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| Name | Class |
|---|---|
| Children's Hospital Acquired Thrombosis consortium | UNKNOWN |
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The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pradaxa-treated patients | Pediatric patients with acute venous thromboembolic events (VTE) and/or at risk of recurrent VTE due to the presence of unresolved clinical risk factors received Pradaxa Pellets orally, either according to the prescribing label or off-label. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Clinically Relevant Bleeding Events | Cumulative incidence of clinically relevant bleeding events was reported as the number of participants with clinically relevant bleeding events, defined as the composite of major bleeding events (MBE) and clinically relevant non-major (CRNM) bleeding events, according to recommendations from international thrombosis and hemostasis committees. MBE were defined as: fatal bleeding; clinically overt bleeding associated with a decrease in hemoglobin of at least 2 grams/deciliter in a 24-hour period; critical site bleeding; bleeding that required an intervention via invasive procedure; and overt bleeding for which a reversal agent was administered. CRNM bleeding was defined as: overt bleeding for which a blood product was administered and did not meet the criteria for major bleeding; bleeding that resulted in a medical or procedural intervention not meeting major bleeding criteria, including a medication change; and bleeding that resulted in hospitalization or an increased level of care. | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Recurrent Venous Thromboembolic Event (VTE) | The occurrence of VTE is reported as the number of participants with recurrent VTE including both symptomatic and asymptomatic events. Symptomatic recurrent VTE is defined as radiologically-confirmed new venous thrombotic or embolic burden at least 7 days post-diagnosis of the index VTE, accompanied by signs and/or symptoms attributable to the new thromboembolism. Asymptomatic VTE was defined by new thrombotic/embolic burden as disclosed by comparison of end-of-treatment imaging versus baseline imaging of the vascular region involved by the index VTE. |
Not provided
Inclusion Criteria:
Pediatric patients aged 3 months to less than 12 years at the time of Pradaxa Pellets initiation
Written informed consent from parents/care givers and patient assent if age appropriate
Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:
Exclusion Criteria:
Not provided
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Pediatric patients aged 3 months to less than 12 years, who may be considered for anticoagulation with Pradaxa Pellets due to venous thromboembolic events (VTE), are usually treated in neonatology, pediatric general surgery, cardiac surgery or intensive care units. Pediatric patients with anticoagulation with Pradaxa Pellets for the prevention of recurrent VTE are usually evaluated by pediatric hematologists in pediatric hematology units. Any of these patients that are prescribed Pradaxa pellets may be considered for inclusion into this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States | ||
| Rady Children's Hospital |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
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.
Patients were excluded if they had any contraindications to Pradaxa Pellets according to the US Prescribing Information, were participating in any randomized clinical trial, or using any investigational product.
Non-interventional, multi-center study in the United States (US) based on newly collected data of pediatric patients receiving Pradaxa pellets as anticoagulation care: after being treated with parenteral anticoagulants for the treatment of acute venous thromboembolic events (VTE); to reduce the risk of VTE recurrence after treatment of VTE; for off-label use in the treatment of VTE or to reduce the risk of VTE recurrence.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pradaxa-treated Patients | Pediatric patients with acute venous thromboembolic events (VTE) and/or at risk of recurrent VTE due to the presence of unresolved clinical risk factors received Pradaxa Pellets orally, either according to the prescribing label or off-label. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Apr 26, 2024 | Apr 13, 2026 |
Not provided
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| From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Mortality Related to Thrombotic or Thromboembolic Events | Number of participants who died with thrombotic or thromboembolic events. | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Occurrence of All Bleeding Events | The occurrence of all-bleeding events is reported as the number of participants experiencing any of the bleeding event described. All bleeding events were defined as the composite of major bleeding events (MBE), clinically relevant non-major (CRNM) bleeding events and minor bleeding events but not leading to hospitalization, increased level of inpatient care, or an intervention by the medical team. Minor bleeding events were defined as any overt or macroscopic evidence of bleeding that does not fulfil the criteria for major bleeding, CRNM bleeding, or important bleeding without intervention according to recommendations from international thrombosis and hemostasis committees. | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Occurrence of Post-thrombotic Syndrome (PTS) | Occurrence of post-thrombotic syndrome (PTS) is reported as the number of participants with PTS. The presence of PTS was evaluated by the Villalta Scale Modified for Children, the Manco-Johnson instrument, or other validated pediatric PTS instrument employed in routine clinical care, according to recommendations from international thrombosis and hemostasis committees. | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Incidence of Adverse Events (AEs) | Incidence of adverse events is reported as number of participants with any adverse event (AEs). | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Incidence of Serious Adverse Events (SAEs) | Incidence of serious adverse events is reported as number of participants with serious adverse event (SAEs). | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Thrombotic Burden at the End of Treatment | Number of participants with thrombotic burden at the end of the treatment period compared to baseline was quantified by image-based resolution status of the thrombus at the discretion of the treating physician, based on the type and location of the initial diagnosis of the thromboembolism. When appropriate, the same approach used for the baseline evaluations was utilized. | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Recurrence of Venous Thromboembolic Event (VTE) While on Treatment | Number of participants with new or recurrent VTE occurring at least 7 days after diagnosis of the VTE captured on the baseline VTE form (index VTE). | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| Duration of Treatment With Dabigatran Etexilate | The median duration of the dabigatran etexilate (Pradaxa Pellets) treatment is reported. | From first Pradaxa Pellets exposure until its discontinuation. Up to 370 days. |
| Compliance With Dabigatran Etexilate Treatment | Number of participants complying with dabigatran etexilate (Pradaxa Pellets) treatment. Compliance was defined as not missing 0-1 treatment dose since the last visit, as evaluated at each time point. Unscheduled follow-up was defined as patient contact in between any scheduled study visit. | From first Pradaxa Pellets exposure until its discontinuation. At 6-week, 3-months, 6-month, and 12-month follow-up, and at unscheduled follow-up (up to 370 days). |
| Incidence of Adverse Events Leading to Drug Discontinuation | Incidence of adverse events leading to discontinuation of Pradaxa Pellets is reported as the number of participants. | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
| San Diego |
| California |
| 92123 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Indiana Hemophilia & Thrombrosis Center | Indianapolis | Indiana | 46260 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| MUSC (Medical university of South Carolina) | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Dell Children's Ascension | Austin | Texas | 78723 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa pellets.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pradaxa-treated Patients | Pediatric patients with acute venous thromboembolic events (VTE) and/or at risk of recurrent VTE due to the presence of unresolved clinical risk factors received Pradaxa Pellets orally, either according to the prescribing label or off-label. |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Cumulative Incidence of Clinically Relevant Bleeding Events | Cumulative incidence of clinically relevant bleeding events was reported as the number of participants with clinically relevant bleeding events, defined as the composite of major bleeding events (MBE) and clinically relevant non-major (CRNM) bleeding events, according to recommendations from international thrombosis and hemostasis committees. MBE were defined as: fatal bleeding; clinically overt bleeding associated with a decrease in hemoglobin of at least 2 grams/deciliter in a 24-hour period; critical site bleeding; bleeding that required an intervention via invasive procedure; and overt bleeding for which a reversal agent was administered. CRNM bleeding was defined as: overt bleeding for which a blood product was administered and did not meet the criteria for major bleeding; bleeding that resulted in a medical or procedural intervention not meeting major bleeding criteria, including a medication change; and bleeding that resulted in hospitalization or an increased level of care. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Occurrence of Recurrent Venous Thromboembolic Event (VTE) | The occurrence of VTE is reported as the number of participants with recurrent VTE including both symptomatic and asymptomatic events. Symptomatic recurrent VTE is defined as radiologically-confirmed new venous thrombotic or embolic burden at least 7 days post-diagnosis of the index VTE, accompanied by signs and/or symptoms attributable to the new thromboembolism. Asymptomatic VTE was defined by new thrombotic/embolic burden as disclosed by comparison of end-of-treatment imaging versus baseline imaging of the vascular region involved by the index VTE. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Mortality Related to Thrombotic or Thromboembolic Events | Number of participants who died with thrombotic or thromboembolic events. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of All Bleeding Events | The occurrence of all-bleeding events is reported as the number of participants experiencing any of the bleeding event described. All bleeding events were defined as the composite of major bleeding events (MBE), clinically relevant non-major (CRNM) bleeding events and minor bleeding events but not leading to hospitalization, increased level of inpatient care, or an intervention by the medical team. Minor bleeding events were defined as any overt or macroscopic evidence of bleeding that does not fulfil the criteria for major bleeding, CRNM bleeding, or important bleeding without intervention according to recommendations from international thrombosis and hemostasis committees. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of Post-thrombotic Syndrome (PTS) | Occurrence of post-thrombotic syndrome (PTS) is reported as the number of participants with PTS. The presence of PTS was evaluated by the Villalta Scale Modified for Children, the Manco-Johnson instrument, or other validated pediatric PTS instrument employed in routine clinical care, according to recommendations from international thrombosis and hemostasis committees. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events (AEs) | Incidence of adverse events is reported as number of participants with any adverse event (AEs). | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Incidence of serious adverse events is reported as number of participants with serious adverse event (SAEs). | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Thrombotic Burden at the End of Treatment | Number of participants with thrombotic burden at the end of the treatment period compared to baseline was quantified by image-based resolution status of the thrombus at the discretion of the treating physician, based on the type and location of the initial diagnosis of the thromboembolism. When appropriate, the same approach used for the baseline evaluations was utilized. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Recurrence of Venous Thromboembolic Event (VTE) While on Treatment | Number of participants with new or recurrent VTE occurring at least 7 days after diagnosis of the VTE captured on the baseline VTE form (index VTE). | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Treatment With Dabigatran Etexilate | The median duration of the dabigatran etexilate (Pradaxa Pellets) treatment is reported. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Median | Full Range | Days | From first Pradaxa Pellets exposure until its discontinuation. Up to 370 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Compliance With Dabigatran Etexilate Treatment | Number of participants complying with dabigatran etexilate (Pradaxa Pellets) treatment. Compliance was defined as not missing 0-1 treatment dose since the last visit, as evaluated at each time point. Unscheduled follow-up was defined as patient contact in between any scheduled study visit. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. Participants with missing values were excluded from the analysis of this outcome. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation. At 6-week, 3-months, 6-month, and 12-month follow-up, and at unscheduled follow-up (up to 370 days). |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events Leading to Drug Discontinuation | Incidence of adverse events leading to discontinuation of Pradaxa Pellets is reported as the number of participants. | All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets. | Posted | Count of Participants | Participants | From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days. |
|
|
From first Pradaxa Pellets exposure until its discontinuation plus 3 days of residual effect period, switch to other anticoagulation therapy, or planned observation time, whichever occurred first. Up to 373 days.
All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
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 | Pradaxa-treated Patients | Pediatric patients with acute venous thromboembolic events (VTE) and/or at risk of recurrent VTE due to the presence of unresolved clinical risk factors received Pradaxa Pellets orally, either according to the prescribing label or off-label. | 0 | 5 | 2 | 5 | 4 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial thrombosis | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Subacute endocarditis | Infections and infestations | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Chills | General disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Pain | General disorders | 27.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Rhinitis allergic | Immune System Disorders | 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
|
The number of Pradaxa Pellets prescriptions was very low, making the enrollment of a sufficient number of patients over the course of the trial unlikely. The study was terminated after 1.5 years with 5 patients enrolled.
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 | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical analysis plan amendment | Jul 23, 2025 | Apr 13, 2026 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical analysis plan | Jul 23, 2024 | Apr 13, 2026 | SAP_002.pdf |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Participants |
|
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