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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients administered with PraxbindTM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PraxbindTM | Drug | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 days following treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®. |
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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
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All patients, who receive PraxbindTM prescribed as per the approved label
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazumdar Shaw Medical centre | Bangalore | 560099 | India | |||
| Columbia Asia Referral Hospital |
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to:
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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.
This was a multicenter, non-interventional, drug administration surveillance program.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated Set: Includes patients, who signed the ICF (Informed consent form), met the eligibility criteria and received Praxbind®.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Treated Set: Includes patients, who signed the ICF (Informed consent form), met the eligibility criteria and received Praxbind®. | Posted | Count of Participants | Participants | Up to 7 days following treatment. |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2018 | Feb 8, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2018 | Feb 8, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000594745 | idarucizumab |
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| Bengaluru |
| 560055 |
| India |
| Care Hospital | Hyderabad | 500034 | India |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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. | Treated Set: Includes patients, who signed the ICF (Informed consent form), met the eligibility criteria and received Praxbind®. | Posted | Number | Percentage of participants | Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®. |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| Proctalgia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
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