Trial Outcomes & Findings for Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP) (NCT NCT00828750)
NCT ID: NCT00828750
Last Updated: 2018-09-17
Results Overview
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Results posted on
2018-09-17
Participant Flow
This study is an open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for the treatment of participants with idiopathic thrombocytopenic purpura (ITP) who had previously been enrolled in eltrombopag trial TRA108109 (NCT00540423).
Participant milestones
| Measure |
Eltrombopag
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
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|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Eltrombopag
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
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|---|---|
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Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Normal PC Remained While No Treatment
|
1
|
Baseline Characteristics
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Baseline characteristics by cohort
| Measure |
Eltrombopag
n=19 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
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|---|---|
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Age, Continuous
|
54.7 Years
STANDARD_DEVIATION 13.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)Population: Safety Population (SP): all participants who received at least one dose of study medication
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.
Outcome measures
| Measure |
Eltrombopag
n=19 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
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|---|---|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
AE
|
19 participants
|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
SAE
|
6 participants
|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
Drug-Related AE
|
5 participants
|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
AE Leading to Withdrawal
|
0 participants
|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
SAE Leading to Withdrawal
|
0 participants
|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
Ongoing AE at the End of Study/Withdrawal
|
15 participants
|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
Mild AE
|
6 participants
|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
Moderate AE
|
13 participants
|
|
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
Severe AE
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)Population: Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.
Platelet counts were measured by blood draw.
Outcome measures
| Measure |
Eltrombopag
n=19 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
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|---|---|
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Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Baseline, n=19
|
5.3 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 1, n=19
|
21.1 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 2, n=19
|
63.2 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 3, n=19
|
78.9 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 4, n=19
|
73.7 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 8, n=19
|
73.7 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 12, n=16
|
68.8 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 16, n=17
|
76.5 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 20, n=15
|
73.3 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 24, n=17
|
82.4 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 28, n=16
|
81.3 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 32, n=16
|
68.8 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 36, n=18
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 40, n=17
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 44, n=17
|
58.8 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 48, n=18
|
83.3 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 52, n=16
|
62.5 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 56, n=14
|
57.1 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 60, n=16
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 64, n=14
|
57.1 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 68, n=14
|
57.1 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 72, n=12
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 76, n=12
|
75.0 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 80, n=12
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 84, n=13
|
69.2 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 88, n=12
|
75.0 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 92, n=11
|
72.7 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 96, n=11
|
54.5 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 100, n=13
|
46.2 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 104, n=11
|
45.5 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 108, n=11
|
72.7 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 112, n=7
|
57.1 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 116, n=7
|
85.7 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 120, n=5
|
40.0 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 124, n=6
|
16.7 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 128, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 132, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Week 136, n=1
|
100 percentage of participants
|
|
Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L
Last Visit/Early Withdrawal Visit, n=19
|
57.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)Population: FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.
Platelet counts were measured by blood draw.
Outcome measures
| Measure |
Eltrombopag
n=19 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
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|---|---|
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Median Platelet Counts
Baseline, n=19
|
20.0 Gi/L
Interval 3.0 to 117.0
|
|
Median Platelet Counts
Week 1, n=19
|
36.0 Gi/L
Interval 4.0 to 308.0
|
|
Median Platelet Counts
Week 2, n=19
|
84.0 Gi/L
Interval 14.0 to 463.0
|
|
Median Platelet Counts
Week 3, n=19
|
85.0 Gi/L
Interval 10.0 to 194.0
|
|
Median Platelet Counts
Week 4, n=19
|
97.0 Gi/L
Interval 5.0 to 259.0
|
|
Median Platelet Counts
Week 8, n=19
|
102.0 Gi/L
Interval 5.0 to 224.0
|
|
Median Platelet Counts
Week 12, n=16
|
85.0 Gi/L
Interval 23.0 to 238.0
|
|
Median Platelet Counts
Week 16, n=17
|
76.0 Gi/L
Interval 8.0 to 217.0
|
|
Median Platelet Counts
Week 20, n=15
|
61.0 Gi/L
Interval 7.0 to 252.0
|
|
Median Platelet Counts
Week 24, n=17
|
70.0 Gi/L
Interval 5.0 to 255.0
|
|
Median Platelet Counts
Week 28, n=16
|
97.0 Gi/L
Interval 17.0 to 202.0
|
|
Median Platelet Counts
Week 32, n=16
|
75.0 Gi/L
Interval 9.0 to 184.0
|
|
Median Platelet Counts
Week 36, n=18
|
73.5 Gi/L
Interval 3.0 to 233.0
|
|
Median Platelet Counts
Week 40, n=17
|
45.0 Gi/L
Interval 4.0 to 222.0
|
|
Median Platelet Counts
Week 44, n=17
|
59.0 Gi/L
Interval 3.0 to 226.0
|
|
Median Platelet Counts
Week 48, n=18
|
71.5 Gi/L
Interval 3.0 to 224.0
|
|
Median Platelet Counts
Week 52, n=16
|
81.0 Gi/L
Interval 5.0 to 303.0
|
|
Median Platelet Counts
Week 56, n=14
|
58.0 Gi/L
Interval 19.0 to 223.0
|
|
Median Platelet Counts
Week 60, n=16
|
48.5 Gi/L
Interval 4.0 to 252.0
|
|
Median Platelet Counts
Week 64, n=14
|
57.5 Gi/L
Interval 5.0 to 201.0
|
|
Median Platelet Counts
Week 68, n=14
|
53.5 Gi/L
Interval 3.0 to 200.0
|
|
Median Platelet Counts
Week 72, n=12
|
51.5 Gi/L
Interval 20.0 to 188.0
|
|
Median Platelet Counts
Week 76, n=12
|
90.0 Gi/L
Interval 39.0 to 241.0
|
|
Median Platelet Counts
Week 80, n=12
|
67.5 Gi/L
Interval 7.0 to 277.0
|
|
Median Platelet Counts
Week 84, n=13
|
86.0 Gi/L
Interval 20.0 to 280.0
|
|
Median Platelet Counts
Week 88, n=12
|
65.0 Gi/L
Interval 14.0 to 205.0
|
|
Median Platelet Counts
Week 92, n=11
|
78.0 Gi/L
Interval 22.0 to 194.0
|
|
Median Platelet Counts
Week 96, n=11
|
57.0 Gi/L
Interval 11.0 to 236.0
|
|
Median Platelet Counts
Week 100, n=13
|
45.0 Gi/L
Interval 15.0 to 282.0
|
|
Median Platelet Counts
Week 104, n=11
|
44.0 Gi/L
Interval 8.0 to 241.0
|
|
Median Platelet Counts
Week 108, n=11
|
69.0 Gi/L
Interval 2.0 to 318.0
|
|
Median Platelet Counts
Week 112, n=7
|
56.0 Gi/L
Interval 15.0 to 146.0
|
|
Median Platelet Counts
Week 116, n=7
|
84.0 Gi/L
Interval 38.0 to 148.0
|
|
Median Platelet Counts
Week 120, n=5
|
21.0 Gi/L
Interval 11.0 to 294.0
|
|
Median Platelet Counts
Week 124, n=6
|
32.0 Gi/L
Interval 8.0 to 156.0
|
|
Median Platelet Counts
Week 128, n=4
|
37.0 Gi/L
Interval 7.0 to 178.0
|
|
Median Platelet Counts
Week 132, n=2
|
34.0 Gi/L
Interval 18.0 to 50.0
|
|
Median Platelet Counts
Week 136, n=1
|
51.0 Gi/L
Interval 51.0 to 51.0
|
|
Median Platelet Counts
Last Visit/Early Withdrawal Visit, n=19
|
75.0 Gi/L
Interval 7.0 to 314.0
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)Population: FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants.
Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
Outcome measures
| Measure |
Eltrombopag
n=19 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
|
|---|---|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 weeks (WKS), MCW=0 week (WK), n=2
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=1 WK, n=2
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=4 WKS, n=2
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=7 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=10 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=13 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=16 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=19 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=22 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=25 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=28 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=31 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=34 WKS, n=2
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=37 WKS, n=2
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=40 WKS, n=2
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. =<52 WKS, MCW >=43 WKS, n=2
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW=0 WK, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=1 WK, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=4 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=7 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=10 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=13 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=16 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=19 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=22 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=25 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=28 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=31 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=34 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=37 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=40 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=43 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=52 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >52 to =<78 WKS, MCW >=65 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW=0 WK, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=1 WK, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=4 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=7 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=10 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=13 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=16 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=19 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=22 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=25 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=28 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=31 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=34 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=37 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=40 WKS, n=1
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=43 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=52 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=65 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >78 to =<104 WKS, MCW >=78 WKS, n=1
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW=0 WK, n=11
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=1 WK, n=11
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=4 WKS, n=11
|
90.9 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=7 WKS, n=11
|
90.9 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=10 WKS, n=11
|
90.9 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=13 WKS, n=11
|
90.9 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=16 WKS, n=11
|
81.8 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=19 WKS, n=11
|
63.6 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=22 WKS, n=11
|
54.5 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=25 WKS, n=11
|
45.5 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=28 WKS, n=11
|
45.5 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=31 WKS, n=11
|
36.4 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=34 WKS, n=11
|
36.4 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=37 WKS, n=11
|
18.2 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=40 WKS, n=11
|
18.2 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=43 WKS, n=11
|
18.2 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=52 WKS, n=11
|
18.2 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=65 WKS, n=11
|
9.1 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=78 WKS, n=11
|
9.1 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=91 WKS, n=11
|
9.1 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=104 WKS, n=11
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >104 to =<130 WKS, MCW >=117 WKS, n=6
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW=0 WK, n=4
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=1 WK, n=4
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=4 WKS, n=4
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=7 WKS, n=4
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=10 WKS, n=4
|
50.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=13 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=16 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=19 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=22 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=25 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=28 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=31 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=34 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=37 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=40 WKS, n=4
|
25.0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=43 WKS, n=4
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=52 WKS, n=4
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=65 WKS, n=4
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=78 WKS, n=4
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=91 WKS, n=4
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=104 WKS, n=4
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Study Med. >130 WKS, MCW >=117 WKS, n=4
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW=0 WK, n=19
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=1 WK, n=19
|
100 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=4 WKS, n=19
|
84.2 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=7 WKS, n=19
|
78.9 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=10 WKS, n=19
|
73.7 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=13 WKS, n=19
|
68.4 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=16 WKS, n=19
|
63.2 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=19 WKS, n=19
|
52.6 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=22 WKS, n=19
|
47.4 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=25 WKS, n=19
|
42.1 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=28 WKS, n=19
|
42.1 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=31 WKS, n=19
|
36.8 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=34 WKS, n=19
|
36.8 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=37 WKS, n=19
|
21.1 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=40 WKS, n=19
|
21.1 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=43 WKS, n=19
|
10.5 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=52 WKS, n=17
|
11.8 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=65 WKS, n=17
|
5.9 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=78 WKS, n=16
|
6.3 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=91 WKS, n=15
|
6.7 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=104 WKS, n=15
|
0 percentage of participants
|
|
Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)
Total, MCW >=117 WKS, n=10
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)Population: FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants.
Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.
Outcome measures
| Measure |
Eltrombopag
n=19 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
|
|---|---|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
Total, n=19
|
19.0 weeks
Interval 1.0 to 91.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
3 Months (13 Weeks), n=18
|
5.0 weeks
Interval 0.0 to 11.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
6 Months (26 Weeks), n=19
|
10.0 weeks
Interval 0.0 to 24.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
9 Months (39 Weeks), n=19
|
12.0 weeks
Interval 0.0 to 36.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
12 Months (52 Weeks), n=17
|
14.0 weeks
Interval 0.0 to 36.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
15 Months (65 Weeks), n=17
|
14.0 weeks
Interval 0.0 to 40.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
18 Months (78 Weeks), n=16
|
15.0 weeks
Interval 0.0 to 53.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
21 Months (91 Weeks), n=15
|
14.0 weeks
Interval 0.0 to 64.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
24 Months (104 Weeks), n=15
|
19.0 weeks
Interval 0.0 to 76.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
27 Months (117 Weeks), n=10
|
17.5 weeks
Interval 0.0 to 91.0
|
|
Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals
30 Months (130 Weeks), n=4
|
7.5 weeks
Interval 3.0 to 40.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)Population: FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants.
Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).
Outcome measures
| Measure |
Eltrombopag
n=19 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
|
|---|---|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Baseline, n=19
|
63 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 1, n=19
|
32 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 2, n=19
|
21 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 3, n=19
|
16 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 4, n=19
|
5 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 8, n=19
|
11 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 12, n=16
|
13 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 16, n=17
|
12 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 20, n=15
|
40 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 24, n=17
|
6 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 28, n=16
|
25 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 32, n=16
|
19 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 36, n=18
|
39 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 40, n=17
|
35 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 44, n=17
|
24 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 48, n=18
|
22 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 52, n=16
|
31 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 56, n=14
|
29 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 60, n=16
|
13 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 64, n=14
|
21 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 68, n=14
|
29 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 72, n=12
|
8 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 76, n=12
|
8 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 80, n=12
|
25 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 84, n=13
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 88, n=12
|
8 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 92, n=11
|
9 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 96, n=11
|
9 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 100, n=13
|
8 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 104, n=11
|
27 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 108, n=11
|
27 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 112, n=7
|
14 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 116, n=7
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 120, n=5
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 124, n=6
|
33 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 128, n=4
|
25 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 132, n=2
|
50 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Week 136, n=1
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Last Visit/Early Withdrawal, n=19
|
21 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)Population: FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis.
Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.
Outcome measures
| Measure |
Eltrombopag
n=15 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
|
|---|---|
|
Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication
|
87 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)Population: FAS
Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.
Outcome measures
| Measure |
Eltrombopag
n=19 Participants
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
|
|---|---|
|
Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
Any Rescue Therapy
|
21 percentage of participants
|
|
Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
New ITP Medication
|
11 percentage of participants
|
|
Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
Increase in Concomitant ITP Medication from B/L
|
11 percentage of participants
|
|
Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
Platelet Transfusion
|
0 percentage of participants
|
|
Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
Splenectomy
|
0 percentage of participants
|
Adverse Events
Eltrombopag
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eltrombopag
n=19 participants at risk
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
|
|---|---|
|
Eye disorders
Cataract
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Renal and urinary disorders
Cystitis-like symptom
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
Other adverse events
| Measure |
Eltrombopag
n=19 participants at risk
Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
63.2%
12/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Bronchitis
|
15.8%
3/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Cystitis
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Influenza
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Fungal infection
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Parotitis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Rhinitis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Infections and infestations
Tinea infection
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Dental caries
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Food poisoning
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Gastric ulcer
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Gastritis atrophic
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Gastritis erosive
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Tongue discolouration
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Eye disorders
Cataract
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Eye disorders
Asthenopia
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Eye disorders
Chalazion
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Eye disorders
Conjunctival haemorrhage
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Eye disorders
Conjunctivitis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Eye disorders
Conjunctivitis allergic
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Eye disorders
Eye pruritus
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Eye disorders
Vision blurred
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
15.8%
3/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Blood and lymphatic system disorders
Anaemia
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.8%
3/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
15.8%
3/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Skin and subcutaneous tissue disorders
Papule
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
General disorders
Chest pain
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
General disorders
Fatigue
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
General disorders
Pyrexia
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
General disorders
Chills
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
General disorders
Oedema
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Nervous system disorders
Headache
|
21.1%
4/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Injury, poisoning and procedural complications
Compression fracture
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Injury, poisoning and procedural complications
Lip injury
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Investigations
Glucose urine present
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Investigations
Haemoglobin decreased
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.5%
2/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Vascular disorders
Hypertension
|
15.8%
3/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Vascular disorders
Hot flush
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Ear and labyrinth disorders
Presbyacusis
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm
|
5.3%
1/19 • Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER