Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT04223856
Description: Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
Frequency Threshold: 5
Time Frame: From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Study: NCT04223856
Study Brief: Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enfortumab Vedotin + Pembrolizumab Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks. 133 None 220 440 435 440 View
Standard of Care Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks. 226 None 169 433 418 433 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Cholangitis sclerosing SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.0 View
Sarcoidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v26.0 View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Campylobacter gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Cytomegalovirus colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pelvic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Perineal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Optic neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Peripheral sensorimotor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Immune-mediated nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Postrenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Urinoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v26.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v26.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Lung opacity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pharyngeal dyskinesia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Acute right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v26.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Large intestinal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Anaemia of malignant disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Immune thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Immune-mediated myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Stress cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v26.0 View
Hypercalcaemia of malignancy SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v26.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v26.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v26.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Colonic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Duodenal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Enterovesical fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Faeces discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Immune-mediated enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Malignant gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Obstructive pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Rectal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Small intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Klebsiella sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pneumonia haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Urinary tract infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Urinary tract infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Heat stroke SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Sternal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Urinary tract stoma complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypercreatininaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Bone lesion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Mobility decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Burkitt's lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Chronic lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Tumour rupture SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Chronic inflammatory demyelinating polyradiculoneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Diabetic hyperglycaemic coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Immune-mediated encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Immune-mediated neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Immune-mediated lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Acute generalised exanthematous pustulosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Dermatitis exfoliative SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Dermatitis exfoliative generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash morbilliform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
SJS-TEN overlap SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Toxic epidermal necrolysis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Toxic erythema of chemotherapy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Aortic aneurysm rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Iliac artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Lymphocele SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v26.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v26.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v26.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v26.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v26.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v26.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View