Trial Outcomes & Findings for A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects (NCT NCT03310021)
NCT ID: NCT03310021
Last Updated: 2023-02-24
Results Overview
The primary efficacy endpoint is the percent change in the anti-FXa activity from baseline to the end of infusion (EOI) nadir.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours
Results posted on
2023-02-24
Participant Flow
Healthy Subjects
One subject in cohort 10 (Edoxaban/Placebo) discontinued due to protocol deviation (mis-enrolled, inclusion criteria #10 not met(weight\>80kg). This subject (100003) is not summarized in tables because he/she did not receive any andexanet/Placebo. The safety population (N=107) is defined as having received study drug andexanet/placebo.
Participant milestones
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
6
|
3
|
8
|
4
|
8
|
4
|
6
|
3
|
6
|
3
|
8
|
4
|
6
|
3
|
10
|
5
|
8
|
3
|
|
Overall Study
COMPLETED
|
6
|
3
|
6
|
3
|
8
|
4
|
7
|
4
|
6
|
3
|
5
|
3
|
8
|
4
|
6
|
3
|
10
|
5
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=10 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.50 years
n=99 Participants
|
51.00 years
n=107 Participants
|
47.50 years
n=206 Participants
|
58.00 years
n=7 Participants
|
45.00 years
n=31 Participants
|
35.50 years
n=30 Participants
|
33.0 years
n=3 Participants
|
31.50 years
n=6 Participants
|
31.50 years
n=114 Participants
|
31.00 years
|
46.50 years
n=19 Participants
|
36.00 years
n=4 Participants
|
34.50 years
n=7 Participants
|
47.00 years
n=7 Participants
|
41.00 years
n=3 Participants
|
53.00 years
n=4 Participants
|
51.00 years
n=2 Participants
|
35.00 years
n=102 Participants
|
28.50 years
n=5 Participants
|
41.00 years
n=5 Participants
|
38.00 years
n=15 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=2 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
36 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
2 Participants
|
4 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=2 Participants
|
4 Participants
n=102 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
71 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
3 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
6 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=2 Participants
|
5 Participants
n=102 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
98 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hoursPopulation: Efficacy Population: all randomized subjects who received andexanet or placebo during the double-blind treatment period and had at least one evaluable post-baseline efficacy assessment as well as the required baseline sample assessment.
The primary efficacy endpoint is the percent change in the anti-FXa activity from baseline to the end of infusion (EOI) nadir.
Outcome measures
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=10 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir.
|
-94.50 percent change
Interval -96.0 to -90.0
|
-29.00 percent change
Interval -32.0 to -18.0
|
-98.00 percent change
Interval -99.0 to -97.0
|
-37.00 percent change
Interval -53.0 to -34.0
|
-81.00 percent change
Interval -89.0 to -51.0
|
-47.50 percent change
Interval -62.0 to -34.0
|
-75.50 percent change
Interval -82.0 to -45.0
|
-37.00 percent change
Interval -46.0 to -16.0
|
-93.00 percent change
Interval -94.0 to -91.0
|
-34.00 percent change
Interval -53.0 to -24.0
|
-97.00 percent change
Interval -98.0 to -96.0
|
-31.00 percent change
Interval -35.0 to -30.0
|
-52.50 percent change
Interval -69.0 to -34.0
|
-37.00 percent change
Interval -67.0 to -17.0
|
-92.00 percent change
Interval -95.0 to -90.0
|
-24.00 percent change
Interval -31.0 to -21.0
|
-93.50 percent change
Interval -98.0 to -89.0
|
-37.00 percent change
Interval -56.0 to -29.0
|
-63.50 percent change
Interval -80.0 to -57.0
|
-27.00 percent change
Interval -34.0 to -25.0
|
SECONDARY outcome
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hoursPopulation: Efficacy Population: all randomized subjects who received andexanet or placebo during the double-blind treatment period and had at least one evaluable post-baseline efficacy assessment as well as the required baseline sample assessment.
The percent change from baseline in anti-FXa activity at its end of bolus (EOB) nadir.
Outcome measures
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=10 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Anti-Fxa Activity From Baseline to the End of Bolus (EOB) Nadir.
|
-94.50 percent change
Interval -95.0 to -92.0
|
-14.00 percent change
Interval -15.0 to -12.0
|
-97.50 percent change
Interval -98.0 to -96.0
|
-18.00 percent change
Interval -29.0 to -1.0
|
-65.50 percent change
Interval -87.0 to -8.0
|
-16.00 percent change
Interval -46.0 to -13.0
|
-22.50 percent change
Interval -78.0 to 0.0
|
-15.00 percent change
Interval -19.0 to 7.0
|
-94.00 percent change
Interval -94.0 to -92.0
|
-10.00 percent change
Interval -21.0 to -7.0
|
-96.00 percent change
Interval -97.0 to -95.0
|
-18.00 percent change
Interval -21.0 to -14.0
|
-58.00 percent change
Interval -78.0 to -1.0
|
-8.00 percent change
Interval -13.0 to -1.0
|
-94.50 percent change
Interval -96.0 to -93.0
|
-5.00 percent change
Interval -16.0 to -3.0
|
-95.00 percent change
Interval -98.0 to -93.0
|
-11.00 percent change
Interval -28.0 to -9.0
|
-73.00 percent change
Interval -80.0 to -61.0
|
-4.00 percent change
Interval -12.0 to -4.0
|
SECONDARY outcome
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hoursPopulation: Efficacy Population: all randomized subjects who received andexanet or placebo during the double-blind treatment period and had at least one evaluable post-baseline efficacy assessment as well as the required baseline sample assessment.
The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOB nadir.
Outcome measures
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=9 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Bolus (EOB) Nadir.
|
-93.00 percent change
Interval -94.7 to -90.38
|
-11.94 percent change
Interval -18.42 to -1.71
|
-97.72 percent change
Interval -97.97 to -95.7
|
-28.57 percent change
Interval -47.06 to -1.06
|
-78.20 percent change
Interval -86.17 to -59.17
|
-17.60 percent change
Interval -27.95 to -10.15
|
-56.05 percent change
Interval -77.92 to -40.69
|
-2.49 percent change
Interval -28.57 to 12.48
|
-94.45 percent change
Interval -96.56 to -93.04
|
5.80 percent change
Interval -8.56 to 36.52
|
-93.57 percent change
Interval -97.3 to -90.08
|
-12.94 percent change
Interval -24.34 to -10.94
|
-70.88 percent change
Interval -87.12 to -44.8
|
-5.48 percent change
Interval -12.67 to 18.07
|
-91.61 percent change
Interval -95.51 to -89.76
|
-0.32 percent change
Interval -28.93 to 33.37
|
-95.51 percent change
Interval -97.09 to -93.43
|
-14.02 percent change
Interval -30.1 to -4.1
|
-75.80 percent change
Interval -85.51 to -70.44
|
-17.91 percent change
Interval -26.8 to 26.42
|
SECONDARY outcome
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hoursPopulation: Efficacy Population: all randomized subjects who received andexanet or placebo during the double-blind treatment period and had at least one evaluable post-baseline efficacy assessment as well as the required baseline sample assessment.
The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOI nadir.
Outcome measures
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=10 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Infusion (EOI) Nadir.
|
-92.940 percent change
Interval -94.61 to -90.4
|
-33.550 percent change
Interval -37.78 to -28.13
|
-98.650 percent change
Interval -99.06 to -97.61
|
-39.390 percent change
Interval -70.67 to -28.72
|
-85.005 percent change
Interval -93.14 to -68.74
|
-48.710 percent change
Interval -49.79 to -38.98
|
-81.040 percent change
Interval -89.3 to -67.66
|
-42.755 percent change
Interval -53.33 to -25.89
|
-93.495 percent change
Interval -96.18 to -91.24
|
-31.830 percent change
Interval -47.46 to -20.36
|
-96.65 percent change
Interval -97.62 to -94.8
|
-29.02 percent change
Interval -32.81 to -20.22
|
-62.72 percent change
Interval -76.52 to -55.03
|
-24.34 percent change
Interval -46.86 to -11.07
|
-90.63 percent change
Interval -91.57 to -86.02
|
-31.45 percent change
Interval -37.88 to 9.45
|
-94.89 percent change
Interval -97.44 to -85.09
|
-37.82 percent change
Interval -54.92 to -36.3
|
-67.10 percent change
Interval -81.33 to -49.62
|
-34.25 percent change
Interval -36.17 to -15.47
|
SECONDARY outcome
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hoursPopulation: Efficacy Population: all randomized subjects who received andexanet or placebo during the double-blind treatment period and had at least one evaluable post-baseline efficacy assessment as well as the required baseline sample assessment.
The change in thrombin generation from baseline to its EOB peak.
Outcome measures
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=10 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Thrombin Generation From Baseline to the End of Bolus (EOB) Nadir.
|
1145.03 nM.min
Interval 708.92 to 1538.44
|
179.94 nM.min
Interval 161.09 to 234.44
|
1337.28 nM.min
Interval 1155.95 to 1632.28
|
209.99 nM.min
Interval 57.26 to 386.49
|
758.92 nM.min
Interval 560.66 to 1494.51
|
215.71 nM.min
Interval -15.75 to 319.23
|
815.07 nM.min
Interval 603.9 to 949.73
|
48.59 nM.min
Interval 22.87 to 165.84
|
1244.30 nM.min
Interval 1106.36 to 1714.52
|
103.13 nM.min
Interval -22.26 to 142.33
|
1177.47 nM.min
Interval 1081.47 to 1564.1
|
0.16 nM.min
Interval -106.2 to 92.65
|
781.42 nM.min
Interval 381.4 to 918.54
|
67.97 nM.min
Interval -319.74 to 157.51
|
1184.62 nM.min
Interval 1038.43 to 1394.74
|
2.69 nM.min
Interval -76.71 to 36.71
|
1306.23 nM.min
Interval 846.48 to 1442.27
|
117.50 nM.min
Interval 44.14 to 163.39
|
902.17 nM.min
Interval 582.77 to 1405.55
|
-92.82 nM.min
Interval -245.48 to 198.13
|
SECONDARY outcome
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hoursPopulation: Efficacy Population: all randomized subjects who received andexanet or placebo during the double-blind treatment period and had at least one evaluable post-baseline efficacy assessment as well as the required baseline sample assessment.
The change in thrombin generation from baseline to its EOI peak.
Outcome measures
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 Participants
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 Participants
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 Participants
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 Participants
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=10 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 Participants
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 Participants
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Thrombin Generation From Baseline to the End of Infusion (EOI) Nadir.
|
1000.630 nM.min
Interval 695.12 to 1519.85
|
171.220 nM.min
Interval 157.74 to 189.72
|
1329.580 nM.min
Interval 1161.36 to 1679.68
|
207.590 nM.min
Interval 126.91 to 287.49
|
804.405 nM.min
Interval 692.88 to 1560.3
|
347.535 nM.min
Interval 107.36 to 482.84
|
910.935 nM.min
Interval 775.95 to 1108.16
|
236.610 nM.min
Interval 126.01 to 295.71
|
1130.575 nM.min
Interval 1022.12 to 1460.71
|
118.130 nM.min
Interval 108.66 to 163.04
|
1119.41 nM.min
Interval 969.95 to 1567.02
|
108.67 nM.min
Interval -67.28 to 150.99
|
833.46 nM.min
Interval 571.27 to 939.46
|
175.72 nM.min
Interval -290.06 to 336.63
|
1058.09 nM.min
Interval 809.14 to 1335.39
|
138.14 nM.min
Interval 119.11 to 145.4
|
1173.38 nM.min
Interval 773.75 to 1399.21
|
293.15 nM.min
Interval 142.08 to 324.41
|
793.44 nM.min
Interval 564.56 to 1339.52
|
-72.69 nM.min
Interval -302.36 to 52.67
|
Adverse Events
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1 Apixaban 5 mg BID/Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 Rivaroxaban 15 mg BID/Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 Edooxaban 60 mg QD/Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 Edooxaban 60 mg QD/Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5 Apixaban 5 mg BID/Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6 Apixaban 10 mg BID/Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 7 Edoxaban 30 mg QD/Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 8 Apixaban 10 mg BID/Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 9 Rivaroxaban 15 mg BID/Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 10 Edoxaban 60 mg QD/Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 participants at risk
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 participants at risk
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 participants at risk
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 participants at risk
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 participants at risk
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 participants at risk
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 participants at risk
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 participants at risk
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 participants at risk
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=10 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
Other adverse events
| Measure |
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
n=6 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 1 Apixaban 5 mg BID/Placebo
n=3 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
n=6 participants at risk
Andexanet 800 mg bolus+ 8 mg/min 120 minute infusion (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 2 Rivaroxaban 15 mg BID/Placebo
n=3 participants at risk
Placebo 800 mg bolus+ 8 mg/min 120 minute infusion placebo (dosing at 4 hours post-rivaroxaban); Japanese Subjects
|
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
n=8 participants at risk
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 3 Edooxaban 60 mg QD/Placebo
n=4 participants at risk
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 3 hours post-edoxaban); Japanese Subjects
|
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
n=8 participants at risk
Andexanet 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 4 Edooxaban 60 mg QD/Placebo
n=4 participants at risk
Placebo 800 mg bolus+8 mg/min 120 minutes infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
n=6 participants at risk
400 mg bolus+4 mg/min 120 minute Andexanet infusion (dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 5 Apixaban 5 mg BID/Placebo
n=3 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (placebo dosing at 3 hours post-apixaban); Caucasian Subjects
|
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
n=6 participants at risk
Andexanet 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 6 Apixaban 10 mg BID/Placebo
n=3 participants at risk
Placebo 800 mg bolus+8 mg/min 120 minute infusion (dosing at 3 hours post-apixaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet
n=8 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 7 Edoxaban 30 mg QD/Placebo
n=4 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 90 minutes post-edoxaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet
n=6 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 8 Apixaban 10 mg BID/Placebo
n=3 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-apixaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet
n=10 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 9 Rivaroxaban 15 mg BID/Placebo
n=5 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-rivaroxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet
n=8 participants at risk
Andexanet 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
Cohort 10 Edoxaban 60 mg QD/Placebo
n=3 participants at risk
Placebo 400 mg bolus+4 mg/min 120 minute infusion (dosing at 8 hours post-edoxaban); Japanese Subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Oral Herpes
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
25.0%
1/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
33.3%
2/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
General disorders
Catheter Site Pain
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
33.3%
1/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
12.5%
1/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
General disorders
Infusion Site Pain
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
General disorders
Vessel Puncture Site Haemorrhage
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
12.5%
1/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
12.5%
1/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
12.5%
1/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
10.0%
1/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
33.3%
1/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
12.5%
1/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
33.3%
2/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
10.0%
1/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
33.3%
1/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
33.3%
1/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
33.3%
1/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
25.0%
1/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
12.5%
1/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
12.5%
1/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
16.7%
1/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/4 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/6 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/10 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/5 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/8 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
0.00%
0/3 • Study day 1 to 39
Treatment emergent AEs occurring between informed consent and the Termination Visit will be recorded on the e-CRFs. All AEs should be monitored until they are resolved, reach a level of stability and are not expected to improve further, or are clearly determined to be due to a subject's stable or chronic condition or intercurrent illness. Any AE that begins after completion of the study and that the Investigator considers to be related to study medication, must be reported to Portola.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place