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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT01026103
Description: None
Frequency Threshold: 5
Time Frame: 30 days post surgery
Study: NCT01026103
Study Brief: Tri Staple Technology Stapler Used in Gastric Bypass
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tri Staple This is a single arm study. None None 2 28 24 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stricture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood Loss NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomitting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View