Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:32 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
NCT ID: NCT03765918
Description: All-Cause Mortality includes all randomized participants. Serious and Other AEs include the safety analysis population. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Frequency Threshold: 5
Time Frame: Up to ~66 months
Study: NCT03765918
Study Brief: Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care (SOC) Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). 131 None 116 315 290 315 View
Pembrolizumab + Standard of Care (SOC) Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). 113 None 179 361 335 361 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Hypercoagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Bradyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Cardiovascular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Pulmonary valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Tracheo-oesophageal fistula SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 27.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Autoimmune pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Duodenal ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrointestinal motility disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Mesenteric arterial occlusion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oesophageal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oesophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oral cavity fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Salivary gland fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Thrombosis mesenteric vessel SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Tongue necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Implant site thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Procedural failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Biliary obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Anaphylactic shock SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Abscess neck SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Abscess oral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Incision site abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Infection parasitic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Infective glossitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Intervertebral discitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Postoperative abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Submandibular abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Superinfection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Wound infection pseudomonas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Acetabulum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Flap necrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Gastrostomy failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Gastrostomy tube site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Implant tissue necrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Incision site swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Lymphatic duct injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Open fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Osteoradionecrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Pharyngeal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post procedural fistula SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Radiation skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Skin flap necrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Stoma site haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Tracheal obstruction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Wound haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Alcohol intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Feeding intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperglycaemic hyperosmolar nonketotic syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Metabolic disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Refeeding syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Osteonecrosis of jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Soft tissue necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Laryngeal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Oesophageal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Pancreatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Tumour associated fever SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Bell's palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 27.0 View
Device leakage SYSTEMATIC_ASSESSMENT Product Issues MedDRA 27.0 View
Internal device exposed SYSTEMATIC_ASSESSMENT Product Issues MedDRA 27.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Immune-mediated nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Laryngeal fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Laryngeal haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Laryngeal obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Laryngeal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Obstructive airways disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Oropharyngeal fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Tracheal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Tracheal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Skin necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Urticarial dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Arterial haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Inferior vena caval occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Lymphatic fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Vascular occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Gastrointestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Swollen tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Swelling face SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Oropharyngeal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Radiation skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pharyngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View