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: 2025-12-25 @ 1:32 AM
Ignite Modification Date: 2025-12-25 @ 11:45 PM
NCT ID: NCT02220894
Description: Population: All participants receiving ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Frequency Threshold: 5
Time Frame: Up to approximately 93 months
Study: NCT02220894
Study Brief: Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pembrolizumab Second Course Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion. 18 None 8 34 21 34 View
Pembrolizumab Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles) 528 None 261 636 535 636 View
Chemotherapy (SOC Treatment) Participants received carboplatin at target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W. 582 None 193 615 577 615 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Oesophageal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Lymph gland infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Normochromic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Splenic infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Duodenal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastrointestinal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Glossitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Incarcerated inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Neutropenic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Oesophageal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Pancreatic mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Rectal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Accidental death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Ill-defined disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Prosthetic cardiac valve thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Hepatitis toxic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Contrast media allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.0 View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Abscess jaw SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Amoebiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Amoebic dysentery SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Biliary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Infective exacerbation of bronchiectasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Infective exacerbation of chronic obstructive airways disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pleural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Post procedural cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Vascular access site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood prolactin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Osteitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Osteoporotic fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Adenocarcinoma gastric SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Anogenital warts SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Infected neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Keratoacanthoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Squamous cell carcinoma of the tongue SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Tumour associated fever SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Tumour necrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Altered state of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Psychomotor hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Glomerulonephritis membranous SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.0 View
Ovarian cyst torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Chronic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Oesophagobronchial fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary artery thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Tracheal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Arterial thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View