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This study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.
Purpose:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge | Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release. Emergency Department/Room (ED/ER). Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:
| From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days. |
| Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible. | From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days. |
| Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible. | From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days. |
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Inclusion criteria:
Exclusion criteria:
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AF patients with bleeding event using Dabigatran etexilate
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Aurora | Colorado | United States | |||
| Boehringer Ingelheim Investigational Site |
297 subjects were captured in the initial screening. 74 patients were deemed ineligible. A total of 3 patients were withdrawn after being included in the final study cohort following verification of ineligibility leaving 220 subjects eligible for study entry who were enrolled and included in the final study.
This was an observational chart abstraction study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| New Britain |
| Connecticut |
| United States |
| Boehringer Ingelheim Investigational Site | Orlando | Florida | United States |
| Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States |
| Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | United States |
| Boehringer Ingelheim Investigational Site | Chesterfield | Missouri | United States |
| Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| Boehringer Ingelheim Investigational Site | Hackensack | New Jersey | United States |
| Boehringer Ingelheim Investigational Site | New York | New York | United States |
| Boehringer Ingelheim Investigational Site | Staten Island | New York | United States |
| Boehringer Ingelheim Investigational Site | Philedelphia | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States |
| Boehringer Ingelheim Investigational Site | Charlottesville | Virginia | United States |
| Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States |
| Boehringer Ingelheim Investigational Site | Roanoke | Virginia | United States |
| Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| Boehringer Ingelheim Investigational Site | Saint John | New Brunswick | Canada |
| Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada |
| Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
Patients who received treatment at two countries (United States and Canada).
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
|
| 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 Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge | Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release. Emergency Department/Room (ED/ER). Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:
| Patients who received treatment at two countries (United States and Canada). | Posted | Number | Percentage of participants | From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible. | Patients who received treatment at two countries (United States and Canada). | Posted | Number | Percentage of participants | From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days. |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible. | Patients who received treatment at two countries (United States and Canada). | Posted | Number | Percentage of participants | From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days. |
|
|
From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge: between 28October2010 (the date of the first data entry) and 01August2013 (the date of data entry closure); Up to 1008 days.
As per the study protocol, the index gastrointestinal and/or and urogenital bleeding event leading to the inclusion of the patient in the study is also included in the definition of Adverse events (AEs).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran (Pradax® in Canada; Pradaxa® in the United States | Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily). | 184 | 220 | 79 | 220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Urogenital haemorrhage | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Occult blood positive | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 19.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Atrial thrombosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Bladder obstruction | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Catheter site haemorrhage | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Embolic stroke | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Emphysematous cholecystitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| International normalised ratio | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| International normalised ratio abnormal | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| International normalised ratio normal | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Microscopic polyangiitis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Renal atrophy | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
Limitations of the data sources included completeness of information available in terms of potential lack of outcome data, medical history data and co-medications. Key limitations: 1. Generalizability. 2. Data quality. 3. Data availability.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
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