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 @ 2:40 AM
Ignite Modification Date: 2025-12-26 @ 1:18 AM
NCT ID: NCT01903733
Description: All-cause mortality: The total number of deaths during study, from randomization (B1871008)/first dose (B1871006) and up to the end of the study are reported for all treated participants and includes deaths which occurred after 30 days post last study drug dose. SAEs and other AEs: Analysis performed on safety set. Data from the 2 parent studies was combined with the data from this study for the analysis of safety as planned.
Frequency Threshold: 5
Time Frame: From first dose of study drug and up to 30 days after last dose (up to approximately 14 years)
Study: NCT01903733
Study Brief: Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bosutinib, CP1L Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML). 23 None 102 248 239 248 View
Bosutinib, CP2L Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib. 55 None 124 284 283 284 View
Bosutinib, CP3L/CP4L Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib. 30 None 44 119 119 119 View
Bosutinib, ADV Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib. 98 None 98 167 164 167 View
Bosutinib, Total Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts. 206 None 368 818 805 818 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Hyperleukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Granulocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Leukostasis syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Splenomegaly NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Left ventricular dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Pericardial haemorrhage NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Aortic valve stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Arteriosclerosis coronary artery NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Bundle branch block right NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Cardiac failure acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Cardiorenal syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Hypertensive cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Pleuropericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Ventricular fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Cytogenetic abnormality NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v23.0 View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v23.0 View
Deafness unilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v23.0 View
Vestibular disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v23.0 View
Goitre NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v23.0 View
Thyroid mass NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v23.0 View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v23.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v23.0 View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v23.0 View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v23.0 View
Retinopathy NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v23.0 View
Retinopathy hypertensive NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v23.0 View
Vitreous haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v23.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Abdominal adhesions NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Anal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Colitis ischaemic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Duodenal ulcer haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Epigastric discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Faecaloma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastric haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastric ulcer haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastritis erosive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastritis haemorrhagic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastrointestinal necrosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Intestinal ischaemia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Large intestinal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Lower gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Mesenteric artery embolism NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Oesophageal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Proctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Rectal polyp NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Retroperitoneal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Multiple organ dysfunction syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Adhesion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Sudden death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Gallbladder disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Bile duct stone NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Cholecystitis chronic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Gallbladder polyp NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Perforation bile duct NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v23.0 View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v23.0 View
Anaphylactic shock NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v23.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v23.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Atypical pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Clostridium difficile colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Appendicitis perforated NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Infectious pleural effusion NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Large intestine infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pyelonephritis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Staphylococcal bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Arthritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Arthritis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Bacterial sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Brain abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Catheter bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Cellulitis of male external genital organ NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Clostridium difficile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Dengue fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Dermatitis infected NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Eczema infected NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Enterococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Enterocolitis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Escherichia bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Escherichia sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Febrile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Gastrointestinal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Gingival abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Hepatitis A NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Infected dermal cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Kidney infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Malaria NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Meningitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Orchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Perirectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pharyngotonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pneumonia fungal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pneumonia necrotising NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Post procedural infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pseudomembranous colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pseudomonal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pulmonary mycosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Salmonella bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Salmonellosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Streptococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Facial bones fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Subdural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Abdominal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Cervical vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Clavicle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Exposure during pregnancy NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Failure to anastomose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Fibula fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Gastrointestinal stoma complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Lower limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Muscle injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Post procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Post procedural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Post procedural haematuria NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Post procedural swelling NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Seroma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Skull fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Subdural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Transfusion reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Traumatic lung injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Vascular pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Wound haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v23.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Intraocular pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Fluid retention NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Hypovolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Gouty arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Intervertebral disc disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Bone cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Groin pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Joint range of motion decreased NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Mandibular mass NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Myositis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Osteochondrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Osteonecrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Synovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Blast cell crisis NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Adenocarcinoma gastric NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Blast crisis in myelogenous leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Squamous cell carcinoma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Chronic myeloid leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Squamous cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Angiomyolipoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Bladder squamous cell carcinoma stage unspecified NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Bowen's disease NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Central nervous system leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Chloroma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Cholangiocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Chronic myelomonocytic leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Colon cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Follicle centre lymphoma, follicular grade I, II, III NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Gastric cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Invasive ductal breast carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Keratoacanthoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Laryngeal neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Lipoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Lung adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Malignant melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Melanocytic naevus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Neoplasm prostate NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Neoplasm skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Non-small cell lung cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Paraproteinaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Uterine leiomyoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Subarachnoid haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Cerebellar infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Nervous system disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Encephalitis post varicella NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Hemiparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Intraventricular haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Ischaemic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Monoparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Parkinson's disease NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Radiculopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Speech disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Trigeminal neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v23.0 View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Completed suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Disorientation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Dissociative disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Hallucination, visual NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Calculus urinary NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Calculus bladder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Cystitis haemorrhagic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
End stage renal disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Prerenal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Renal artery stenosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Renal disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v23.0 View
Breast hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v23.0 View
Cervical dysplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v23.0 View
Dysfunctional uterine bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v23.0 View
Metrorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v23.0 View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v23.0 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v23.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pulmonary hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Acute pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Interstitial lung disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Lung disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pleuritic pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Bronchiectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Bronchitis chronic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Lung infiltration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Organising pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pleurisy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pulmonary fibrosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Respiratory arrest NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Vocal cord polyp NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Angioedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Circumoral oedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Pregnancy of partner NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA v23.0 View
Allogenic bone marrow transplantation therapy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA v23.0 View
Cyst removal NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA v23.0 View
Knee arthroplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA v23.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Aortic stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Venous thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Coronary artery stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Anogenital warts NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v23.0 View
Carotid arteriosclerosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Tubulointerstitial nephritis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v23.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v23.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v23.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v23.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v23.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v23.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.0 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v23.0 View