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 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
NCT ID:
NCT02554903
Description:
The safety analysis included all participants who received at least one dose of study drug.
Frequency Threshold:
2
Time Frame:
Up to 16 weeks
Study:
NCT02554903
Study Brief:
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Macitentan 10 Milligrams (mg) | Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12. | 1 | None | 16 | 28 | 24 | 28 | View |
| Placebo | Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12. | 2 | None | 16 | 29 | 24 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Blood Loss Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Haemolysis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Leukaemoid Reaction | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Atrial Flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Cardiac Failure Acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Right Ventricular Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Sinus Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Ventricular Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Complication Associated with Device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Peripheral Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Bacterial Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Enterococcal Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Groin Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Septic Shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Streptococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Anticoagulation Drug Level below Therapeutic | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Alkaline Phosphatase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Bilirubin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| International Normalised Ratio Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Left Ventricular End-Diastolic Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Liver Function Test Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Troponin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Fluid Overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Fluid Retention | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypovolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Chest Wall Haematoma | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Cerebral Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Haemorrhagic Stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Reversible Ischaemic Neurological Deficit | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Dyspnoea Exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Atrial Flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Cardiogenic Shock | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Cardiorenal Syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Systolic Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Ventricular Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Vision Blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 23.0 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Gingival Bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Melaena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Catheter Site Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Chest Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Complication Associated with Device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Feeling Abnormal | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Impaired Healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Medical Device Site Discharge | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Medical Device Site Erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Medical Device Site Rash | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Peripheral Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Candida Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Medical Device Site Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Ophthalmic Herpes Simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Fractured Sacrum | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Post Procedural Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Skin Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Spinal Compression Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Anticoagulation Drug Level above Therapeutic | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Anticoagulation Drug Level below Therapeutic | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Alkaline Phosphatase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Bilirubin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Potassium Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Sodium Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Triglycerides Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Urea Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Uric Acid Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Body Temperature Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Cystatin C Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Echocardiogram Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Ejection Fraction Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Electrocardiogram St Segment Elevation | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Haematocrit Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Haemoglobin Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Haemoglobin Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Heart Rate Irregular | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Hepatic Enzyme Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| International Normalised Ratio Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| N-Terminal Prohormone Brain Natriuretic Peptide Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Platelet Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Protein Total Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Smear Cervix Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Troponin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Venous Pressure Jugular Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Weight Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| White Blood Cell Count Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Fluid Overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Gout | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypervolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypovolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Joint Effusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Neck Mass | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Carpal Tunnel Syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Lumbosacral Radiculopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Neuropathy Peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Benign Prostatic Hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Breast Tenderness | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Dyspnoea Paroxysmal Nocturnal | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Orthopnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Pleuritic Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Pulmonary Hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Sleep Apnoea Syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Chronic Pigmented Purpura | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Hypersensitivity Vasculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Palpable Purpura | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Skin Lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Skin Tightness | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Orthostatic Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |