Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 12:01 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT00824161
Description: None
Frequency Threshold: 5
Time Frame: Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
Study: NCT00824161
Study Brief: Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TAS-109 TAS-109 2.0 mg/m\^2/day None None 9 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Catheter bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Blood Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View