Trial · NCT02074358
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
NCT02074358, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2015-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects. Trials, record NCT02074358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02074358
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
- NCT number
- NCT02074358
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 43 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Anticoagulation
- Interventions
- Apixaban, Cofact (4-Factor PCC), Beriplex P/N (4-Factor PCC), Placebo (Saline solution)
- First posted
- 2014-02-28
- Last updated
- 2015-08-13
- Other registries' IDs
- eudract:2013-000646-18
- Results first posted
- 2015-08-13
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo) | ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. Dedicated software (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting "thrombogram" curve. Pre-infusion baseline= sample on Day 4, 3 hours post apixaban dose (just prior to IV infusion of PCC or placebo). Samples on Day 4 were obtained at 0 (pre-dose), 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. ETP was measured as nanomolar\*minute (nM\*min). |
| Primary | PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 1 pre-dose apixaban (pre-apixaban Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo) | ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. A dedicated software program (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting "thrombogram" curve. Pre-dose Apixaban baseline was Day 1 pre-dose (0 hour). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. |
| Secondary | PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Lag Time and Time to Peak parameters were measured in minutes. |
| Secondary | PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Peak height parameter was measured in nanomolar (nM). |
| Secondary | PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Velocity Index parameter was measured in nM per minute (nM/min). |
| Secondary | PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents \[HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT\]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. PT (Neoplastin CT+), PT (Recombiplastin 2G) and activated partial thromboplastin time (aPTT) parameters were measured in seconds. |
| Secondary | PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents \[HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT\]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction. |
| Secondary | PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | Anti-FXa activity was measured using a validated method at Esoterix Coagulation Laboratory (Englewood, CO) using the Diagnostica Stago Rotachrom (Registered) Heparin assay on a STA-Compact (Registered) analyzer. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. The results of this chromogenic assay were reported in low molecular weight heparin (LMWH) activity units per milliliter (U/mL), which are equivalent to international units per milliliter (IU/mL) with assay reportable range: 0.1 to 18.4 IU/mL. |
| Secondary | PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion. | TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes. |
| Secondary | PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion. | TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo) | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | nM*min | MEAN |
| SECONDARY | PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | minutes | MEAN |
| SECONDARY | PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | nM | MEAN |
| SECONDARY | PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | nM/min | MEAN |
| SECONDARY | PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | seconds | MEAN |
| SECONDARY | PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | fraction | MEAN |
| SECONDARY | PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | U/mL | MEAN |
| SECONDARY | PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | minutes | MEAN |
| SECONDARY | PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | nM | MEAN |
| SECONDARY | PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion. | PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis. | nM/min | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment A: Apixaban + Placebo | 95.8 | 95% Confidence Interval 21.3 to 170.2 | nM*min | |
| Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment B: Apixaban + Cofact (4-Factor PCC) | 521.0 | 95% Confidence Interval 314.6 to 727.4 | nM*min | |
| Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 186.3 | 95% Confidence Interval 49.7 to 322.9 | nM*min | |
| PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment A: Apixaban + Placebo | TGA Lag Time (n=15, 14, 15) | -0.16 | 95% Confidence Interval -0.59 to 0.26 | minutes |
| PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment B: Apixaban + Cofact (4-Factor PCC) | TGA Lag Time (n=15, 14, 15) | -0.38 | 95% Confidence Interval -0.85 to 0.10 | minutes |
| PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | TGA Lag Time (n=15, 14, 15) | -0.32 | 95% Confidence Interval -0.75 to 0.10 | minutes |
| PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment A: Apixaban + Placebo | TGA Time to Peak (n=15, 14, 15) | -1.29 | 95% Confidence Interval -3.45 to 0.87 | minutes |
| PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment B: Apixaban + Cofact (4-Factor PCC) | TGA Time to Peak (n=15, 14, 15) | 0.06 | 95% Confidence Interval -1.30 to 1.42 | minutes |
| PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | TGA Time to Peak (n=15, 14, 15) | 3.32 | 95% Confidence Interval 1.97 to 4.68 | minutes |
| PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo | Treatment A: Apixaban + Placebo | 11.1 | 95% Confidence Interval 5.1 to 17.0 | nM |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment ABC | 3 | |
| Overall Study | STARTED | Treatment ACB | 3 | |
| Overall Study | STARTED | Treatment BAC | 2 | |
| Overall Study | STARTED | Treatment BCA | 2 | |
| Overall Study | STARTED | Treatment CAB | 3 | |
| Overall Study | STARTED | Treatment CBA | 2 | |
| Overall Study | COMPLETED | Treatment ABC | 3 | |
| Overall Study | COMPLETED | Treatment ACB | 3 | |
| Overall Study | COMPLETED | Treatment BAC | 2 | |
| Overall Study | COMPLETED | Treatment BCA | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Treatment A: Apixaban + Placebo | 0 | 15 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment B: Apixaban + Cofact (4-Factor PCC) | 0 | 15 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 2 | 15 | |
| other | Flatulence | Gastrointestinal disorders | Treatment A: Apixaban + Placebo | 0 | 15 | |
| other | Flatulence | Gastrointestinal disorders | Treatment B: Apixaban + Cofact (4-Factor PCC) | 1 | 15 | |
| other | Flatulence | Gastrointestinal disorders | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 0 | 15 | |
| other | Nasopharyngitis | Infections and infestations | Treatment A: Apixaban + Placebo | 0 | 15 | |
| other | Nasopharyngitis | Infections and infestations | Treatment B: Apixaban + Cofact (4-Factor PCC) | 2 | 15 | |
| other | Nasopharyngitis | Infections and infestations | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 0 | 15 | |
| other | Dizziness | Nervous system disorders | Treatment A: Apixaban + Placebo | 0 | 15 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A: Apixaban + Placebo | ||
| Total, all-cause mortality | Treatment B: Apixaban + Cofact (4-Factor PCC) | ||
| Total, all-cause mortality | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | ||
| Total, other adverse events | Treatment A: Apixaban + Placebo | 1 | 15 |
| Total, other adverse events | Treatment B: Apixaban + Cofact (4-Factor PCC) | 5 | 15 |
| Total, other adverse events | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 2 | 15 |
| Total, serious adverse events | Treatment A: Apixaban + Placebo | 0 | 15 |
| Total, serious adverse events | Treatment B: Apixaban + Cofact (4-Factor PCC) | 0 | 15 |
| Total, serious adverse events | Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
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Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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