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 @ 1:41 AM
Ignite Modification Date: 2025-12-25 @ 11:57 PM
NCT ID: NCT00805194
Description: Number of participants at risk corresponds to all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated to the treatment groups according to the treatment actually received.
Frequency Threshold: 5
Time Frame: From the first drug administration until 28 days after the last drug administration, up to 42 months
Study: NCT00805194
Study Brief: LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nintedanib Plus Docetaxel Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h). 107 None 224 652 569 652 View
Placebo Plus Docetaxel Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h). 77 None 206 655 547 655 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastrointestinal necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Neutropenic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Device occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Cholecystocholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Abscess rupture SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
H1N1 influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Neutropenic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Acetabulum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Haemarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Hepatic cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Metastases to chest wall SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Metastases to kidney SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Metastases to skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Metastatic pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Tumour necrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Diplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Epiduritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Facial paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hemiplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Monoparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Restless legs syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Mental disorder due to a general medical condition SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Bladder perforation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Alveolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Bronchial haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Bronchial secretion retention SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Bronchostenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Obstructive airways disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory depression SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Tracheal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Subclavian artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View