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 @ 6:29 PM
Ignite Modification Date:
2025-12-25 @ 3:59 PM
NCT ID:
NCT00380068
Description:
None
Frequency Threshold:
5
Time Frame:
AEs were to be collected during study and up to 72 hours after last dose. SAEs, including deaths, that occurred during the study or within 4 weeks of receiving the last dose of study drug, whether or not related to study drug, were to be reported.
Study:
NCT00380068
Study Brief:
Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ambrisentan | Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg). | None | None | 97 | 224 | 203 | 224 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| drug interaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| international normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| narcotic intoxication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (9.1) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| atrioventricular block third degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (9.1) | View |
| blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| bronchiectasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| bronchitis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| central line infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| drug hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| enteritis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| enterobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| hypervolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| hypoventilation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| migraine with aura | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| ovarian cyst ruptured | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.1) | View |
| pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| pulmonary fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| pulomonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| raynaud's phenomenon | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| recurrent cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| sedation | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| shock haemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| sickle cell anaemia with crisis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (9.1) | View |
| spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| systemic lupus erythematosus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| transaminase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| tremor | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.1) | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (9.1) | View |
| iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (9.1) | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (9.1) | View |
| cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| cor pulmonale | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| diverticular perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| arthritis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| catheter sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| sepsis syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| thrombosis in device | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| fracture nonunion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| scleroderma | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (9.1) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| nervousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (9.1) | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| vasculitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| brain natriuretic peptide increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (9.1) | View |
| palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| international normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (9.1) | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |