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To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prizbind® for Intravenous Solution | Patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prizbind® | Drug | Prizbind® |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Drug Reactions (ADRs) | Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported. | From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is > 100, it was set to 100. | From the end of the first infusion up to 4 hours after the last infusion on Day 1. |
Not provided
Inclusion criteria:
Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators
Exclusion criteria:
None
Not provided
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Patients who are prescribed with Prizbind
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37845427 | Derived | Yasaka M, Yokota H, Suzuki M, Asakura H, Yamane T, Ogi Y, Kimoto T, Nakayama D. Idarucizumab for Emergency Reversal of the Anticoagulant Effects of Dabigatran: Final Results of a Japanese Postmarketing Surveillance Study. Cardiol Ther. 2023 Dec;12(4):723-740. doi: 10.1007/s40119-023-00333-6. Epub 2023 Oct 17. | |
| 32152956 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
All patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators were enrolled. Any screening was not conducted.
This post marketing surveillance (PMS) was a non-interventional study based on new data collection to gather data on safety and effectiveness of the Prizbind® for Intravenous Solution under Japanese clinical condition. All patients were administered Prizbind® for Intravenous Solution after the approval at the sites contracted with the sponsor were to be registered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prizbind® for Intravenous Solution | Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prizbind® for Intravenous Solution | Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. |
| 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 | Number of Patients With Adverse Drug Reactions (ADRs) | Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported. | Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®. | Posted | Count of Participants | Participants | From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days. |
|
From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
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 | Prizbind® for Intravenous Solution | Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2019 | Oct 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2021 | Oct 6, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000594745 | idarucizumab |
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| Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is > 100, it was set to 100. Maximum Reversal was categorized in the following 4 categories: 100% 80% <= and < 100% 50% <= and < 80% < 50% | From the end of the first infusion up to 4 hours after the last infusion on Day 1. |
| Yasaka M, Yokota H, Suzuki M, Asakura H, Yamane T, Ogi Y, Ochiai K, Nakayama D. Idarucizumab for Emergency Reversal of Anticoagulant Effects of Dabigatran: Interim Results of a Japanese Post-Marketing Surveillance Study. Cardiol Ther. 2020 Jun;9(1):167-188. doi: 10.1007/s40119-020-00165-8. Epub 2020 Mar 9. |
| Adverse Event |
|
| CRFs not valid |
|
| CRFs with missing information on the date of termination of PMS |
|
| 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 |
|
|
|
| Secondary | Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is > 100, it was set to 100. | Patients of the effectiveness set (all patients with Prizbind® in the safety set who have at least one available effectiveness data) whose activated partial thromboplastin time (aPTT) value at baseline exceeded the upper limit of normal (ULN). | Posted | Median | Inter-Quartile Range | percentage | From the end of the first infusion up to 4 hours after the last infusion on Day 1. |
|
|
|
| Secondary | Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is > 100, it was set to 100. Maximum Reversal was categorized in the following 4 categories: 100% 80% <= and < 100% 50% <= and < 80% < 50% | Patients of the effectiveness set (all patients with Prizbind® in the safety set who have at least one available effectiveness data) whose activated partial thromboplastin time (aPTT) value at baseline exceeded the upper limit of normal (ULN). | Posted | Count of Participants | Participants | From the end of the first infusion up to 4 hours after the last infusion on Day 1. |
|
|
|
| 103 |
| 813 |
| 192 |
| 813 |
| 0 |
| 813 |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Mediastinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Spinal cord haemorrhage | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vascular parkinsonism | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Eye haematoma | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pericardial haemorrhage | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ventricle rupture | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac perforation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhagic infarction | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Peripheral circulatory failure | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Coeliac artery occlusion | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Immobilisation syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Suture related complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Postoperative delirium | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Tumour rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Aneurysm ruptured | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Microscopic polyangiitis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rectal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Mesenteric arterial occlusion | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Traumatic shock | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| <50 % |
|