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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
NCT ID: NCT00364351
Description: The Safety Analysis Set included all randomized participant who received at least 1 dose of randomized treatment, 623 in vandetanib and 614 in erlotinib.
Frequency Threshold: 5
Time Frame: None
Study: NCT00364351
Study Brief: Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vandetanib Vandetanib 300 mg. None None 197 623 539 623 View
Erlotinib Erlotinib. None None 155 614 542 614 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Cardio-Respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Cardiopulmonary Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Postinfarction Angina SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Right Ventricular Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Abdominal Wall Haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Colitis Ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Gastrointestinal Ulcer Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Inguinal Hernia Strangulated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Oesophageal Stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Complication Associated With Device SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Sudden Death SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Biliary Colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 20.0 View
Anaphylactic Shock SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 20.0 View
Abscess Limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Arthritis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Atypical Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Clostridium Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Gastroenteritis Clostridial SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Genital Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Hepatobiliary Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Infective Exacerbation Of Chronic Obstructive Airways Disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Mycobacterial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Pneumonia Haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Pulmonary Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Pulmonary Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Streptococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Subcutaneous Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Femoral Neck Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Gastroenteritis Radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Humerus Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Post Procedural Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Radiation Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Spinal Compression Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Subdural Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Vascular Graft Occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.0 View
Body Temperature Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
C-Reactive Protein Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Electrocardiogram Qt Prolonged SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Electrocardiogram St-T Change SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Electrocardiogram T Wave Inversion SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
International Normalised Ratio Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Spinal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
B-Cell Small Lymphocytic Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 20.0 View
Cancer Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 20.0 View
Lymphangiosis Carcinomatosa SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 20.0 View
Prostate Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 20.0 View
Altered State Of Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Cerebral Ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Cerebral Thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Paralysis Recurrent Laryngeal Nerve SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Psychomotor Hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Speech Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Spinal Cord Compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Device Failure SYSTEMATIC_ASSESSMENT Product Issues MedDra 20.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 20.0 View
Completed Suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 20.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 20.0 View
Mental Status Changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 20.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.0 View
Tubulointerstitial Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.0 View
Acquired Tracheo-Oesophageal Fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Asthmatic Crisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Bronchial Fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Interstitial Lung Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pleural Fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pulmonary Haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Dermatitis Acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Dermatitis Exfoliative SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Eczema Asteatotic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Erythema Multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Palmar-Plantar Erythrodysaesthesia Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Photosensitivity Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Rash Erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Rash Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Thoracotomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDra 20.0 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Hypovolaemic Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Jugular Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Peripheral Arterial Occlusive Disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Peripheral Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Subclavian Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.0 View
Thrombotic Thrombocytopenic Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.0 View
Torsade De Pointes SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.0 View
Ulcerative Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDra 20.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Multiple Organ Dysfunction Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Neutropenic Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Pleural Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Pleural Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Pneumococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Malignant Pleural Effusion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 20.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Calculus Urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.0 View
Laryngeal Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Lung Infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 20.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 20.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 20.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 20.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Dermatitis Acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 20.0 View