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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:01 AM
NCT ID: NCT02757105
Description: None
Frequency Threshold: 5.0
Time Frame: 1 year, 2 months
Study: NCT02757105
Study Brief: Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
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 1 tablet matching placebo, once daily for 8 weeks 0 None 0 51 47 51 View
RHB-102 1 tablet containing 3 mg immediate release and 9 mg sustained release ondansetron, once daily for 8 weeks 0 None 0 75 68 75 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation TEAE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Flatulence TEAE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Urinary Tract Infection TEAE NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Alanine aminotransferase increased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Aspartate aminotransferase increased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood creatinine increased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood glucose increased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood magnesium increased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood potassium increased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood sodium decreased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Hemoglobin decreased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Protein urine present TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
White blood cells urine positive TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
pH urine increased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Headache TEAE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Lymphocyte count decreased TEAE NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View