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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Control Arm | Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management. * Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide. * Treatment duration: for at least 20 months Locally-used WHO-approved MDR-TB regimen in Korea | 2 | None | 19 | 89 | 87 | 89 | View |
| Experimental Arm | Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative. * Delamanid (100 mg bid for the entire treatment period) * Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment) * Levofloxacin (750 \~1000 mg/day) * Pyrazinamide (1000\~ 2000 mg/day) Linezolid Delamanid Levofloxacin Pyrazinamide | 5 | None | 20 | 79 | 78 | 79 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hepatitis alcoholic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Meningitis cryptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Adenomyosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Cytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Immune thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Epidural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Poisoning deliberate | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Thoracic vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Computerised tomogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hepatitis B DNA increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cholangiocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumothorax spontaneous | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Ligament operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Bone marrow failure | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Glossodynia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lip ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Oral mucosa erosion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Tongue discolouration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Condition aggravated | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Granuloma | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Patella fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Colour vision tests abnormal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hepatic enzyme abnormal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Intraocular pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Coccydynia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Gouty arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle rigidity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myofascial pain syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Tendon pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Lipoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Lung cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Thyroid neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cranial nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Peripheral sensorimotor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hallucination, visual | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Obsessive thoughts | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Bladder disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sputum increased | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Cold sweat | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Eczema asteatotic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Deafness neurosensory | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Cushingoid | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Glare | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Optic nerve disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Optic neuropathy | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chronic gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Functional gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastritis erosive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastroduodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrointestinal tract irritation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vessel puncture site bruise | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hepatitis toxic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Liver disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Dermatophytosis of nail | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tinea pedis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Calculus bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Calculus ureteric | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |