Trial Outcomes & Findings for A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot (NCT NCT05966740)
NCT ID: NCT05966740
Last Updated: 2026-06-02
Results Overview
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.
TERMINATED
5 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.
2026-06-02
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Early termination
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1
|
Baseline Characteristics
A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
Baseline characteristics by cohort
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
|
Age, Continuous
|
7.73 Years
STANDARD_DEVIATION 3.13 • n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
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.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
|
|---|---|
|
Cumulative Incidence of Clinically Relevant Bleeding Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
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.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
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Occurrence of Recurrent Venous Thromboembolic Event (VTE)
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
Number of participants who died with thrombotic or thromboembolic events.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
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Mortality Related to Thrombotic or Thromboembolic Events
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
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.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
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Occurrence of All Bleeding Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
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.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
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Occurrence of Post-thrombotic Syndrome (PTS)
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
Incidence of adverse events is reported as number of participants with any adverse event (AEs).
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
|
Incidence of Adverse Events (AEs)
|
4 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
Incidence of serious adverse events is reported as number of participants with serious adverse event (SAEs).
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
|
Incidence of Serious Adverse Events (SAEs)
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
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.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
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Thrombotic Burden at the End of Treatment
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
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).
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
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Recurrence of Venous Thromboembolic Event (VTE) While on Treatment
|
2 Participants
|
SECONDARY outcome
Timeframe: From first Pradaxa Pellets exposure until its discontinuation. Up to 370 days.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
The median duration of the dabigatran etexilate (Pradaxa Pellets) treatment is reported.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
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Duration of Treatment With Dabigatran Etexilate
|
118.0 Days
Interval 28.0 to 370.0
|
SECONDARY outcome
Timeframe: 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).Population: 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.
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.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
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Compliance With Dabigatran Etexilate Treatment
6 Week follow-up
|
4 Participants
|
|
Compliance With Dabigatran Etexilate Treatment
3 Months follow-up
|
1 Participants
|
|
Compliance With Dabigatran Etexilate Treatment
6 Months follow-up
|
2 Participants
|
|
Compliance With Dabigatran Etexilate Treatment
12 Months follow-up
|
0 Participants
|
|
Compliance With Dabigatran Etexilate Treatment
Unscheduled follow-up
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All patients enrolled in the study according to the eligibility criteria and who received at least one dose of Pradaxa Pellets.
Incidence of adverse events leading to discontinuation of Pradaxa Pellets is reported as the number of participants.
Outcome measures
| Measure |
Pradaxa-treated Patients
n=5 Participants
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.
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|---|---|
|
Incidence of Adverse Events Leading to Drug Discontinuation
|
1 Participants
|
Adverse Events
Pradaxa-treated Patients
Serious adverse events
| Measure |
Pradaxa-treated Patients
n=5 participants at risk
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.
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|---|---|
|
Cardiac disorders
Atrial thrombosis
|
20.0%
1/5 • 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.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
20.0%
1/5 • 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.
|
|
Cardiac disorders
Chest pain
|
20.0%
1/5 • 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.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
20.0%
1/5 • 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.
|
|
General disorders
Pyrexia
|
20.0%
1/5 • 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.
|
|
Infections and infestations
Rhinovirus infection
|
20.0%
1/5 • 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.
|
|
Infections and infestations
Subacute endocarditis
|
20.0%
1/5 • 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.
|
Other adverse events
| Measure |
Pradaxa-treated Patients
n=5 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • 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.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
20.0%
1/5 • 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.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
20.0%
1/5 • 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.
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • 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.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
20.0%
1/5 • 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.
|
|
Endocrine disorders
Adrenal insufficiency
|
20.0%
1/5 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • 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.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • 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.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • 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.
|
|
Gastrointestinal disorders
Oral candidiasis
|
20.0%
1/5 • 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.
|
|
General disorders
Chills
|
20.0%
1/5 • 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.
|
|
General disorders
Fatigue
|
40.0%
2/5 • 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.
|
|
General disorders
Pain
|
20.0%
1/5 • 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.
|
|
General disorders
Peripheral swelling
|
20.0%
1/5 • 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.
|
|
General disorders
Pyrexia
|
80.0%
4/5 • 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.
|
|
Immune System Disorders
Rhinitis allergic
|
20.0%
1/5 • 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.
|
|
Infections and infestations
Influenza
|
20.0%
1/5 • 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.
|
|
Infections and infestations
Rhinovirus infection
|
20.0%
1/5 • 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.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.0%
1/5 • 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • 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.
|
|
Injury, poisoning and procedural complications
Head injury
|
20.0%
1/5 • 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.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
20.0%
1/5 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • 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.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • 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.
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • 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.
|
|
Renal and urinary disorders
Haematuria
|
20.0%
1/5 • 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
20.0%
1/5 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
1/5 • 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.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
20.0%
1/5 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • 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.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER