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 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT01536535
Description: None
Frequency Threshold: 1
Time Frame: Adverse events were collected from Baseline through to the 52 week visit.
Study: NCT01536535
Study Brief: Predicting Response to Standardized Pediatric Colitis Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mild UC Mild = Initiated on 5-Aminosalicylates (ASA) or on oral CS with PUCAI \< 45 0 None 21 178 157 178 View
Moderate to Severe UC Moderate/Severe = Initiated on IV CS or oral CS with PUCAI ≥45 0 None 79 250 224 250 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalized for UC complications NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitus acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Clostridium difficile colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Generalised tonic-clonic seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypersensitivity to mesalamine severe headache and pleuritic chest pain NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Intentional Overdose NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intestinal anastomosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vasculitic rash NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Clostridium difficile NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View