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 @ 2:59 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT00831233
Description: Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Frequency Threshold: 5
Time Frame: 12 weeks.
Study: NCT00831233
Study Brief: Symptomatic Study Investigating Degarelix in Patients Suffering From 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 240 mg/80 mg Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL) None None 0 27 14 27 View
Goserelin (3.6 mg) + Bicalutamide (50 mg) Goserelin (3.6 mg) + bicalutamide (50 mg) None None 1 13 7 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.1) View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (10.1) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.1) View
Prostatic obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.1) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.1) View
Reproductive tract hypoplasia, male SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (10.1) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.1) View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.1) View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.1) View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.1) View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (10.1) View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (10.1) View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.1) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.1) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.1) View
Prostatic obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.1) View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.1) View