** 3

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Blood glucose fluctuation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** C-reactive protein increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Gamma-glutamyltransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 338

**Num Events:** 4

**Term:** General physical condition abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Hepatic enzyme increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Liver function test abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 2

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 341

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 338

**Num Events:** 8

**Term:** Accidental overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 338

**Num Events:** 5

**Term:** Cervical vertebral fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Chemical peritonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Hip fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Infusion related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 1

**Term:** Post procedural bile leak

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Prescribed overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 341

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 338

**Num Events:** 2

**Term:** Rib fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

**Term:** Traumatic haemothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 341

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 338

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 346

**Group ID:** BG001

**Value:** 347

**Group ID:** BG002

**Value:** 693

**Units:** Participants

### Group

**ID:** BG000

**Title:** Gemcitabine Plus TH-302

**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

### Group

**ID:** BG001

**Title:** Gemcitabine Plus Placebo

**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.70

**Value:** 65

#### Measurement

**Group ID:** BG001

**Spread:** 9.82

**Value:** 63.8

#### Measurement

**Group ID:** BG002

**Spread:** 9.77

**Value:** 64.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 155

#### Measurement

**Group ID:** BG001

**Value:** 168

#### Measurement

**Group ID:** BG002

**Value:** 323

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 191

#### Measurement

**Group ID:** BG001

**Value:** 179

#### Measurement

**Group ID:** BG002

**Value:** 370

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** twilson@thresholdpharm.com
**Organization:** Threshold Pharmaceuticals
**Phone:** 302-359-0565
**Title:** Thomas Wilson
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.6
- **Spread:** 
- **Upper Limit:** 9.9
- **Value:** 8.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.7
- **Spread:** 
- **Upper Limit:** 8.3
- **Value:** 7.6
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.8
- **Spread:** 
- **Upper Limit:** 5.6
- **Value:** 5.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.6
- **Spread:** 
- **Upper Limit:** 3.8
- **Value:** 3.7
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Overall survival is defined as time from randomization to death or last day known to be alive.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
**Title:** Overall Survival
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** OG000
**Title:** Gemcitabine Plus TH-302
##### Group
**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** OG001
**Title:** Gemcitabine Plus Placebo
#### Outcome Measure 2
**Description:** Progression Free Survival is defined as the time from randomization to either first observation of progressive disease or occurrence of death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
**Title:** Progression Free Survival
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** OG000
**Title:** Gemcitabine Plus TH-302
##### Group
**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** OG001
**Title:** Gemcitabine Plus Placebo
### Participant Flow Module
#### Group
**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** FG000
**Title:** Gemcitabine Plus TH-302
#### Group
**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** FG001
**Title:** Gemcitabine Plus Placebo
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 346
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 347
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 346
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 347
**Has Results:** True