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 @ 5:56 PM
Ignite Modification Date: 2025-12-25 @ 3:19 PM
NCT ID: NCT00937768
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00937768
Study Brief: Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Androgen Deprivation Therapy Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1. 0 None 0 8 8 8 View
No Androgen Deprivation Therapy Patients undergo observation every 3 months for 9 months. 0 None 1 8 6 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10 View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View