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 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT03528902
Description: None
Frequency Threshold: 0
Time Frame: AEs were monitored throughout the duration of enrollment but were specifically reviewed with participants at weeks 3, 6, 9, 12, 15, 18, 21 and 24.
Study: NCT03528902
Study Brief: Tamoxifen Therapy to Treat Pulmonary Arterial Hypertension
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 arm Placebo Oral Tablet: Placebo daily for 24 weeks. 0 None 2 9 5 9 View
Tamoxifen 20 mg po TID for 24 weeks Tamoxifen: Tamoxifen 20 mg po daily for 24 weeks. 0 None 0 9 5 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hot Flashes SYSTEMATIC_ASSESSMENT General disorders None View
Night Sweats SYSTEMATIC_ASSESSMENT General disorders None View
Mood Alterations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nonspecific pain SYSTEMATIC_ASSESSMENT General disorders None View
Alteration in smell SYSTEMATIC_ASSESSMENT General disorders None View