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 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
NCT ID:
NCT00549302
Description:
All treatment emergent adverse events (TEAEs) defined as a Serious Adverse Event (SAEs) and Other Non-serious Adverse Event (AEs) which were either first reported or worsened in severity during the Double-Blind Period or the Open-Label Period when compared with baseline observed in Study LVGY (NCT00125918) and were merged into 1 reporting group.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00549302
Study Brief:
Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs
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 20 mg or 40 mg Double-Blind and 40 mg Open-Label | Tadalafil 20 mg administered orally as 1 tadalafil 20-mg tablet and 1 matched placebo tablet, once daily from Day 1 up to 52 weeks of treatment, or tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Day 1 up to 52 weeks of treatment in Double-Blind Period; and tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Week 53 up to Week 243 in Open-Label Period. | None | None | 184 | 357 | 334 | 357 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(13) | View |
| Anaemia macrocytic | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(13) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(13) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Aortic valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Arrhythmia supraventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Atrial tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cardiac flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cardio-respiratory distress | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cor pulmonale | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Cyanosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Hypertensive heart disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Pericardial haemorrhage | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Right ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Sinus arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA(13) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA(13) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA(13) | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA(13) | View |
| Visual disturbance | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA(13) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Colonic polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Gastric volvulus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Gastrointestinal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Gingival hypertrophy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Intestinal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Oesophageal achalasia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Oesophageal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Device malfunction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Injection site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Medical device complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Sensation of pressure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Sudden cardiac death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA(13) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA(13) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA(13) | View |
| Hepatitis toxic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA(13) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Bronchitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Campylobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Campylobacter intestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Clostridial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Gastroenteritis salmonella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Herpes zoster ophthalmic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Mycobacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Pneumonia staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Staphylococcal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Fractured sacrum | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Post procedural discharge | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Post procedural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Postoperative wound complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Pubic rami fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Therapeutic agent toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(13) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA(13) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA(13) | View |
| Cardiac output decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA(13) | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA(13) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Bunion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Cervical spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Exostosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Osteolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Scleroderma | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Systemic lupus erythematosus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Systemic sclerosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Breast cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Leiomyosarcoma metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Multiple myeloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Oesophageal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Oropharyngeal cancer stage iv | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Uterine leiomyosarcoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13) | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Cervical myelopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Complicated migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Dystonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Premature labour | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA(13) | View |
| Anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Bipolar disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Emotional disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA(13) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA(13) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA(13) | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA(13) | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA(13) | View |
| Haemorrhagic ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA(13) | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA(13) | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA(13) | View |
| Ovarian cyst ruptured | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA(13) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Bronchial haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Pulmonary arterial hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Pulmonary granuloma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA(13) | View |
| Skin lesion excision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA(13) | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Paradoxical embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Peripheral vascular disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(13) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(13) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(13) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(13) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(13) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA(13) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(13) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(13) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(13) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(13) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Pulmonary arterial hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(13) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA(13) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(13) | View |