Trial Outcomes & Findings for A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study) (NCT NCT02329327)
NCT ID: NCT02329327
Last Updated: 2022-02-16
Results Overview
Anti-fXa activity was measured to assess the ability of andexanet to reverse the anticoagulant effect of FXa inhibitors. Baseline was defined as the last value obtained prior to the start of the andexanet bolus. The change from baseline was calculated as the reduction in anti-fXa activity from baseline to the on-treatment nadir (that is, the minimum value between end of bolus and end of infusion). Percent reduction was calculated as the ratio between the maximum change from baseline and the baseline value, multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
479 participants
Primary outcome timeframe
Baseline, 12 Hours (post infusion)
Results posted on
2022-02-16
Participant Flow
Participant milestones
| Measure |
Andexanet
Participants received andexanet as an intravenous (IV) bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Andexanet - Additional Participants
Two additional participants received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
|---|---|---|
|
Overall Study
STARTED
|
477
|
2
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
477
|
2
|
|
Overall Study
Efficacy Population
|
347
|
2
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
COMPLETED
|
392
|
2
|
|
Overall Study
NOT COMPLETED
|
85
|
0
|
Reasons for withdrawal
| Measure |
Andexanet
Participants received andexanet as an intravenous (IV) bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Andexanet - Additional Participants
Two additional participants received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
|---|---|---|
|
Overall Study
Death
|
78
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
Baseline Characteristics
A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
Baseline characteristics by cohort
| Measure |
Andexanet
n=477 Participants
Participants received andexanet as an intravenous (IV) bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Andexanet - Additional Participants
n=2 Participants
Two additional participants received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.9 years
STANDARD_DEVIATION 10.66 • n=99 Participants
|
71.0 years
STANDARD_DEVIATION 11.31 • n=107 Participants
|
77.9 years
STANDARD_DEVIATION 10.66 • n=206 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
259 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
449 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
451 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
414 participants
n=99 Participants
|
0 participants
n=107 Participants
|
414 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race : Black or African American
|
29 participants
n=99 Participants
|
0 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race : Other
|
25 participants
n=99 Participants
|
2 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race : Missing
|
9 participants
n=99 Participants
|
0 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
North America
|
212 participants
n=99 Participants
|
0 participants
n=107 Participants
|
212 participants
n=206 Participants
|
|
Region of Enrollment
Europe
|
248 participants
n=99 Participants
|
0 participants
n=107 Participants
|
248 participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
17 participants
n=99 Participants
|
2 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
FXa Inhibitor
Apixaban
|
245 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
|
FXa Inhibitor
Rivaroxaban
|
174 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
|
FXa Inhibitor
Edoxaban
|
36 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
FXa Inhibitor
Enoxaparin
|
22 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Bleed Type
Gastrointestinal
|
109 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Bleed Type
Intracranial Hemorrhage
|
329 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
331 Participants
n=206 Participants
|
|
Bleed Type
Other
|
39 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 Hours (post infusion)Population: Efficacy Population: all participants who received any amount of andexanet, met clinical bleeding criteria, and had an anti-fXa level of ≥75 nanograms/milliliter (ng/mL) for apixaban and rivaroxaban, ≥40 ng/mL for edoxaban, and ≥0.25 international units (IU)/mL for enoxaparin.
Anti-fXa activity was measured to assess the ability of andexanet to reverse the anticoagulant effect of FXa inhibitors. Baseline was defined as the last value obtained prior to the start of the andexanet bolus. The change from baseline was calculated as the reduction in anti-fXa activity from baseline to the on-treatment nadir (that is, the minimum value between end of bolus and end of infusion). Percent reduction was calculated as the ratio between the maximum change from baseline and the baseline value, multiplied by 100.
Outcome measures
| Measure |
FXa Inhibitor: Apixaban
n=169 Participants
Participants who had recently received FXa inhibitor apixaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Rivaroxaban
n=130 Participants
Participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Edoxaban
n=28 Participants
Participants who had recently received FXa inhibitor edoxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Enoxaparin
n=17 Participants
Participants who had recently received FXa inhibitor enoxaparin received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Rivaroxaban - Additional Participants
n=2 Participants
Two additional participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Bleed Type: Intracranial Hemorrhage
Participants with an intracranial hemorrhage who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Bleed Type: Other
Participants with other types of bleeding who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Andexanet: Low Dose
Participants who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over \~120 minutes.
|
Andexanet: High Dose
Participants who had recently received FXa inhibitors received andexanet as an IV 800-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over \~120 minutes.
|
Overall
Participants who had recently received FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Does not include the 2 additional participants whose data were obtained and evaluated after the data cutoff date of 30-June-2020.
|
FXa Inhibitor: Rivaroxaban - Additional Participants
Two additional participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Bleed Type: Intracranial Hemorrhage - Additional Participants
Two additional participants with an intracranial hemorrhage who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Andexanet: Low Dose - Additional Participant
One additional participant who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over \~120 minutes. Data from this participant were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Andexanet: High Dose - Additional Participant
One additional participant who had recently received FXa inhibitors received andexanet as an IV 800-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over \~120 minutes. Data from this participant were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline In Anti-fXa Activity By FXa Inhibitor
|
-93.3 Percent Change
Interval -94.2 to -92.5
|
-94.1 Percent Change
Interval -95.1 to -93.0
|
-71.3 Percent Change
Interval -82.3 to -65.2
|
-75.41 Percent Change
Interval -79.17 to -66.67
|
-96.3 Percent Change
Interval -98.3 to -94.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 Hours (post infusion)Population: Efficacy Population: all participants who received any amount of andexanet, met clinical bleeding criteria, and had an anti-fXa level of ≥75 ng/mL for apixaban and rivaroxaban, ≥40 ng/mL for edoxaban, and ≥0.25 IU/mL for enoxaparin.
Hemostatic efficacy was achieved when the body had time to produce thrombin and a subsequent clot and was rated by the EAC as: excellent; good; poor/none; not evaluable due to non-administrative reasons; not evaluable due to administrative reasons. These ratings were based on pre-specified criteria that were included in the EAC Charter. The EAC was blinded to anti-fXa activity levels. Participant results were classified as either success or failure based on the hemostatic efficacy rating (success = excellent/good, failure = poor/none). Participants rated by the EAC as non-evaluable due to administrative reasons were excluded from the analysis of hemostatic efficacy.
Outcome measures
| Measure |
FXa Inhibitor: Apixaban
n=169 Participants
Participants who had recently received FXa inhibitor apixaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Rivaroxaban
n=127 Participants
Participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Edoxaban
n=28 Participants
Participants who had recently received FXa inhibitor edoxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Enoxaparin
n=16 Participants
Participants who had recently received FXa inhibitor enoxaparin received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Rivaroxaban - Additional Participants
n=74 Participants
Two additional participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Bleed Type: Intracranial Hemorrhage
n=244 Participants
Participants with an intracranial hemorrhage who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Bleed Type: Other
n=22 Participants
Participants with other types of bleeding who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Andexanet: Low Dose
n=269 Participants
Participants who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over \~120 minutes.
|
Andexanet: High Dose
n=71 Participants
Participants who had recently received FXa inhibitors received andexanet as an IV 800-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over \~120 minutes.
|
Overall
n=340 Participants
Participants who had recently received FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Does not include the 2 additional participants whose data were obtained and evaluated after the data cutoff date of 30-June-2020.
|
FXa Inhibitor: Rivaroxaban - Additional Participants
n=2 Participants
Two additional participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Bleed Type: Intracranial Hemorrhage - Additional Participants
n=2 Participants
Two additional participants with an intracranial hemorrhage who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Andexanet: Low Dose - Additional Participant
n=1 Participants
One additional participant who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over \~120 minutes. Data from this participant were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Andexanet: High Dose - Additional Participant
n=1 Participants
One additional participant who had recently received FXa inhibitors received andexanet as an IV 800-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over \~120 minutes. Data from this participant were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Participants Achieving Hemostatic Efficacy
Excellent/Good
|
134 Participants
|
102 Participants
|
22 Participants
|
14 Participants
|
61 Participants
|
193 Participants
|
18 Participants
|
218 Participants
|
54 Participants
|
272 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Participants Achieving Hemostatic Efficacy
Poor/None
|
35 Participants
|
25 Participants
|
6 Participants
|
2 Participants
|
13 Participants
|
51 Participants
|
4 Participants
|
51 Participants
|
17 Participants
|
68 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 Hours (post infusion)Population: Efficacy Population: all participants who received any amount of andexanet, met clinical bleeding criteria, and had an anti-fXa level of ≥75 ng/mL for apixaban and rivaroxaban, ≥40 ng/mL for edoxaban, and ≥0.25 IU/mL for enoxaparin.
This outcome measure assessed the relationship between hemostatic efficacy and anti-fXa activity in participants receiving an FXa inhibitor who had acute major bleeding. Anti-fXa activity was measured to assess the ability of andexanet to reverse the anticoagulant effect of FXa inhibitors. Baseline was defined as the last value obtained prior to the start of the andexanet bolus. Hemostatic efficacy was achieved when the body had time to produce thrombin and a subsequent clot and was rated by the EAC as: excellent; good; poor/none; not evaluable due to non-administrative reasons; not evaluable due to administrative reasons.
Outcome measures
| Measure |
FXa Inhibitor: Apixaban
n=169 Participants
Participants who had recently received FXa inhibitor apixaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Rivaroxaban
n=127 Participants
Participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Edoxaban
n=28 Participants
Participants who had recently received FXa inhibitor edoxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Enoxaparin
n=16 Participants
Participants who had recently received FXa inhibitor enoxaparin received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
FXa Inhibitor: Rivaroxaban - Additional Participants
n=2 Participants
Two additional participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Bleed Type: Intracranial Hemorrhage
Participants with an intracranial hemorrhage who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Bleed Type: Other
Participants with other types of bleeding who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes.
|
Andexanet: Low Dose
Participants who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over \~120 minutes.
|
Andexanet: High Dose
Participants who had recently received FXa inhibitors received andexanet as an IV 800-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over \~120 minutes.
|
Overall
Participants who had recently received FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Does not include the 2 additional participants whose data were obtained and evaluated after the data cutoff date of 30-June-2020.
|
FXa Inhibitor: Rivaroxaban - Additional Participants
Two additional participants who had recently received FXa inhibitor rivaroxaban received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Bleed Type: Intracranial Hemorrhage - Additional Participants
Two additional participants with an intracranial hemorrhage who had recently received an FXa inhibitor received andexanet as an IV bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion administered over \~120 minutes. Data from these 2 participants were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Andexanet: Low Dose - Additional Participant
One additional participant who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over \~120 minutes. Data from this participant were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
Andexanet: High Dose - Additional Participant
One additional participant who had recently received FXa inhibitors received andexanet as an IV 800-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over \~120 minutes. Data from this participant were obtained and evaluated after the data cutoff date of 30-June-2020 and, as such, are presented separately.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline In Anti-fXa Activity By Hemostatic Efficacy
Excellent/Good
|
-93.4 Percent Change
Interval -94.3 to -92.6
|
-94.6 Percent Change
Interval -95.2 to -93.5
|
-75.8 Percent Change
Interval -84.4 to -65.2
|
-75.20 Percent Change
Interval -77.08 to -65.91
|
-96.3 Percent Change
Interval -98.3 to -94.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline In Anti-fXa Activity By Hemostatic Efficacy
Poor/None
|
-93.3 Percent Change
Interval -95.3 to -90.6
|
-92.4 Percent Change
Interval -96.5 to -85.0
|
-65.2 Percent Change
Interval -85.3 to 3.0
|
-78.44 Percent Change
Interval -82.46 to -74.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Andexanet: Low Dose
Serious events: 157 serious events
Other events: 40 other events
Deaths: 66 deaths
Andexanet: High Dose
Serious events: 43 serious events
Other events: 8 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Andexanet: Low Dose
n=382 participants at risk
Participants who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over \~120 minutes.
|
Andexanet: High Dose
n=97 participants at risk
Participants who had recently received FXa inhibitors received andexanet as an IV 800- mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over \~120 minutes.
|
|---|---|---|
|
Nervous system disorders
Ischaemic Stroke
|
2.1%
8/382 • Number of events 8 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.0%
4/382 • Number of events 4 • Day 1 through Day 37.
|
4.1%
4/97 • Number of events 4 • Day 1 through Day 37.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
1.8%
7/382 • Number of events 7 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
1.3%
5/382 • Number of events 5 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Cerebral Infarction
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
Nervous system disorders
Seizure
|
1.0%
4/382 • Number of events 4 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Neurological Decompensation
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
Nervous system disorders
Intraventricular Haemorrhage
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
0.00%
0/2 • Day 1 through Day 37.
|
|
Nervous system disorders
Brain Oedema
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Intracranial Venous Sinus Thrombosis
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Syncope
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Altered State Of Consciousness
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Basal Ganglia Haemorrhage
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Basilar Artery Thrombosis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Brain Compression
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Carotid Artery Aneurysm
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Cerebellar Infarction
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Cerebellar Ischaemia
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Cerebral Haematoma
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Cerebral Ventricle Dilatation
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Embolic Stroke
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Encephalopathy
|
0.26%
1/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Epilepsy
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/2 • Day 1 through Day 37.
|
|
Nervous system disorders
Facial Paresis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Headache
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Hydrocephalus
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Slow Response To Stimuli
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Nervous system disorders
Status Epilepticus
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Pneumonia
|
3.7%
14/382 • Number of events 15 • Day 1 through Day 37.
|
6.2%
6/97 • Number of events 6 • Day 1 through Day 37.
|
|
Infections and infestations
Sepsis
|
1.0%
4/382 • Number of events 4 • Day 1 through Day 37.
|
3.1%
3/97 • Number of events 3 • Day 1 through Day 37.
|
|
Infections and infestations
Septic Shock
|
1.0%
4/382 • Number of events 4 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Urinary Tract Infection
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Cellulitis
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Infections and infestations
CNS Ventriculitis
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Infections and infestations
Cystitis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Infections and infestations
Implant Site Infection
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Infections and infestations
Paronychia
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Serratia Bacteraemia
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Infections and infestations
Subdural Empyema
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Tracheostomy Infection
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Infections and infestations
Urosepsis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.6%
10/382 • Number of events 10 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.8%
7/382 • Number of events 7 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.8%
7/382 • Number of events 7 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.79%
3/382 • Number of events 4 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Secretion Retention
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Cardiac Failure
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
3.1%
3/97 • Number of events 3 • Day 1 through Day 37.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
Cardiac disorders
Myocardial Infarction
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
Cardiac disorders
Cardiogenic Shock
|
1.0%
4/382 • Number of events 4 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Cardiac Arrest
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Cardiac disorders
Atrial Thrombosis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Cardiac disorders
Bradycardia
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Cardiac disorders
Atrioventricular Block
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Cardiac Ventricular Thrombosis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.3%
5/382 • Number of events 6 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Vascular disorders
Hypotension
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Vascular disorders
Arteriosclerosis
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Vascular disorders
Hypertension
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Vascular disorders
Aorto-Duodenal Fistula
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Vascular disorders
Haematoma
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Vascular disorders
Shock Haemorrhagic
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.26%
1/382 • Number of events 2 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Melaena
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Faecaloma
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Large Intestinal Haemorrhage
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
General disorders
Multi-Organ Failure
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
General disorders
General Physical Health Deterioration
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
General disorders
Death
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
General disorders
Gait Disturbance
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
General disorders
Sudden Cardiac Death
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
General disorders
Sudden Death
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
General disorders
Swelling
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
1.6%
6/382 • Number of events 6 • Day 1 through Day 37.
|
2.1%
2/97 • Number of events 2 • Day 1 through Day 37.
|
|
Injury, poisoning and procedural complications
Brain Herniation
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic Astrocytoma
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Investigations
CSF Red Blood Cell Count Positive
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Investigations
Electroencephalogram Abnormal
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Investigations
Liver Function Test Abnormal
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Investigations
Transaminases Increased
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Investigations
Troponin I Increased
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Blood and lymphatic system disorders
Heparin-Induced Thrombocytopenia
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.79%
3/382 • Number of events 3 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Renal and urinary disorders
Renal Failure
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Renal and urinary disorders
Urinary Retention
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Metabolism and nutrition disorders
Metabolic Syndrome
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Psychiatric disorders
Mental Status Changes
|
0.52%
2/382 • Number of events 2 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Psychiatric disorders
Mental Disorder Due To A General Medical Condition
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Ear and labyrinth disorders
Deafness
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Eye disorders
Diplopia
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Hepatobiliary disorders
Ischaemic Hepatitis
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Social circumstances
Social Stay Hospitalisation
|
0.26%
1/382 • Number of events 1 • Day 1 through Day 37.
|
0.00%
0/97 • Day 1 through Day 37.
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
|
Surgical and medical procedures
Ventricular Drainage
|
0.00%
0/382 • Day 1 through Day 37.
|
1.0%
1/97 • Number of events 1 • Day 1 through Day 37.
|
Other adverse events
| Measure |
Andexanet: Low Dose
n=382 participants at risk
Participants who had recently received FXa inhibitors received andexanet as an IV 400-mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 480 mg (4 mg/minute) administered over \~120 minutes.
|
Andexanet: High Dose
n=97 participants at risk
Participants who had recently received FXa inhibitors received andexanet as an IV 800- mg bolus administered over \~15 to 30 minutes, followed immediately by a continuous infusion of 960 mg (8 mg/minute) administered over \~120 minutes.
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
10.5%
40/382 • Number of events 40 • Day 1 through Day 37.
|
8.2%
8/97 • Number of events 8 • Day 1 through Day 37.
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: +1.855.752.2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place