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 @ 10:36 PM
Ignite Modification Date: 2025-12-25 @ 8:08 PM
NCT ID: NCT01320735
Description: None
Frequency Threshold: 0
Time Frame: From signing of informed consent up to 24 months of observation of treatment period and 30 days of follow up period
Study: NCT01320735
Study Brief: Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Advanced PCa Participants with advanced PCa None None 13 283 73 283 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DISEASE PROGRESSION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 17 View
CARDIAC DISORDER NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 17 View
MYOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 17 View
PROSTATE CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v 17 View
RENAL CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v 17 View
CHOLECYSTITIS ACUTE NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v 17 View
URINARY RETENTION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v 17 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 17 View
BRONCHITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 17 View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 17 View
DISEASE PROGRESSION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 17 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 17 View
ASTHENIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 17 View
OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v 17 View
HOT FLUSH NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v 17 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v 17 View
GYNAECOMASTIA NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v 17 View
BREAST ENLARGEMENT NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v 17 View
ACQUIRED HYDROCELE NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v 17 View
ERECTILE DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v 17 View
GASTRITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 17 View
PEPTIC ULCER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 17 View
GASTRIC ULCER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 17 View
DERMATITIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 17 View
DIABETES MELLITUS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v 17 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 17 View
CARDIAC DISORDER NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 17 View
MYOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 17 View
ARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 17 View
ARTHROPATHY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 17 View
PROSTATE CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v 17 View
RENAL CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v 17 View
CHOLECYSTITIS ACUTE NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v 17 View
RIB FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v 17 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v 17 View
URINARY RETENTION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v 17 View