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 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT00932451
Description: All causality (serious and non-serious) AEs
Frequency Threshold: 5
Time Frame: Active reporting period is from the time of informed consent until at least 28 days after study treatment last dose. For serious adverse events: those with the possibility of being related to study drug must be reported as minimum thereafter.
Study: NCT00932451
Study Brief: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Crizotinib 250 mg BID Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day. None None 539 1066 1038 1066 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Troponin I increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Fluid retention NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Chest wall mass NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Myopathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Pathological fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Spinal column stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Spondylolisthesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Systemic lupus erythematosus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Gallbladder cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Malignant melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Metastases to meninges NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Neuroendocrine tumour NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Plasma cell myeloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Small cell lung cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Squamous cell carcinoma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (v18.1) View
Aphasia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Brain oedema NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Cerebellar infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Chorea NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Coma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Depressed level of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Generalised tonic-clonic seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Intracranial pressure increased NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Ischaemic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Nervous system disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Neurological decompensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Paraplegia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Peripheral sensorimotor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Pyramidal tract syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Spinal cord compression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Vocal cord paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Completed suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Disorientation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Mania NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Renal cyst haemorrhage NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Ureteral polyp NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Urinary tract obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (v18.1) View
Benign prostatic hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (v18.1) View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (v18.1) View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Alveolitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Asphyxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Interstitial lung disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Lung infiltration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pleuritic pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pulmonary arterial hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pulmonary artery thrombosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pulmonary haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Pulmonary thrombosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Rales NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Paraneoplastic pemphigus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (v18.1) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (v18.1) View
Pleural decortication NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (v18.1) View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Hypovolaemic shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Peripheral embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Superior vena cava syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Vasculitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Vena cava thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Venous thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (v18.1) View
Angina Unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Vascular stent thrombosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Lymphangitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Craniocerebral injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Postoperative wound complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Haemothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Basophilia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Eosinophilia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Monocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Thrombocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Myocarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Syncope NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Optic atrophy NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Vitreous haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Abdominal wall haematoma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Intestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Oesophageal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Pancreatic atrophy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Peptic ulcer haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Peritoneal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Condition aggravated NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Device dislocation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Generalised oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Mass NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Multi-organ failure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (v18.1) View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (v18.1) View
Hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (v18.1) View
Hepatocellular injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (v18.1) View
Hepatotoxicity NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (v18.1) View
Contrast media allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (v18.1) View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Bone abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Candiduria NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Chest wall abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Clostridium difficile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Empyema NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Infectious pleural effusion NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Infective spondylitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Lung abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Meningitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Metapneumovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Oesophageal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Osteomyelitis chronic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Pneumonia fungal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Pneumonia staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Renal cyst infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Soft tissue infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Bone fissure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Dislocation of vertebra NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Femoral neck fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Lower limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Pelvic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Radiation necrosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Radiation pneumonitis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Subdural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Traumatic haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Coronary artery stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Cyanosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Left ventricular failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Diarrhoea haemorrhagic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Retroperitoneal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Subileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Hepatic failure NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (v18.1) View
Renal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (v18.1) View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (v18.1) View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Photopsia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (v18.1) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (v18.1) View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (v18.1) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (v18.1) View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (v18.1) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (v18.1) View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (v18.1) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (v18.1) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (v18.1) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (v18.1) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (v18.1) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (v18.1) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (v18.1) View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (v18.1) View