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 @ 10:54 PM
Ignite Modification Date: 2025-12-25 @ 8:22 PM
NCT ID: NCT01220869
Description: Adverse events were evaluated at each visit.
Frequency Threshold: 5
Time Frame: Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days.
Study: NCT01220869
Study Brief: A Study of Degarelix in Taiwanese Patients With Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Degarelix Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days). None None 9 110 69 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.0) View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (14.0) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Carcinoembryonic antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (14.0) View
Bladder obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (14.0) View
Leukaemoid reaction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (14.0) View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.0) View
Chest wall mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Focal segmental glomerulosclerosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (14.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (14.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (14.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.0) View