Adverse Events Module

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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 @ 4:40 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT01761266
Description: The safety analysis set included all participants who received at least 1 dose of study drug. All-cause mortality was reported for all participants randomized.
Frequency Threshold: 5
Time Frame: All treatment-emergent adverse events were collected from first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 8 years)
Study: NCT01761266
Study Brief: A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lenvatinib Participants received lenvatinib capsules 12 mg based on the participant's body weight \>=60 kg or 8 mg based on the participant's body weight \<60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. 415 None 209 476 469 476 View
Sorafenib Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. 402 None 149 475 469 475 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Salmonellosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Mantle cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Metastases to adrenals SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Anaemia vitamin B12 deficiency SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Heart valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Varices oesophageal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Acute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Biliary dilatation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Chronic hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Haemobilia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Hepatic pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Hydrocholecystis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Liver abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Appendiceal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Groin abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Perihepatic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pleural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Postoperative abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Scrotal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Aspergillus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Diabetic foot infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Ophthalmic herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Perineal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia escherichia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Traumatic haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Clostridium test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Liver carcinoma ruptured SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Metastases to spine SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Infected neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Tumour necrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Tumour rupture SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Malignant ascites SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Malignant pleural effusion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Plasma cell myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Coma hepatic SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Diplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Paralysis recurrent laryngeal nerve SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Basal ganglia haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Thrombotic cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
IgA nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Hepatopulmonary syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Necrotising bronchiolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Non-cardiogenic pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pulmonary infarction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Pneumothorax traumatic SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Hepatorenal syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Intracranial tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View