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The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure.
The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - patients with uncontrolled or life-threatening bleeding | Experimental |
| |
| Group B - patients not bleeding but requiring emergency surgery or invasive procedure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idarucizumab | Drug | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time | Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 41.26 seconds. | From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period. |
| Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time | Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 35.54 seconds. | From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only) | Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported. | Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period. |
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Inclusion criteria:
≥ 18 years at screening.
Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Currently taking dabigatran etexilate
They meet the following criteria:
Exclusion criteria:
Group A:
Group B:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing AnZhen Hospital | Beijing | 100029 | China | |||
| Peking University First Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This study was to demonstrate the reversal of the anticoagulant effects of dabigatran by intravenous administration of idarucizumab in patients treated with dabigatran etexilate who had uncontrolled bleeding or required emergency surgery or procedures over treatment period of 1 day following by 30 days follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients who were taking dabigatran etexilate and had uncontrolled or life-threatening bleeding requiring urgent medical or surgical intervention were included in this group. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jun 1, 2017 | May 19, 2021 |
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| Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery | Number of participants with major bleeding (for Group B only) intra-operatively and up to 24 hours post-surgery per International Society for Thrombosis and Hemostasis (ISTH) classification is reported. | Up to 24 hours post-surgery. |
| Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1) | Minimum unbound sum dabigatran concentrations since the end of first infusion up to 4 hours after the completion of the last infusion (Cmin,1) is reported. | Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion. |
| 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. The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 39.80 seconds. | From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period. |
| Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT) | Maximum reversal of anticoagulation as measured by thrombin time (TT) is reported. The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If calculated reversal is > 100, it was set to 100. 100% ULN is 14.22 seconds. | From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period. |
| Numbers of Participants With Any Adverse Events - on Treatment | Numbers of participants with any adverse events during on treatment period is reported. | Since the first infusion up until 5 days after the completion of the second infusion. |
| Numbers of Participants With Any Adverse Events - Including Post Treatment Period | Numbers of participants with any adverse events until end of study is reported. | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
| Number of Participants With Serious Adverse Events - on Treatment | Number of participants with Serious adverse events during on treatment period is reported. | Since the first infusion up until 5 days after the completion of the second infusion. |
| Number of Participants With Serious Adverse Events - Including Post Treatment Period | Number of participants with Serious adverse events until the end of study is reported. | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
| Number of Participants With Drug-related Adverse Events - on Treatment | Numbers of patients with drug-related adverse events during on treatment period is reported. | Since the first infusion up until 5 days after the completion of the second infusion. |
| Number of Participants With Drug-related Adverse Events - Including Post Treatment Period | Numbers of patients with drug-related adverse events until end of study is reported. | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
| Number of Participants With Immune Reaction Adverse Event - on Treatment | Number of participants with immune reaction adverse event during on treatment period is reported. | Since the first infusion up until 5 days after the completion of the second infusion. |
| Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period | Number of participants with immune reaction adverse event until end of study is reported. | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
| Number of Participants With Thrombotic Events - on Treatment | Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported. | Since the first infusion up until 5 days after the completion of the second infusion. |
| Number of Participants With Thrombotic Events - Including Post Treatment Period | Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported. | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
| Beijing |
| 100034 |
| China |
| Cardiovascular Institute and Fu Wai Hospital | Beijing | 100037 | China |
| First Affiliated Hospital of Dalian Medical University | Dalian | 116011 | China |
| Guangdong Provincial People's Hospital | Guangzhou | 510080 | China |
| Sun yet-sen Memorial Hospital, Sun yet-sen Univesity | Guangzhou | 510288 | China |
| 2nd Affiliated Hosp Zhejiang University College of Medical | Hangzhou | 310009 | China |
| Zhejiang Province People's Hospital | Hangzhou | 310014 | China |
| The Second Affiliated Hospital to Nanchang University | Nanchang | 330006 | China |
| Jiangsu Province Hospital | Nanjing, Jiangsu Province | 210029 | China |
| Shanghai First People's Hospital | Shanghai | 200080 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | 830054 | China |
| The First Affiliated Hospital of Wenzhou Med College | Wenzhou | 325000 | China |
| FG001 | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable. |
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| NOT COMPLETED |
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Treated set (TS): include all patients who are administered with idarucizumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients who were taking dabigatran etexilate and had uncontrolled or life-threatening bleeding requiring urgent medical or surgical intervention were included in this group. |
| BG001 | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time | Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 41.26 seconds. | Pharmacodynamic (PD) set (PDS): comprise all patients in the treated set who provided at least one evaluable pre-dose and at least one post-dose observation for PD endpoints or biomarker measures. Only participants with non-missing outcomes are included in the analysis. | Posted | Median | 95% Confidence Interval | Percentage | From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period. |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time | Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 35.54 seconds. | Pharmacodynamic (PD) set (PDS): comprise all patients in the treated set who provided at least one evaluable pre-dose and at least one post-dose observation for PD endpoints or biomarker measures. Only participants with non-missing outcomes are included in the analysis. | Posted | Median | 95% Confidence Interval | Percentage | From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period. |
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| Secondary | Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only) | Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported. | Treated set (TS): include all patients who are administered with idarucizumab. Patients with no evaluable post-baseline bleeding assessment are excluded. This analysis only included patients with uncontrolled or life-threatening bleeding, and non-Intracranial Hemorrhage (non-ICH) in Group A. | Posted | Number | Percentage of participants | Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery | Number of participants with major bleeding (for Group B only) intra-operatively and up to 24 hours post-surgery per International Society for Thrombosis and Hemostasis (ISTH) classification is reported. | Treated set (TS): include all patients who are administered with idarucizumab. This analysis only included patients not bleeding but requiring emergency surgery or invasive procedure (Group B). | Posted | Count of Participants | Participants | Up to 24 hours post-surgery. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1) | Minimum unbound sum dabigatran concentrations since the end of first infusion up to 4 hours after the completion of the last infusion (Cmin,1) is reported. | Pharmacokinetic (PK) set (PKS): comprise all patients in the TS who provided at least one PK endpoint. The PKS will be used for all PK analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion. |
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| 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. The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 39.80 seconds. | Pharmacodynamic (PD) set (PDS): comprise all patients in the treated set who provided at least one evaluable pre-dose and at least one post-dose observation for PD endpoints or biomarker measures. Only participants with non-missing outcomes are included in the analysis. | Posted | Median | 95% Confidence Interval | Percentage | From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period. |
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| Secondary | Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT) | Maximum reversal of anticoagulation as measured by thrombin time (TT) is reported. The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If calculated reversal is > 100, it was set to 100. 100% ULN is 14.22 seconds. | Pharmacodynamic (PD) set (PDS): comprise all patients in the treated set who provided at least one evaluable pre-dose and at least one post-dose observation for PD endpoints or biomarker measures. Only participants with non-missing outcomes are included in the analysis. | Posted | Median | 95% Confidence Interval | Percentage | From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period. |
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| Secondary | Numbers of Participants With Any Adverse Events - on Treatment | Numbers of participants with any adverse events during on treatment period is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since the first infusion up until 5 days after the completion of the second infusion. |
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| Secondary | Numbers of Participants With Any Adverse Events - Including Post Treatment Period | Numbers of participants with any adverse events until end of study is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
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| Secondary | Number of Participants With Serious Adverse Events - on Treatment | Number of participants with Serious adverse events during on treatment period is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since the first infusion up until 5 days after the completion of the second infusion. |
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| Secondary | Number of Participants With Serious Adverse Events - Including Post Treatment Period | Number of participants with Serious adverse events until the end of study is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
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| Secondary | Number of Participants With Drug-related Adverse Events - on Treatment | Numbers of patients with drug-related adverse events during on treatment period is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since the first infusion up until 5 days after the completion of the second infusion. |
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| Secondary | Number of Participants With Drug-related Adverse Events - Including Post Treatment Period | Numbers of patients with drug-related adverse events until end of study is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
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| Secondary | Number of Participants With Immune Reaction Adverse Event - on Treatment | Number of participants with immune reaction adverse event during on treatment period is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since the first infusion up until 5 days after the completion of the second infusion. |
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| Secondary | Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period | Number of participants with immune reaction adverse event until end of study is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
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| Secondary | Number of Participants With Thrombotic Events - on Treatment | Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since the first infusion up until 5 days after the completion of the second infusion. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Thrombotic Events - Including Post Treatment Period | Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported. | Treated set (TS): include all patients who are administered with idarucizumab. | Posted | Count of Participants | Participants | Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days. |
|
Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Treated set (TS): include all patients who are administered with idarucizumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A - Patients With Uncontrolled or Life-threatening Bleeding | Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients who were taking dabigatran etexilate and had uncontrolled or life-threatening bleeding requiring urgent medical or surgical intervention were included in this group. | 0 | 13 | 7 | 13 | 13 | 13 |
| EG001 | Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure | Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable. | 1 | 6 | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperfibrinolysis | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dysbiosis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac procedure complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Urethral injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Antithrombin III decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood cholinesterase decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood uric acid decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Fibrin degradation products increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Gamma-glutamyltransferase decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| High density lipoprotein decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Lymphocyte percentage decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Monocyte percentage decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Myoglobin blood increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Neutrophil percentage increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Prothrombin time prolonged | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Pulmonary arterial pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Thrombin time prolonged | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Troponin I increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2019 | May 19, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594745 | idarucizumab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure |
Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable. |
| OG002 | Total | All participants in Group A or B were included in this group. |
|
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|
Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable. |
| OG002 | Total | All participants in Group A or B were included in this group. |
|
|
Two vials of 2.5 grams (g) of idarucizumab (BI 655075) (Total: 5g) were administered via intravenous infusions once over a 1-day treatment period. Two vials of idarucizumab were administered no more than 15 minutes apart. Patients included in this group were those who were taking dabigatran etexilate and may not be bleeding, but do require an emergency surgery or other invasive procedure for a condition other than bleeding, where therapeutic anticoagulation with dabigatran etexilate was undesirable. |
| OG002 | Total | All participants in Group A or B were included in this group. |
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