Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with nonvalvular atrial fibrillation (NVAF) | Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prazaxa® Capsules | Drug | Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) | Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places. | From baseline till the last administration + 6 days. Up to 364 days. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
An observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for nonvalvular atrial fibrillation must be according to regular medical practice and at discretion of physician (i.e., no randomised assignment of patient to treatment [Prazaxa® Capsules or other treatment] is performed).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rie Ikeda, 81364172200 | zzCDMJP_PV_PMS@boehringer-ingelheim.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd | Tokyo | Japan |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Out of the 5660 enrolled subjects case report forms (CRF) were collected for 5565 subjects. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety profile of Prazaxa® in a real-world setting and not to compare between different dose groups.
Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Nonvalvular Atrial Fibrillation (NVAF) | Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set 1: This patient set included all patients who were documented to take at least one dose of Prazasa® except patients who experienced with Prazaxa® treatment for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after the entry.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Nonvalvular Atrial Fibrillation (NVAF) | Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) | Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places. | Safety Set 1: This patient set included all patients who were documented to take at least one dose of Prazasa® except patients who experienced with Prazaxa® treatment for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after the entry. | Posted | Number | Percentage of participants | From baseline till the last administration + 6 days. Up to 364 days. |
|
From baseline till the last administration + 6 days. Up to 364 days.
Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Nonvalvular Atrial Fibrillation (NVAF) | Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2017 | Nov 30, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2021 | Nov 30, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Patients received Prazaxa treatment before |
|
| Other personal reason |
|
| To take a contraindication/careful administration drug |
|
| Lost to follow-up (changing hospital) |
|
| Lost to follow-up (unknown reason) |
|
| To conduct invasive treatment of operation |
|
| Improvement of nonvalvular atrial fibrillation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
|
|
| 51 |
| 5,436 |
| 416 |
| 5,436 |
| 0 |
| 5,436 |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Endophthalmitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pyelitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Infective spondylitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Bacterial prostatitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Complicated appendicitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Angiocentric lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Gastrointestinal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Soft tissue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Basedow's disease | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral atrophy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral disorder | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrial thrombosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pericardial haemorrhage | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Tachycardia paroxysmal | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Embolism arterial | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemorrhagic infarction | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atheroembolism | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Rectal ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastric hypomotility | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatitis fulminant | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Primary biliary cholangitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Postrenal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oedema due to cardiac disease | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
| Finger amputation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
| Mitral valve replacement | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
| Valvuloplasty cardiac | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac operation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |