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 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
NCT ID:
NCT00734604
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00734604
Study Brief:
A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
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 Once a Day [T(OaD)] | Tadalafil 5 mg once a day \[T(OaD)\] | None | None | 4 | 378 | 66 | 378 | View |
| Sildenafil Citrate as Needed [S(PRN)] | Sildenafil citrate 100 mg as needed \[S(PRN)\] | None | None | 5 | 378 | 73 | 378 | View |
| Tadalafil as Needed [T(PRN)] | Tadalafil 20 mg as needed \[T(PRN)\] | None | None | 2 | 378 | 70 | 378 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coronary artery occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Oesophageal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Elbow operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 12.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.0 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 12.0 | View |
| Hypogonadism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 12.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 12.0 | View |
| Abnormal sensation in eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Cyanopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Eye disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Metamorphopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Photopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Visual brightness | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Anal pruritus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.0 | View |
| Food allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.0 | View |
| Ear infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Onychomycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Pharyngotonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Joint sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Soft tissue injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Nerve compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Balanitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Ejaculation failure | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Perineal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Priapism | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Cataract operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 12.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |