Hemorrhage
Conditions
Brief summary
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
Interventions
DRUGPrizbind®
Prizbind®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Drug Reactions (ADRs) | From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days. | Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | From the end of the first infusion up to 4 hours after the last infusion on Day 1. | Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100. |
| Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | From the end of the first infusion up to 4 hours after the last infusion on Day 1. | Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100. Maximum Reversal was categorized in the following 4 categories: 100% 80% \<= and \< 100% 50% \<= and \< 80% \< 50% |
Countries
Japan
Participant flow
Recruitment details
This post marketing surveillance (PMS) was a non-interventional study based on new data collection to gather data on safety and effectiveness of the Prizbind® for Intravenous Solution under Japanese clinical condition. All patients were administered Prizbind® for Intravenous Solution after the approval at the sites contracted with the sponsor were to be registered.
Pre-assignment details
All patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators were enrolled. Any screening was not conducted.
Participants by arm
| Arm | Count |
|---|---|
| Prizbind® for Intravenous Solution Patients who had been treated with dabigatran etexilate and required rapid reversal of the anticoagulant effects of dabigatran were administered intravenously 2 vials of 2.5 gram (g) of Prizbind® (total dose: 5 g). Two vials of Prizbind® were administered as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. | 813 |
| Total | 813 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 81 |
| Overall Study | CRFs not valid | 1 |
| Overall Study | CRFs with missing information on the date of termination of PMS | 6 |
| Overall Study | Did not require collection of CRFs | 588 |
| Overall Study | Discharge from hospital | 118 |
| Overall Study | Other than listed | 37 |
Baseline characteristics
| Characteristic | Prizbind® for Intravenous Solution | — |
|---|---|---|
| Age, Continuous | 76.7 Years STANDARD_DEVIATION 9.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 267 Participants | — |
| Sex: Female, Male Male | 546 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 103 / 813 |
| other Total, other adverse events | 0 / 813 |
| serious Total, serious adverse events | 192 / 813 |
Outcome results
Primary
Number of Patients With Adverse Drug Reactions (ADRs)
Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported.
Time frame: From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Population: Safety Set: This patient set included all patients who had no invalid registration, who were documented to have taken at least one dose of Prizbind®.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prizbind® for Intravenous Solution | Number of Patients With Adverse Drug Reactions (ADRs) | 30 Participants |
Secondary
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100.
Time frame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.
Population: Patients of the effectiveness set (all patients with Prizbind® in the safety set who have at least one available effectiveness data) whose activated partial thromboplastin time (aPTT) value at baseline exceeded the upper limit of normal (ULN).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prizbind® for Intravenous Solution | Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | 100.0 percentage |
Secondary
Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100. Maximum Reversal was categorized in the following 4 categories: 100% 80% \<= and \< 100% 50% \<= and \< 80% \< 50%
Time frame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.
Population: Patients of the effectiveness set (all patients with Prizbind® in the safety set who have at least one available effectiveness data) whose activated partial thromboplastin time (aPTT) value at baseline exceeded the upper limit of normal (ULN).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prizbind® for Intravenous Solution | Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | 100 % | 65 Participants |
| Prizbind® for Intravenous Solution | Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | 80<= and <100 % | 16 Participants |
| Prizbind® for Intravenous Solution | Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | 50<= and <80 % | 9 Participants |
| Prizbind® for Intravenous Solution | Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT) | <50 % | 13 Participants |