Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic
Conditions
Keywords
eltrombopag, thrombopoietin receptor agonist, ITP, blood platelet
Brief summary
An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).
Interventions
DRUGEltrombopag oral tablets
Eltrombopag oral tablets once daily
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has signed and dated written informed consent. * Subject (\>=20 years) diagnosed with ITP. * Subject previously enrolled in TRA108109 (NCT00540423) must have completed the treatment and follow-up periods as defined in that protocol. * Subject has no intercurrent medical event at risk of thrombosis such as thrombophilia. * Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must be within 1.2 times the upper limit of the normal range with no history of hypercoagulable state. * A complete blood count (CBC), within the reference range, with the following exceptions: * Hemoglobin: patients with haemoglobin level \< the lower limit of normal are eligible for inclusion if hemorrhage is present. * Neutrophil count \>= 1,500/L (1.5x10E9/L) is required for inclusion. * The following clinical chemistries MUST NOT exceed 1.2 times the upper limit of the normal reference range: creatinine, total bilirubin and alkaline phosphatase. * The following clinical chemistries MUST NOT exceed 2 times the upper limit of the normal reference range: ALT and AST. * Albumin must be not less than 80% of the lower limit of normal. * Female subjects must either be: * of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal \> 1 year), or * of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: * Reticulocyte count within the reference range or elevated in case of bleeding.
Exclusion criteria
* Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic ITP. (Note: Severe is defined as \>= Grade 3 as a rule according to the Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80, dated 29 June 1992) * History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial infarction, deep vein thrombosis) within the last 1 year. * History of drug/alcohol abuse or dependence within the last 1 year. * Suspected blood disorder other than ITP. * Suspected platelet aggregation abnormality. * Suspected cyclic thrombocytopenia. * Suspected Evans Syndrome. * Subjects who met the GSK Liver Stopping Criteria in the previous eltrombopag study TRA108109 (NCT00540423). * Current or history of HIV infection or hepatitis B virus or hepatitis C virus infections. * Current malignancy or history of malignancy that was treated with chemotherapy or radiotherapy. * Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. * Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator). * Treatment with an investigational drug within 30 days preceding the first dose of study medication. * Pre-existing cardiovascular disease, or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Platelet Counts | 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) | Platelet counts were measured by blood draw. |
| 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.) | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) | 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. |
| 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, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks) | 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. |
| 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; 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) | Platelet counts were measured by blood draw. |
| Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) | 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. |
| Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy | From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days) | Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy. |
| Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | 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) | Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s). |
Countries
Japan
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Normal PC Remained While No Treatment | 1 |
Baseline characteristics
| Characteristic | Eltrombopag |
|---|---|
| Age, Continuous | 54.7 Years STANDARD_DEVIATION 13.57 |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 19 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 19 |
| serious Total, serious adverse events | 6 / 19 |
Outcome results
Primary
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | AE | 19 participants |
| Eltrombopag | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | SAE | 6 participants |
| Eltrombopag | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | Drug-Related AE | 5 participants |
| Eltrombopag | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | AE Leading to Withdrawal | 0 participants |
| Eltrombopag | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | SAE Leading to Withdrawal | 0 participants |
| Eltrombopag | 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 |
| Eltrombopag | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | Mild AE | 6 participants |
| Eltrombopag | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | Moderate AE | 13 participants |
| Eltrombopag | Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category | Severe AE | 0 participants |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
Secondary
Median Platelet Counts
Platelet counts were measured by blood draw.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Eltrombopag | Median Platelet Counts | Week 88, n=12 | 65.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 92, n=11 | 78.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 96, n=11 | 57.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 100, n=13 | 45.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 104, n=11 | 44.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 108, n=11 | 69.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 112, n=7 | 56.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 116, n=7 | 84.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 120, n=5 | 21.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 124, n=6 | 32.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 128, n=4 | 37.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 132, n=2 | 34.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Baseline, n=19 | 20.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 1, n=19 | 36.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 2, n=19 | 84.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 3, n=19 | 85.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 4, n=19 | 97.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 8, n=19 | 102.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 12, n=16 | 85.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 16, n=17 | 76.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 20, n=15 | 61.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 24, n=17 | 70.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 28, n=16 | 97.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 32, n=16 | 75.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 36, n=18 | 73.5 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 40, n=17 | 45.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 44, n=17 | 59.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 48, n=18 | 71.5 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 52, n=16 | 81.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 56, n=14 | 58.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 60, n=16 | 48.5 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 64, n=14 | 57.5 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 68, n=14 | 53.5 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 72, n=12 | 51.5 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 76, n=12 | 90.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 80, n=12 | 67.5 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 84, n=13 | 86.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Week 136, n=1 | 51.0 Gi/L |
| Eltrombopag | Median Platelet Counts | Last Visit/Early Withdrawal Visit, n=19 | 75.0 Gi/L |
Secondary
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
Platelet counts were measured by blood draw.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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
Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication
Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Last Visit/Early Withdrawal, n=19 | 21 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Baseline, n=19 | 63 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 1, n=19 | 32 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 2, n=19 | 21 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 3, n=19 | 16 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 4, n=19 | 5 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 8, n=19 | 11 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 12, n=16 | 13 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 16, n=17 | 12 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 20, n=15 | 40 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 24, n=17 | 6 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 28, n=16 | 25 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 32, n=16 | 19 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 36, n=18 | 39 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 40, n=17 | 35 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 44, n=17 | 24 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 48, n=18 | 22 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 52, n=16 | 31 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 56, n=14 | 29 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 60, n=16 | 13 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 64, n=14 | 21 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 68, n=14 | 29 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 72, n=12 | 8 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 76, n=12 | 8 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 80, n=12 | 25 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 84, n=13 | 0 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 88, n=12 | 8 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 92, n=11 | 9 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 96, n=11 | 9 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 100, n=13 | 8 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 104, n=11 | 27 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 108, n=11 | 27 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 112, n=7 | 14 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 116, n=7 | 0 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 120, n=5 | 0 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 124, n=6 | 33 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 128, n=4 | 25 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 132, n=2 | 50 percentage of participants |
| Eltrombopag | Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication | Week 136, n=1 | 0 percentage of participants |
Secondary
Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy
Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.
Time frame: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy | Any Rescue Therapy | 21 percentage of participants |
| Eltrombopag | Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy | New ITP Medication | 11 percentage of participants |
| Eltrombopag | Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy | Increase in Concomitant ITP Medication from B/L | 11 percentage of participants |
| Eltrombopag | Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy | Platelet Transfusion | 0 percentage of participants |
| Eltrombopag | Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy | Splenectomy | 0 percentage of participants |
Secondary
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.)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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 |
| Eltrombopag | 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
Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag | Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication | 87 percentage of participants |