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 @ 3:52 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT01294592
Description: SAEs and non-serious AEs are reported for members of the ITT Population.
Frequency Threshold: 5
Time Frame: Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years).
Study: NCT01294592
Study Brief: Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dutasteride Plus Tamsulosin Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months. None None 38 369 43 369 View
Watchful Waiting All: Escalated Yes and No All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. None None 25 373 13 373 View
Watchful Waiting Escalated=Yes All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. None None 19 229 12 229 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Heart valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pilonidal cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infective exacerbation of chronic obstructive airways SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infected cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis necrotising SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebellar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bladder neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bronchial carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Myxoid liposarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural haematuria SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Anaemia megaloblastic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Polymyalgia rheumatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Retrograde ejaculation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View