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 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT04767061
Description: At each study visit, the investigator inquired about the occurrence of AE/SAEs since the last visit. Additionally, interim events history was collected during each weekly dose modification phone call, and during each follow-up call. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis), and time of resolution/stabilization of the event.
Frequency Threshold: 5
Time Frame: During the intervention period, which can include up to 4 periods, with each period being up to 6 weeks, and through the follow-up period, which lasts for 1 year after the subject's end of intervention date.
Study: NCT04767061
Study Brief: Impact of Beta-blockers on Physical Function in HFpEF
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ON Beta Blockers Subjects on their standard of care beta-blocker dosage (the dosage they were on when they enrolled in the trial). 0 None 0 9 6 9 View
OFF Beta Blockers Subjects titrated off their standard-of-care beta-blocker dosage (not on any beta-blocker). 0 None 0 9 7 9 View
Subjects in Follow-Up After completing their intervention phase, and deciding whether they prefer to continue or discontinue their beta-blocker, subjects proceed to a 12-month-long follow-up phase. 1 None 2 9 5 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Nervous System Disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Eye disorders - other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Retinal Vascular Disorder SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View