Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:22 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT02671461
Description: None
Frequency Threshold: 5
Time Frame: From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Study: NCT02671461
Study Brief: Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
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 Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141 0 None 0 3 0 3 View
BMS-986141 0.8 mg BMS-986141 0.8 mg QD for up to 28 days 0 None 0 5 4 5 View
BMS-986141 4.8 mg BMS-986141 4.8 mg QD for up to 28 days 0 None 1 7 3 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood Potassium Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Tinea Pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Vaginal Discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Vulvovaginal Pruritis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Micturation Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View