Adverse Events Module

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 @ 12:35 AM
Ignite Modification Date: 2025-12-25 @ 10:43 PM
NCT ID: NCT01985867
Description: None
Frequency Threshold: 0
Time Frame: during 4 weeks of the intervention
Study: NCT01985867
Study Brief: Lcr35 for Children With Functional Constipation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks None None 0 46 3 46 View
Lactobacillus Casei Rhamnosus Lcr35 Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks) None None 0 48 0 48 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
change in the stool smell NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain and flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
loss of appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View