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 @ 9:30 PM
Ignite Modification Date: 2025-12-25 @ 7:15 PM
NCT ID: NCT00970632
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00970632
Study Brief: A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tadalafil 5 mg Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks None None 2 171 39 171 View
Tamsulosin 0.4 mg Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks None None 2 168 40 168 View
Placebo Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks None None 0 172 35 172 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Reflux oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Allergy to arthropod bite SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Multiple allergies SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Genital herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Haematospermia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Penile pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Retrograde ejaculation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Scar pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Meniscus removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.1 View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Ill-defined disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Venous insufficiency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Semen volume decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Sebaceous adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Carotid arteriosclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View