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 @ 12:59 AM
Ignite Modification Date: 2025-12-25 @ 11:13 PM
NCT ID: NCT04267393
Description: None
Frequency Threshold: 5
Time Frame: The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication Adverse Events and Serious Adverse Events: (From first dose to last dose + 24 week follow up): Approximately 36 Weeks All-Cause mortality (From randomization to end of study): Approximately 42 Weeks.
Study: NCT04267393
Study Brief: Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
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 Placebo QW 0 None 1 39 17 39 View
Treatment 1 BMS-986263 45mg QW 0 None 1 41 24 41 View
Treatment 2 BMS-986263 90mg QW 0 None 2 42 29 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View
Infected cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.1 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.1 View
Procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.1 View