Thromboembolism
Conditions
Brief summary
This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.
Interventions
DRUGPraxbindTM
Drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding \- Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
Exclusion criteria
-Participation in a PraxbindTM clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs) | Up to 7 days following treatment. | Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding | Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®. | Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding. |
Countries
India
Participant flow
Recruitment details
This was a multicenter, non-interventional, drug administration surveillance program.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Praxbind® | — |
|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 8.44 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.
Time frame: 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®.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Praxbind® | Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs) | Number of participants with ADRs | 0 Participants |
| Praxbind® | Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs) | Number of participants with AEs | 0 Participants |
Secondary
Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding
Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding.
Time frame: 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®.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Praxbind® | Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding | For emergency surgery/urgent procedures | 20 Percentage of participants |
| Praxbind® | 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 | 80 Percentage of participants |