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 @ 2:31 AM
Ignite Modification Date: 2025-12-26 @ 1:07 AM
NCT ID: NCT03302234
Description: All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. Pembrolizumab + Ipilimumab (second course) was not reported since no participants were eligible for second course treatment.
Frequency Threshold: 5
Time Frame: Up to approximately 56 months
Study: NCT03302234
Study Brief: Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
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+Ipilimumab (First Course) Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to \~1 year). 191 None 146 282 251 282 View
Pembrolizumab+Placebo (First Course) Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. 188 None 114 281 232 281 View
Pembrolizumab + Placebo (Second Course) Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. 4 None 4 18 10 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Haemolytic anaemia 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
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Acute myocardial infarction 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
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Autoimmune pericarditis 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 congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Adrenocortical insufficiency acute 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
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Inappropriate antidiuretic hormone secretion SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Lymphocytic hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Ophthalmoplegia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Autoimmune colitis 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
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastrointestinal toxicity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Immune-mediated enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Salivary gland calculus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Small intestinal haemorrhage 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
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
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Cholelithiasis migration SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Cholestatic liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary 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
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.0 View
Infusion related hypersensitivity reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.0 View
Adrenalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Chronic sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Diverticulitis intestinal haemorrhagic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Infection 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
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pneumonia legionella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Psoas abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Renal abscess 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
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Thrombophlebitis septic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Acetabulum 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
Ilium 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
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Skull fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Diabetic metabolic decompensation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Type 1 diabetes mellitus 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
Eosinophilic fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Osteoporotic fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Polymyalgia rheumatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Vertebral lesion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Ductal adenocarcinoma of pancreas SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Endometrial 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
Laryngeal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Paraneoplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Small intestine carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Autoimmune encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cerebral infarction 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
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Peripheral sensorimotor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Sensory disturbance 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
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Autoimmune nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Chronic obstructive pulmonary disease 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
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Immune-mediated lung disease 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
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary granuloma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Dermatitis exfoliative SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Rash macular 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
Angiopathy SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 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
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Contrast media allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urinary 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
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Weight 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
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypophosphataemia 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
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast 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
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View