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 @ 3:09 AM
Ignite Modification Date: 2025-12-26 @ 1:48 AM
NCT ID: NCT00527605
Description: None
Frequency Threshold: 0
Time Frame: The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
Study: NCT00527605
Study Brief: Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matching oral placebo once a day for 6 months None None 1 127 25 127 View
Dutasteride 0.5 mg Oral dutasteride 0.5 milligrams (mg) once a day for 6 months None None 0 126 27 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Throat irritation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Blood glucose increased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Red blood cells urine SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tinnitus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Poor quality sleep SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urethral pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Libido decreased SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pigmentation disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View