Trial Outcomes & Findings for A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban (NCT NCT02207725)
NCT ID: NCT02207725
Last Updated: 2023-08-08
Results Overview
In Part I, the primary endpoint was percent change from baseline in anti-fXa activity at the nadir, when nadir was defined as the smaller value for anti-fXa activity at the +2 minutes or +5 minutes time point following the end of the bolus. In Part II, the primary endpoint was the percent change from baseline in anti-fXa activity from its baseline to nadir, when nadir was defined as the smaller value for anti-fXa activity between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion. The baseline for the primary endpoint in both parts was the anti-fXa activity just prior to administration of andexanet, 3 hours following the Day 4 dose of apixaban. Anti-fXa activity was measured by a modified chromogenic assay.
COMPLETED
PHASE3
68 participants
Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)
2023-08-08
Participant Flow
Subject recruitment occurred at investigative site in the US between March 2014 through December 2014
Apixaban was administered orally at 5 mg twice daily for 3.5 days to steady-state and then administered andexanet as a bolus (400 mg; Part I) or as a bolus followed by an infusion (400 mg bolus followed by 4 mg/min infusion for 120 minutes, 880 mg total dose; Part II). Bolus was started 3 hours after the last apixaban dose.
Participant milestones
| Measure |
Placebo (Part I)
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
25
|
9
|
25
|
|
Overall Study
COMPLETED
|
9
|
24
|
8
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Part I)
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
|---|---|---|---|---|
|
Overall Study
Did Not Receive Treatment
|
0
|
1
|
1
|
1
|
Baseline Characteristics
A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban
Baseline characteristics by cohort
| Measure |
Placebo (Part I)
n=9 Participants
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
n=24 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
n=8 Participants
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
n=24 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 3.54 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 6.37 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 6.91 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 7.83 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 6.64 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)Population: Modified Intent-to-Treat Population included all subjects receiving andexanet/placebo with anti-fXa activity baseline value at ≥1 timepoints: 2 or 5 minute after the end of the bolus (Part I; N = 33); 110 minute during continuous infusion, 2 minute before or 5 minute after the end of continuous infusion (Part II; N = 31).
In Part I, the primary endpoint was percent change from baseline in anti-fXa activity at the nadir, when nadir was defined as the smaller value for anti-fXa activity at the +2 minutes or +5 minutes time point following the end of the bolus. In Part II, the primary endpoint was the percent change from baseline in anti-fXa activity from its baseline to nadir, when nadir was defined as the smaller value for anti-fXa activity between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion. The baseline for the primary endpoint in both parts was the anti-fXa activity just prior to administration of andexanet, 3 hours following the Day 4 dose of apixaban. Anti-fXa activity was measured by a modified chromogenic assay.
Outcome measures
| Measure |
Placebo (Part I)
n=9 Participants
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
n=24 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
n=8 Participants
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
n=23 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II)
|
-20.71 Percent change in anti-fXa activity
Standard Deviation 8.559
|
-93.86 Percent change in anti-fXa activity
Standard Deviation 1.650
|
-32.70 Percent change in anti-fXa activity
Standard Deviation 5.578
|
-92.34 Percent change in anti-fXa activity
Standard Deviation 2.809
|
SECONDARY outcome
Timeframe: Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part II)Population: mITT; 33 and 31 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively.
The percent change from baseline in anti-fXa activity at the nadir, following the bolus, when nadir was defined as the smaller value for anti-fXa activity at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part II). Baseline was the last assessment obtained prior to the first dose of andexanet or placebo
Outcome measures
| Measure |
Placebo (Part I)
n=8 Participants
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
n=23 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
|---|---|---|---|---|
|
Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Part II)
|
-16.73 Percent change in anti-fXa activity
Standard Deviation 4.104
|
-93.49 Percent change in anti-fXa activity
Standard Deviation 1.525
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)Population: mITT; 33 and 31 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis in Part I and II, respectively.
Occurrence of ≥80% reduction in anti-fXa activity from its baseline to nadir, when nadir was defined as the smaller value for anti-fXa activity at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part I) or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) \[Part II\]. Baseline was the last assessment obtained prior to the first dose of andexanet or placebo
Outcome measures
| Measure |
Placebo (Part I)
n=9 Participants
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
n=24 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
n=8 Participants
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
n=23 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
|---|---|---|---|---|
|
Efficacy: Number of Participants With ≥80% Reduction in the Anti-fXa Activity From Baseline to Nadir
|
0 Participants
|
24 Participants
|
0 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)Population: 54 subjects who received apixaban were included in the apixaban pharmacokinetics (PK) analysis
Change from baseline in free apixaban concentration (ng/mL) at the nadir, when nadir was defined as the smaller value for free apixaban at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part I) or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) \[Part II\]. Free plasma concentrations of apixaban was determined using a validated method that involved analysis of citrated human plasma with high-throughput equilibrium dialysis followed by liquid chromatography mass spectrometry.
Outcome measures
| Measure |
Placebo (Part I)
n=9 Participants
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
n=24 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
n=8 Participants
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
n=23 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
|---|---|---|---|---|
|
Efficacy -Change From Baseline in Free Apixaban Concentration at the Nadir
|
-1.854 ng/mL
Standard Deviation 1.6152
|
-9.338 ng/mL
Standard Deviation 3.2043
|
-2.964 ng/mL
Standard Deviation 1.1567
|
-6.480 ng/mL
Standard Deviation 2.7814
|
SECONDARY outcome
Timeframe: Baseline to +2 minutes or +10 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)Population: 33 and 31 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively; mITT population
Change in ETP from baseline to its peak, where peak was defined as the largest value for ETP between the +2 minute time point and the +10 minute time point after the end of the andexanet bolus (inclusive) {Part I\] or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) \[Part II\]. Baseline was the last assessment obtained prior to the first dose of andexanet or placebo. ETP was measured using a tissue factor-initiated thrombin generation assay.
Outcome measures
| Measure |
Placebo (Part I)
n=9 Participants
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
n=24 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
n=8 Participants
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
n=23 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
|---|---|---|---|---|
|
Efficacy: Change in Thrombin Generation (ETP) From Baseline to Its Peak [Parts I and II]
|
88.182 nmol/min
Standard Deviation 125.7621
|
1323.180 nmol/min
Standard Deviation 335.4321
|
189.409 nmol/min
Standard Deviation 184.7842
|
1193.060 nmol/min
Standard Deviation 263.3471
|
SECONDARY outcome
Timeframe: Baseline to +2 minutes or +10 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)Population: 33 and 31 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively; mITT population
Number of participants with ETP above the lower limit of the normal range at its peak, between the +2 minute time point and the +10 minute time point after the end of the andexanet bolus (inclusive) \[Part I\] or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) \[Part II\]. ETP was measured using a tissue factor-initiated thrombin generation assay
Outcome measures
| Measure |
Placebo (Part I)
n=9 Participants
Placebo was administered intravenously (IV) as a bolus (Part I). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part I)
n=24 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute (Part 1). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
Placebo (Part II)
n=8 Participants
Placebo was administered IV as a bolus followed by a continuous infusion for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban).
|
Andexanet (Part II)
n=23 Participants
Andexanet was administered IV as a bolus of 400 mg at a target rate of approximately 30 mg/minute, followed by a continuous infusion of 480 mg at 4 mg/minute for 120 minutes (Part II). The bolus was started 3 hours after the last apixaban dose (at the approximate steady-state Cmax for apixaban)
|
|---|---|---|---|---|
|
Efficacy: Number of Participants With Thrombin Generation (ETP) Above the Lower Limit of the Derived Normal Range at Its Peak (mITT Population)
|
1 Participants
|
24 Participants
|
2 Participants
|
23 Participants
|
Adverse Events
Placebo (Part I)
Andexanet (Part I)
Placebo (Part II)
Andexanet (Part II)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Part I)
n=9 participants at risk
Vehicle Control
|
Andexanet (Part I)
n=24 participants at risk
400 mg bolus
|
Placebo (Part II)
n=8 participants at risk
Vehicle Control
|
Andexanet (Part II)
n=24 participants at risk
400 mg bolus + 480 mg infusion (4 mg/min)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/8 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
8.3%
2/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
|
General disorders
Vessel Puncture Site Haemorrhage
|
11.1%
1/9 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/8 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
16.7%
4/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
|
General disorders
Vessel Puncture Site Pain
|
11.1%
1/9 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
8.3%
2/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/8 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
|
General disorders
Vessel Puncture Site Swelling
|
0.00%
0/9 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/8 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
8.3%
2/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/9 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
12.5%
3/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
25.0%
2/8 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
16.7%
4/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
8.3%
2/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/8 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
12.5%
3/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/8 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
11.1%
1/9 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
12.5%
3/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
12.5%
1/8 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
0.00%
0/24 • ~8 to 12 weeks
The Safety Analysis Population consisted of all subjects randomized and treated with study drug (andexanet or placebo)
|
Additional Information
Head of Clinical Development
Portola Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Conducted in healthy volunteers at Clinical Research Organization.
- Publication restrictions are in place
Restriction type: OTHER