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Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure

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ClinicalTrials.gov Identifier: NCT01976104
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Thrombocytopenia Associated With Liver Disease
Interventions Drug: avatrombopag (lower baseline platelet count)
Drug: placebo (lower baseline platelet count)
Drug: avatrombopag (higher baseline platelet count)
Drug: placebo (higher baseline platelet count)
Enrollment 204
Recruitment Details  
Pre-assignment Details A total of 346 participants signed informed consent. Of these 346 participants, 142 were screen failures and 204 were randomized into the study. Of the 142 screen failures, 119 did not meet inclusion/exclusion criteria and 13 withdrew consent, 3 experienced an adverse event, 1 was lost to follow-up and 6 had other not specified reasons.
Arm/Group Title 60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Hide Arm/Group Description Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 millilgrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Period Title: Overall Study
Started 43 70 33 58
Completed 37 68 31 55
Not Completed 6 2 2 3
Reason Not Completed
Adverse Event             0             0             1             0
Lost to Follow-up             3             0             1             1
Subject Choice             0             1             0             1
Withdrawal by Subject             3             0             0             1
Other             0             1             0             0
Arm/Group Title 60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count) Total
Hide Arm/Group Description Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5. Total of all reporting groups
Overall Number of Baseline Participants 43 70 33 58 204
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) was defined as the group of all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 70 participants 33 participants 58 participants 204 participants
57.3  (11.98) 58.6  (14.18) 59.2  (10.31) 57.9  (11.11) 58.2  (12.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 70 participants 33 participants 58 participants 204 participants
Female
16
  37.2%
20
  28.6%
16
  48.5%
25
  43.1%
77
  37.7%
Male
27
  62.8%
50
  71.4%
17
  51.5%
33
  56.9%
127
  62.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 70 participants 33 participants 58 participants 204 participants
Hispanic or Latino
12
  27.9%
11
  15.7%
7
  21.2%
15
  25.9%
45
  22.1%
Not Hispanic or Latino
29
  67.4%
56
  80.0%
25
  75.8%
42
  72.4%
152
  74.5%
Unknown or Not Reported
2
   4.7%
3
   4.3%
1
   3.0%
1
   1.7%
7
   3.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 70 participants 33 participants 58 participants 204 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
10
  23.3%
25
  35.7%
8
  24.2%
12
  20.7%
55
  27.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   4.7%
2
   2.9%
0
   0.0%
2
   3.4%
6
   2.9%
White
27
  62.8%
40
  57.1%
24
  72.7%
40
  69.0%
131
  64.2%
More than one race
4
   9.3%
3
   4.3%
0
   0.0%
4
   6.9%
11
   5.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.0%
0
   0.0%
1
   0.5%
1.Primary Outcome
Title Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure
Hide Description Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).
Time Frame Randomization (Visit 2), up to 7 Days following a scheduled procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis Set (FAS) was defined as the group of all randomized participants.
Arm/Group Title 60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Hide Arm/Group Description:
Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Overall Number of Participants Analyzed 43 70 33 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
34.9
(20.6 to 49.1)
68.6
(57.7 to 79.4)
33.3
(17.2 to 49.4)
87.9
(79.5 to 96.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 60 mg Placebo (Lower Baseline Platelet Count), 60 mg Avatrombopag (Lower Baseline Platelet Count)
Comments The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.
Method of Estimation Estimation Parameter Difference of proportion versus placebo
Estimated Value 33.7
Confidence Interval (2-Sided) 95%
15.8 to 51.6
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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 40 mg Placebo (Higher Baseline Platelet Count), 40 mg Avatrombopag (Higher Baseline Platelet Count)
Comments The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort
Method of Estimation Estimation Parameter Difference of proportion versus placebo
Estimated Value 54.6
Confidence Interval (2-Sided) 95%
36.5 to 72.7
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.
2.Secondary Outcome
Title Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on Scheduled Procedure Day
Hide Description Responders were defined as participants who achieved a platelet count greater than or equal to 50 x 10^9/L on the procedure day. Participants missing a platelet count on the procedure day were conservatively considered as not achieving a platelet count of 50x10^9/L in the analysis, (i.e. Non-responders).
Time Frame Day 10 to Day 13 (Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Hide Arm/Group Description:
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Overall Number of Participants Analyzed 43 70 33 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
7.0
(0.0 to 14.6)
67.1
(56.1 to 78.1)
39.4
(22.7 to 56.1)
93.1
(86.6 to 99.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 60 mg Placebo (Lower Baseline Platelet Count), 60 mg Avatrombopag (Lower Baseline Platelet Count)
Comments The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.
Method of Estimation Estimation Parameter Difference of proportion versus placebo
Estimated Value 60.2
Confidence Interval (2-Sided) 95%
46.8 to 73.5
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.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 40 mg Placebo (Higher Baseline Platelet Count), 40 mg Avatrombopag (Higher Baseline Platelet Count)
Comments The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.
Method of Estimation Estimation Parameter Difference of proportion versus placebo
Estimated Value 53.7
Confidence Interval (2-Sided) 95%
35.8 to 71.6
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 Change From Baseline in Platelet Counts on Scheduled Procedure Day
Hide Description Last observation carried forward was used for participants with a missing platelet count on the scheduled procedure day. Platelet count was measured preprocedure and before any platelet transfusion.
Time Frame Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants with data available at both Baseline and post-Baseline were analyzed.
Arm/Group Title 60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Hide Arm/Group Description:
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Overall Number of Participants Analyzed 43 69 33 58
Mean (Standard Deviation)
Unit of Measure: platelet count x 10^9 per liter
3.0  (10.01) 31.3  (24.9) 5.9  (14.89) 44.9  (32.96)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 60 mg Placebo (Lower Baseline Platelet Count), 60 mg Avatrombopag (Lower Baseline Platelet Count)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.
Method of Estimation Estimation Parameter Difference in change of platelet count
Estimated Value 25.4
Confidence Interval (2-Sided) 95%
19.5 to 32.0
Estimation Comments Difference in change from Baseline of platelet count for avatrombopag versus placebo within each Baseline platelet count cohort was based on Hodges-Lehmann estimation; 95% CI was the asymptotic (Moses) CI
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 40 mg Placebo (Higher Baseline Platelet Count), 40 mg Avatrombopag (Higher Baseline Platelet Count)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.
Method of Estimation Estimation Parameter Difference in change of platelet count
Estimated Value 36.3
Confidence Interval (2-Sided) 95%
25.5 to 45.5
Estimation Comments Difference in change from baseline of platelet count for avatrombopag vs. placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.
4.Other Pre-specified Outcome
Title Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After Randomization and up to 7 Days After an Scheduled Procedure
Hide Description The severity of bleeding events was assessed by the investigator (or appropriately delegated study site personnel) using the WHO bleeding scale. The WHO bleeding scale is a clinical investigator-assessed five-point scale with Grade 0 = No bleeding, Grade 1 = Petechial bleeding, Grade 2 = Mild blood loss (clinically significant), Grade 3 = Gross blood loss requires transfusion (severe), and Grade 4 = Debilitating blood loss, retinal or cerebral associated with fatality. Participants with missing information are considered as having a WHO bleeding score greater than or equal to 2 in the analysis.
Time Frame Baseline (Visit 2) up to 7 days post scheduled procedure
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Hide Arm/Group Description:
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Overall Number of Participants Analyzed 43 70 33 58
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 1.4 6.1 1.7
5.Other Pre-specified Outcome
Title Number of Participants Experiencing an Adverse Event
Hide Description Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events, including platelet transfusion-related complications; routine laboratory evaluation for hematology, serum chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of 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. Treatment-emergent adverse events (TEAEs) were 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. Treatment-related AEs were considered by the investigator to be possibly or probably related to study drug.
Time Frame From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. One participant in the High Baseline Platelet Count Cohort received 60 mg avatrombopag and hence was included in the <40×10^9/L Low Baseline Platelet Count Cohort in all safety analyses.
Arm/Group Title 60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Hide Arm/Group Description:
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.
Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
Overall Number of Participants Analyzed 43 70 33 57
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
22
  51.2%
36
  51.4%
15
  45.5%
28
  49.1%
Treatment-related TEAEs
9
  20.9%
6
   8.6%
2
   6.1%
4
   7.0%
Serious TEAEs
1
   2.3%
1
   1.4%
1
   3.0%
1
   1.8%
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%
Time Frame From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months
Adverse Event Reporting Description Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.
 
Arm/Group Title 60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Hide Arm/Group Description Participants with a baseline platelet count of less than 40 x 10^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of less than 40 x 10^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5. Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.
All-Cause Mortality
60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/70 (0.00%)   1/33 (3.03%)   0/57 (0.00%) 
Hide Serious Adverse Events
60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/43 (2.33%)   1/70 (1.43%)   1/33 (3.03%)   1/57 (1.75%) 
Cardiac disorders         
Acute myocardial infarction  1  0/43 (0.00%)  0/70 (0.00%)  1/33 (3.03%)  0/57 (0.00%) 
Gastrointestinal disorders         
Haematemesis  1  0/43 (0.00%)  1/70 (1.43%)  0/33 (0.00%)  0/57 (0.00%) 
Ileus paralytic  1  0/43 (0.00%)  0/70 (0.00%)  0/33 (0.00%)  1/57 (1.75%) 
General disorders         
Multiple organ dysfunction syndrome  1  0/43 (0.00%)  0/70 (0.00%)  1/33 (3.03%)  0/57 (0.00%) 
Nervous system disorders         
Hepatic encephalopathy  1  1/43 (2.33%)  0/70 (0.00%)  0/33 (0.00%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  0/43 (0.00%)  0/70 (0.00%)  0/33 (0.00%)  1/57 (1.75%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
60 mg Placebo (Lower Baseline Platelet Count) 60 mg Avatrombopag (Lower Baseline Platelet Count) 40 mg Placebo (Higher Baseline Platelet Count) 40 mg Avatrombopag (Higher Baseline Platelet Count)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/43 (51.16%)   30/70 (42.86%)   15/33 (45.45%)   14/57 (24.56%) 
Gastrointestinal disorders         
Abdominal pain  1  3/43 (6.98%)  2/70 (2.86%)  1/33 (3.03%)  2/57 (3.51%) 
Abdominal pain upper  1  5/43 (11.63%)  2/70 (2.86%)  3/33 (9.09%)  1/57 (1.75%) 
Diarrhoea  1  3/43 (6.98%)  3/70 (4.29%)  0/33 (0.00%)  2/57 (3.51%) 
Nausea  1  5/43 (11.63%)  6/70 (8.57%)  2/33 (6.06%)  3/57 (5.26%) 
General disorders         
Fatigue  1  3/43 (6.98%)  1/70 (1.43%)  0/33 (0.00%)  2/57 (3.51%) 
Puncture site haemorrhage  1  0/43 (0.00%)  0/70 (0.00%)  3/33 (9.09%)  0/57 (0.00%) 
Pyrexia  1  2/43 (4.65%)  11/70 (15.71%)  4/33 (12.12%)  4/57 (7.02%) 
Injury, poisoning and procedural complications         
Transfusion reaction  1  1/43 (2.33%)  0/70 (0.00%)  2/33 (6.06%)  0/57 (0.00%) 
Nervous system disorders         
Dizziness  1  3/43 (6.98%)  3/70 (4.29%)  1/33 (3.03%)  0/57 (0.00%) 
Headache  1  4/43 (9.30%)  2/70 (2.86%)  1/33 (3.03%)  2/57 (3.51%) 
Renal and urinary disorders         
Haematuria  1  0/43 (0.00%)  0/70 (0.00%)  2/33 (6.06%)  0/57 (0.00%) 
1
Term from vocabulary, MedDRA (19.1)
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
Layout table for Results Point of Contact information
Name/Title: Eisai Inc.
Organization: Eisai Call Center
Phone: 888-422-4743
EMail: esi_medinfo@eisai.com
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01976104    
Other Study ID Numbers: E5501-G000-311
2013-000934-36 ( EudraCT Number )
First Submitted: October 24, 2013
First Posted: November 5, 2013
Results First Submitted: December 27, 2017
Results First Posted: February 27, 2018
Last Update Posted: February 27, 2018