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: 2025-12-26 @ 4:00 PM
Ignite Modification Date: 2025-12-26 @ 4:00 PM
NCT ID: NCT05320406
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT05320406
Study Brief: RElugolix VErsus LeUprolide Cardiac Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (Radiation Therapy Alone) Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy 0 None 0 28 23 28 View
Arm II (Radiation Therapy Plus Leuprolide) Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC 1 None 1 31 27 31 View
Arm III (Radiation Therapy Plus Relugolix) Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy Relugolix: Given PO 0 None 0 31 30 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cystitis noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View