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 @ 7:18 PM
Ignite Modification Date: 2025-12-25 @ 4:57 PM
NCT ID: NCT01576003
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT01576003
Study Brief: Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Glutamine L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months) 0 None 1 2 2 2 View
Placebo L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months) 0 None 2 3 3 3 View
Healthy Control No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days. 0 None 0 4 0 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Viral Illness NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization for fever in a patient with a central line SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus (RSV) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diaper Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Otitis Media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Central Venous Catheter (CVC) dislodged SYSTEMATIC_ASSESSMENT General disorders None View
Rash Maculopapular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View