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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:54 PM
NCT ID: NCT02551094
Description: None
Frequency Threshold: 0
Time Frame: The time period covered was from randomization to last follow up which lasted 3.5 years.
Study: NCT02551094
Study Brief: Colchicine Cardiovascular Outcomes Trial (COLCOT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Colchicine 0.5 mg tablet of colchicine taken once a day colchicine: 0.5 mg tablet taken once a day 41 None 383 2330 372 2330 View
Colchicine Placebo 0.5 mg tablet of placebo taken once a day colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet 44 None 404 2346 371 2346 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastro-intestinal SAE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection SAE SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SAE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Septic Shock SAE SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
HF hospitalization SAE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea AE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
GI Haemorrhage AE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaemia AE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia AE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia AE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Nauseau AE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence AE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View