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 @ 3:24 PM
Ignite Modification Date: 2025-12-25 @ 1:42 PM
NCT ID: NCT04766892
Description: All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Pre-specified for all doses to be collected combined per treatment.
Frequency Threshold: 5
Time Frame: Participants were assessed for All-Cause Mortality from first dose of study drug until their study completion (assessed up to approximately 1063 days) SAEs and Other AEs were assessed from first dose to 56 days following last dose of study drug (assessed for an average of 225 days up to a max of approximately 270 days)
Study: NCT04766892
Study Brief: A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mavacamten Mavacamten 1 None 5 30 18 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.1 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.1 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.1 View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View