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: 2025-12-25 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
NCT ID: NCT00416494
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00416494
Study Brief: Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent 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
Initial Cohort oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1. Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1 None None 6 19 19 19 View
Second Cohort oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1. bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1 Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort None None 9 31 29 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bowel Perforation None Gastrointestinal disorders None View
Acute Calculus Cholecystitis None Gastrointestinal disorders None View
Wound Dehisence None General disorders None View
Congestive Heart Failure None Cardiac disorders None View
Seizure None Nervous system disorders None View
Syncope None Vascular disorders None View
Altered mental status None Nervous system disorders None View
Diarrhea None Gastrointestinal disorders None View
Bowel obstruction None Gastrointestinal disorders None View
Pain None General disorders None View
Vomiting None Gastrointestinal disorders None View
Angina None Cardiac disorders None View
Cellulitis None Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia None Gastrointestinal disorders None View
Abdominal Cramping None Gastrointestinal disorders None View
Allergic reaction None Immune system disorders None View
Chills None General disorders None View
Neutropenia None Investigations None View
Constipation None Gastrointestinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dehydration None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Edema None Respiratory, thoracic and mediastinal disorders None View
Fatigue None General disorders None View
Fever None General disorders None View
Flatuance None Gastrointestinal disorders None View
Hand-foot syndrome None Skin and subcutaneous tissue disorders None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View
Infection None Infections and infestations None View
Insomnia None General disorders None View
Nausea None Gastrointestinal disorders None View
Pain None General disorders None View
Skin rash None Skin and subcutaneous tissue disorders None View
Shortness of breath None Respiratory, thoracic and mediastinal disorders None View
Vomiting None Gastrointestinal disorders None View