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 @ 2:34 PM
Ignite Modification Date: 2025-12-25 @ 1:06 PM
NCT ID: NCT02551159
Description: None
Frequency Threshold: 5
Time Frame: Adverse events and serious adverse events will be collected from the time of signature of informed consent throughout the treatment period and including the follow-up period (up to 90 days after the last dose of investigational product or until initiation of another therapy) for an average of approximately 4 years.
Study: NCT02551159
Study Brief: Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck 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
Durvalumab + Tremelimumab tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression 356 None 168 408 317 408 View
Durvalumab durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression 176 None 78 202 153 202 View
Standard of Care (SOC) either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent 171 None 94 196 182 196 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Obstructive pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Superinfection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Carbon monoxide poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Gastrostomy failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Troponin t increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Autoimmune myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Osteonecrosis of jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Infected neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebrovascular disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 23.0 View
Device occlusion SYSTEMATIC_ASSESSMENT Product Issues MedDRA 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary infarction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Lymph node haemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Duodenal ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pneumatosis intestinalis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Tongue oedema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Soft tissue inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatorenal failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Abscess neck SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Tracheal obstruction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Colorectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Neuroendocrine tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Oesophageal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Adjustment disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Upper airway obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Peripheral venous disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Blood loss anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Laryngeal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pharyngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Post procedural fistula SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View