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 |
|---|---|---|---|---|---|---|---|---|
| Part A: Cohort 1, LV 2.5 mg/kg | Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk). | 9 | None | 5 | 10 | 10 | 10 | View |
| Part A: Cohort 2, LV 2.5 mg/kg | Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk. | 2 | None | 1 | 2 | 2 | 2 | View |
| Part A: Cohort 3, LV 2.5 mg/kg | Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk. | 10 | None | 7 | 13 | 13 | 13 | View |
| Part A: Cohort 4, LV 2.5 mg/kg | Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk. | 7 | None | 2 | 7 | 6 | 7 | View |
| Part A: Cohort 5, LV 2.5 mg/kg | Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk. | 4 | None | 3 | 5 | 5 | 5 | View |
| Part A: Cohort 6, LV 2.5 mg/kg | Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk. | 5 | None | 3 | 12 | 12 | 12 | View |
| Part B: Cohort 1, LV 1.25 mg/kg | Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion. | 13 | None | 6 | 16 | 15 | 16 | View |
| Part B: Cohort 2, LV 1.25 mg/kg | Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 13 | None | 5 | 16 | 16 | 16 | View |
| Part B: Cohort 3, LV 1.25 mg/kg | Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 14 | None | 9 | 19 | 19 | 19 | View |
| Part B: Cohort 4, LV 1.25 mg/kg | Participants with HNSCC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 12 | None | 8 | 14 | 14 | 14 | View |
| Part B: Cohort 5, LV 1.25 mg/kg | Participants with esophageal-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 12 | None | 9 | 17 | 17 | 17 | View |
| Part B: Cohort 6, LV 1.25 mg/kg | Participants with GEJ were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 13 | None | 12 | 21 | 19 | 21 | View |
| Part B: Cohort 7, LV 1.25 mg/kg | Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 7 | None | 4 | 13 | 13 | 13 | View |
| Part B: Cohort 8, LV 1.25 mg/kg | Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 16 | None | 11 | 30 | 30 | 30 | View |
| Part B: Cohort 1, LV 1.0 mg/kg | Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion. | 2 | None | 1 | 2 | 2 | 2 | View |
| Part B: Cohort 3, LV 1.0 mg/kg | Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 1 | None | 2 | 2 | 2 | 2 | View |
| Part B: Cohort 4, LV 1.0 mg/kg | Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 2 | None | 1 | 2 | 2 | 2 | View |
| Part B: Cohort 6, LV 1.0 mg/kg | Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion. | 2 | None | 0 | 2 | 2 | 2 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Stress cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Laryngocele | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v26.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v26.1 | View |
| Inappropriate antidiuretic hormone secretion | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Conjunctivitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Liver abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Periorbital cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Brain natriuretic peptide increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Mobility decreased | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Lymphangiosis carcinomatosa | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | View |
| Tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | View |
| Acute motor-sensory axonal neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Demyelinating polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Petit mal epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Vocal cord paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Bronchial obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Pharyngeal haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Oesophageal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Oesophageal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Small intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Complication associated with device | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Biliary sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Biliary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Anaemia macrocytic | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v26.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v26.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v26.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v26.1 | View |
| Androgen deficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v26.1 | View |
| Hyperprolactinaemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v26.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v26.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v26.1 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v26.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Swollen tongue | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Tongue ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Injection site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v26.1 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v26.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v26.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Conjunctivitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Escherichia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Lymphangitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Oral fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Sputum purulent | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Burns first degree | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Blood magnesium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Iron binding capacity total decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Troponin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Abnormal loss of weight | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypercreatininaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypermagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Soft tissue necrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | View |
| Tumour associated fever | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Hypogeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Lumbar radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Neurotoxicity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Peripheral sensorimotor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Poor quality sleep | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Genital burning sensation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v26.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Laryngeal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Laryngeal ventricle prolapse | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Skin maceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Skin toxicity | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |
| Raynaud's phenomenon | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Retching | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v26.1 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Asterixis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |