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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:57 PM
NCT ID: NCT01229267
Description: The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
Frequency Threshold: 5
Time Frame: Adverse events were collected up to approximately 5 years after vaccination 1.
Study: NCT01229267
Study Brief: A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
V212 [Including High Antigen Lot] Participants received V212 Consistency Lot 1, 2, 3 or High Antigen Lot 0.5 mL administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT. 136 None 420 657 625 657 View
Placebo Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT. 107 None 374 554 512 554 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Cholelithiasis obstructive SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Graft versus host disease in liver SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Graft versus host disease in lung SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Groin abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Postoperative abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Brain contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Lactose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Tetany SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Angioimmunoblastic T-cell lymphoma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Hodgkin's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Hodgkin's disease nodular sclerosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Hodgkin's disease recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Langerhans' cell histiocytosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Non-Hodgkin's lymphoma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Non-Hodgkin's lymphoma refractory SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Nonkeratinising carcinoma of nasopharynx SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Rectal cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Small cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Hypoglycaemic coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Intracranial venous sinus thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Abdominal lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Acquired haemophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Anaemia megaloblastic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Immune thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Methaemoglobinaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Sickle cell anaemia with crisis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Splenic infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiac amyloidosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiac ventricular thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Acute vestibular syndrome SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Intraocular haematoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dyskinesia oesophageal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal infarction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intra-abdominal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Mesenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Neutropenic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pancreatic insufficiency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pneumatosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Ulcer haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Granulomatous liver disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hydrocholecystis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Acute graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Amyloidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Anaphylactic shock SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Engraftment syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Graft versus host disease SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Graft versus host disease in gastrointestinal tract SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Primary amyloidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Actinomycotic pulmonary infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Adenovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Aspergilloma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Aspergillus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
BK virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Candida sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cholangitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Chronic hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Clostridium colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Coxsackie viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cytomegalovirus colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cytomegalovirus oesophagitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Enterocolitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Enterovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Epididymitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Fungal oesophagitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis rotavirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastrointestinal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
H1N1 influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Haemophilus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Herpes zoster disseminated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Infected lymphocele SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Infection in an immunocompromised host SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Infective exacerbation of chronic obstructive airways disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Klebsiella bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Lower respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Lung infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Meningitis pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Meningoencephalitis herpetic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumocystis jirovecii infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia cytomegaloviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia parainfluenzae viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia respiratory syncytial viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pseudomonal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pulmonary mycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Retinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Scrotal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Streptococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Thrombophlebitis septic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Varicella zoster virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Wound infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Allergic transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Comminuted fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Delayed engraftment SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Forearm fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Multiple fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Peroneal nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Procedural hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Transplant dysfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Traumatic haemothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Food intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Cervical spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pseudarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Acute leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Acute myeloid leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Acute promyelocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Adenocarcinoma gastric SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Anaplastic large cell lymphoma T- and null-cell types SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Anaplastic large cell lymphoma T- and null-cell types recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Anaplastic large-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Angiocentric lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
B-cell lymphoma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
B-cell lymphoma stage IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Basosquamous carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Bladder cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Breast cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Central nervous system lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Chronic lymphocytic leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Chronic myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Colon adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Colorectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Diffuse large B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Diffuse large B-cell lymphoma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Diffuse large B-cell lymphoma refractory SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Extranodal marginal zone B-cell lymphoma (MALT type) recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Follicle centre lymphoma, follicular grade I, II, III recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Laryngeal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Lymphoplasmacytoid lymphoma/immunocytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Malignant lymphoid neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Mantle cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Mantle cell lymphoma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Neuroendocrine carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Non-Hodgkin's lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Paraneoplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Pericardial effusion malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Peripheral T-cell lymphoma unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Peripheral T-cell lymphoma unspecified recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Plasma cell myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Plasma cell myeloma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Plasmablastic lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Plasmacytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Precursor T-lymphoblastic lymphoma/leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Precursor T-lymphoblastic lymphoma/leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Primary mediastinal large B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
T-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
T-cell lymphoma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Tumour flare SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Autonomic nervous system imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Carotid artery aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Carotid artery disease SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cerebellar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Threatened labour SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 19.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Hypomania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Schizoaffective disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Acute prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Cystitis haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
End stage renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Renal injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Acquired phimosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Idiopathic pneumonia syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Lung consolidation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Obstructive airways disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Restrictive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Dermatitis exfoliative SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash vesicular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Venoocclusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View