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: 2025-12-24 @ 1:00 PM
Ignite Modification Date: 2025-12-25 @ 12:19 PM
NCT ID: NCT03730961
Description: None
Frequency Threshold: 5
Time Frame: From first dose to 100 days post-last dose (up to ca. 4 months)
Study: NCT03730961
Study Brief: An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BMS-986231 BMS-986231 administered 8 hours continuous IV infusion at the dose of 12 μg/kg/min, corresponding to an infusion rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes. 0 None 1 23 6 23 View
Placebo Placebo administered 8 hours continuous IV infusion of D5W administered at the flow rate of 20 mL/H. At hour 4 after the start of the infusion, 40 mg IV bolus of furosemide administered through a separate IV line, given slowly over 1 to 2 minutes. 0 None 2 23 3 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 22.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 22.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders 22.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 22.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 22.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 22.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 22.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 22.1 View