Adverse Events Module

Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module


Ignite Creation Date: 2025-12-24 @ 7:52 PM
Ignite Modification Date: 2025-12-25 @ 5:28 PM
NCT ID: NCT04032704
Description: Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Frequency Threshold: 5
Time Frame: From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)
Study: NCT04032704
Study Brief: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Event Groups(If Any):

Event Groups

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
Serious Events(If Any):

Serious Events

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
Other Events(If Any):

Other Events

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