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: 2025-12-25 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT01773967
Description: None
Frequency Threshold: 0
Time Frame: 35 days, long term follow up 1 year
Study: NCT01773967
Study Brief: Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lactobacillus Rhamnosus GG LGG 10\^10 cfu PO bid x 5 days LGG: LGG 10\^10 cfu PO BID X 5 days 0 None 8 483 55 483 View
Placebo micro-crystalline cellulose PO bid x 5 days micro-crystalline cellulose: 1 capsule PO bid x 5 days 0 None 13 488 49 488 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
lower respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
fever SYSTEMATIC_ASSESSMENT General disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View