Trial Outcomes & Findings for PraxbindTM India PMS Program (NCT NCT03359889)
NCT ID: NCT03359889
Last Updated: 2023-08-25
Results Overview
Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.
COMPLETED
5 participants
Up to 7 days following treatment.
2023-08-25
Participant Flow
This was a multicenter, non-interventional, drug administration surveillance program.
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Praxbind®
Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
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|---|---|
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Praxbind®
n=5 Participants
Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
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Age, Continuous
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64.8 years
STANDARD_DEVIATION 8.44 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 7 days following treatment.Population: Treated Set: Includes patients, who signed the ICF (Informed consent form), met the eligibility criteria and received Praxbind®.
Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.
Outcome measures
| Measure |
Praxbind®
n=5 Participants
Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
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|---|---|
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Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
Number of participants with ADRs
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0 Participants
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Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
Number of participants with AEs
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0 Participants
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SECONDARY outcome
Timeframe: Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®.Population: Treated Set: Includes patients, who signed the ICF (Informed consent form), met the eligibility criteria and received Praxbind®.
Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding.
Outcome measures
| Measure |
Praxbind®
n=5 Participants
Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
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|---|---|
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Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding
For emergency surgery/urgent procedures
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20 Percentage of participants
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Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding
In life-threatening or uncontrolled bleeding
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80 Percentage of participants
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Adverse Events
Praxbind®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Praxbind®
n=5 participants at risk
Patients in a clinical practice setting treated with Pradaxa® (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran were treated with idarucizumab (Praxbind®). 1 vial of 50 milliliter (ml) contains 2.5 gram (g) idarucizumab (50 milligram/milliliter) given as an intravenous (IV) infusion, total recommended dose of 5 g.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
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20.0%
1/5 • Up to 7 days following treatment.
Treated Set: Includes patients, who signed the ICF (Informed consent form), met the eligibility criteria and received Praxbind®.
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Gastrointestinal disorders
Proctalgia
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20.0%
1/5 • Up to 7 days following treatment.
Treated Set: Includes patients, who signed the ICF (Informed consent form), met the eligibility criteria and received Praxbind®.
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Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place