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 @ 3:36 PM
Ignite Modification Date: 2025-12-25 @ 1:48 PM
NCT ID: NCT01111292
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01111292
Study Brief: Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (Inositol) Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90. Inositol: Given PO Laboratory Biomarker Analysis: Correlative studies None None 0 3 3 3 View
Arm II (Placebo) Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90. Placebo: Given PO Laboratory Biomarker Analysis: Correlative studies None None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal disorder: Stomach Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disprder: Hemorroids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal Disorder: Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disorder: Amal Henorrhage: Blood in sttol NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disorders - other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disorder: Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disorder: Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal Disorder: High Bilirubin NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View