Purpura, Thrombocytopaenic, Idiopathic
Conditions
Keywords
idiopathic thrombocytopenic purpura, thrombocytopenia, pharmacodynamics, ITP, eltrombopag, pharmacokinetics, chronic ITP, pediatrics
Brief summary
Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized, placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17 years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label fashion, and a review of safety, pharmacokinetic and platelet count data will be performed regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized treatment, all patients will receive eltrombopag in an open label fashion. The total duration of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week review of the first 5 patients no safety issues are identified, dosing will begin in the next lower age cohort with an initial group of 5 patients. The same procedure will be followed in terms of safety review and subsequent enrolment and randomisation of the additional patients. Initiation of the younger age cohort will take place once data from the previous has been evaluated. Doses will be adjusted according to platelet counts and tolerability. The study will include a review of the safety data by a Data Safety Monitoring Board.
Interventions
DRUGeltrombopag
thrombopoietin receptor agonist
DRUGPlacebo
placebo for comparison
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subjects between 1 year and \<18 years of age at Day 1. * Written informed consent from subject's guardian and accompanying informed assent from subject (for children over 6 years old). * Confirmed diagnosis of chronic ITP, according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines \[George, 1996; BCSH, 2003\]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia. * Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments. * Day 1 (or within 48 hours prior) platelet count \<30 Gi/L. * Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective. * Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1. * Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective. * Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range. * Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder. * The following clinical chemistries for the subjects MUST NOT exceed the upper limit of normal (ULN) reference range by more than 20%: creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%. * For subjects of child-bearing potential (after menarche): subject must not be sexually active or is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must use one of the following highly effective methods of contraception (i.e., Pearl Index \<1.0%) from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: * Complete abstinence from intercourse; * Intrauterine device (IUD); * Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); * Systemic contraceptives (combined or progesterone only).
Exclusion criteria
* Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease). * Concurrent or past malignant disease, including myeloproliferative disorder. * Subjects who are not suitable for continuation of their current therapy for at least 7 additional additional weeks. * Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1. * History of platelet agglutination abnormality that prevents reliable measurement of platelet counts. * Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening. * Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis). * Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders) * Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for \>3 consecutive days within 2 weeks of Day 1. * Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist. * For female subjects who have reached menarche status, an inability or unwillingness to provide a blood or urine specimen for pregnancy testing. * Female subjects who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2) | From Day 8 up to Day 43 of Part 2 | Participants who achieved a platelet count \>=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weighted Mean Platelet Count | Baseline and Day 43 of Part 2 | The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment. |
| Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1. | From Day 1 of treatment up to Week 24 of Part 1 | The percentage of participants achieving platelet counts \>=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported. |
| Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3. | Part 2/3 up to Study Week 31 | The percentage of participants achieving platelet counts \>=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment during Part 2/3 of the study were reported. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31. |
| Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3. | From Day 1 of treatment up to Study Week 31 | The area under the concentration-time curve over the dosing interval (AUC0-t) data was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. From the final model, a single value of AUC(0-t) was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose. |
| Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3. | From Day 1 of treatment up to Study Week 31 | The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose. |
| Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3 | From Day 1 of treatment up to Study Week 31 | The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose. |
| Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3 | From Day 1 of treatment up to Study Week 31 | The apparent plasma clearance following oral dosing of eltrombopag (CL/F) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of CL/F was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose. |
| Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2 | From Baseline through Week 7 of Part 2 | The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count |
| Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3 | From Baseline up to Study Week 31 | The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2/3. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31. |
| Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | From Baseline up to Week 24+ 1 day of Part 1 | The participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 1 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 1 Day 1 to the last dose of study medication + 1 day. |
| Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3 | Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day. |
| Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3 | Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31. |
| Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Baseline, Week 6, Week 12, and Week 24 of Part 1 | The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used. |
| Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Baseline and Week 6 of Part 2 | The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used. |
| Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | From Baseline to end of treatment up to Study Week 31 | The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1=never, 2=seldom, 3=sometimes, 4=often, 5=always and 9=not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used. |
| Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | From Baseline through Week 7 of Part 2 | The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2. |
| Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | From Baseline of Part 2/3 through Follow-up | The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2. |
| Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Post-Baseline from Week 1 through Follow-up up to Study Week 35 | Clinical chemistry parameters included: aspartate amino transferase (AST, reference range \[RR\]: 0-38 International Units per Liter \[IU/L\]), alkaline phosphatase (ALP: RR: 50 - 375 IU/L), total bilirubin (RR: 3.42 - 22.23 micromoles \[umol\]/L), albumin grams \[g/L\], alanine amino transferase (ALT, RR: 5-30 IU/L), prothrombin international normalized ratio (PT INR, RR-0.9 - 1.2), activated partial thromboplastin time (APTT, RR: 24.2 - 32.9 seconds), glucose (RR: 4.107- 6.55018 millimoles \[mmol\]/L), potassium (3 - 5 mmol/L), and sodium (135 - 143 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated clinical chemistry data outside of the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment |
| Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Post-Baseline from Week 1 through Follow-up up to Study Week 35 | Hematology parameters included: erythrocytes (RR: 4.2 - 6.1 teragrams per liter \[TI/L\]), hemoglobin (RR: 125 - 165 g/L), hematocrit (RR: 0.36 - 0.46), platelets (RR: 170 - 430 gigagrams per liter \[GI/L\]), mean platelet volume (MPV, RR: 4 - 14 femotoliter \[fL\]), leukocytes (RR: 3.4 - 11.2 GI/L), total neutrophils (RR: 2.1 - 4.9 GI/L), lymphocytes (RR: 1.4 - 2.9 GI/L), monocytes (RR: 0.2 - 0.9 GI/L), eosinophils (RR: 0.2 - 0.7 GI/L), and basophils (RR: 0.02 - 0.12 GI/L). Baseline values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment |
| Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2) | Between Day 15 and Day 43 of Part 2 | Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count \>=50 Gi/L during treatment with eltrombopag in \>= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here. |
| Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | From Baseline up to Study Week 24 of Part 1 | Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. |
| Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | From Baseline and post-Baseline up to Study Week 7 of Part 2 | Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. |
| Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | From Baseline and post-Baseline up to Study Week 31 of Part 2/3 | Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31. |
| Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | From Baseline through Study Week 35 | Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: \<85, 85-115, \>115; for Cohort 2: \<85, 85-120,\>120; and Cohort 3: \<95, 95-135, \>135. RR for DBP (mmHg) for Cohort 1: \<45, 45-70,\>70; for Cohort 2: \<50, 50-75, \>75; and Cohort 3: \<55, 55-85, \>85. |
| Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | From Baseline through Week 24 | Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment. |
| Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | From Week 1 to Week 7 of Part 2 | Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment. |
| Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35 | Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31. |
| Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | From Week 1 to Follow-up Week 4 of Part 1, up to Study Week 28 | Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline (MPB) visit included any scheduled and unscheduled post-Baseline assessment.. |
| Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | From Week 1 to Week 7 of Part 2 | Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. |
| Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | From Week 1to Follow-up Week 4 of Part 2/3, up to Study Week 35 | Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31. |
| Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | Baseline and Week 24 of Part 1 | Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1. |
| Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | Baseline and Week 7 of Part 2 | Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1. |
| Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | Baseline and Week 24 of Part 2/3 up to Study Week 31 | Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1. |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1 | From Treatment + 1 day up to Week 24 of Part1 | An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations. |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | From Treatment + 1 day up to Week 7 of Part 2 | An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations. |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3 | From Treatment + 1 day up to Week 31 of Part2/3 | An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations. |
| Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Baseline, 3and 6-mo Follow-up of Part 1 | The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no. |
| Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | BL, 3 and 6mo Follow-up of Part 2/3 | The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Number of participants with a change in visual acuity and change in visual acuity due to the worsening of cataracts since Baseline are presented for Part 2/3 Follow-up Visits at 3-months (FU3) and 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no. |
| Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Post-Baseline from Week 1 through Follow-up up to Study Week 35 | Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute \[ ml/min\]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles \[mg/mmol\]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-baseline assessment |
Countries
Canada, France, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
Pediatric participants (par.) meeting eligibility criteria were enrolled into 3 cohorts depending upon age. Cohort 1 enrolled participants who were between 12 and 17 years old, Cohort 2 enrolled participants who were between 6 and 11 years old, and Cohort 3 enrolled participants who were between 1 and 5 years old.
Pre-assignment details
15 par. were randomized to a 24-Week (Wk) Open-Label (OL) eltrombopag Dose-Finding period (pd) (Part 1) then did not continue. 67 par. were randomized to a 7-Wk Double-Blind placebo-controlled pd (Part 2), followed by a 24-Wk OL eltrombopag-only pd (Part 2/3) and a 4-Wk Follow-Up pd.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 Eltrombopag Dose-Finding Period Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of \<27 kg received 12.5 mg QD, par with a body weight of \>=27 kg received 25 mg QD; par of East Asian ancestry with a body weight \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response. | 15 |
| Part 2 (Randomized Period) Cohort 1-Placebo Par aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response. | 8 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag Par aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response. | 16 |
| Part 2 (Randomized Period) Cohort 2-Placebo Par aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Par with a body weight of <=27 kg received 25 mg QD and par with a body weight of >=27 kg QD received 50 mg QD. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response. | 9 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag Par aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, par with a weight of <27 kg received 25 mg QD and par with a weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and par with a weight of >=27 kg received 25 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response. | 19 |
| Part 2 (Randomized Period) Cohort 3-Placebo Par aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Par of East Asian ancestry received 0.8 mg/kg/day. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response. | 5 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag Par aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Par of East Asian ancestry began at 0.8 mg/kg/day. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response. | 10 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 2/3(Eltrombopag Open-Label Period) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Part 2/3(Eltrombopag Open-Label Period) | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part 2/3(Eltrombopag Open-Label Period) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
| Part 2/3(Eltrombopag Open-Label Period) | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Part 2/3(Eltrombopag Open-Label Period) | Randomized but did not receive treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Part 2/3(Eltrombopag Open-Label Period) | Withdrawal by parent/guardian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Part 2 (7 Week Randomized Period) | Lost to Follow-up | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
| Part 2 (7 Week Randomized Period) | Protocol Violation | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 0 | 1 | 0 | 0 | 0 |
| Part 2 (7 Week Randomized Period) | Withdrawal by parent/ guardian | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1 Eltrombopag Dose-Finding Period | Part 2 (Randomized Period) Cohort 1-Placebo | Part 2 (Randomized Period) Cohort 1- Eltrombopag | Part 2 (Randomized Period) Cohort 2-Placebo | Part 2 (Randomized Period) Cohort 2-Eltrombopag | Part 2 (Randomized Period) Cohort 3-Placebo | Part 2 (Randomized Period) Cohort 3- Eltrombopag | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 9.1 Years STANDARD_DEVIATION 4.61 | 14.6 Years STANDARD_DEVIATION 1.69 | 13.7 Years STANDARD_DEVIATION 1.58 | 8.6 Years STANDARD_DEVIATION 2.24 | 8.2 Years STANDARD_DEVIATION 1.87 | 3.6 Years STANDARD_DEVIATION 1.34 | 3.3 Years STANDARD_DEVIATION 1.34 | 9.3 Years STANDARD_DEVIATION 4.49 |
| Race/Ethnicity, Customized African American/African Heritage | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - Japanese/East Asian Heritage | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Mixed Race | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European | 9 Participants | 7 Participants | 14 Participants | 8 Participants | 17 Participants | 5 Participants | 7 Participants | 67 Participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 8 Participants | 8 Participants | 14 Participants | 2 Participants | 5 Participants | 48 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 8 Participants | 1 Participants | 5 Participants | 3 Participants | 5 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 15 | 20 / 21 | 36 / 44 | 62 / 65 |
| serious Total, serious adverse events | 2 / 15 | 2 / 21 | 4 / 44 | 8 / 65 |
Outcome results
Primary
Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)
Participants who achieved a platelet count \>=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.
Time frame: From Day 8 up to Day 43 of Part 2
Population: Intent-to-Treat (ITT) Population: all enrolled participants during Part 2. The ITT Population was the primary population used for assessing efficacy. Only evaluable participants were considered for analysis where participants with a Baseline platelet count \>10Gi/L was considered as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2) | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2) | 62.5 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2) | 33.3 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2) | 63.2 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2) | 80.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2) | 60.0 Percentage of Participants |
Secondary
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2
The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.
Time frame: Baseline and Week 6 of Part 2
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Baseline, n=6, 11, 9, 10, 2, 8 | 83.94 Score on scale | Standard Deviation 8.674 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Week 6, n= 8,11,7,13, 5, 9 | 79.46 Score on scale | Standard Deviation 10.971 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Baseline, n=6, 11, 9, 10, 2, 8 | 76.84 Score on scale | Standard Deviation 15.049 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Week 6, n= 8,11,7,13, 5, 9 | 79.46 Score on scale | Standard Deviation 13.899 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Baseline, n=6, 11, 9, 10, 2, 8 | 71.05 Score on scale | Standard Deviation 19.581 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Week 6, n= 8,11,7,13, 5, 9 | 74.65 Score on scale | Standard Deviation 20.968 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Baseline, n=6, 11, 9, 10, 2, 8 | 66.36 Score on scale | Standard Deviation 17.321 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Week 6, n= 8,11,7,13, 5, 9 | 80.16 Score on scale | Standard Deviation 13.776 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Baseline, n=6, 11, 9, 10, 2, 8 | 82.61 Score on scale | Standard Deviation 7.686 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Week 6, n= 8,11,7,13, 5, 9 | 88.01 Score on scale | Standard Deviation 3.333 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Baseline, n=6, 11, 9, 10, 2, 8 | 78.23 Score on scale | Standard Deviation 9.575 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2 | Week 6, n= 8,11,7,13, 5, 9 | 80.85 Score on scale | Standard Deviation 15.082 |
Secondary
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1
The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.
Time frame: Baseline, Week 6, Week 12, and Week 24 of Part 1
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Baseline, n=5, 5, 5 | 73.18 Score on scale | Standard Deviation 15.743 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 6, n=4, 5, 5 | 82.84 Score on scale | Standard Deviation 9.131 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 12, n=4, 4, 4 | 84.14 Score on scale | Standard Deviation 11.712 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 24, n= 3, 4, 3 | 76.38 Score on scale | Standard Deviation 20.228 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 24, n= 3, 4, 3 | 82.50 Score on scale | Standard Deviation 15.995 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Baseline, n=5, 5, 5 | 53.95 Score on scale | Standard Deviation 16.534 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 12, n=4, 4, 4 | 66.43 Score on scale | Standard Deviation 12.349 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 6, n=4, 5, 5 | 61.57 Score on scale | Standard Deviation 13.664 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 24, n= 3, 4, 3 | 78.87 Score on scale | Standard Deviation 12.056 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 6, n=4, 5, 5 | 71.54 Score on scale | Standard Deviation 14.798 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Week 12, n=4, 4, 4 | 65.58 Score on scale | Standard Deviation 17.887 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1 | Baseline, n=5, 5, 5 | 74.80 Score on scale | Standard Deviation 17.199 |
Secondary
Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3
The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1=never, 2=seldom, 3=sometimes, 4=often, 5=always and 9=not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.
Time frame: From Baseline to end of treatment up to Study Week 31
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Baseline, n=17, 18, 10 | 79.34 Score on scale | Standard Deviation 13.315 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 6, n=11, 13, 9 | 79.46 Score on scale | Standard Deviation 13.899 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 12, n=9, 7, 2 | 84.25 Score on scale | Standard Deviation 7.531 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 24, n=17, 11, 8 | 82.16 Score on scale | Standard Deviation 16.926 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 24, n=17, 11, 8 | 83.93 Score on scale | Standard Deviation 13.327 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Baseline, n=17, 18, 10 | 70.59 Score on scale | Standard Deviation 16.237 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 12, n=9, 7, 2 | 76.48 Score on scale | Standard Deviation 19.948 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 6, n=11, 13, 9 | 80.16 Score on scale | Standard Deviation 13.776 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 24, n=17, 11, 8 | 77.93 Score on scale | Standard Deviation 22.971 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 6, n=11, 13, 9 | 80.85 Score on scale | Standard Deviation 15.082 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Week 12, n=9, 7, 2 | 88.10 Score on scale | Standard Deviation 11.166 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3 | Baseline, n=17, 18, 10 | 79.10 Score on scale | Standard Deviation 9.016 |
Secondary
Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3
The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2/3. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
Time frame: From Baseline up to Study Week 31
Population: ITT Population only those participants enrolled in Part 2/3 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2/3.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3 | 2.0 Weeks |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3 | 8.0 Weeks |
| Part 2 (Randomized Period) Cohort 2-Placebo | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3 | 4.0 Weeks |
Secondary
Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2
The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count
Time frame: From Baseline through Week 7 of Part 2
Population: ITT Population, only those participants enrolled in Part 2 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2 | 0.0 Weeks |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2 | 1.0 Weeks |
| Part 2 (Randomized Period) Cohort 2-Placebo | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2 | 0.0 Weeks |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2 | 2.0 Weeks |
| Part 2 (Randomized Period) Cohort 3-Placebo | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2 | 1.0 Weeks |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2 | 1.0 Weeks |
Secondary
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline (MPB) visit included any scheduled and unscheduled post-Baseline assessment..
Time frame: From Week 1 to Follow-up Week 4 of Part 1, up to Study Week 28
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 2, n=3, 2, 0 | 77.7 Beats per minute | Standard Deviation 8.74 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 20, n=5, 4, 4 | 79.8 Beats per minute | Standard Deviation 13.03 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 10, n=5, 5, 5 | 80.6 Beats per minute | Standard Deviation 14.93 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 3, n=5, 5, 5 | 92.8 Beats per minute | Standard Deviation 31.16 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 19, n=3, 0, 2 | 88.0 Beats per minute | Standard Deviation 20.81 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 11, n=5, 3, 5 | 86.6 Beats per minute | Standard Deviation 11.04 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 4, n=1, 0, 2 | 89.0 Beats per minute | — |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 18, n=3, 3, 4 | 88.0 Beats per minute | Standard Deviation 10.44 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 15, n=3, 4, 4 | 77.3 Beats per minute | Standard Deviation 6.66 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 12, n=4, 4, 5 | 80.5 Beats per minute | Standard Deviation 12.07 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 1, n=1, 1, 3 | 81.0 Beats per minute | — |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 17, n=2, 0, 3 | 67.5 Beats per minute | Standard Deviation 20.51 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 13, n=4, 4, 4 | 90.8 Beats per minute | Standard Deviation 15.52 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 4, n=5, 5, 5 | 86.4 Beats per minute | Standard Deviation 10.92 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 16, n=5, 3, 4 | 86.4 Beats per minute | Standard Deviation 18.6 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 14, n=3, 3, 3 | 81.0 Beats per minute | Standard Deviation 9.85 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 1, n= 4, 5, 5 | 85.3 Beats per minute | Standard Deviation 4.79 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 24, n=5, 5, 5 | 79.6 Beats per minute | Standard Deviation 7.86 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 5, n=5, 5, 5 | 84.6 Beats per minute | Standard Deviation 9.48 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Day 1, n=4, 5, 5, | 84.3 Beats per minute | Standard Deviation 11.32 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 23, n=4, 2, 5 | 71.5 Beats per minute | Standard Deviation 13.03 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 6, n=5, 5, 4 | 76.4 Beats per minute | Standard Deviation 10.5 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 3, n=2, 1, 2 | 87.0 Beats per minute | Standard Deviation 2.83 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Screening, n=5, 5, 5 | 85.2 Beats per minute | Standard Deviation 15.71 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 7, n=5, 5, 5 | 82.0 Beats per minute | Standard Deviation 9.46 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 2, n=5, 5, 5 | 80.4 Beats per minute | Standard Deviation 12.97 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 22, n=3, 4, 4 | 70.3 Beats per minute | Standard Deviation 14.36 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 8, n=5, 5, 5 | 83.0 Beats per minute | Standard Deviation 5.2 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | MBP, n=5, 5, 5 | 108.8 Beats per minute | Standard Deviation 24.01 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 21, n=3, 2, 5 | 79.0 Beats per minute | Standard Deviation 6.93 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 9, n=5, 5, 5 | 80.4 Beats per minute | Standard Deviation 13.35 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 22, n=3, 4, 4 | 86.5 Beats per minute | Standard Deviation 9.04 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Screening, n=5, 5, 5 | 88.4 Beats per minute | Standard Deviation 8.5 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Day 1, n=4, 5, 5, | 88.2 Beats per minute | Standard Deviation 12.89 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 1, n= 4, 5, 5 | 90.8 Beats per minute | Standard Deviation 11.19 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 2, n=5, 5, 5 | 84.4 Beats per minute | Standard Deviation 16.77 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 3, n=5, 5, 5 | 91.4 Beats per minute | Standard Deviation 11.04 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 4, n=5, 5, 5 | 84.0 Beats per minute | Standard Deviation 7.62 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 5, n=5, 5, 5 | 88.4 Beats per minute | Standard Deviation 9.58 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 6, n=5, 5, 4 | 89.8 Beats per minute | Standard Deviation 13.79 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 7, n=5, 5, 5 | 96.2 Beats per minute | Standard Deviation 17.84 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 8, n=5, 5, 5 | 89.4 Beats per minute | Standard Deviation 15.04 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 9, n=5, 5, 5 | 79.2 Beats per minute | Standard Deviation 11.34 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 10, n=5, 5, 5 | 84.4 Beats per minute | Standard Deviation 10.31 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 11, n=5, 3, 5 | 97.7 Beats per minute | Standard Deviation 16.5 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 12, n=4, 4, 5 | 92.0 Beats per minute | Standard Deviation 12.83 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 13, n=4, 4, 4 | 86.5 Beats per minute | Standard Deviation 7.05 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 14, n=3, 3, 3 | 87.0 Beats per minute | Standard Deviation 8.66 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 15, n=3, 4, 4 | 86.8 Beats per minute | Standard Deviation 11.87 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 16, n=5, 3, 4 | 103.0 Beats per minute | Standard Deviation 5.57 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 17, n=2, 0, 3 | NA Beats per minute | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 18, n=3, 3, 4 | 86.7 Beats per minute | Standard Deviation 17.01 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 19, n=3, 0, 2 | NA Beats per minute | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 20, n=5, 4, 4 | 96.8 Beats per minute | Standard Deviation 12.58 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 21, n=3, 2, 5 | 75.5 Beats per minute | Standard Deviation 3.54 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 23, n=4, 2, 5 | 82.5 Beats per minute | Standard Deviation 3.54 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 24, n=5, 5, 5 | 85.8 Beats per minute | Standard Deviation 6.91 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 1, n=1, 1, 3 | 125.0 Beats per minute | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 2, n=3, 2, 0 | 84.5 Beats per minute | Standard Deviation 28.99 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 3, n=2, 1, 2 | 78.0 Beats per minute | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 4, n=1, 0, 2 | NA Beats per minute | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | MBP, n=5, 5, 5 | 109.8 Beats per minute | Standard Deviation 14.17 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 19, n=3, 0, 2 | 94.0 Beats per minute | Standard Deviation 8.49 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 9, n=5, 5, 5 | 101.6 Beats per minute | Standard Deviation 5.59 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 1, n= 4, 5, 5 | 103.8 Beats per minute | Standard Deviation 8.47 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 20, n=5, 4, 4 | 111.8 Beats per minute | Standard Deviation 14.97 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 8, n=5, 5, 5 | 111.8 Beats per minute | Standard Deviation 10.62 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Screening, n=5, 5, 5 | 102.0 Beats per minute | Standard Deviation 7.97 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 21, n=3, 2, 5 | 101.0 Beats per minute | Standard Deviation 18.63 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 7, n=5, 5, 5 | 103.2 Beats per minute | Standard Deviation 8.93 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 6, n=5, 5, 4 | 103.0 Beats per minute | Standard Deviation 8.29 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 22, n=3, 4, 4 | 100.0 Beats per minute | Standard Deviation 18.63 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 5, n=5, 5, 5 | 107.8 Beats per minute | Standard Deviation 9.58 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 3, n=2, 1, 2 | 98.0 Beats per minute | Standard Deviation 8.49 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 23, n=4, 2, 5 | 100.0 Beats per minute | Standard Deviation 13.14 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 4, n=5, 5, 5 | 98.6 Beats per minute | Standard Deviation 14.29 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Day 1, n=4, 5, 5, | 102.4 Beats per minute | Standard Deviation 13.22 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 24, n=5, 5, 5 | 96.0 Beats per minute | Standard Deviation 4.74 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 3, n=5, 5, 5 | 106.2 Beats per minute | Standard Deviation 11.1 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 14, n=3, 3, 3 | 101.0 Beats per minute | Standard Deviation 11 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | MBP, n=5, 5, 5 | 119.6 Beats per minute | Standard Deviation 5.73 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 15, n=3, 4, 4 | 102.5 Beats per minute | Standard Deviation 3.87 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 13, n=4, 4, 4 | 103.8 Beats per minute | Standard Deviation 3.5 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 1, n=1, 1, 3 | 107.7 Beats per minute | Standard Deviation 10.79 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 16, n=5, 3, 4 | 93.0 Beats per minute | Standard Deviation 18.96 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 12, n=4, 4, 5 | 101.4 Beats per minute | Standard Deviation 16.62 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 2, n=5, 5, 5 | 96.8 Beats per minute | Standard Deviation 10.66 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 17, n=2, 0, 3 | 97.7 Beats per minute | Standard Deviation 12.01 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 11, n=5, 3, 5 | 106.6 Beats per minute | Standard Deviation 11.19 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 4, n=1, 0, 2 | 99.0 Beats per minute | Standard Deviation 26.87 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 18, n=3, 3, 4 | 102.8 Beats per minute | Standard Deviation 16.88 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | Week 10, n=5, 5, 5 | 105.4 Beats per minute | Standard Deviation 9.29 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1 | FU Week 2, n=3, 2, 0 | NA Beats per minute | — |
Secondary
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
Time frame: From Week 1to Follow-up Week 4 of Part 2/3, up to Study Week 35
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 13, n=11, 13, 8 | 78.1 Beats per minute | Standard Deviation 8.47 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 4, n=24, 25, 13 | 81.9 Beats per minute | Standard Deviation 9.81 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 23, n=8, 7, 6 | 80.4 Beats per minute | Standard Deviation 11.25 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 14, n=13, 12, 7 | 74.5 Beats per minute | Standard Deviation 11.15 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Screening, n=16, 15, 10 | 82.8 Beats per minute | Standard Deviation 17.28 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 22, n=11, 6, 5 | 83.2 Beats per minute | Standard Deviation 10.57 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 15, n=12, 14, 5 | 82.5 Beats per minute | Standard Deviation 9.41 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 7, n=22, 25, 11 | 82.1 Beats per minute | Standard Deviation 11.47 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 21, n=4, 10, 3 | 82.3 Beats per minute | Standard Deviation 10.53 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 16, n=17, 14, 8v | 81.3 Beats per minute | Standard Deviation 11.24 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 3, n=24, 24, 12 | 83.3 Beats per minute | Standard Deviation 10.63 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 20, n=13, 13, 7 | 79.0 Beats per minute | Standard Deviation 10.98 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 17, n=13, 11, 5 | 79.7 Beats per minute | Standard Deviation 11.69 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | MPB, n=24, 26, 15 | 102.2 Beats per minute | Standard Deviation 9.35 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 19, n=14, 14, 6 | 82.1 Beats per minute | Standard Deviation 12.33 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 18, n=16, 12, 4 | 81.1 Beats per minute | Standard Deviation 8.79 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 8, n=19, 20, 10 | 79.9 Beats per minute | Standard Deviation 11.85 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 1, n=24, 26, 14 | 79.9 Beats per minute | Standard Deviation 10.82 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 4, n=11, 13, 7 | 81.6 Beats per minute | Standard Deviation 11.89 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 9, n=17, 16, 12 | 87.4 Beats per minute | Standard Deviation 15.75 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 5, n=24, 24, 11 | 80.8 Beats per minute | Standard Deviation 13 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 3, n=6, 5, 4 | 83.7 Beats per minute | Standard Deviation 13.03 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 10, n=16, 13, 11 | 87.9 Beats per minute | Standard Deviation 11.74 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 2, n=23, 26, 13 | 79.9 Beats per minute | Standard Deviation 10.02 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 2, n=8, 7, 7 | 83.0 Beats per minute | Standard Deviation 8.54 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 11, n=15, 14, 12 | 81.5 Beats per minute | Standard Deviation 10.2 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Day 1 , n=22, 22, 15 | 78.7 Beats per minute | Standard Deviation 8.67 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 1, n=6, 6, 3 | 86.3 Beats per minute | Standard Deviation 5.85 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 12, n=17, 16, 9 | 81.1 Beats per minute | Standard Deviation 11.98 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 6, n=23, 24, 11 | 82.2 Beats per minute | Standard Deviation 10.45 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 24, n=23, 23, 11 | 81.2 Beats per minute | Standard Deviation 9.7 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 2, n=23, 26, 13 | 92.5 Beats per minute | Standard Deviation 16.91 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 3, n=24, 24, 12 | 95.4 Beats per minute | Standard Deviation 12.31 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 4, n=24, 25, 13 | 91.7 Beats per minute | Standard Deviation 13.42 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 5, n=24, 24, 11 | 91.7 Beats per minute | Standard Deviation 14.72 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 6, n=23, 24, 11 | 91.6 Beats per minute | Standard Deviation 16.82 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 7, n=22, 25, 11 | 91.1 Beats per minute | Standard Deviation 16.61 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 8, n=19, 20, 10 | 90.8 Beats per minute | Standard Deviation 16.68 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 9, n=17, 16, 12 | 91.9 Beats per minute | Standard Deviation 17.79 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 10, n=16, 13, 11 | 94.3 Beats per minute | Standard Deviation 17.82 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 11, n=15, 14, 12 | 89.3 Beats per minute | Standard Deviation 16.28 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 12, n=17, 16, 9 | 91.1 Beats per minute | Standard Deviation 16.39 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 13, n=11, 13, 8 | 97.0 Beats per minute | Standard Deviation 21.79 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 14, n=13, 12, 7 | 94.8 Beats per minute | Standard Deviation 18.07 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 15, n=12, 14, 5 | 94.4 Beats per minute | Standard Deviation 18.94 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 16, n=17, 14, 8v | 91.4 Beats per minute | Standard Deviation 15.08 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 17, n=13, 11, 5 | 96.1 Beats per minute | Standard Deviation 20.8 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 18, n=16, 12, 4 | 95.8 Beats per minute | Standard Deviation 23.01 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 19, n=14, 14, 6 | 96.5 Beats per minute | Standard Deviation 20.24 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 20, n=13, 13, 7 | 95.9 Beats per minute | Standard Deviation 17.44 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 21, n=4, 10, 3 | 90.3 Beats per minute | Standard Deviation 10.71 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 22, n=11, 6, 5 | 99.7 Beats per minute | Standard Deviation 5.5 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 23, n=8, 7, 6 | 89.0 Beats per minute | Standard Deviation 22.38 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 24, n=23, 23, 11 | 93.5 Beats per minute | Standard Deviation 12.59 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 1, n=6, 6, 3 | 94.2 Beats per minute | Standard Deviation 18.03 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 2, n=8, 7, 7 | 87.9 Beats per minute | Standard Deviation 12.77 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 3, n=6, 5, 4 | 92.4 Beats per minute | Standard Deviation 11.55 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 4, n=11, 13, 7 | 92.3 Beats per minute | Standard Deviation 16.1 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | MPB, n=24, 26, 15 | 110.9 Beats per minute | Standard Deviation 15.03 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Screening, n=16, 15, 10 | 94.3 Beats per minute | Standard Deviation 17.53 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Day 1 , n=22, 22, 15 | 92.0 Beats per minute | Standard Deviation 14.14 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 1, n=24, 26, 14 | 94.8 Beats per minute | Standard Deviation 17.54 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 1, n=24, 26, 14 | 97.8 Beats per minute | Standard Deviation 15.67 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 23, n=8, 7, 6 | 96.2 Beats per minute | Standard Deviation 10.68 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 12, n=17, 16, 9 | 105.3 Beats per minute | Standard Deviation 19.58 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Screening, n=16, 15, 10 | 104.8 Beats per minute | Standard Deviation 21.82 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 24, n=23, 23, 11 | 95.3 Beats per minute | Standard Deviation 17.75 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 11, n=15, 14, 12 | 99.3 Beats per minute | Standard Deviation 15.39 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 5, n=24, 24, 11 | 97.4 Beats per minute | Standard Deviation 17.92 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 1, n=6, 6, 3 | 100.0 Beats per minute | Standard Deviation 20.07 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 10, n=16, 13, 11 | 97.8 Beats per minute | Standard Deviation 18.77 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 3, n=24, 24, 12 | 99.4 Beats per minute | Standard Deviation 16.56 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 2, n=8, 7, 7 | 110.0 Beats per minute | Standard Deviation 27.47 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 9, n=17, 16, 12 | 100.9 Beats per minute | Standard Deviation 15.19 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Day 1 , n=22, 22, 15 | 100.8 Beats per minute | Standard Deviation 15.71 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 3, n=6, 5, 4 | 92.0 Beats per minute | Standard Deviation 12.19 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 8, n=19, 20, 10 | 94.2 Beats per minute | Standard Deviation 25.71 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 4, n=24, 25, 13 | 110.6 Beats per minute | Standard Deviation 22.55 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | FU Week 4, n=11, 13, 7 | 102.3 Beats per minute | Standard Deviation 18.87 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 18, n=16, 12, 4 | 99.8 Beats per minute | Standard Deviation 5.56 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 17, n=13, 11, 5 | 102.2 Beats per minute | Standard Deviation 22.61 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 7, n=22, 25, 11 | 101.5 Beats per minute | Standard Deviation 16.91 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 19, n=14, 14, 6 | 104.2 Beats per minute | Standard Deviation 18.88 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 16, n=17, 14, 8v | 99.8 Beats per minute | Standard Deviation 17.16 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 2, n=23, 26, 13 | 99.8 Beats per minute | Standard Deviation 12.64 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 20, n=13, 13, 7 | 91.6 Beats per minute | Standard Deviation 17.18 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 15, n=12, 14, 5 | 98.0 Beats per minute | Standard Deviation 8.72 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | MPB, n=24, 26, 15 | 121.2 Beats per minute | Standard Deviation 20.42 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 21, n=4, 10, 3 | 99.7 Beats per minute | Standard Deviation 15.28 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 14, n=13, 12, 7 | 95.6 Beats per minute | Standard Deviation 12.09 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 6, n=23, 24, 11 | 102.8 Beats per minute | Standard Deviation 20.31 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 22, n=11, 6, 5 | 98.6 Beats per minute | Standard Deviation 18.2 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3 | Week 13, n=11, 13, 8 | 99.5 Beats per minute | Standard Deviation 20.57 |
Secondary
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment.
Time frame: From Week 1 to Week 7 of Part 2
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 2, n=7, 15, 9, 17 | 79.4 Beats per minute | Standard Deviation 8.75 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 1, n=8, 16, 9, 17 | 76.4 Beats per minute | Standard Deviation 8.5 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | MBP, n=8, 16, 9, 17 | 88.3 Beats per minute | Standard Deviation 7.72 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 7, n=8, 16, 9, 17 | 74.1 Beats per minute | Standard Deviation 6.92 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 17 | 77.0 Beats per minute | Standard Deviation 9.5 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 9, 16 | 79.3 Beats per minute | Standard Deviation 9.44 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Day 1, n=6, 14, 9, 13 | 77.2 Beats per minute | Standard Deviation 12.32 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Screening, n=8, 16, 9, 15 | 80.1 Beats per minute | Standard Deviation 10.11 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 4, n=8, 16, 9, 16 | 76.3 Beats per minute | Standard Deviation 6.96 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16 | 81.5 Beats per minute | Standard Deviation 12.21 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Day 1, n=6, 14, 9, 13 | 81.3 Beats per minute | Standard Deviation 8.7 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Screening, n=8, 16, 9, 15 | 82.8 Beats per minute | Standard Deviation 17.28 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 1, n=8, 16, 9, 17 | 80.1 Beats per minute | Standard Deviation 12.04 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 2, n=7, 15, 9, 17 | 81.7 Beats per minute | Standard Deviation 9.79 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16 | 84.0 Beats per minute | Standard Deviation 10.93 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 4, n=8, 16, 9, 16 | 82.4 Beats per minute | Standard Deviation 10.39 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 9, 16 | 82.5 Beats per minute | Standard Deviation 13.87 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 17 | 83.2 Beats per minute | Standard Deviation 11.01 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 7, n=8, 16, 9, 17 | 82.8 Beats per minute | Standard Deviation 11.68 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | MBP, n=8, 16, 9, 17 | 97.6 Beats per minute | Standard Deviation 7.51 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 2, n=7, 15, 9, 17 | 89.0 Beats per minute | Standard Deviation 12.44 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 17 | 86.8 Beats per minute | Standard Deviation 11.62 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Screening, n=8, 16, 9, 15 | 86.9 Beats per minute | Standard Deviation 16.1 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16 | 86.6 Beats per minute | Standard Deviation 13.39 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 1, n=8, 16, 9, 17 | 89.9 Beats per minute | Standard Deviation 18.48 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Day 1, n=6, 14, 9, 13 | 93.0 Beats per minute | Standard Deviation 14.04 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 4, n=8, 16, 9, 16 | 84.4 Beats per minute | Standard Deviation 15.91 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 7, n=8, 16, 9, 17 | 96.7 Beats per minute | Standard Deviation 15.39 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | MBP, n=8, 16, 9, 17 | 106.1 Beats per minute | Standard Deviation 11.92 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 9, 16 | 95.3 Beats per minute | Standard Deviation 14.96 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 9, 16 | 92.4 Beats per minute | Standard Deviation 15.18 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 17 | 90.1 Beats per minute | Standard Deviation 17.74 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Day 1, n=6, 14, 9, 13 | 88.8 Beats per minute | Standard Deviation 12.84 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | MBP, n=8, 16, 9, 17 | 108.6 Beats per minute | Standard Deviation 17.08 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 7, n=8, 16, 9, 17 | 91.6 Beats per minute | Standard Deviation 17.68 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Screening, n=8, 16, 9, 15 | 94.3 Beats per minute | Standard Deviation 17.53 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 4, n=8, 16, 9, 16 | 91.5 Beats per minute | Standard Deviation 14.45 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16 | 95.8 Beats per minute | Standard Deviation 13.57 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 2, n=7, 15, 9, 17 | 91.8 Beats per minute | Standard Deviation 16.96 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 1, n=8, 16, 9, 17 | 98.4 Beats per minute | Standard Deviation 19.76 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 9, 16 | 89.0 Beats per minute | Standard Deviation 15.52 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 2, n=7, 15, 9, 17 | 95.3 Beats per minute | Standard Deviation 7.09 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16 | 97.0 Beats per minute | Standard Deviation 14.67 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 4, n=8, 16, 9, 16 | 93.5 Beats per minute | Standard Deviation 17 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Screening, n=8, 16, 9, 15 | 91.5 Beats per minute | Standard Deviation 6.56 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 17 | 84.8 Beats per minute | Standard Deviation 13.15 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | MBP, n=8, 16, 9, 17 | 106.8 Beats per minute | Standard Deviation 12.28 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 7, n=8, 16, 9, 17 | 101.5 Beats per minute | Standard Deviation 16.6 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 1, n=8, 16, 9, 17 | 98.5 Beats per minute | Standard Deviation 13.44 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Day 1, n=6, 14, 9, 13 | 98.7 Beats per minute | Standard Deviation 5.69 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 4, n=8, 16, 9, 16 | 116.1 Beats per minute | Standard Deviation 23.26 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | MBP, n=8, 16, 9, 17 | 117.5 Beats per minute | Standard Deviation 21.68 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Day 1, n=6, 14, 9, 13 | 99.6 Beats per minute | Standard Deviation 15.84 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 1, n=8, 16, 9, 17 | 96.4 Beats per minute | Standard Deviation 17.08 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16 | 102.6 Beats per minute | Standard Deviation 17.44 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 9, 16 | 99.8 Beats per minute | Standard Deviation 19.51 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 2, n=7, 15, 9, 17 | 102.5 Beats per minute | Standard Deviation 11.81 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 17 | 103.0 Beats per minute | Standard Deviation 23.14 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Screening, n=8, 16, 9, 15 | 101.5 Beats per minute | Standard Deviation 23.48 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2 | Week 7, n=8, 16, 9, 17 | 105.3 Beats per minute | Standard Deviation 15.18 |
Secondary
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
Time frame: From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Day 1 , n=21, 21, 15 | 19.2 Breaths per minute | Standard Deviation 2.57 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 19, n=14, 13, 6 | 18.1 Breaths per minute | Standard Deviation 1.49 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 10, n=16, 13, 11 | 18.7 Breaths per minute | Standard Deviation 2.27 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 2, n=6, 5, 7 | 18.7 Breaths per minute | Standard Deviation 1.63 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 18, n=16, 12, 4 | 19.1 Breaths per minute | Standard Deviation 3.79 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 11, n=15, 13, 12 | 18.9 Breaths per minute | Standard Deviation 1.28 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 3, n=24, 23, 12 | 18.8 Breaths per minute | Standard Deviation 1.73 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 17, n=13, 10, 5 | 19.0 Breaths per minute | Standard Deviation 2.08 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 12, n=17, 16, 9 | 18.6 Breaths per minute | Standard Deviation 1.9 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Screening, n=16, 14, 10 | 18.5 Breaths per minute | Standard Deviation 1.75 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 16, n=16, 14, 8 | 18.6 Breaths per minute | Standard Deviation 1.26 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 13, n=11, 13, 8 | 19.3 Breaths per minute | Standard Deviation 1.56 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 1, n=6, 6, 3 | 18.8 Breaths per minute | Standard Deviation 1.6 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 15, n=12, 13, 5 | 18.7 Breaths per minute | Standard Deviation 1.76 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 14, n=13, 11, 7 | 18.7 Breaths per minute | Standard Deviation 2.98 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 4, n=23, 23, 13 | 19.0 Breaths per minute | Standard Deviation 2.59 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 4, n=10, 12, 7 | 19.4 Breaths per minute | Standard Deviation 0.97 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 24, n=22, 23, 11 | 19.1 Breaths per minute | Standard Deviation 2.03 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 5, n=23, 23, 11 | 18.9 Breaths per minute | Standard Deviation 2.13 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 1, n=24, 25, 14 | 19.1 Breaths per minute | Standard Deviation 1.74 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 23, n=8, 7, 6 | 20.4 Breaths per minute | Standard Deviation 2.72 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 6, n=23, 22, 11 | 19.3 Breaths per minute | Standard Deviation 2.3 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | MPB, n=24, 26, 15 | 23.0 Breaths per minute | Standard Deviation 2.78 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 22, n=11, 7, 5 | 19.7 Breaths per minute | Standard Deviation 2.94 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 7, n=22, 25, 11 | 18.8 Breaths per minute | Standard Deviation 1.99 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 3, n=6, 4, 4 | 19.0 Breaths per minute | Standard Deviation 1.67 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 21, n=4, 10, 3 | 18.8 Breaths per minute | Standard Deviation 3.4 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 8, n=19, 19, 10 | 19.2 Breaths per minute | Standard Deviation 2.32 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 2, n=22, 24, 13 | 19.4 Breaths per minute | Standard Deviation 2.56 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 20, n=13, 13, 7 | 17.4 Breaths per minute | Standard Deviation 1.94 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 9, n=17, 16, 12 | 19.5 Breaths per minute | Standard Deviation 2.96 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 22, n=11, 7, 5 | 19.1 Breaths per minute | Standard Deviation 2.79 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Day 1 , n=21, 21, 15 | 2.12 Breaths per minute | Standard Deviation 7.74 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 1, n=24, 25, 14 | 20.4 Breaths per minute | Standard Deviation 3.93 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 2, n=22, 24, 13 | 21.8 Breaths per minute | Standard Deviation 6.85 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 3, n=24, 23, 12 | 21.2 Breaths per minute | Standard Deviation 4.4 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 4, n=23, 23, 13 | 20.9 Breaths per minute | Standard Deviation 3.82 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 5, n=23, 23, 11 | 19.8 Breaths per minute | Standard Deviation 3.19 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 6, n=23, 22, 11 | 20.6 Breaths per minute | Standard Deviation 4.11 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 7, n=22, 25, 11 | 20.1 Breaths per minute | Standard Deviation 4.46 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 8, n=19, 19, 10 | 23.4 Breaths per minute | Standard Deviation 6.23 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 9, n=17, 16, 12 | 22.0 Breaths per minute | Standard Deviation 3.95 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 10, n=16, 13, 11 | 22.8 Breaths per minute | Standard Deviation 3.83 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 11, n=15, 13, 12 | 22.8 Breaths per minute | Standard Deviation 3.11 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 12, n=17, 16, 9 | 22.2 Breaths per minute | Standard Deviation 3.76 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 13, n=11, 13, 8 | 23.4 Breaths per minute | Standard Deviation 7.68 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 14, n=13, 11, 7 | 19.9 Breaths per minute | Standard Deviation 5.49 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 15, n=12, 13, 5 | 21.1 Breaths per minute | Standard Deviation 2.53 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 16, n=16, 14, 8 | 22.9 Breaths per minute | Standard Deviation 7.97 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 17, n=13, 10, 5 | 22.4 Breaths per minute | Standard Deviation 6.45 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 18, n=16, 12, 4 | 22.0 Breaths per minute | Standard Deviation 4.53 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 19, n=14, 13, 6 | 24.5 Breaths per minute | Standard Deviation 19.33 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 20, n=13, 13, 7 | 20.9 Breaths per minute | Standard Deviation 3.52 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 21, n=4, 10, 3 | 20.2 Breaths per minute | Standard Deviation 3.55 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Screening, n=16, 14, 10 | 21.2 Breaths per minute | Standard Deviation 6.57 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 23, n=8, 7, 6 | 21.1 Breaths per minute | Standard Deviation 3.24 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 24, n=22, 23, 11 | 20.2 Breaths per minute | Standard Deviation 3.11 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 1, n=6, 6, 3 | 20.0 Breaths per minute | Standard Deviation 3.41 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 2, n=6, 5, 7 | 20.8 Breaths per minute | Standard Deviation 4.15 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 3, n=6, 4, 4 | 23.0 Breaths per minute | Standard Deviation 4.16 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 4, n=10, 12, 7 | 20.8 Breaths per minute | Standard Deviation 1.86 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | MPB, n=24, 26, 15 | 27.7 Breaths per minute | Standard Deviation 13 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 19, n=14, 13, 6 | 24.0 Breaths per minute | Standard Deviation 6.45 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 8, n=19, 19, 10 | 22.0 Breaths per minute | Standard Deviation 1.79 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 2, n=6, 5, 7 | 22.2 Breaths per minute | Standard Deviation 4.02 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 20, n=13, 13, 7 | 33.00 Breaths per minute | Standard Deviation 16.77 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 7, n=22, 25, 11 | 22.4 Breaths per minute | Standard Deviation 4.6 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 1, n=24, 25, 14 | 25.1 Breaths per minute | Standard Deviation 7.63 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 21, n=4, 10, 3 | 28.0 Breaths per minute | Standard Deviation 10.58 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 6, n=23, 22, 11 | 23.3 Breaths per minute | Standard Deviation 4.92 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Screening, n=16, 14, 10 | 21.5 Breaths per minute | Standard Deviation 2.56 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 22, n=11, 7, 5 | 26.0 Breaths per minute | Standard Deviation 4.9 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 5, n=23, 23, 11 | 26.9 Breaths per minute | Standard Deviation 12.91 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 3, n=6, 4, 4 | 24.8 Breaths per minute | Standard Deviation 5.5 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 23, n=8, 7, 6 | 23.7 Breaths per minute | Standard Deviation 5.13 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 4, n=23, 23, 13 | 24.3 Breaths per minute | Standard Deviation 6.37 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Day 1 , n=21, 21, 15 | 21.7 Breaths per minute | Standard Deviation 4.76 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 24, n=22, 23, 11 | 23.8 Breaths per minute | Standard Deviation 5.47 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 14, n=13, 11, 7 | 23.4 Breaths per minute | Standard Deviation 4.86 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 13, n=11, 13, 8 | 21.0 Breaths per minute | Standard Deviation 2.62 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 3, n=24, 23, 12 | 24.0 Breaths per minute | Standard Deviation 6.09 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 15, n=12, 13, 5 | 24.4 Breaths per minute | Standard Deviation 8.76 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 12, n=17, 16, 9 | 23.6 Breaths per minute | Standard Deviation 4.98 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | MPB, n=24, 26, 15 | 27.7 Breaths per minute | Standard Deviation 11.54 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 16, n=16, 14, 8 | 24.3 Breaths per minute | Standard Deviation 6.88 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 11, n=15, 13, 12 | 22.2 Breaths per minute | Standard Deviation 5.29 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 1, n=6, 6, 3 | 26.0 Breaths per minute | Standard Deviation 10.39 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 17, n=13, 10, 5 | 25.2 Breaths per minute | Standard Deviation 9.65 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 10, n=16, 13, 11 | 23.3 Breaths per minute | Standard Deviation 6.83 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 2, n=22, 24, 13 | 25.2 Breaths per minute | Standard Deviation 10.83 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 18, n=16, 12, 4 | 29.0 Breaths per minute | Standard Deviation 10.52 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | Week 9, n=17, 16, 12 | 22.5 Breaths per minute | Standard Deviation 4.48 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3 | FU Week 4, n=10, 12, 7 | 21.0 Breaths per minute | Standard Deviation 3.74 |
Secondary
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.
Time frame: From Baseline through Week 24
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 10, n=5,5,5 | 19.6 Breaths per min | Standard Deviation 2.61 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 2, n=3,2,0 | 19.3 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 20, n=5,4,4 | 19.6 Breaths per min | Standard Deviation 1.67 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 11, n=5,3,4 | 19.6 Breaths per min | Standard Deviation 1.67 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 4, n=5,5,5 | 18.8 Breaths per min | Standard Deviation 1.79 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 19, n=3,0,2 | 19.3 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 12, n=4,3,4 | 19.5 Breaths per min | Standard Deviation 1 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 4, n=1,0,1 | 18.0 Breaths per min | — |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 18, n=3,3,4 | 19.3 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 13, n=4,4,4 | 19.5 Breaths per min | Standard Deviation 1 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 1, n=1,1,3 | 20.0 Breaths per min | — |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 17, n=2,0,3 | 18.0 Breaths per min | Standard Deviation 0 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 14, n=3,3,3 | 18.7 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 5, n=5,5,4 | 20.4 Breaths per min | Standard Deviation 2.19 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 16, n=5,3,4 | 18.8 Breaths per min | Standard Deviation 3.35 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 15, n=3,3,3 | 18.0 Breaths per min | Standard Deviation 2 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 2, n=5,5,4 | 20.6 Breaths per min | Standard Deviation 3.44 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 24, n=5,5,4 | 19.6 Breaths per min | Standard Deviation 0.89 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 6, n=5,5,4 | 18.4 Breaths per min | Standard Deviation 2.61 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 1, n=4,5,4 | 21.5 Breaths per min | Standard Deviation 4.43 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 23, n=4,2,4 | 20.0 Breaths per min | Standard Deviation 1.63 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 7, n=5,5,5 | 19.2 Breaths per min | Standard Deviation 1.1 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 3, n=2,1,2 | 21.0 Breaths per min | Standard Deviation 4.24 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | BL, n=4, 5, 4 | 20.0 Breaths per min | Standard Deviation 0 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 8, n=5,5,5 | 19.8 Breaths per min | Standard Deviation 3.03 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 3, n=5,5,5 | 22.0 Breaths per min | Standard Deviation 5.66 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 22, n=3,4,3 | 19.3 Breaths per min | Standard Deviation 2.31 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 9, n=5,4,5 | 19.2 Breaths per min | Standard Deviation 2.28 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | MPB, n=5, 5, 5 | 24.4 Breaths per min | Standard Deviation 4.56 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 21, n=3,2,5 | 19.3 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 22, n=3,4,3 | 21.0 Breaths per min | Standard Deviation 2 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | BL, n=4, 5, 4 | 21.4 Breaths per min | Standard Deviation 4.1 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 1, n=4,5,4 | 22.0 Breaths per min | Standard Deviation 6 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 2, n=5,5,4 | 19.4 Breaths per min | Standard Deviation 4.98 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 3, n=5,5,5 | 17.0 Breaths per min | Standard Deviation 5.1 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 4, n=5,5,5 | 17.2 Breaths per min | Standard Deviation 4.82 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 5, n=5,5,4 | 20.2 Breaths per min | Standard Deviation 6.87 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 6, n=5,5,4 | 20.2 Breaths per min | Standard Deviation 5.02 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 7, n=5,5,5 | 23.4 Breaths per min | Standard Deviation 9.15 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 8, n=5,5,5 | 20.4 Breaths per min | Standard Deviation 3.05 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 9, n=5,4,5 | 22.5 Breaths per min | Standard Deviation 3.79 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 10, n=5,5,5 | 18.0 Breaths per min | Standard Deviation 4 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 11, n=5,3,4 | 20.3 Breaths per min | Standard Deviation 3.21 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 12, n=4,3,4 | 20.0 Breaths per min | Standard Deviation 0 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 13, n=4,4,4 | 21.0 Breaths per min | Standard Deviation 2.16 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 14, n=3,3,3 | 22.7 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 15, n=3,3,3 | 21.3 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 16, n=5,3,4 | 20.0 Breaths per min | Standard Deviation 4 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 17, n=2,0,3 | NA Breaths per min | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 18, n=3,3,4 | 21.3 Breaths per min | Standard Deviation 3.06 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 19, n=3,0,2 | NA Breaths per min | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 20, n=5,4,4 | 21.5 Breaths per min | Standard Deviation 3 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 21, n=3,2,5 | 19.00 Breaths per min | Standard Deviation 1.41 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 23, n=4,2,4 | 20.0 Breaths per min | Standard Deviation 0 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 24, n=5,5,4 | 23.0 Breaths per min | Standard Deviation 3.16 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 1, n=1,1,3 | 20.0 Breaths per min | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 2, n=3,2,0 | 26.5 Breaths per min | Standard Deviation 9.19 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 3, n=2,1,2 | 28.0 Breaths per min | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 4, n=1,0,1 | NA Breaths per min | — |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | MPB, n=5, 5, 5 | 29.8 Breaths per min | Standard Deviation 6.02 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 10, n=5,5,5 | 22.4 Breaths per min | Standard Deviation 1.67 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 2, n=5,5,4 | 24.0 Breaths per min | Standard Deviation 5.42 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 20, n=5,4,4 | 23.5 Breaths per min | Standard Deviation 3.42 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 9, n=5,4,5 | 22.0 Breaths per min | Standard Deviation 2 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | BL, n=4, 5, 4 | 25.5 Breaths per min | Standard Deviation 4.43 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 21, n=3,2,5 | 23.6 Breaths per min | Standard Deviation 3.51 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 8, n=5,5,5 | 23.8 Breaths per min | Standard Deviation 4.82 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 7, n=5,5,5 | 24.4 Breaths per min | Standard Deviation 6.69 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 22, n=3,4,3 | 27.3 Breaths per min | Standard Deviation 7.57 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 6, n=5,5,4 | 24.5 Breaths per min | Standard Deviation 2.52 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 3, n=2,1,2 | 24.5 Breaths per min | Standard Deviation 4.95 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 23, n=4,2,4 | 21.5 Breaths per min | Standard Deviation 1.91 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 5, n=5,5,4 | 24.3 Breaths per min | Standard Deviation 5.56 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 1, n=4,5,4 | 26.5 Breaths per min | Standard Deviation 6.4 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 24, n=5,5,4 | 24.8 Breaths per min | Standard Deviation 7.09 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 4, n=5,5,5 | 25.4 Breaths per min | Standard Deviation 5.98 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | MPB, n=5, 5, 5 | 32.2 Breaths per min | Standard Deviation 13.9 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 15, n=3,3,3 | 24.0 Breaths per min | Standard Deviation 2 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 14, n=3,3,3 | 27.3 Breaths per min | Standard Deviation 7.57 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 1, n=1,1,3 | 22.0 Breaths per min | Standard Deviation 2 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 16, n=5,3,4 | 30.8 Breaths per min | Standard Deviation 16.88 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 13, n=4,4,4 | 23.0 Breaths per min | Standard Deviation 3.46 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 3, n=5,5,5 | 23.6 Breaths per min | Standard Deviation 6.07 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 17, n=2,0,3 | 24.0 Breaths per min | Standard Deviation 4 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 12, n=4,3,4 | 27.6 Breaths per min | Standard Deviation 11.52 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 4, n=1,0,1 | 24.0 Breaths per min | — |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 18, n=3,3,4 | 29.0 Breaths per min | Standard Deviation 13.22 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 11, n=5,3,4 | 25.0 Breaths per min | Standard Deviation 5.03 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | FU Week 2, n=3,2,0 | NA Breaths per min | — |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1 | Week 19, n=3,0,2 | 28.0 Breaths per min | Standard Deviation 11.31 |
Secondary
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.
Time frame: From Week 1 to Week 7 of Part 2
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 7, n=7, 16, 9, 17, 4, 8 | 20.9 Breaths per min | Standard Deviation 2.27 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | MPB, n=8, 16, 9, 17, 4, 11 | 21.5 Breaths per min | Standard Deviation 2.33 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 2, n=6, 15, 9, 16, 4, 10 | 19.3 Breaths per min | Standard Deviation 2.73 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 8, 15, 3, 8 | 19.3 Breaths per min | Standard Deviation 1.04 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 15, 4, 9 | 20.3 Breaths per min | Standard Deviation 2.25 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 4, n=7, 16, 8, 14, 4, 10 | 19.4 Breaths per min | Standard Deviation 2.51 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 1, n=7, 16 ,9, 17, 2, 10 | 19.0 Breaths per min | Standard Deviation 1 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | BL, n= 5, 14, 9, 12, 3, 10 | 19.6 Breaths per min | Standard Deviation 1.67 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16, 4, 9 | 18.8 Breaths per min | Standard Deviation 1.83 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | MPB, n=8, 16, 9, 17, 4, 11 | 21.3 Breaths per min | Standard Deviation 21.8 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 8, 15, 3, 8 | 18.5 Breaths per min | Standard Deviation 2.1 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 1, n=7, 16 ,9, 17, 2, 10 | 18.8 Breaths per min | Standard Deviation 1.76 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 2, n=6, 15, 9, 16, 4, 10 | 18.9 Breaths per min | Standard Deviation 2.7 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | BL, n= 5, 14, 9, 12, 3, 10 | 18.4 Breaths per min | Standard Deviation 2.38 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 7, n=7, 16, 9, 17, 4, 8 | 18.4 Breaths per min | Standard Deviation 1.5 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16, 4, 9 | 18.9 Breaths per min | Standard Deviation 1.93 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 15, 4, 9 | 19.4 Breaths per min | Standard Deviation 2.16 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 4, n=7, 16, 8, 14, 4, 10 | 18.6 Breaths per min | Standard Deviation 2.8 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 1, n=7, 16 ,9, 17, 2, 10 | 19.9 Breaths per min | Standard Deviation 2.26 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 8, 15, 3, 8 | 20.5 Breaths per min | Standard Deviation 2.98 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16, 4, 9 | 20.1 Breaths per min | Standard Deviation 2.76 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 7, n=7, 16, 9, 17, 4, 8 | 20.9 Breaths per min | Standard Deviation 3.33 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | MPB, n=8, 16, 9, 17, 4, 11 | 22.7 Breaths per min | Standard Deviation 2.45 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 2, n=6, 15, 9, 16, 4, 10 | 19.8 Breaths per min | Standard Deviation 2.33 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 15, 4, 9 | 20.6 Breaths per min | Standard Deviation 2.19 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 4, n=7, 16, 8, 14, 4, 10 | 19.8 Breaths per min | Standard Deviation 2.49 |
| Part 2 (Randomized Period) Cohort 2-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | BL, n= 5, 14, 9, 12, 3, 10 | 19.4 Breaths per min | Standard Deviation 3.13 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 8, 15, 3, 8 | 19.7 Breaths per min | Standard Deviation 2.74 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | BL, n= 5, 14, 9, 12, 3, 10 | 21.5 Breaths per min | Standard Deviation 10.03 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 1, n=7, 16 ,9, 17, 2, 10 | 20.7 Breaths per min | Standard Deviation 4.48 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 2, n=6, 15, 9, 16, 4, 10 | 23.0 Breaths per min | Standard Deviation 8.01 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16, 4, 9 | 22.3 Breaths per min | Standard Deviation 4.78 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 4, n=7, 16, 8, 14, 4, 10 | 21.4 Breaths per min | Standard Deviation 4.29 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 15, 4, 9 | 20.6 Breaths per min | Standard Deviation 4.12 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 7, n=7, 16, 9, 17, 4, 8 | 20.7 Breaths per min | Standard Deviation 7.87 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | MPB, n=8, 16, 9, 17, 4, 11 | 26.6 Breaths per min | Standard Deviation 7.87 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 4, n=7, 16, 8, 14, 4, 10 | 21.5 Breaths per min | Standard Deviation 1 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16, 4, 9 | 21.0 Breaths per min | Standard Deviation 2.58 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 15, 4, 9 | 21.0 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 2, n=6, 15, 9, 16, 4, 10 | 21.5 Breaths per min | Standard Deviation 5 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | MPB, n=8, 16, 9, 17, 4, 11 | 23.5 Breaths per min | Standard Deviation 3.42 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 7, n=7, 16, 9, 17, 4, 8 | 18.5 Breaths per min | Standard Deviation 1.91 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 1, n=7, 16 ,9, 17, 2, 10 | 19.0 Breaths per min | Standard Deviation 1.41 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | BL, n= 5, 14, 9, 12, 3, 10 | 18.7 Breaths per min | Standard Deviation 1.15 |
| Part 2 (Randomized Period) Cohort 3-Placebo | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 8, 15, 3, 8 | 20.0 Breaths per min | Standard Deviation 2 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | BL, n= 5, 14, 9, 12, 3, 10 | 21.4 Breaths per min | Standard Deviation 2.12 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 3, n=8, 16, 9, 16, 4, 9 | 25.8 Breaths per min | Standard Deviation 7.17 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 5, n=8, 16, 8, 15, 3, 8 | 29.0 Breaths per min | Standard Deviation 14.77 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | MPB, n=8, 16, 9, 17, 4, 11 | 30.0 Breaths per min | Standard Deviation 13.39 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 7, n=7, 16, 9, 17, 4, 8 | 23.5 Breaths per min | Standard Deviation 6.12 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 6, n=8, 16, 9, 15, 4, 9 | 24.4 Breaths per min | Standard Deviation 6.69 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 2, n=6, 15, 9, 16, 4, 10 | 27.1 Breaths per min | Standard Deviation 11.7 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 4, n=7, 16, 8, 14, 4, 10 | 25.4 Breaths per min | Standard Deviation 7.18 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2 | Week 1, n=7, 16 ,9, 17, 2, 10 | 28.2 Breaths per min | Standard Deviation 9.54 |
Secondary
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.
Time frame: Baseline and Week 24 of Part 1
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, MS, BL, n=3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, NR, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, Neg, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, Trace, BL, n=3 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, 1+, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, 2+, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, 3+, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, 4+, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, MS, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, NR, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, Neg, BL, n=3 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, normal, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 5, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 15(1+), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 30(2+), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 60(3+), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 110(4+), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, MS, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, NR, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Neg, BL, n=3 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Trace(5), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Small(15), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Moderate(40), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Large(80), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Large(160), BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, MS, BL,n=3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, NR, BL,n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, Neg, BL,n=3 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, 1+, BL,n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, 2+, BL,n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, 3+, BL,n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, Non haemolysed trace, BL,n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, haemolysed trace, BL,n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, MS, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, NR, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, normal result, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, Neg, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 5, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 5.5, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 6, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 6.5, BL, n=3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 7, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 7.5,BL, n=3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 8, BL, n=3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 8.5, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 9, BL, n=3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, MS, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, NR, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, Neg, W24, n=4 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, Trace, W24, n=4 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, 1+, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, 2+, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, 3+, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UP, 4+, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, MS, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, NR, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, Neg, W24, n=4 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, normal, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 5, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 15(1+), W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 30(2+), W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 60(3+), W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UG, 110(4+), W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, MS, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, NR, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Neg, W24, n=4 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Trace(5), W24, n=4 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Small(15), W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Moderate(40), W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Large(80), W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UK, Large(160), W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, MS, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, NR, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, Neg, W24, n=4 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, 1+, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, 2+, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, 3+, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, Non haemolysed trace, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | UOB, haemolysed trace, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, MS, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, NR, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, normal result, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, Neg, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 5, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 5.5, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 6, W24, n=4 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 6.5, W24, n=4 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 7, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 7.5,W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 8, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 8.5, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1 | pH, 9, W24, n=4 | 0 Participants |
Secondary
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.
Time frame: Baseline and Week 24 of Part 2/3 up to Study Week 31
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, MS, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, NR, BL, n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, Neg, BL, n=11 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, Trace, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, 1+, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, 2+, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, 3+, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, 4+, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, MS, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, NR, BL, n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, Neg, BL, n=11 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, normal, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 5, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 15(1+), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 30(2+), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 60(3+), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 110(4+), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, MS, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, NR, BL, n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Neg, BL, n=11 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Trace(5), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Small(15), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Moderate(40), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Large(80), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Large(160), BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, MS, BL,n=11 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, NR, BL,n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, Neg, BL,n=11 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, 1+, BL,n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, 2+, BL,n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, 3+, BL,n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, Non haemolysed trace, BL,n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, haemolysed trace, BL,n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, MS, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, NR, BL, n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, normal result, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, Neg, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 5, BL, n=11 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 5.5, BL, n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 6, BL, n=11 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 6.5, BL, n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 7, BL, n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 7.5,BL, n=11 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 8, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 8.5, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 9, BL, n=11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, MS, W24, n=34 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, NR, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, Neg, W24, n=34 | 32 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, Trace, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, 1+, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, 2+, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, 3+, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UP, 4+, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, MS, W24, n=4 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, NR, W24, n=4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, Neg, W24, n=33 | 29 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, normal, W24, n=33 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 5, W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 15(1+), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 30(2+), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 60(3+), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UG, 110(4+), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, MS, W24, n=33 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, NR, W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Neg, W24, n=33 | 32 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Trace(5), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Small(15), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Moderate(40), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Large(80), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UK, Large(160), W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, MS, W24, n=33 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, NR, W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, Neg, W24, n=33 | 31 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, 1+, W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, 2+, W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, 3+, W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, Non haemolysed trace, W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | UOB, haemolysed trace, W24, n=33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, MS, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, NR, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, normal result, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, Neg, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 5, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 5.5, W24, n=34 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 6, W24, n=34 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 6.5, W24, n=34 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 7, W24, n=34 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 7.5,W24, n=34 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 8, W24, n=34 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 8.5, W24, n=34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3 | pH, 9, W24, n=34 | 0 Participants |
Secondary
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1.
Time frame: Baseline and Week 7 of Part 2
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 8.5, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, Neg, BL, n=10, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 9, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Moderate(40), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, MS, BL, n=10, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Large(80), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, Neg, W7, n=2, 3 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, normal, BL, n=10, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, Trace, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Large(160), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 1+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 2+, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 2+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, MS, BL, n=9, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 3+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 5, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 4+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, NR, BL, n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, Neg, BL, n=10, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, Neg, BL, n=9, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, Neg, W7, n=2, 3 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 15(1+), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, normal, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 1+, BL,n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 3+, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 15(1+), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 2+, BL,n=9, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 30(2+), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 30(2+), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 60(3+), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 3+, BL, n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 110(4+), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 9, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, Non haemolysed trace, BL,n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 60(3+), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Neg, W7, n=2, 3 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, haemolysed trace, BL, n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Trace(5), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 4+, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Small(15), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, MS, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Moderate(40), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 110(4+), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Large(80), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, NR, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Large(160), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, Trace, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, MS, W7, n=2, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, normal result, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, MS, BL, n=10, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, Neg, W7, n=2, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, Neg, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 1+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, MS, BL, n=10, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 2+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 5, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 3+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, NR, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, Non haemolysed trace, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 5.5, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, haemolysed trace, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, NR, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 6, BL, n=10, 9 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Neg, BL, n=10, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, normal result, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 6.5, BL, n=10, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, Neg, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, NR, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 5, W7, n=2, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 7, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 5.5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Trace(5), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 6, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 7.5,BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 6.5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 1+, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 7, W7, n=2, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 8, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 7.5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Small(15), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 8, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 8.5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 8, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 8.5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 9, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, MS, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, NR, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, Neg, BL, n=10, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, Trace, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 1+, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 2+, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 3+, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 4+, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, MS, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, NR, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, Neg, BL, n=10, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, normal, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 5, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 15(1+), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 30(2+), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 60(3+), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 110(4+), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, MS, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, NR, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Neg, BL, n=10, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Trace(5), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Small(15), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Moderate(40), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Large(80), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Large(160), BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, MS, BL, n=9, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, NR, BL, n=9, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, Neg, BL, n=9, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 1+, BL,n=9, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 2+, BL,n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 3+, BL, n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, Non haemolysed trace, BL,n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, haemolysed trace, BL, n=9, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, MS, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, NR, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, normal result, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, Neg, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 5, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 5.5, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 6, BL, n=10, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 6.5, BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 7, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 7.5,BL, n=10, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 8, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 8.5, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 9, BL, n=10, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, Neg, W7, n=2, 3 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, Trace, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 1+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 2+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 3+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UP, 4+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, Neg, W7, n=2, 3 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, normal, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 15(1+), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 30(2+), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 60(3+), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UG, 110(4+), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Neg, W7, n=2, 3 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Trace(5), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Small(15), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Moderate(40), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Large(80), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UK, Large(160), W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, Neg, W7, n=2, 3 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 1+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 2+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, 3+, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, Non haemolysed trace, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | UOB, haemolysed trace, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, MS, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, NR, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, normal result, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, Neg, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 5.5, W7, n=2, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 6, W7, n=2, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 6.5, W7, n=2, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 7, W7, n=2, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2 | pH, 7.5, W7, n=2, 3 | 0 Participants |
Secondary
Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3
Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
Time frame: From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3
Population: ITT Population, only those participants enrolled during Part 2/3 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | New ITP Medication | 8 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Increase concomitant ITP medication from Baseline | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Platelet transfusion | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Splenectomy | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Splenectomy | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | New ITP Medication | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Platelet transfusion | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Increase concomitant ITP medication from Baseline | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Splenectomy | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Increase concomitant ITP medication from Baseline | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | Platelet transfusion | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3 | New ITP Medication | 4 Participants |
Secondary
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Number of participants with a change in visual acuity and change in visual acuity due to the worsening of cataracts since Baseline are presented for Part 2/3 Follow-up Visits at 3-months (FU3) and 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no.
Time frame: BL, 3 and 6mo Follow-up of Part 2/3
Population: Safety Population: all subjects who have received at least one dose of the investigational product during Part 2/3 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU3, no | 13 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU3, yes | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU6, no | 16 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU6, yes | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU3, no | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU3, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU6, no | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU6, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU6, no | 22 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU6, no | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU6, yes | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU3, no | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU3, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU3, no | 17 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU3, yes | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU6, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU6, no | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU3, yes | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU3, no | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change in VA at FU6, yes | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU6, no | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU3, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU3, no | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts | Change due to cataracts at FU6, yes | 0 Participants |
Secondary
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no.
Time frame: Baseline, 3and 6-mo Follow-up of Part 1
Population: Safety Population: all subjects who have received at least one dose of the investigational product during Part 1 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU3, no | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU3, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU6, no | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU6, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU3, no | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU3, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU6, no | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU6, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU6, no | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU6, no | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU6, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU3, no | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU3, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU3, no | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU3, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU6, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU6, no | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU3, yes | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU3, no | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change in VA at FU6, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU6, no | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU3, yes | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU3, no | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1 | Change due to cataracts at FU6, yes | 0 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.
Time frame: From Treatment + 1 day up to Week 24 of Part1
Population: Safety Population: all participants who received at least one dose of the investigational product during Part 1 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1 | Any AE | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1 | Any SAE | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1 | Any AE | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1 | Any SAE | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1 | Any AE | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1 | Any SAE | 0 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.
Time frame: From Treatment + 1 day up to Week 7 of Part 2
Population: Safety Population: all participants who received at least one dose of the investigational product during Part 2 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any AE | 8 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any SAE | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any AE | 13 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any SAE | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any AE | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any SAE | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any AE | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any SAE | 3 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any AE | 3 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any SAE | 0 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any AE | 9 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2 | Any SAE | 0 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.
Time frame: From Treatment + 1 day up to Week 31 of Part2/3
Population: Safety Population: all participants who received at least one dose of the investigational product during Part 2/3 were analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3 | Any AE | 22 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3 | Any SAE | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3 | Any AE | 26 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3 | Any SAE | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3 | Any AE | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3 | Any SAE | 0 Participants |
Secondary
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.
Time frame: From Baseline through Week 7 of Part 2
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 14 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 15 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 16 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 9 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10 | 16 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 16 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 14 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 17 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 17 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10 | 17 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 7 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 3 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10 | 1 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 3 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 0 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 3 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 5 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 7 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 5, Grades 2-4, n=8, 16, 9, 16, 5, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 7, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9 | 5 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 9 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 7 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10 | 8 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 0-1, n=8, 16, 9, 17, 5, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 1-4, n=8, 16, 9, 17, 5, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 4, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2 | Week 6, Grades 2-4, n=8, 16, 9, 17, 5, 9 | 0 Participants |
Secondary
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.
Time frame: From Baseline of Part 2/3 through Follow-up
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 1-4, n=24, 26, 15 | 14 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 1-4, n=16, 14, 11 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 2-4, n=24, 26, 14 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 0-1, n=24, 25, 14 | 21 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 0-1, n=16, 14, 11 | 16 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 0-1, n=8, 5, 3 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 0-1, n=4, 10, 3 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 2-4, n=16, 14, 11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 0-1, n=19, 21, 11 | 19 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 2-4, n=8, 5, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 1-4, n=16, 15, 12 | 15 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 2-4, n=13, 13, 8 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 2-4, n=24, 25, 14 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 0-1, n=16, 15, 12 | 16 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 1-4, n=8, 7,6 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 1-4, n=7, 7, 7 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 2-4, n=16, 15, 12 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 1-4, n=22, 25, 14 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 0-1, n=24, 28, 15 | 17 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 1-4, n=19, 16, 9 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 2-4, n=4, 10, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 1-4, n=24, 26, 13 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 0-1, n=19, 16, 9 | 18 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 0-1, n=7, 7, 7 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 0-1, n=8, 7,6 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 2-4, n=19, 16, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 2-4, n=19, 21, 11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 0-1, n=24, 26, 15 | 20 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 1-4, n=12, 14, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 2-4, n=7, 7, 7 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 0-1, n=24, 26, 13 | 24 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 0-1, n=12, 14, 10 | 12 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 1-4, n=13, 13, 8 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 2-4, n=22, 25, 14 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 2-4, n=12, 14, 10 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 1-4, n=5, 5, 5 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 2-4, n=8, 7,6 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 1-4, n=15, 11, 17 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 1-4, n=24, 28, 15 | 23 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 2-4, n=24, 26, 13 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 0-1, n=15, 11, 17 | 15 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 0-1, n=5, 5, 5 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 1-4, n=4, 10, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 2-4, n=15, 11, 17 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 1-4, n=17, 16, 12 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 2-4, n=5, 5, 5 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 1-4, n=12, 14, 6 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22, Grades 1-4, n=12,7, 5 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 1-4, n=24, 24, 13 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 0-1, n=12, 14, 6 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 1-4, n=23, 24, 13 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 1-4, n=9, 14, 8 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 2-4, n=12, 14, 6 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 2-4, n=23, 24, 12 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 2-4, n=24, 26, 15 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 1-4, n=17, 15, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 1-4, n=24, 25, 14 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 0-1, n=24, 24, 13 | 21 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 0-1, n=17, 15, 9 | 17 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 0-1, n=9, 14, 8 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 0-1, n=24, 26, 14 | 21 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 2-4, n=17, 15, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 0-1, n=17, 16, 12 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 2-4, n=9, 14, 8 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 1-4, n=13, 11, 5 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 0-1, n=23, 14, 13 | 21 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 2-4, n=24, 24, 13 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 0-1, n=13, 11, 5 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22 Grades 0-1, n=12,7, 5 | 12 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 1, n=15, 18, 10 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 2-4, n=13, 11, 5 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 1-4, n=19, 21, 11 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 2-4, n=23, 14, 13 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 1-4, n=16, 12 ,4 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 0-1, n=15, 18, 10 | 15 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 1-4, n=23, 24, 12 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 0-1, n=16, 12 ,4 | 16 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 2-4, n=24, 28, 15 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 2-4, n=17, 16, 12 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 2-4, n=16, 12 ,4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 2-4, n=15, 18, 10 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 1-4, n=24, 26, 14 | 15 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 1-4, n=14, 15, 7 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 0-1, n=22, 25, 14 | 20 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 0-1, n=23, 24, 12 | 23 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 0-1, n=14, 15, 7 | 14 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 1-4, n=8, 5, 3 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 0-1, n=13, 13, 8 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 2-4, n=14, 15, 7 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22 Grades 2-4, n=12,7, 5 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 2-4, n=14, 15, 7 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 1-4, n=13, 13, 8 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 2-4, n=13, 13, 8 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 2-4, n=23, 24, 12 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 1-4, n=4, 10, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 0-1, n=4, 10, 3 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 2-4, n=4, 10, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 1-4, n=22, 25, 14 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22, Grades 1-4, n=12,7, 5 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22 Grades 0-1, n=12,7, 5 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22 Grades 2-4, n=12,7, 5 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 0-1, n=22, 25, 14 | 24 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 1-4, n=8, 7,6 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 0-1, n=24, 26, 14 | 23 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 0-1, n=8, 7,6 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 2-4, n=8, 7,6 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 2-4, n=22, 25, 14 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 1-4, n=23, 24, 13 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 2-4, n=24, 28, 15 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 0-1, n=23, 14, 13 | 24 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 2-4, n=23, 14, 13 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 1-4, n=19, 21, 11 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 1-4, n=8, 5, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 0-1, n=8, 5, 3 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 2-4, n=8, 5, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 0-1, n=19, 21, 11 | 19 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 1-4, n=7, 7, 7 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 2-4, n=24, 26, 14 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 0-1, n=7, 7, 7 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 2-4, n=7, 7, 7 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 2-4, n=19, 21, 11 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 1-4, n=5, 5, 5 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 0-1, n=5, 5, 5 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 2-4, n=5, 5, 5 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 1-4, n=17, 16, 12 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 1-4, n=9, 14, 8 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 0-1, n=9, 14, 8 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 2-4, n=9, 14, 8 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 0-1, n=17, 16, 12 | 16 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 1, n=15, 18, 10 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 1-4, n=24, 25, 14 | 9 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 0-1, n=15, 18, 10 | 18 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 2-4, n=15, 18, 10 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 2-4, n=17, 16, 12 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 0-1, n=13, 13, 8 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 1-4, n=16, 14, 11 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 0-1, n=16, 14, 11 | 12 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 0-1, n=24, 25, 14 | 23 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 2-4, n=16, 14, 11 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 1-4, n=24, 26, 15 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 1-4, n=16, 15, 12 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 0-1, n=16, 15, 12 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 2-4, n=24, 25, 14 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 2-4, n=16, 15, 12 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 1-4, n=19, 16, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 0-1, n=19, 16, 9 | 14 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 1-4, n=24, 26, 13 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 2-4, n=19, 16, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 1-4, n=12, 14, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 0-1, n=12, 14, 10 | 13 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 0-1, n=24, 26, 13 | 26 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 2-4, n=12, 14, 10 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 0-1, n=24, 26, 15 | 24 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 1-4, n=15, 11, 17 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 0-1, n=15, 11, 17 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 2-4, n=24, 26, 13 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 2-4, n=15, 11, 17 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 0-1, n=24, 28, 15 | 25 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 1-4, n=12, 14, 6 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 0-1, n=12, 14, 6 | 14 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 1-4, n=24, 24, 13 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 2-4, n=12, 14, 6 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 1-4, n=17, 15, 9 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 0-1, n=17, 15, 9 | 14 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 0-1, n=24, 24, 13 | 24 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 2-4, n=17, 15, 9 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 2-4, n=24, 26, 15 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 1-4, n=13, 11, 5 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 0-1, n=13, 11, 5 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 2-4, n=24, 24, 13 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 2-4, n=13, 11, 5 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 1-4, n=24, 28, 15 | 18 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 1-4, n=16, 12 ,4 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 0-1, n=16, 12 ,4 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 1-4, n=23, 24, 12 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 2-4, n=16, 12 ,4 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 1-4, n=14, 15, 7 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 0-1, n=14, 15, 7 | 14 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 0-1, n=23, 24, 12 | 22 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 1-4, n=24, 26, 14 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 0-1, n=16, 12 ,4 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 1-4, n=24, 28, 15 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 0-1, n=24, 28, 15 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Baseline, Grades 2-4, n=24, 28, 15 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 1-4, n=24, 26, 15 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 0-1, n=24, 26, 15 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 1, Grades 2-4, n=24, 26, 15 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 1-4, n=24, 26, 14 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 0-1, n=24, 26, 14 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 2, Grades 2-4, n=24, 26, 14 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 1-4, n=24, 25, 14 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 0-1, n=24, 25, 14 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 3, Grades 2-4, n=24, 25, 14 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 1-4, n=24, 26, 13 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 0-1, n=24, 26, 13 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 4, Grades 2-4, n=24, 26, 13 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 1-4, n=24, 24, 13 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 0-1, n=24, 24, 13 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 5, Grades 2-4, n=24, 24, 13 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 1-4, n=23, 24, 12 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 0-1, n=23, 24, 12 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 6, Grades 2-4, n=23, 24, 12 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 1-4, n=22, 25, 14 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 0-1, n=22, 25, 14 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 7, Grades 2-4, n=22, 25, 14 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 1-4, n=19, 21, 11 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 0-1, n=19, 21, 11 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 8, Grades 2-4, n=19, 21, 11 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 1-4, n=17, 16, 12 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 0-1, n=17, 16, 12 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 9, Grades 2-4, n=17, 16, 12 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 1-4, n=16, 14, 11 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 0-1, n=16, 14, 11 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 10, Grades 2-4, n=16, 14, 11 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 1-4, n=16, 15, 12 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 0-1, n=16, 15, 12 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 11, Grades 2-4, n=16, 15, 12 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 1-4, n=19, 16, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 0-1, n=19, 16, 9 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 12, Grades 2-4, n=19, 16, 9 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 1-4, n=12, 14, 10 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 0-1, n=12, 14, 10 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 13, Grades 2-4, n=12, 14, 10 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 1-4, n=15, 11, 17 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 0-1, n=15, 11, 17 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 14, Grades 2-4, n=15, 11, 17 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 1-4, n=12, 14, 6 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 0-1, n=12, 14, 6 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 15, Grades 2-4, n=12, 14, 6 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 1-4, n=17, 15, 9 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 0-1, n=17, 15, 9 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 16, Grades 2-4, n=17, 15, 9 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 1-4, n=13, 11, 5 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 0-1, n=13, 11, 5 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 17, Grades 2-4, n=13, 11, 5 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 1-4, n=16, 12 ,4 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 0-1, n=13, 13, 8 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 18, Grades 2-4, n=16, 12 ,4 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 1-4, n=14, 15, 7 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 0-1, n=14, 15, 7 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 19, Grades 2-4, n=14, 15, 7 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 1-4, n=13, 13, 8 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 20, Grades 2-4, n=13, 13, 8 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 1-4, n=4, 10, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 0-1, n=4, 10, 3 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 21, Grades 2-4, n=4, 10, 3 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22, Grades 1-4, n=12,7, 5 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22 Grades 0-1, n=12,7, 5 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 22 Grades 2-4, n=12,7, 5 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 1-4, n=8, 7,6 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 0-1, n=8, 7,6 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 23, Grades 2-4, n=8, 7,6 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 1-4, n=23, 24, 13 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 0-1, n=23, 14, 13 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Week 24, Grades 2-4, n=23, 14, 13 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 1-4, n=8, 5, 3 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 0-1, n=8, 5, 3 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 1, Grades 2-4, n=8, 5, 3 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 1-4, n=7, 7, 7 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 0-1, n=7, 7, 7 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 2, Grades 2-4, n=7, 7, 7 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 1-4, n=5, 5, 5 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 0-1, n=5, 5, 5 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 3, Grades 2-4, n=5, 5, 5 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 1-4, n=9, 14, 8 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 0-1, n=9, 14, 8 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Follow Up Week 4, Grades 2-4, n=9, 14, 8 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 1, n=15, 18, 10 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 0-1, n=15, 18, 10 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3 | Any Follow Up Visit, Grades 2-4, n=15, 18, 10 | 3 Participants |
Secondary
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1
Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.
Time frame: From Baseline up to Study Week 24 of Part 1
Population: Safety Population, only those participants enrolled during Part 1 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | Epithelial Renal Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | Epithelial Renal Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | Epithelial Renal Cell Casts | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1 | RBC Casts | 0 Participants |
Secondary
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.
Time frame: From Baseline and post-Baseline up to Study Week 7 of Part 2
Population: Safety Population, only those participants enrolled during Part 2 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt Epithelial Renal Tubular Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL Epithelial Renal Tubular Cell Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt RBC Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL Epithelial Renal Tubular Cell Casts | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt Epithelial Renal Tubular Cell Casts | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL Epithelial Renal Tubular Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt Epithelial Renal Tubular Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL Epithelial Renal Tubular Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt Epithelial Renal Tubular Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt Epithelial Renal Tubular Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL Epithelial Renal Tubular Cell Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 3-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL Epithelial Renal Tubular Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Post-BL WBC Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2 | Pre-trt Epithelial Renal Tubular Cell Casts | 0 Participants |
Secondary
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3
Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
Time frame: From Baseline and post-Baseline up to Study Week 31 of Part 2/3
Population: Safety Population, only those participants enrolled during Part 2/3 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt Epithelial Renal Tubular Cell Casts | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt RBC Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL Epithelial Renal Tubular Cell Casts | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL WBC Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt Epithelial Renal Tubular Cell Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL Epithelial Renal Tubular Cell Casts | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt RBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt WBC Casts | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL WBC Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL Epithelial Renal Tubular Cell Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Pre-trt Epithelial Renal Tubular Cell Casts | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3 | Post-BL RBC Casts | 1 Participants |
Secondary
Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Clinical chemistry parameters included: aspartate amino transferase (AST, reference range \[RR\]: 0-38 International Units per Liter \[IU/L\]), alkaline phosphatase (ALP: RR: 50 - 375 IU/L), total bilirubin (RR: 3.42 - 22.23 micromoles \[umol\]/L), albumin grams \[g/L\], alanine amino transferase (ALT, RR: 5-30 IU/L), prothrombin international normalized ratio (PT INR, RR-0.9 - 1.2), activated partial thromboplastin time (APTT, RR: 24.2 - 32.9 seconds), glucose (RR: 4.107- 6.55018 millimoles \[mmol\]/L), potassium (3 - 5 mmol/L), and sodium (135 - 143 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated clinical chemistry data outside of the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment
Time frame: Post-Baseline from Week 1 through Follow-up up to Study Week 35
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PTT, high, n=15, 21, 41, 63 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Total Bilirubin, low, n=15, 21, 44, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Glucose, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Sodium, low, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Direct Bilirubin, high, n=10, 16, 34, 55 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Albumin, low, n=15, 21, 24, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Direct Bilirubin, low, n=10, 16, 34, 55 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT INR, low, n=15, 20, 42, 64 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Albumin, high, n=15, 21, 24, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Glucose, low, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Potassium, high, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT INR, high, n=15, 20, 42, 64 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Potassium, low, n=15, 21, 44, 65, | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT, high, n=13, 20, 36, 61 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALT, high, n= 15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | AST high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PTT, low, n=15, 21, 41, 63 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALP, low, n=15, 21, 24, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | AST low, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT, low, n=13, 20, 36, 61 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Sodium, high, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALP, high, n=15, 21, 24, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALT, low, n= 15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Total Bilirubin, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT, high, n=13, 20, 36, 61 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Sodium, high, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Potassium, low, n=15, 21, 44, 65, | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Total Bilirubin, low, n=15, 21, 44, 65 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALP, high, n=15, 21, 24, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALP, low, n=15, 21, 24, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Albumin, low, n=15, 21, 24, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Direct Bilirubin, high, n=10, 16, 34, 55 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Glucose, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALT, high, n= 15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PTT, low, n=15, 21, 41, 63 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Direct Bilirubin, low, n=10, 16, 34, 55 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Sodium, low, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | AST high, n=15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Albumin, high, n=15, 21, 24, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT INR, low, n=15, 20, 42, 64 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Total Bilirubin, high, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Glucose, low, n=15, 21, 44, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PTT, high, n=15, 21, 41, 63 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT INR, high, n=15, 20, 42, 64 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALT, low, n= 15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Potassium, high, n=15, 21, 44, 65 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT, low, n=13, 20, 36, 61 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | AST low, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | AST low, n=15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT, low, n=13, 20, 36, 61 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PTT, high, n=15, 21, 41, 63 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PTT, low, n=15, 21, 41, 63 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Glucose, high, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Glucose, low, n=15, 21, 44, 65 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Potassium, high, n=15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Potassium, low, n=15, 21, 44, 65, | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | AST high, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALT, high, n= 15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALT, low, n= 15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Total Bilirubin, high, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Total Bilirubin, low, n=15, 21, 44, 65 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Direct Bilirubin, high, n=10, 16, 34, 55 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Sodium, high, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Direct Bilirubin, low, n=10, 16, 34, 55 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Albumin, high, n=15, 21, 24, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Sodium, low, n=15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Albumin, low, n=15, 21, 24, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALP, high, n=15, 21, 24, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALP, low, n=15, 21, 24, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT INR, high, n=15, 20, 42, 64 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT INR, low, n=15, 20, 42, 64 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT, high, n=13, 20, 36, 61 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALT, low, n= 15, 21, 44, 65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT, high, n=13, 20, 36, 61 | 24 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Albumin, low, n=15, 21, 24, 65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALT, high, n= 15, 21, 44, 65 | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | AST low, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Sodium, low, n=15, 21, 44, 65 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT INR, low, n=15, 20, 42, 64 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALP, high, n=15, 21, 24, 65 | 13 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | AST high, n=15, 21, 44, 65 | 17 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Potassium, low, n=15, 21, 44, 65, | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PTT, high, n=15, 21, 41, 63 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | ALP, low, n=15, 21, 24, 65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Potassium, high, n=15, 21, 44, 65 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Glucose, low, n=15, 21, 44, 65 | 29 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT, low, n=13, 20, 36, 61 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PT INR, high, n=15, 20, 42, 64 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Direct Bilirubin, low, n=10, 16, 34, 55 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Glucose, high, n=15, 21, 44, 65 | 27 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Albumin, high, n=15, 21, 24, 65 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Direct Bilirubin, high, n=10, 16, 34, 55 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Sodium, high, n=15, 21, 44, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Total Bilirubin, low, n=15, 21, 44, 65 | 31 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Total Bilirubin, high, n=15, 21, 44, 65 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | PTT, low, n=15, 21, 41, 63 | 9 Participants |
Secondary
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Hematology parameters included: erythrocytes (RR: 4.2 - 6.1 teragrams per liter \[TI/L\]), hemoglobin (RR: 125 - 165 g/L), hematocrit (RR: 0.36 - 0.46), platelets (RR: 170 - 430 gigagrams per liter \[GI/L\]), mean platelet volume (MPV, RR: 4 - 14 femotoliter \[fL\]), leukocytes (RR: 3.4 - 11.2 GI/L), total neutrophils (RR: 2.1 - 4.9 GI/L), lymphocytes (RR: 1.4 - 2.9 GI/L), monocytes (RR: 0.2 - 0.9 GI/L), eosinophils (RR: 0.2 - 0.7 GI/L), and basophils (RR: 0.02 - 0.12 GI/L). Baseline values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment
Time frame: Post-Baseline from Week 1 through Follow-up up to Study Week 35
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hemoglobin, high, n= 15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Erythrocytes low, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Basophils, high, n=15, 21, 44, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Leukocytes, high, n=15, 21, 44, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Erythrocytes high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Mean Platelet Volume, low, n=12, 17, 40, 59 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Basophils, low, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Monocytes, high, n=15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Mean Platelet Volume, high, n=12, 17, 40, 59 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Neutrophils, high, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Platelets, low, n=15, 21, 44, 65 | 15 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Lymphocytes, high, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Monocytes, low, n=15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Lymphocytes, low, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Platelets, high, n=15, 21, 44, 65 | 9 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hematocrit, low, n=15, 21, 44, 65 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Eosinophils, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Neutrophils, low, n=15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hematocrit, high, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hemoglobin low, n= 15, 21, 44, 65 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Eosinophils, low, n=15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Leukocytes, low, n=15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Platelets, high, n=15, 21, 44, 65 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Lymphocytes, high, n=15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Lymphocytes, low, n=15, 21, 44, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Monocytes, high, n=15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Monocytes, low, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Eosinophils, high, n=15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Eosinophils, low, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Basophils, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Basophils, low, n=15, 21, 44, 65 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Mean Platelet Volume, high, n=12, 17, 40, 59 | 10 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Mean Platelet Volume, low, n=12, 17, 40, 59 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Erythrocytes high, n=15, 21, 44, 65 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Erythrocytes low, n=15, 21, 44, 65 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hemoglobin, high, n= 15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hemoglobin low, n= 15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hematocrit, high, n=15, 21, 44, 65 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hematocrit, low, n=15, 21, 44, 65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Platelets, low, n=15, 21, 44, 65 | 21 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Leukocytes, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Leukocytes, low, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Neutrophils, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Neutrophils, low, n=15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Platelets, high, n=15, 21, 44, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hemoglobin, high, n= 15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Monocytes, high, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Eosinophils, high, n=15, 21, 44, 65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Platelets, low, n=15, 21, 44, 65 | 44 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Neutrophils, low, n=15, 21, 44, 65 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hematocrit, high, n=15, 21, 44, 65 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Lymphocytes, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Leukocytes, high, n=15, 21, 44, 65 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Leukocytes, low, n=15, 21, 44, 65 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Basophils, low, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Eosinophils, low, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Mean Platelet Volume, high, n=12, 17, 40, 59 | 23 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Neutrophils, high, n=15, 21, 44, 65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hematocrit, low, n=15, 21, 44, 65 | 22 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Lymphocytes, low, n=15, 21, 44, 65 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Mean Platelet Volume, low, n=12, 17, 40, 59 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Erythrocytes low, n=15, 21, 44, 65 | 13 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Basophils, high, n=15, 21, 44, 65 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Monocytes, low, n=15, 21, 44, 65 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Erythrocytes high, n=15, 21, 44, 65 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hemoglobin low, n= 15, 21, 44, 65 | 15 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Erythrocytes high, n=15, 21, 44, 65 | 15 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Erythrocytes low, n=15, 21, 44, 65 | 24 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Leukocytes, low, n=15, 21, 44, 65 | 19 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hemoglobin, high, n= 15, 21, 44, 65 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Eosinophils, high, n=15, 21, 44, 65 | 24 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Lymphocytes, high, n=15, 21, 44, 65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hemoglobin low, n= 15, 21, 44, 65 | 32 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hematocrit, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Monocytes, low, n=15, 21, 44, 65 | 23 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Hematocrit, low, n=15, 21, 44, 65 | 39 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Monocytes, high, n=15, 21, 44, 65 | 15 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Platelets, high, n=15, 21, 44, 65 | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Neutrophils, high, n=15, 21, 44, 65 | 33 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Platelets, low, n=15, 21, 44, 65 | 65 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Lymphocytes, low, n=15, 21, 44, 65 | 25 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Basophils, low, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Leukocytes, high, n=15, 21, 44, 65 | 27 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Mean Platelet Volume, high, n=12, 17, 40, 59 | 47 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Basophils, high, n=15, 21, 44, 65 | 20 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Mean Platelet Volume, low, n=12, 17, 40, 59 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Neutrophils, low, n=15, 21, 44, 65 | 21 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Eosinophils, low, n=15, 21, 44, 65 | 9 Participants |
Secondary
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute \[ ml/min\]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles \[mg/mmol\]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-baseline assessment
Time frame: Post-Baseline from Week 1 through Follow-up up to Study Week 35
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine, high, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine, low, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine Clearance Derived, high, n=15, 21,44,65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine Clearance Derived, low, n=15, 21,44,65 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Protein/Creatinine, high, n=12, 19, 38, 58 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Protein/Creatinine, low, n=12, 19, 38, 58 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Urea, high, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Urea, low, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Protein/Creatinine, low, n=12, 19, 38, 58 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Protein/Creatinine, high, n=12, 19, 38, 58 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine, low, n=15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Urea, low, n=15, 21, 44, 65 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Urea, high, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine Clearance Derived, low, n=15, 21,44,65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine Clearance Derived, high, n=15, 21,44,65 | 17 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine, high, n=15, 21, 44, 65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Urea, high, n=15, 21, 44, 65 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine Clearance Derived, high, n=15, 21,44,65 | 28 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine Clearance Derived, low, n=15, 21,44,65 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Protein/Creatinine, high, n=12, 19, 38, 58 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Protein/Creatinine, low, n=12, 19, 38, 58 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Urea, low, n=15, 21, 44, 65 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine, high, n=15, 21, 44, 65 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine, low, n=15, 21, 44, 65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine Clearance Derived, high, n=15, 21,44,65 | 46 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine Clearance Derived, low, n=15, 21,44,65 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine, low, n=15, 21, 44, 65 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Creatinine, high, n=15, 21, 44, 65 | 13 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Protein/Creatinine, high, n=12, 19, 38, 58 | 18 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Urea, low, n=15, 21, 44, 65 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Urea, high, n=15, 21, 44, 65 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3 | Protein/Creatinine, low, n=12, 19, 38, 58 | 0 Participants |
Secondary
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: \<85, 85-115, \>115; for Cohort 2: \<85, 85-120,\>120; and Cohort 3: \<95, 95-135, \>135. RR for DBP (mmHg) for Cohort 1: \<45, 45-70,\>70; for Cohort 2: \<50, 50-75, \>75; and Cohort 3: \<55, 55-85, \>85.
Time frame: From Baseline through Study Week 35
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, DBP, high, n=9, 0, 0, 32 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, DBP, low, n=15, 20, 41, 40 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, DBP, high, n=14, 18, 38, 59 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, DBP, low, n=14, 18, 38, 59 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, DBP, high, n=14, 19, 42, 63 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, DBP, low, n=14, 19, 42, 63 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, DBP, high, n=15, 20, 42, 61 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, DBP, low, n=15, 20, 42, 61 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, DBP, high,n=15, 21, 41, 60 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, DBP, low,n=15, 21, 41, 60 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, DBP,high, n=15, 21, 42, 62 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, DBP,low, n=15, 21, 42, 62 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, DBP, high, n=15, 19, 40, 59 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, DBP, low, n=15, 19, 40, 59 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, DBP, high, n=14, 21, 42, 58 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, DBP, low, n=14, 21, 42, 58 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, DBP, high, n=15, 21, 42, 58 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, DBP, low, n=15, 21, 42, 58 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, DBP,high,n=15, 0, 0, 49 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, DBP,low,n=15, 0, 0, 49 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, DBP, high, n=15, 0, 0, 45 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, DBP, low, n=15, 0, 0, 45 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, DBP, high, n=15, 0, 0, 40 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, DBP, low, n=15, 0, 0, 40 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, DBP, high, n=13, 0, 0, 41 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, DBP, low, n=13, 0, 0, 41 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, DBP, high, n=13, 0, 0, 42 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, DBP, low, n=13, 0, 0, 42 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, DBP, high, n=12, 0, 0, 32 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, DBP, low, n=12, 0, 0, 32 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, DBP, high, n=15 ,20 ,41 ,40 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, DBP, low, n=9, 0, 0, 32 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, DBP, high, n=11, 0, 0, 31 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, DBP, low, n=11, 0, 0, 31 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, DBP,high,n=12, 0, 0, 39 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, DBP,low,n=12, 0, 0, 39 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, DBP,high,n=5, 0, 0, 29 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, DBP,low,n=5, 0, 0, 29 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, DBP,high,n=9, 0, 0, 32 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, DBP,low,n=9, 0, 0, 32 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, DBP,high,n=5, 0, 0, 34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, DBP,low,n=5, 0, 0, 34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, DBP,high,n=13, 0, 0, 33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, DBP,low,n=13, 0, 0, 33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, DBP,high,n=10, 0, 0, 17 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, DBP,low,n=10, 0, 0, 17 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, DBP,high,n=11, 0, 0, 23 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, DBP,low,n=11, 0, 0, 23 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, DBP,high,n=11, 0, 0, 21 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, DBP,low,n=11, 0, 0, 21 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24 DBP,high,n=15, 0, 0, 58 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, DBP,low,n=15, 0, 0, 58 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, DBP,high,n=5, 0, 0, 13 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, DBP,low,n=5, 0, 0, 13 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, DBP,high,n=5, 0, 0, 21 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, DBP,low,n=5, 0, 0, 21 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, DBP,high,n=5, 0, 0, 14 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, DBP,low,n=5, 0, 0, 14 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, DBP,high,n=3, 0, 0, 31 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, DBP,low,n=3, 0, 0, 31 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, SBP, high, n=15, 20, 41, 40 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, SBP, low, n=15, 20, 41, 40 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, SBP,high,n=14, 18, 38, 59 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, SBP,low,n=14, 18, 38, 59 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, SBP,high,n=14, 19, 42, 63 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, SBP,low,n=14, 19, 42, 63 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, SBP,high,n=15, 20, 43, 62 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, SBP,low,n=15, 20, 43, 62 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, SBP,high,n=15, 21, 41, 60 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, SBP,low,n=15, 21, 41, 60 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, SBP,high,n=15, 21, 42, 62 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, SBP,low,n=15, 21, 42, 62 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, SBP,high,n=15, 19, 40, 59 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, SBP, low, n=15, 19, 40, 59 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, SBP,high,n=14, 21, 42, 58 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, SBP,low,n=14, 21, 42, 58 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, SBP,high,n=15, 21, 42, 58 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, SBP,low,n=15, 21, 42, 58 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, SBP,high,n=15, 0, 0, 49 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, SBP,low,n=15, 0, 0, 49 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, SBP,high,n=15, 0, 0, 45 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, SBP,low,n=15, 0, 0, 45 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, SBP,high,n=15, 0, 0, 40 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, SBP,low,n=15, 0, 0, 40 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, SBP,high,n=13, 0, 0, 41 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, SBP,low,n=13, 0, 0, 41 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, SBP,high,n=13, 0, 0, 42 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, SBP,low,n=13, 0, 0, 42 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, SBP,high,n=12, 0, 0, 32 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, SBP,low,n=12, 0, 0, 32 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, SBP,high,n=9, 0, 0, 32 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, SBP,low,n=9, 0, 0, 32 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, SBP,high,n=11, 0, 0, 31 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, SBP,low,n=11, 0, 0, 31 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16 SBP,high,n=12, 0, 0, 39 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, SBP,low,n=12, 0, 0, 39 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, SBP,high,n=5, 0, 0, 29 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, SBP,low,n=5, 0, 0, 29 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, SBP,high,n=9, 0, 0, 32 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, SBP,low,n=9, 0, 0, 32 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, SBP,high,n=5, 0, 0, 34 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, SBP,low,n=5, 0, 0, 34 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, SBP,high,n=13, 0, 0, 33 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, SBP,low,n=13, 0, 0, 33 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, SBP,high,n=10, 0, 0, 17 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, SBP,low,n=10, 0, 0, 17 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, SBP,high,n=11, 0, 0, 23 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, SBP,low,n=11, 0, 0, 23 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, SBP,high,n=11, 0, 0, 21 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, SBP,low,n=11, 0, 0, 21 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, SBP,high,n=15, 0, 0, 58 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, SBP, low, n=15, 0, 0, 58 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, SBP, high,n=5, 0, 0, 13 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, SBP, low,n=5, 0, 0, 13 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, SBP, high,n=5, 0, 0, 21 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, SBP, low,n=5, 0, 0, 21 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, SBP, high,n=5, 0, 0, 14 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, SBP, low,n=5, 0, 0, 14 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, SBP, high,n=3, 0, 0, 31 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, SBP,low,n=3, 0, 0, 31 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, SBP, high,n=5, 0, 0, 14 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, SBP, high, n=15, 20, 41, 40 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, DBP,low,n=15, 0, 0, 49 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, SBP, high,n=5, 0, 0, 13 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, SBP,low,n=10, 0, 0, 17 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, SBP, low, n=15, 20, 41, 40 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, DBP,high,n=5, 0, 0, 34 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, SBP,high,n=12, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, DBP, low, n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, SBP,high,n=14, 18, 38, 59 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, DBP,high,n=15, 0, 0, 49 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, SBP,low,n=13, 0, 0, 42 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, SBP,high,n=13, 0, 0, 42 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, SBP,low,n=14, 18, 38, 59 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, SBP,high,n=5, 0, 0, 34 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, SBP,low,n=13, 0, 0, 41 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, DBP,low,n=5, 0, 0, 34 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, SBP,high,n=14, 19, 42, 63 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, DBP, low, n=13, 0, 0, 42 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, SBP, low, n=15, 0, 0, 58 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, SBP,high,n=11, 0, 0, 23 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, SBP,low,n=14, 19, 42, 63 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, DBP, low, n=15, 21, 42, 58 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, SBP,high,n=13, 0, 0, 41 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, DBP, high, n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, SBP,high,n=15, 20, 43, 62 | 7 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, DBP,high,n=13, 0, 0, 33 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, SBP,low,n=15, 0, 0, 40 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, SBP,high,n=15, 0, 0, 40 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, SBP,low,n=15, 20, 43, 62 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, DBP,high,n=12, 0, 0, 39 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, SBP,low,n=15, 0, 0, 45 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, SBP,high,n=15, 0, 0, 58 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, SBP,high,n=15, 21, 41, 60 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16 SBP,high,n=12, 0, 0, 39 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, SBP,high,n=15, 0, 0, 45 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, SBP,low,n=11, 0, 0, 23 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, SBP,low,n=15, 21, 41, 60 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, DBP, high, n=15, 21, 42, 58 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, SBP,low,n=15, 0, 0, 49 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, DBP,low,n=13, 0, 0, 33 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, SBP,high,n=15, 21, 42, 62 | 6 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, DBP, high, n=12, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, SBP,high,n=15, 0, 0, 49 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, SBP,low,n=15, 21, 42, 58 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, SBP,low,n=15, 21, 42, 62 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, DBP, low, n=14, 21, 42, 58 | 0 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, SBP,low,n=11, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, SBP,low,n=3, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, SBP,high,n=15, 19, 40, 59 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, SBP, low,n=5, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, SBP,high,n=15, 21, 42, 58 | 5 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, SBP,high,n=11, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, SBP, low, n=15, 19, 40, 59 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, DBP,high,n=10, 0, 0, 17 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, SBP, low,n=5, 0, 0, 14 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, DBP, high, n=13, 0, 0, 42 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, SBP,high,n=14, 21, 42, 58 | 8 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, DBP, high, n=14, 21, 42, 58 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, SBP,low,n=14, 21, 42, 58 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, SBP,low,n=5, 0, 0, 34 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, DBP,low,n=10, 0, 0, 17 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, DBP, low, n=13, 0, 0, 41 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, DBP, low, n=15, 19, 40, 59 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, DBP,low,n=12, 0, 0, 39 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, DBP,high,n=11, 0, 0, 23 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, DBP, low, n=12, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, SBP,low,n=11, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, DBP, high, n=15, 19, 40, 59 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, DBP,low,n=11, 0, 0, 23 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, SBP,high,n=5, 0, 0, 29 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, SBP, low,n=5, 0, 0, 13 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, DBP, high, n=13, 0, 0, 41 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, DBP,high,n=11, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, DBP,high,n=5, 0, 0, 29 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, DBP,low, n=15, 21, 42, 62 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, SBP,high,n=13, 0, 0, 33 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, DBP,low,n=11, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, DBP, high, n=11, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, DBP,high, n=15, 21, 42, 62 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, DBP, low, n=15, 0, 0, 40 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24 DBP,high,n=15, 0, 0, 58 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, SBP,low,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, DBP, low,n=15, 21, 41, 60 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, SBP,high,n=11, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, DBP,low,n=15, 0, 0, 58 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, DBP,low,n=5, 0, 0, 29 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, DBP, high,n=15, 21, 41, 60 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, SBP, high,n=3, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, DBP,high,n=5, 0, 0, 13 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, SBP,low,n=5, 0, 0, 29 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, DBP, low, n=15, 20, 42, 61 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, SBP,low,n=13, 0, 0, 33 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, DBP,low,n=5, 0, 0, 13 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, DBP, high, n=15, 0, 0, 40 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, DBP, high, n=15, 20, 42, 61 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, SBP, high,n=5, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, DBP,high,n=5, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, DBP,high,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, DBP, low, n=14, 19, 42, 63 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, SBP,low,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, DBP,low,n=5, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, SBP,high,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, DBP, high, n=14, 19, 42, 63 | 3 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, DBP, low, n=14, 18, 38, 59 | 1 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, DBP,high,n=5, 0, 0, 14 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, DBP, low, n=15, 0, 0, 45 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, DBP, high, n=14, 18, 38, 59 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, SBP,high,n=10, 0, 0, 17 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, DBP,low,n=5, 0, 0, 14 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, SBP,low,n=12, 0, 0, 39 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, DBP, low, n=15, 20, 41, 40 | 2 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, DBP,low,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, DBP,high,n=3, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, DBP, low, n=11, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, SBP,high,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, DBP, high, n=15 ,20 ,41 ,40 | 4 Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, DBP,low,n=3, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, DBP, high, n=15, 0, 0, 45 | NA Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, SBP,low,n=12, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, DBP,high,n=5, 0, 0, 13 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, DBP, high, n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, DBP, low, n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, SBP, high,n=5, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, DBP, high, n=11, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, DBP, low, n=11, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, SBP,high,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, DBP,high,n=12, 0, 0, 39 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, DBP,low,n=12, 0, 0, 39 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, DBP,high,n=5, 0, 0, 29 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, DBP,low,n=5, 0, 0, 29 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, SBP,low,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, DBP,high,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, DBP,low,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, DBP,high,n=5, 0, 0, 34 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, DBP,low,n=5, 0, 0, 34 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, SBP,high,n=5, 0, 0, 34 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, DBP,high,n=13, 0, 0, 33 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, DBP,low,n=13, 0, 0, 33 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, DBP,high,n=10, 0, 0, 17 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, DBP,low,n=10, 0, 0, 17 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, SBP,low,n=5, 0, 0, 34 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, DBP,high,n=11, 0, 0, 23 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, DBP,low,n=11, 0, 0, 23 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, SBP, low,n=5, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, DBP,high,n=11, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, DBP,low,n=11, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, SBP,high,n=13, 0, 0, 33 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24 DBP,high,n=15, 0, 0, 58 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, DBP,low,n=15, 0, 0, 58 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, SBP,low,n=5, 0, 0, 29 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, DBP,low,n=5, 0, 0, 13 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, SBP,low,n=13, 0, 0, 33 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, DBP,high,n=5, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, DBP,low,n=5, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, DBP,high,n=5, 0, 0, 14 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, DBP,low,n=5, 0, 0, 14 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, SBP,high,n=10, 0, 0, 17 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, DBP,high,n=3, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, DBP,low,n=3, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, SBP, high, n=15, 20, 41, 40 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, SBP, low, n=15, 20, 41, 40 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, SBP,low,n=10, 0, 0, 17 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, SBP,high,n=14, 18, 38, 59 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, SBP,low,n=14, 18, 38, 59 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, SBP, high,n=5, 0, 0, 14 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, SBP,high,n=14, 19, 42, 63 | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, SBP,low,n=14, 19, 42, 63 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, SBP,high,n=11, 0, 0, 23 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, SBP,high,n=15, 20, 43, 62 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, SBP,low,n=15, 20, 43, 62 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, SBP,high,n=15, 21, 41, 60 | 12 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, SBP,low,n=15, 21, 41, 60 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, SBP,low,n=11, 0, 0, 23 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, SBP,high,n=15, 21, 42, 62 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, SBP,low,n=15, 21, 42, 62 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, SBP,high,n=15, 19, 40, 59 | 13 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, SBP, low, n=15, 19, 40, 59 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, SBP,high,n=11, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, SBP,high,n=14, 21, 42, 58 | 11 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, SBP,low,n=14, 21, 42, 58 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, SBP,high,n=15, 21, 42, 58 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, SBP,low,n=15, 21, 42, 58 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, SBP,low,n=11, 0, 0, 21 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, SBP,high,n=15, 0, 0, 49 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, SBP,low,n=15, 0, 0, 49 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, SBP, low,n=5, 0, 0, 14 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, SBP,high,n=15, 0, 0, 45 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, SBP,low,n=15, 0, 0, 45 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, SBP,high,n=15, 0, 0, 58 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, SBP,high,n=15, 0, 0, 40 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, SBP,low,n=15, 0, 0, 40 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, SBP,high,n=13, 0, 0, 41 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, SBP,low,n=13, 0, 0, 41 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, SBP, low, n=15, 0, 0, 58 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, SBP,high,n=13, 0, 0, 42 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, SBP,low,n=13, 0, 0, 42 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, SBP,low,n=3, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, SBP,high,n=12, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, SBP,low,n=12, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, SBP, high,n=5, 0, 0, 13 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, DBP, high, n=15 ,20 ,41 ,40 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, DBP, low, n=15, 20, 41, 40 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, SBP,high,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, DBP, high, n=14, 18, 38, 59 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, DBP, low, n=14, 18, 38, 59 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, DBP, high, n=14, 19, 42, 63 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, DBP, low, n=14, 19, 42, 63 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, SBP,low,n=9, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, DBP, high, n=15, 20, 42, 61 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, DBP, low, n=15, 20, 42, 61 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, DBP, high,n=15, 21, 41, 60 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, DBP, low,n=15, 21, 41, 60 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, SBP,high,n=11, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, DBP,high, n=15, 21, 42, 62 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, DBP,low, n=15, 21, 42, 62 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, DBP, high, n=15, 19, 40, 59 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, DBP, low, n=15, 19, 40, 59 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, SBP,low,n=11, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, DBP, high, n=14, 21, 42, 58 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, DBP, low, n=14, 21, 42, 58 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, SBP, low,n=5, 0, 0, 13 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, DBP, high, n=15, 21, 42, 58 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, DBP, low, n=15, 21, 42, 58 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16 SBP,high,n=12, 0, 0, 39 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, DBP,high,n=15, 0, 0, 49 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, DBP,low,n=15, 0, 0, 49 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, DBP, high, n=15, 0, 0, 45 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, DBP, low, n=15, 0, 0, 45 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, SBP,low,n=12, 0, 0, 39 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, DBP, high, n=15, 0, 0, 40 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, DBP, low, n=15, 0, 0, 40 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, SBP, high,n=3, 0, 0, 31 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, DBP, high, n=13, 0, 0, 41 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, DBP, low, n=13, 0, 0, 41 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, SBP,high,n=5, 0, 0, 29 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, DBP, high, n=13, 0, 0, 42 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, DBP, low, n=13, 0, 0, 42 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, DBP, high, n=12, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, DBP, low, n=12, 0, 0, 32 | NA Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, SBP, low,n=5, 0, 0, 13 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, SBP,high,n=10, 0, 0, 17 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, DBP,low,n=9, 0, 0, 32 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, DBP, high, n=15 ,20 ,41 ,40 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, DBP,high,n=3, 0, 0, 31 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, DBP,low,n=5, 0, 0, 14 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, DBP, high, n=13, 0, 0, 42 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, DBP, low, n=15, 20, 41, 40 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, DBP, high, n=15, 0, 0, 45 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, DBP,high,n=5, 0, 0, 14 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, SBP,low,n=9, 0, 0, 32 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, DBP, high, n=14, 18, 38, 59 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, SBP,high,n=9, 0, 0, 32 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, SBP,low,n=3, 0, 0, 31 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, DBP,high,n=9, 0, 0, 32 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, DBP, low, n=14, 18, 38, 59 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, SBP, high,n=5, 0, 0, 13 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, DBP,low,n=5, 0, 0, 21 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, SBP,high,n=5, 0, 0, 29 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, DBP, high, n=14, 19, 42, 63 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, SBP,low,n=13, 0, 0, 33 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, DBP,high,n=5, 0, 0, 21 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, DBP, low, n=15, 0, 0, 45 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, DBP, low, n=14, 19, 42, 63 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, DBP, low, n=11, 0, 0, 31 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, DBP,low,n=5, 0, 0, 13 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, DBP,low,n=5, 0, 0, 29 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, DBP, high, n=15, 20, 42, 61 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, SBP,low,n=9, 0, 0, 32 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 1, DBP,high,n=5, 0, 0, 13 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, DBP, high, n=9, 0, 0, 32 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, DBP, low, n=15, 20, 42, 61 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, SBP, low,n=5, 0, 0, 21 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, DBP,low,n=15, 0, 0, 58 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, DBP, high, n=15, 0, 0, 40 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, DBP, high,n=15, 21, 41, 60 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, SBP,high,n=13, 0, 0, 33 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24 DBP,high,n=15, 0, 0, 58 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, SBP,low,n=12, 0, 0, 39 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, DBP, low,n=15, 21, 41, 60 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, DBP,high,n=5, 0, 0, 29 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, DBP,low,n=11, 0, 0, 21 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, DBP, low, n=13, 0, 0, 42 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, DBP,high, n=15, 21, 42, 62 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, SBP,high,n=11, 0, 0, 31 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, DBP,high,n=11, 0, 0, 21 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, DBP, low, n=15, 0, 0, 40 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, DBP,low, n=15, 21, 42, 62 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, DBP,low,n=11, 0, 0, 23 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, SBP,low,n=5, 0, 0, 34 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, DBP, high, n=11, 0, 0, 31 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, DBP, high, n=15, 19, 40, 59 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, DBP,high,n=11, 0, 0, 23 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, DBP,low,n=10, 0, 0, 17 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 2, SBP, high,n=5, 0, 0, 21 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, DBP, low, n=15, 19, 40, 59 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 14, DBP, low, n=9, 0, 0, 32 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, DBP,high,n=10, 0, 0, 17 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, DBP, high, n=13, 0, 0, 41 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, DBP, high, n=14, 21, 42, 58 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, SBP,high,n=11, 0, 0, 21 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, SBP,high,n=14, 21, 42, 58 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 15, SBP,low,n=11, 0, 0, 31 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, SBP,low,n=14, 21, 42, 58 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, SBP, low, n=15, 19, 40, 59 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 5, SBP,high,n=15, 19, 40, 59 | 17 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, DBP,low,n=13, 0, 0, 33 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, SBP,high,n=15, 21, 42, 58 | 13 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, SBP,low,n=15, 21, 42, 62 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, SBP,low,n=11, 0, 0, 23 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, DBP,low,n=12, 0, 0, 39 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, SBP,low,n=15, 21, 42, 58 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 6, DBP, low, n=14, 21, 42, 58 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 4, SBP,high,n=15, 21, 42, 62 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 18, SBP,high,n=9, 0, 0, 32 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, SBP,high,n=15, 0, 0, 49 | 16 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 23, SBP,low,n=11, 0, 0, 21 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, SBP,low,n=15, 21, 41, 60 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, SBP,high,n=5, 0, 0, 34 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, SBP,low,n=15, 0, 0, 49 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, DBP, low, n=12, 0, 0, 32 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 3, SBP,high,n=15, 21, 41, 60 | 17 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, DBP, high, n=15, 21, 42, 58 | 7 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, SBP,high,n=15, 0, 0, 45 | 15 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, SBP, high,n=5, 0, 0, 14 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, SBP,low,n=15, 20, 43, 62 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 20, DBP,high,n=13, 0, 0, 33 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 9, SBP,low,n=15, 0, 0, 45 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, DBP,low,n=5, 0, 0, 34 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 22, SBP,high,n=11, 0, 0, 23 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, DBP, low, n=13, 0, 0, 41 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, SBP,high,n=15, 0, 0, 40 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, SBP,high,n=15, 0, 0, 58 | 19 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 2, SBP,high,n=15, 20, 43, 62 | 15 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 7, DBP, low, n=15, 21, 42, 58 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 10, SBP,low,n=15, 0, 0, 40 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 3, SBP, low,n=5, 0, 0, 14 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, SBP,low,n=14, 19, 42, 63 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, DBP, high, n=12, 0, 0, 32 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, SBP,high,n=13, 0, 0, 41 | 9 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 1, SBP,high,n=14, 19, 42, 63 | 18 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, SBP,low,n=14, 18, 38, 59 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 19, DBP,high,n=5, 0, 0, 34 | 1 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 11, SBP,low,n=13, 0, 0, 41 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16, DBP,high,n=12, 0, 0, 39 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 21, SBP,low,n=10, 0, 0, 17 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, DBP,high,n=15, 0, 0, 49 | 4 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, SBP,high,n=13, 0, 0, 42 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 24, SBP, low, n=15, 0, 0, 58 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Day 1, SBP,high,n=14, 18, 38, 59 | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 16 SBP,high,n=12, 0, 0, 39 | 14 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 12, SBP,low,n=13, 0, 0, 42 | 3 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, SBP, high,n=3, 0, 0, 31 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, SBP, low, n=15, 20, 41, 40 | 2 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 17, SBP,low,n=5, 0, 0, 29 | 0 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, SBP,high,n=12, 0, 0, 32 | 8 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Screening, SBP, high, n=15, 20, 41, 40 | 10 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | FU Week 4, DBP,low,n=3, 0, 0, 31 | 5 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 8, DBP,low,n=15, 0, 0, 49 | 6 Participants |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3 | Week 13, SBP,low,n=12, 0, 0, 32 | 3 Participants |
Secondary
Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.
The percentage of participants achieving platelet counts \>=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported.
Time frame: From Day 1 of treatment up to Week 24 of Part 1
Population: ITT Population only those participants enrolled during Part 1 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1. | 80 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1. | 80 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1. | 60 Percentage of Participants |
Secondary
Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3.
The percentage of participants achieving platelet counts \>=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment during Part 2/3 of the study were reported. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
Time frame: Part 2/3 up to Study Week 31
Population: ITT Population. Only evaluable participants were included for this analysis, where participants with a baseline platelet count \>10 Gi/L was considered as evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3. | 75.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3. | 82.1 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3. | 86.7 Percentage of Participants |
Secondary
Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)
Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count \>=50 Gi/L during treatment with eltrombopag in \>= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here.
Time frame: Between Day 15 and Day 43 of Part 2
Population: Intent-to-Treat (ITT) Population, only those participants enrolled in Part 2 of this study were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2) | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2) | 35.6 Percentage of Participants |
Secondary
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.
The participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 1 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 1 Day 1 to the last dose of study medication + 1 day.
Time frame: From Baseline up to Week 24+ 1 day of Part 1
Population: ITT Population, only those participants enrolled during Part 1 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Taking an ITP medication at BL | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Attempted red or dis | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Permanent red or dis of all BL ITP mediation | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Permanent red or dis at least 1 BL ITP medcation | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Permanent red or dis at least 1 BL ITP medcation | 100.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Taking an ITP medication at BL | 20.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Permanent red or dis of all BL ITP mediation | 100.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Attempted red or dis | 100.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Permanent red or dis at least 1 BL ITP medcation | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Attempted red or dis | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Permanent red or dis of all BL ITP mediation | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1. | Taking an ITP medication at BL | 0 Percentage of Participants |
Secondary
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3
Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day.
Time frame: From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3
Population: ITT Population, only those participants enrolled during Part 2/3 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Perm dis at least 1 BL ITP med | 33.3 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Permanent (perm) dis of all BL ITP medication(med) | 16.7 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Taking an ITP medication at BL | 25.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Attempted red or dis | 66.7 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Perm dis all BL ITP med taken prior to Part 2/3 | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Permanent (perm) dis of all BL ITP medication(med) | 20.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Taking an ITP medication at BL | 17.9 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Attempted red or dis | 20.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Perm dis at least 1 BL ITP med | 20.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Perm dis all BL ITP med taken prior to Part 2/3 | 40.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Perm dis all BL ITP med taken prior to Part 2/3 | 0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Perm dis at least 1 BL ITP med | 50.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Taking an ITP medication at BL | 13.3 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Permanent (perm) dis of all BL ITP medication(med) | 50.0 Percentage of Participants |
| Part 2 (Randomized Period) Cohort 2-Placebo | Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3 | Attempted red or dis | 100.0 Percentage of Participants |
Secondary
Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3.
The area under the concentration-time curve over the dosing interval (AUC0-t) data was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. From the final model, a single value of AUC(0-t) was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
Time frame: From Day 1 of treatment up to Study Week 31
Population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3. | 101 Microgram*hour per milliliter (ug*h/mL) |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3. | 132 Microgram*hour per milliliter (ug*h/mL) |
| Part 2 (Randomized Period) Cohort 2-Placebo | Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3. | 142 Microgram*hour per milliliter (ug*h/mL) |
Secondary
Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3
The apparent plasma clearance following oral dosing of eltrombopag (CL/F) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of CL/F was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
Time frame: From Day 1 of treatment up to Study Week 31
Population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3 | 0.50 liter per hour (L/hr) |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3 | 0.38 liter per hour (L/hr) |
| Part 2 (Randomized Period) Cohort 2-Placebo | Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3 | 0.25 liter per hour (L/hr) |
Secondary
Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.
The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
Time frame: From Day 1 of treatment up to Study Week 31
Population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3. | Cmax | 6.65 micrograms per milliliter (ug/mL) |
| Part 2 (Randomized Period) Cohort 1-Placebo | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3. | Ct | 2.42 micrograms per milliliter (ug/mL) |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3. | Cmax | 9.19 micrograms per milliliter (ug/mL) |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3. | Ct | 2.95 micrograms per milliliter (ug/mL) |
| Part 2 (Randomized Period) Cohort 2-Placebo | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3. | Cmax | 10.7 micrograms per milliliter (ug/mL) |
| Part 2 (Randomized Period) Cohort 2-Placebo | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3. | Ct | 2.91 micrograms per milliliter (ug/mL) |
Secondary
Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3
The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
Time frame: From Day 1 of treatment up to Study Week 31
Population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3 | 4.0 hour (hr) |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3 | 4.0 hour (hr) |
| Part 2 (Randomized Period) Cohort 2-Placebo | Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3 | 2.0 hour (hr) |
Secondary
Weighted Mean Platelet Count
The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment.
Time frame: Baseline and Day 43 of Part 2
Population: ITT Population. Only participants during Part 2 with a value at baseline and post-baseline were considered for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | Weighted Mean Platelet Count | Baseline | 12.2 Gi/L | Standard Deviation 8.59 |
| Part 2 (Randomized Period) Cohort 1-Placebo | Weighted Mean Platelet Count | Day 43 | 30.5 Gi/L | Standard Deviation 24.98 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Weighted Mean Platelet Count | Baseline | 15.5 Gi/L | Standard Deviation 8.03 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | Weighted Mean Platelet Count | Day 43 | 68 Gi/L | Standard Deviation 56.78 |