Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:15 PM
Ignite Modification Date: 2025-12-24 @ 4:15 PM
NCT ID: NCT03322566
Description: All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Frequency Threshold: 5
Time Frame: Up to 25 months
Study: NCT03322566
Study Brief: A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)
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 + Chemotherapy + Epacadostat Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles). 38 None 47 90 87 90 View
Pembrolizumab + Chemotherapy + Placebo Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles). 35 None 41 86 81 86 View
Pembrolizumab + Epacadostat Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles. 26 None 20 52 51 52 View
Total Total 99 None 108 228 219 228 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23 View
Breakthrough pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Gallbladder rupture SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Gastrointestinal toxicity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hypopharyngeal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Malignant pleural effusion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Ophthalmic herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Pancreatic enzymes increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Paraneoplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Radiation necrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Vocal cord paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23 View