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 @ 1:04 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT01127061
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01127061
Study Brief: Study of Exercise Training in Hypertrophic Cardiomyopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exercise Training Participants in the exercise group will be follow an individualized moderate-intensity exercise prescription (designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test). Exercise regimen will begin at a low level of intensity (3 sessions per week, 20 minutes per session, at a heart rate corresponding to 60% of heart rate reserve), then increase in duration and training intensity to a goal of up to 60 minutes per session, 4 to 7 sessions per week, at 70% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter. No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise. 0 None 0 67 34 67 View
Usual Activity Participants in this group are not restricted in their activities. They simply are not guided in their physical activities by the study team. At the end of the 4-month study period, they will also receive an individualized exercise prescription for personal use. 0 None 0 69 38 69 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nonsustained ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Major musculoskeletal injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Minor musculoskeletal injury SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View