Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
NCT ID:
NCT02156804
Description:
None
Frequency Threshold:
5
Time Frame:
Between first dose and 30 days after last dose ( up to 2 years)
Study:
NCT02156804
Study Brief:
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| NIVOLUMAB 3 MG/KG IV | Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks | 527 | None | 593 | 1008 | 857 | 1008 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Fistula | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Anal neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Bowen's disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Chronic lymphocytic leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Melanoma recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to abdominal cavity | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to adrenals | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to bladder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Tonsil cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Brain stem haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Central nervous system lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Cerebral haematoma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Haemorrhagic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Coronary artery occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Ischaemic cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 21.1 | View |
| Addison's disease | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Autoimmune thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Hypopituitarism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Lymphocytic hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Secondary adrenocortical insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Steroid withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Ectropion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Iridocyclitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Iritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Macular hole | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Ulcerative keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Autoimmune colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Autoimmune pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Ileal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Intestinal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Intussusception | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Large intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Small intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Treatment failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hepatic pain | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hepatomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Immune-mediated hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Jaundice cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Liver disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Anaphylactic shock | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Autoimmune disorder | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Contrast media allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Abdominal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Appendiceal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Bronchopulmonary aspergillosis allergic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Device related sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Diarrhoea infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Haematoma infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Infected dermal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Infected lymphocele | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Infective exacerbation of chronic obstructive airways disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Latent tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Perirectal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pneumococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pneumonia legionella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pseudomembranous colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Septic encephalopathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Vascular device infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Viral diarrhoea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Dose calculation error | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Fractured sacrum | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Procedural headache | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Radiation necrosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| CSF test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| General physical condition abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Pancreatic enzymes increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Troponin T increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hypoproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Type 1 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Mobility decreased | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Osteochondrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Infected neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Intracranial tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Malignant ascites | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Malignant neoplasm of spinal cord | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to bone | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to lung | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to meninges | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to peritoneum | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastases to spine | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastasis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Metastatic malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Pituitary tumour benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Tumour associated fever | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Tumour flare | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Tumour necrosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Altered state of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Brachial plexopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Brain injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Facial paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Facial paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Hypertensive encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Lumbar radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Miller Fisher syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Myasthenia gravis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Narcolepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Nervous system disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Peripheral nerve lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Peripheral sensorimotor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Sensorimotor disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Status epilepticus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 21.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Personality change | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Autoimmune nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Bladder pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Postrenal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Tubulointerstitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Ureteric stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Ovarian cyst ruptured | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Penile oedema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Testicular oedema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Pulmonary toxicity | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Dermatitis exfoliative | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Generalised erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Pemphigoid | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Rash generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Angiopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Extremity necrosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Jugular vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Peripheral venous disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Superior vena cava syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Vascular occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Coronary artery insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Adrenal haemorrhage | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Vitreous haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Anal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Pubis fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Non-Hodgkin's lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Diabetic hyperosmolar coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Generalised tonic-clonic seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Neurological decompensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 21.1 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Respiratory muscle weakness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Lymphocele | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Vitiligo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |