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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:26 AM
NCT ID: NCT01415960
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01415960
Study Brief: Efficacy and Safety of Leuprolide Acetate 22.5 mg Depot in Treatment of 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
Leuprolide Acetate 22.5 mg Depot Leuprolide acetate 22.5 mg depot administered twice, 3 months apart Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart None None 12 163 141 163 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CONGESTIVE HEART FAILURE None Cardiac disorders None View
MYOCARDIAL INFARCTION None Cardiac disorders None View
DIARRHEA None Gastrointestinal disorders None View
INCARCERATED INGUINAL HERNIA None Gastrointestinal disorders None View
RECTAL BLEEDING None Gastrointestinal disorders None View
NON-CARDIAC CHEST PAIN None General disorders None View
PNEUMONIA None Infections and infestations None View
FALL None Injury, poisoning and procedural complications None View
DEHYDRATION None Metabolism and nutrition disorders None View
DIABETIC KETOACIDOSIS None Metabolism and nutrition disorders None View
BENIGN NEOPLASM OF BLADDER None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
SYNCOPE None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
TEAE Related Fatigue None General disorders None View
TEAE Related Injection site pain None General disorders None View
TEAE Related Hot Flushes None Vascular disorders None View