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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02227693
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Thrombocytopenia Associated With Chronic Liver Disease
Interventions Drug: avatrombopag
Drug: Placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Hide Arm/Group Description Participants took 60 milligrams (mg) placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days. 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. 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. Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
Period Title: Overall Study
Started 11 7 11 10
Completed 11 7 11 10
Not Completed 0 0 0 0
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg) Total
Hide Arm/Group Description Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days. 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. Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days. Total of all reporting groups
Overall Number of Baseline Participants 11 7 11 10 39
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): The FAS was the group of randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 7 participants 11 participants 10 participants 39 participants
71.1  (8.49) 64.6  (8.42) 64.6  (9.59) 62.1  (7.32) 65.8  (8.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 7 participants 11 participants 10 participants 39 participants
Female
4
  36.4%
1
  14.3%
5
  45.5%
3
  30.0%
13
  33.3%
Male
7
  63.6%
6
  85.7%
6
  54.5%
7
  70.0%
26
  66.7%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Visit 4 (Day 10)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Hide Arm/Group Description:
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
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.
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.
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
9.1
(0.2 to 41.3)
28.6
(3.7 to 71.0)
63.6
(30.8 to 89.1)
40.0
(12.2 to 73.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.146
Comments [Not Specified]
Method Shirley-Williams test
Comments P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.
Method of Estimation Estimation Parameter Difference of responder rate vs. placebo
Estimated Value 19.5
Confidence Interval (2-Sided) 95%
-18.1 to 57.0
Estimation Comments Difference of responder rate vs. placebo = responder rate for avatrombopag – responder rate for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Shirley-Williams test
Comments P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.
Method of Estimation Estimation Parameter Difference of responder rate vs. placebo
Estimated Value 54.5
Confidence Interval (2-Sided) 95%
21.4 to 87.7
Estimation Comments Difference of responder rate vs. placebo = responder rate for avatrombopag – responder rate for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Shirley-Williams test
Comments P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.
Method of Estimation Estimation Parameter Difference of responder rate vs. placebo
Estimated Value 30.9
Confidence Interval (2-Sided) 95%
-3.9 to 65.7
Estimation Comments Difference of responder rate vs. placebo = responder rate for avatrombopag – responder rate for placebo; 95% CI is calculated based on normal approximation.
2.Secondary Outcome
Title Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit
Hide Description 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.
Time Frame Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Hide Arm/Group Description:
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
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.
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.
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Visit 3 (Day 4 or Day 5)
0.0
(0.0 to 28.5)
14.3
(0.4 to 57.9)
27.3
(6.0 to 61.0)
0.0
(0.0 to 30.8)
Visit 4 (Day 10)
9.1
(0.2 to 41.3)
71.4
(29.0 to 96.3)
81.8
(48.2 to 97.7)
50.0
(18.7 to 81.3)
Visit 5 (Day 17)
27.3
(6.0 to 61.0)
0.0
(0.0 to 41.0)
54.5
(23.4 to 83.3)
20.0
(2.5 to 55.6)
Visit 6 (Day 35)
18.2
(2.3 to 51.8)
0.0
(0.0 to 41.0)
9.1
(0.2 to 41.3)
0.0
(0.0 to 30.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments Visit 3 (Day 4 or Day 5)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.388
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 14.3
Confidence Interval (2-Sided) 95%
-11.6 to 40.2
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 3 (Day 4 or Day 5)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 27.3
Confidence Interval (2-Sided) 95%
1.0 to 53.6
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments Visit 4 (Day 10)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 62.3
Confidence Interval (2-Sided) 95%
24.8 to 99.9
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 4 (Day 10)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 72.7
Confidence Interval (2-Sided) 95%
44.3 to 100.0
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 4 (Day 10)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 40.9
Confidence Interval (2-Sided) 95%
5.6 to 76.2
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments Visit 5 (Day 17)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value -27.3
Confidence Interval (2-Sided) 95%
-53.6 to -1.0
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 5 (Day 17)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.386
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 27.3
Confidence Interval (2-Sided) 95%
-12.2 to 66.8
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 5 (Day 17)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value -7.3
Confidence Interval (2-Sided) 95%
-43.4 to 28.9
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments Visit 6 (Day 35)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.496
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value -18.2
Confidence Interval (2-Sided) 95%
-41.0 to 4.6
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 6 (Day 35)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value -9.1
Confidence Interval (2-Sided) 95%
-37.5 to 19.3
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 6 (Day 35)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value -18.2
Confidence Interval (2-Sided) 95%
-41.0 to 4.6
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
3.Secondary Outcome
Title Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit
Hide Description 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.
Time Frame Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Hide Arm/Group Description:
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
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.
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.
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Visit 3 (Day 4 or Day 5)
0.0
(0.0 to 28.5)
0.0
(0.0 to 41.0)
0.0
(0.0 to 28.5)
0.0
(0.0 to 30.8)
Visit 4 (Day 10)
0.0
(0.0 to 28.5)
0.0
(0.0 to 41.0)
63.6
(30.8 to 89.1)
30.0
(6.7 to 65.2)
Visit 5 (Day 17)
0.0
(0.0 to 28.5)
0.0
(0.0 to 41.0)
0.0
(0.0 to 28.5)
10.0
(0.3 to 44.5)
Visit 6 (Day 35)
0.0
(0.0 to 28.5)
0.0
(0.0 to 41.0)
0.0
(0.0 to 28.5)
0.0
(0.0 to 30.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 4 (Day 10)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 63.6
Confidence Interval (2-Sided) 95%
35.2 to 92.1
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 4 (Day 10)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 30.0
Confidence Interval (2-Sided) 95%
1.6 to 58.4
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 5 (Day 17)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportion vs. placebo
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
-8.6 to 28.6
Estimation Comments Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.
4.Secondary Outcome
Title Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit
Hide Description 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.
Time Frame Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Hide Arm/Group Description:
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
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.
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.
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Number
Unit of Measure: Percentage of participants
Visit 3 (Day 4 or Day 5) 0.0 0.0 0.0 0.0
Visit 4 (Day 10) 0.0 0.0 0.0 0.0
Visit 5 (Day 17) 0.0 0.0 0.0 0.0
Visit 6 (Day 35) 0.0 0.0 0.0 0.0
5.Secondary Outcome
Title Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit
Hide Description 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.
Time Frame Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Hide Arm/Group Description:
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
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.
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.
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Number
Unit of Measure: Percentage of participants
Visit 3 (Day 4 or Day 5) 0.0 0.0 0.0 0.0
Visit 4 (Day 10) 0.0 0.0 0.0 0.0
Visit 5 (Day 17) 0.0 0.0 0.0 0.0
Visit 6 (Day 35) 0.0 0.0 0.0 0.0
6.Secondary Outcome
Title Platelet Count and Change From Baseline in Platelet Count by Visit
Hide Description [Not Specified]
Time Frame Baseline, Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Hide Arm/Group Description:
Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.
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.
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.
Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
Overall Number of Participants Analyzed 11 7 11 10
Mean (Standard Deviation)
Unit of Measure: Number of platelets x 10^9/L
Visit 2 (Baseline) Platelet count Number Analyzed 11 participants 7 participants 11 participants 10 participants
40.59  (7.024) 40.57  (5.556) 41.23  (5.159) 28.85  (7.568)
Visit 3 (Day 4 or Day 5) Platelet count Number Analyzed 11 participants 7 participants 11 participants 10 participants
41.27  (8.344) 44.71  (6.102) 46.09  (8.860) 32.70  (9.967)
Visit 3 (Day 4 or Day 5) Change from baseline Number Analyzed 11 participants 7 participants 11 participants 10 participants
0.68  (2.848) 4.14  (7.099) 4.86  (6.569) 3.85  (6.223)
Visit 4 (Day 10) Platelet count Number Analyzed 11 participants 7 participants 11 participants 10 participants
43.91  (10.568) 53.29  (5.678) 79.36  (24.800) 55.90  (22.507)
Visit 4 (Day 10) Change from baseline Number Analyzed 11 participants 7 participants 11 participants 10 participants
3.32  (7.163) 12.71  (9.486) 38.14  (22.781) 27.05  (22.700)
Visit 5 (Day 17) Platelet count Number Analyzed 11 participants 7 participants 11 participants 10 participants
40.10  (9.916) 41.33  (4.803) 55.73  (14.826) 41.80  (16.578)
Visit 5 (Day 17) Change from baseline Number Analyzed 10 participants 6 participants 11 participants 10 participants
0.40  (5.243) 1.75  (3.402) 14.50  (11.874) 12.95  (12.857)
Visit 6 (Day 35) Platelet count Number Analyzed 10 participants 6 participants 11 participants 9 participants
41.50  (10.845) 39.67  (5.574) 41.36  (8.262) 31.44  (8.353)
Visit 6 (Day 35) Change from baseline Number Analyzed 10 participants 6 participants 11 participants 9 participants
1.80  (4.614) 0.08  (1.686) 0.14  (8.382) 2.33  (4.265)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments Visit 3 (Day 4 or Day 5)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.296
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 3 (Day 4 or Day 5)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 3 (Day 4 or Day 5)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments Visit 4 (Day 10)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 4 (Day 10)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 4 (Day 10)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments Visit 5 (Day 17)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 5 (Day 17)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 5 (Day 17)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (20 mg)
Comments Visit 6 (Day 35)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (40 mg)
Comments Visit 6 (Day 35)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo (60 mg), Avatrombopag (60 mg)
Comments Visit 6 (Day 35)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.901
Comments P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least one dose of study drug and had at least one safety assessment.
Arm/Group Title Placebo Avatrombopag 20-mg Avatrombopag 40-mg Avatrombopag 60-mg
Hide Arm/Group Description:
Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days
60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
All TEAEs
8
  72.7%
4
  57.1%
8
  72.7%
3
  30.0%
Treatment-related TEAEs
0
   0.0%
2
  28.6%
2
  18.2%
0
   0.0%
Serious TEAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
TEAEs leading to study drug dose adjustment
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
TEAEs leading to study drug withdrawal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
TEAEs leading to study drug dose reduction
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
TEAEs leading to study drug dose interruption
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Other Pre-specified Outcome
Title Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
Hide Description [Not Specified]
Time Frame From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Avatrombopag 20-mg Avatrombopag 40-mg Avatrombopag 60-mg
Hide Arm/Group Description:
Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days
60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin
1
   9.1%
0
   0.0%
0
   0.0%
1
  10.0%
Leukocytes
4
  36.4%
4
  57.1%
2
  18.2%
0
   0.0%
Alkaline phosphatase (ALP)
1
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
Alanine aminotransferase (ALT)
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
Bilirubin
1
   9.1%
1
  14.3%
2
  18.2%
2
  20.0%
Gamma-glutamyl transferase (γ-GTP)
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
Calcium
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
Albumin
1
   9.1%
1
  14.3%
1
   9.1%
0
   0.0%
Glucose
3
  27.3%
2
  28.6%
2
  18.2%
1
  10.0%
Triglycerides
9
  81.8%
0
   0.0%
1
   9.1%
0
   0.0%
Aspartate aminotransferase (AST)
0
   0.0%
1
  14.3%
0
   0.0%
1
  10.0%
9.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Findings in Laboratory Values for Serum
Hide Description [Not Specified]
Time Frame From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Avatrombopag 20-mg Avatrombopag 40-mg Avatrombopag 60-mg
Hide Arm/Group Description:
Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days
60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Findings in Laboratory Values for Urinalysis
Hide Description [Not Specified]
Time Frame From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Avatrombopag 20-mg Avatrombopag 40-mg Avatrombopag 60-mg
Hide Arm/Group Description:
Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days
60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Hide Description [Not Specified]
Time Frame From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Avatrombopag 20-mg Avatrombopag 40-mg Avatrombopag 60-mg
Hide Arm/Group Description:
Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days
60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
12.Other Pre-specified Outcome
Title Number of Participants With Markedly Abnormal Electrocardiographs
Hide Description [Not Specified]
Time Frame From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Avatrombopag 20-mg Avatrombopag 40-mg Avatrombopag 60-mg
Hide Arm/Group Description:
Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days
40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days
60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days
Overall Number of Participants Analyzed 11 7 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 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.
Adverse Event Reporting Description 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."
 
Arm/Group Title Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Hide Arm/Group Description Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days. 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. 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. Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.
All-Cause Mortality
Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/7 (0.00%)   0/11 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/7 (0.00%)   0/11 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (60 mg) Avatrombopag (20 mg) Avatrombopag (40 mg) Avatrombopag (60 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/11 (72.73%)   4/7 (57.14%)   8/11 (72.73%)   3/10 (30.00%) 
Eye disorders         
Conjunctival Haemorrhage  1  0/11 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders         
Abdominal Discomfort  1  1/11 (9.09%)  1/7 (14.29%)  0/11 (0.00%)  0/10 (0.00%) 
Ascites  1  1/11 (9.09%)  0/7 (0.00%)  0/11 (0.00%)  0/10 (0.00%) 
Constipation  1  0/11 (0.00%)  0/7 (0.00%)  2/11 (18.18%)  0/10 (0.00%) 
Diarrhoea  1  1/11 (9.09%)  1/7 (14.29%)  0/11 (0.00%)  1/10 (10.00%) 
Haematochezia  1  1/11 (9.09%)  0/7 (0.00%)  0/11 (0.00%)  0/10 (0.00%) 
Nausea  1  0/11 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/10 (10.00%) 
General disorders         
Injection Site Reaction  1  0/11 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/10 (0.00%) 
Puncture Site Pain  1  0/11 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/10 (10.00%) 
Thirst  1  0/11 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/10 (0.00%) 
Vessel Puncture Site Haematoma  1  0/11 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/10 (0.00%) 
Infections and infestations         
Acute Sinusitis  1  0/11 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/10 (0.00%) 
Gastroenteritis  1  0/11 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/10 (0.00%) 
Nasopharyngitis  1  0/11 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  1/10 (10.00%) 
Injury, poisoning and procedural complications         
Post Embolisation Syndrome  1  0/11 (0.00%)  0/7 (0.00%)  2/11 (18.18%)  1/10 (10.00%) 
Post Procedural Complication  1  1/11 (9.09%)  2/7 (28.57%)  2/11 (18.18%)  0/10 (0.00%) 
Investigations         
Alanine Aminotransferase Increased  1  0/11 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/10 (0.00%) 
Aspartate Aminotransferase Increased  1  0/11 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/10 (0.00%) 
Blood Glucose Increased  1  1/11 (9.09%)  1/7 (14.29%)  1/11 (9.09%)  0/10 (0.00%) 
Blood pressure increased  1  0/11 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/10 (10.00%) 
White Blood Cell Count Decreased  1  0/11 (0.00%)  1/7 (14.29%)  0/11 (0.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal Chest Pain  1  1/11 (9.09%)  0/7 (0.00%)  0/11 (0.00%)  0/10 (0.00%) 
Myalgia  1  1/11 (9.09%)  0/7 (0.00%)  0/11 (0.00%)  0/10 (0.00%) 
Neck Pain  1  1/11 (9.09%)  0/7 (0.00%)  0/11 (0.00%)  0/10 (0.00%) 
Nervous system disorders         
Headache  1  0/11 (0.00%)  0/7 (0.00%)  0/11 (0.00%)  1/10 (10.00%) 
Psychiatric disorders         
Insomnia  1  1/11 (9.09%)  0/7 (0.00%)  0/11 (0.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  1/11 (9.09%)  0/7 (0.00%)  0/11 (0.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders         
Blister  1  0/11 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/10 (0.00%) 
Eczema Asteatotic  1  0/11 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/10 (0.00%) 
Erythema  1  0/11 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/10 (0.00%) 
Haemorrhage Subcutaneous  1  1/11 (9.09%)  1/7 (14.29%)  1/11 (9.09%)  0/10 (0.00%) 
Rosacea  1  0/11 (0.00%)  0/7 (0.00%)  1/11 (9.09%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
Phone: 1-888-274-2378
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT02227693     History of Changes
Other Study ID Numbers: E5501-J081-204
First Submitted: August 26, 2014
First Posted: August 28, 2014
Results First Submitted: December 4, 2017
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019