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 @ 12:08 PM
Ignite Modification Date: 2025-12-25 @ 11:59 AM
NCT ID: NCT01656161
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01656161
Study Brief: Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced 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
Triptorelin Embonate 22.5 mg Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169. None None 17 120 117 120 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Diabetic hyperglycaemic coma SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hip fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Meningitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Radius fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lethargy SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View