Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-25 @ 4:18 PM
NCT ID:
NCT02130557
Description:
All-cause mortality: The total number of deaths occurred during study (from randomization and up to month 60) are reported for all randomized participants, not only for treated participants, and included deaths which occurred after 28 days post last study drug dose. Serious AEs and other AEs: Analysis performed on safety population. The safety population included all participants, regardless of Philadelphia chromosome or transcript status, who received at least 1 dose of study medication.
Frequency Threshold:
5
Time Frame:
From first dose of drug up to 28 days after last dose (up to Month 60)
Study:
NCT02130557
Study Brief:
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Imatinib | Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. | 14 | None | 68 | 265 | 260 | 265 | View |
| Bosutinib | Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. | 14 | None | 98 | 268 | 264 | 268 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Agranulocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Haemolysis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Haemolytic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiac failure acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Coronary artery disease | 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 |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Atrial thrombosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardio-respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Coronary artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Pleuropericarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Sinus node dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Hydrocele | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v23.0 | View |
| Vertigo positional | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v23.0 | View |
| Thyroid disorder | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v23.0 | View |
| Eye haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Ocular hypertension | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Retinal vein occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Retinopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Diarrhoea | 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 |
| Necrotising oesophagitis | 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 |
| Abdominal wall haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Anal fissure | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Diverticulum intestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Food poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Hypoaesthesia oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Intra-abdominal haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Large intestine polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Oedematous pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Hyperthermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Implant site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Swelling face | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Hepatotoxicity | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Portal vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v23.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Abscess limb | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Appendicitis perforated | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Candida pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Cholecystitis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Fournier's gangrene | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Hepatitis E | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Infected dermal cyst | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Infective pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Liver abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Meningococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Neutropenic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Orchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Oropharyngitis fungal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Pelvic abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Periorbital cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Respiratory tract infection viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Splenic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Patella fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Post procedural haemorrhage | 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 |
| Tendon rupture | 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 creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood sodium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Tumour lysis syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Musculoskeletal chest 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 |
| 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 |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Rectal cancer | 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 |
| Bladder papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Carcinoid tumour of the caecum | 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 |
| Endometrial cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Fallopian tube cancer stage III | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Fibromatosis | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Hepatocellular carcinoma | 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 |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Myelodysplastic syndrome | 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 |
| Prostatic adenoma | 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 |
| Transitional cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Haemorrhagic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | 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 |
| Unintended pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v23.0 | View |
| Acute kidney injury | 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 |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Calculus bladder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Nephrotic syndrome | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Ureterolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Prostatic dysplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Uterine haemorrhage | 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 |
| Chronic obstructive pulmonary disease | 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 |
| Pneumothorax | 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 |
| 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 |
| Pulmonary toxicity | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Angioedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Lichen planus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Rash | 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 |
| Pregnancy of partner | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA v23.0 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Hypovolaemic shock | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Periorbital oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | 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 |
| 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 |
| Eyelid oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye 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 |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Sinusitis | 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 |
| Amylase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | 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 |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Arthralgia | 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 |
| 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 |
| Back pain | 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 |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v23.0 | View |
| Depression | 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 |
| 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 |
| Alopecia | 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 |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |