Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia (NCT NCT02227693)
NCT ID: NCT02227693
Last Updated: 2019-02-28
Results Overview
Responders were defined as participants whose platelet count was greater than or equal to 50×10\^9/liter (L) and change from baseline was at least 20×10\^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Baseline and Visit 4 (Day 10)
Results posted on
2019-02-28
Participant Flow
A total of 56 participants were screened to enter into the study. Of these, 17 participants were screening failures, and 39 were randomized into the study. Of the 17 screening failures, 14 participants failed to meet the inclusion/exclusion criteria, 1 participant withdrew consent, and 2 participants were excluded for scheduling conflicts.
Participant milestones
| Measure |
Placebo (60 mg)
Participants took 60 milligrams (mg) placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
7
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia
Baseline characteristics by cohort
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Avatrombopag (40 mg), Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 8.49 • n=93 Participants
|
64.6 years
STANDARD_DEVIATION 8.42 • n=4 Participants
|
64.6 years
STANDARD_DEVIATION 9.59 • n=27 Participants
|
62.1 years
STANDARD_DEVIATION 7.32 • n=483 Participants
|
65.8 years
STANDARD_DEVIATION 8.92 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Visit 4 (Day 10)Population: Full Analysis Set (FAS) included all randomized participants who received at least one dose of study drug.
Responders were defined as participants whose platelet count was greater than or equal to 50×10\^9/liter (L) and change from baseline was at least 20×10\^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
SECONDARY outcome
Timeframe: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)Population: FAS
Responders were defined as the participants whose platelet count greater than or equal to 50 x 10\^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit
Visit 3 (Day 4 or Day 5)
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit
Visit 4 (Day 10)
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
71.4 Percentage of participants
Interval 29.0 to 96.3
|
81.8 Percentage of participants
Interval 48.2 to 97.7
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit
Visit 5 (Day 17)
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
0.0 Percentage of participants
Interval 0.0 to 41.0
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit
Visit 6 (Day 35)
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
0.0 Percentage of participants
Interval 0.0 to 41.0
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
SECONDARY outcome
Timeframe: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)Population: FAS
Responders were defined as the participants whose platelet count greater than or equal to 75 x 10\^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit
Visit 3 (Day 4 or Day 5)
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
0.0 Percentage of participants
Interval 0.0 to 41.0
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit
Visit 4 (Day 10)
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
0.0 Percentage of participants
Interval 0.0 to 41.0
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit
Visit 5 (Day 17)
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
0.0 Percentage of participants
Interval 0.0 to 41.0
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit
Visit 6 (Day 35)
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
0.0 Percentage of participants
Interval 0.0 to 41.0
|
0.0 Percentage of participants
Interval 0.0 to 28.5
|
0.0 Percentage of participants
Interval 0.0 to 30.8
|
SECONDARY outcome
Timeframe: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)Population: FAS
Responders were defined as the participants whose platelet count greater than or equal to 150 x 10\^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit
Visit 3 (Day 4 or Day 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit
Visit 4 (Day 10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit
Visit 5 (Day 17)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit
Visit 6 (Day 35)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)Population: FAS
Responders were defined as the participants whose platelet count greater than or equal to 200 x 10\^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit
Visit 3 (Day 4 or Day 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit
Visit 4 (Day 10)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit
Visit 5 (Day 17)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit
Visit 6 (Day 35)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)Population: FAS
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 3 (Day 4 or Day 5) Platelet count
|
41.27 Number of platelets x 10^9/L
Standard Deviation 8.344
|
44.71 Number of platelets x 10^9/L
Standard Deviation 6.102
|
46.09 Number of platelets x 10^9/L
Standard Deviation 8.860
|
32.70 Number of platelets x 10^9/L
Standard Deviation 9.967
|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 2 (Baseline) Platelet count
|
40.59 Number of platelets x 10^9/L
Standard Deviation 7.024
|
40.57 Number of platelets x 10^9/L
Standard Deviation 5.556
|
41.23 Number of platelets x 10^9/L
Standard Deviation 5.159
|
28.85 Number of platelets x 10^9/L
Standard Deviation 7.568
|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 3 (Day 4 or Day 5) Change from baseline
|
0.68 Number of platelets x 10^9/L
Standard Deviation 2.848
|
4.14 Number of platelets x 10^9/L
Standard Deviation 7.099
|
4.86 Number of platelets x 10^9/L
Standard Deviation 6.569
|
3.85 Number of platelets x 10^9/L
Standard Deviation 6.223
|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 4 (Day 10) Platelet count
|
43.91 Number of platelets x 10^9/L
Standard Deviation 10.568
|
53.29 Number of platelets x 10^9/L
Standard Deviation 5.678
|
79.36 Number of platelets x 10^9/L
Standard Deviation 24.800
|
55.90 Number of platelets x 10^9/L
Standard Deviation 22.507
|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 4 (Day 10) Change from baseline
|
3.32 Number of platelets x 10^9/L
Standard Deviation 7.163
|
12.71 Number of platelets x 10^9/L
Standard Deviation 9.486
|
38.14 Number of platelets x 10^9/L
Standard Deviation 22.781
|
27.05 Number of platelets x 10^9/L
Standard Deviation 22.700
|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 5 (Day 17) Platelet count
|
40.10 Number of platelets x 10^9/L
Standard Deviation 9.916
|
41.33 Number of platelets x 10^9/L
Standard Deviation 4.803
|
55.73 Number of platelets x 10^9/L
Standard Deviation 14.826
|
41.80 Number of platelets x 10^9/L
Standard Deviation 16.578
|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 5 (Day 17) Change from baseline
|
0.40 Number of platelets x 10^9/L
Standard Deviation 5.243
|
1.75 Number of platelets x 10^9/L
Standard Deviation 3.402
|
14.50 Number of platelets x 10^9/L
Standard Deviation 11.874
|
12.95 Number of platelets x 10^9/L
Standard Deviation 12.857
|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 6 (Day 35) Platelet count
|
41.50 Number of platelets x 10^9/L
Standard Deviation 10.845
|
39.67 Number of platelets x 10^9/L
Standard Deviation 5.574
|
41.36 Number of platelets x 10^9/L
Standard Deviation 8.262
|
31.44 Number of platelets x 10^9/L
Standard Deviation 8.353
|
|
Platelet Count and Change From Baseline in Platelet Count by Visit
Visit 6 (Day 35) Change from baseline
|
1.80 Number of platelets x 10^9/L
Standard Deviation 4.614
|
0.08 Number of platelets x 10^9/L
Standard Deviation 1.686
|
0.14 Number of platelets x 10^9/L
Standard Deviation 8.382
|
2.33 Number of platelets x 10^9/L
Standard Deviation 4.265
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 monthsPopulation: Safety Analysis Set included all participants who received at least one dose of study drug and had at least one safety assessment.
Safety assessments consisted of monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms; physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. A treatment-emergent adverse event (TEAE) was defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. For each category, a participant with two or more adverse events in that category was counted only once. Treatment-related TEAEs were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing causality.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs leading to study drug dose interruption
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
All TEAEs
|
8 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related TEAEs
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs leading to study drug dose adjustment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs leading to study drug withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs leading to study drug dose reduction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Hemoglobin
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Leukocytes
|
4 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Alkaline phosphatase (ALP)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Alanine aminotransferase (ALT)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Bilirubin
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Gamma-glutamyl transferase (γ-GTP)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Calcium
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Albumin
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Glucose
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Triglycerides
|
9 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Aspartate aminotransferase (AST)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Laboratory Values for Serum
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Laboratory Values for Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)Population: The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Outcome measures
| Measure |
Placebo (60 mg)
n=11 Participants
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 Participants
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 Participants
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 Participants
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Electrocardiographs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo (60 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Avatrombopag (20 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Avatrombopag (40 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Avatrombopag (60 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (60 mg)
n=11 participants at risk
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (20 mg)
n=7 participants at risk
Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
|
Avatrombopag (40 mg)
n=11 participants at risk
Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.
|
Avatrombopag (60 mg)
n=10 participants at risk
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Gastrointestinal disorders
Ascites
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
18.2%
2/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
10.0%
1/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Gastrointestinal disorders
Haematochezia
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
10.0%
1/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
General disorders
Injection Site Reaction
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
General disorders
Puncture Site Pain
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
10.0%
1/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
General disorders
Thirst
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
10.0%
1/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Injury, poisoning and procedural complications
Post Embolisation Syndrome
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
18.2%
2/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
10.0%
1/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
28.6%
2/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
18.2%
2/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Investigations
Blood Glucose Increased
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Investigations
Blood pressure increased
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
10.0%
1/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
10.0%
1/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
14.3%
1/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
9.1%
1/11 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
0.00%
0/10 • From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.
Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed "as treated."
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER