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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:26 PM
NCT ID: NCT02394769
Description: None
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT02394769
Study Brief: ASPirin Intervention for the REDuction of Colorectal Cancer Risk
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Dose Aspirin The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks. Aspirin 0 None 0 60 17 60 View
Placebo (For Aspirin) The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks. Placebo for Aspirin 0 None 0 60 14 60 View
Low Dose Aspirin The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks. Aspirin 0 None 0 60 17 60 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GI upset (i.e. heartburn/acid reflux/nausea/gas) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Unrelated infection/cold symptoms/sinus related SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Extended bleeding/bruising SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Bleeding hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Seasonal allergies SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Other, unrelated SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View