Hepatitis C, Chronic
Conditions
Keywords
Thrombocytopenia, Hepatitis C, chronic
Brief summary
The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count \<80,000 /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate to a higher rate of sustained viral response.
Interventions
DRUGSB-497115-GR
TPO receptor agonist to increase platelet count
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned, as well as provided a written consent. * A subject age between ≥20 and \<75 years at time of informed consent. * A subject who applies to one of the following: Female subject with non-childbearing potential \[i.e., physiologically incapable of becoming pregnant, who: has had a hysterectomy, or had a bilateral oophorectomy (ovariectomy), or had a bilateral tubal ligation, or is post-menopausal for greater than one year\]. Female subject with childbearing potential, has a negative urine or serum pregnancy test at screening and within the 24-hour period prior to the first dose of SB-497115-GR, and completely abstains from intercourse or agree to use two of the following acceptable methods of contraception for 14 days before exposure to SB-497115-GR, throughout the clinical trial, and for 24 weeks after completion or premature discontinuation from the study. Intrauterine device or intrauterine system that meets the effectiveness criteria as stated in the product label. Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. Double-barrier contraception (condom with spermicidal jelly, or diaphragm with spermicide). Male subject with childbearing potential partner completely abstains from intercourse or agree to use condom and diaphragm with spermicide. * Subjects who were diagnosed as hepatitis C or compensated liver cirrhosis (Child-Pugh class A) without hepatic encephalopathy, or ascites. If there is a clear cirrhosis, treatment should be given with care as there is a potential of progressing to liver failure. * Subjects who, in the opinion of the investigator, are appropriate candidates for Peg-IFN and RBV combination therapy for 48 weeks. * HCV positive by TaqMan test at screening. * Subject who fulfil all the organ functions below. Items Values Platelet \<80,000 /μL Haemoglobin ≥12.0 g/dL\* Absolute neutrophil count (ANC) ≥1500 /μL\* Creatinine clearance \>50 mL/minute Total bilirubin \<2.0 mg/dL Albumin \>3.0 g/dL Prothrombin time \>60% \*If the investigators consider the values are sufficient to give Peg-IFN/RBV, then a subject can be enrolled upon consulting the Medical Monitor.
Exclusion criteria
* Subject who relapsed or did not respond after 48 weeks of Peg-IFN/RBV therapy had been given with sufficient dose previously. * Subject with history of IFN (including Peg-IFN) therapy or Peg-IFN/RBV therapy, but could not been treated with optimal Peg-IFN/RBV therapy due to the reasons other than thrombocytopenia. * Subject who received IFN therapy (including Peg-IFN), antiviral therapy (excluding oseltamivir phosphate, etc.), immuno-modulatory treatment, radiotherapy or phlebotomy within 3 months (90 days) prior to the first dose of SB-497115-GR. * Treatment with an investigational drug within 30 days prior to the first dose of SB-497115-GR or 5 half-lives of that investigational drug (whichever is longer). * Subject with decompensated liver disease. * Chronic liver disease other than chronic hepatitis C (e.g., autoimmune hepatitis, alcohol-induced hepatitis, drug-induced hepatitis, etc.). * Subject with idiopathic thrombocytopenic purpura or active autoimmune disease. * Subject who have had a malignancy diagnosed and/or treated within the past 5 years. * Subjects who require endoscopic treatment for varices or documented history of clinically significant bleeding from oesophageal or gastric varices. * Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin. * Subject with serious cardiac, cerebrovascular, chronic pulmonary disease or interstitial lung disease, or documented history of any of these diseases. * Pre-existing cardiac disease (congestive heart failure in New York Heart Association Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTcF \>450 msec or if with bundle brunch block, QTcF \>480 msec. * Subject with depression, psychiatric disorder requiring treatment or suicidal ideation or suicide attempt history, or history of these. * Subject with uncontrolled hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic). * Subject with diabetes mellitus that can not be controlled by treatment. * Thyroid dysfunction not adequately controlled. * Subjects with haemoglobinopathies. * History or current condition of seizure disorder. * Subject who was positive for Human Immunodeficiency Virus (HIV) antibody or Hepatitis B Virus (HBV) antigen. * Subject with arterial or venous thrombosis history or evidence of portal vein thrombosis on abdominal imaging (e.g., by computerized tomography or magnetic resonance imaging) within 3 months. * History of alcohol/drug abuse or dependence. * History of platelet clumping that prevents reliable measurement of platelet counts. * Subjects planning to have cataract surgery. * History of major organ transplantation. * Known hypersensitivity to SB-497115-GR ingredients, IFN (including Peg-IFN), nucleoside analogues or biological agents (i.e., vaccines). * Pregnant or nursing women or a male subject with pregnant partner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1 | From Baseline up to Week 9 in Part 1 | Participants were assessed for a shift from a baseline platelet count of \<80 Gi/L to a count \>=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw. |
| Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2 | From Antiviral Baseline to up to Week 48 in Part 2 | Participants were assessed for continuously maintaining platelet counts \>=50 Gi/L during Part 2. Platelet counts were measured by blood draw. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Platelet Count at the Indicated Time Points in Part 2 | Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 | Platelet counts were measured by blood draw |
| Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2 | Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2 | Platelet counts were measured by blood draw at specified timepoints. |
| Minimum Platelet Count on Antiviral Therapy | From Antiviral Baseline to up to Week 48 in Part 2 | Participants were assessed for platelet counts during antiviral therapy in Part 2. Platelet counts were measured by blood draw. |
| Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | From Baseline up to Week 9 in Part 1 | Participants received eltrombopag at escalating dosages until a platelet count of \>=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw. |
| Number of Antiviral Therapy Dose Reductions in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV. |
| Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN. |
| Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN. |
| Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV |
| Time to First Dose Reduction of Antiviral Therapy in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction. |
| Number of Participants Who Discontinued Antiviral Therapy in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2 |
| Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2 |
| Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2 |
| Number of Participants Achieving Adherence to Antiviral Therapy in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration |
| Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration. |
| Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration. |
| Number of Participants With Sustained Virologic Response (SVR) in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2 |
| Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment. |
| Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment. |
| Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment. |
| Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2 | The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal. |
| Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, FU Week 12 and FU Week 24 after Part 2 | The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2 |
| Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | From Baseline up to week 9 in Part 1 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. |
| Number of Participants With Any AE and Any SAE in Part 2 | From Antiviral Baseline up to Week 48 in Part 2 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. |
| Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | From FU Baseline up to FU Week 24 after Part 2 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24 | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline |
| Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. |
| Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 | The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. |
| Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 | The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline. |
| Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 | The heart rate was measured in participants at the indicated time points. |
| Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. |
| Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. |
| Mean Weight at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 | The weight of participants was recorded at the indicated time points. |
| Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 | The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. |
| Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 | The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline |
| Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 | The Body temperature of participants was recorded at the indicated time points.. |
| Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24 | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline |
| Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2 | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline |
| Mean BMI at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2 | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. |
| Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | From Baseline up to Week 9 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. |
| Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | From Antiviral Baseline up to Week 48 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. |
| Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | From FU Week 4 to FU Week 24 | Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. |
| Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | From Baseline up to Week 9 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. |
| Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | From Antiviral Baseline up to Week 48 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. |
| Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | From FU Week 4 to FU Week 24 | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. |
| Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24 | Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. |
| Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal | Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. |
| Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline and FU Week 24 | Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001. |
| Median Platelet Count at the Indicated Time Points in Part 1 | Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 | Platelet counts were measured by blood draw |
| Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | FU Baseline and FU Week 24 | The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. |
| Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Baseline; Week 24, Week 48, Withdrawal/Completion | Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF). |
| Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24 | Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF). |
| Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Baseline; Week 24, Week 48, Withdrawal/Completion | Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth). |
| Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24 | Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth). |
| Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal | The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. |
| Time in Weeks to Achieve Platelet Count >= 100 Gi/L | From Baseline up to Week 9 in Part 1 | Participants were assessed for achieving platelet counts \>=100 Gi/L during Part 1. Platelet counts were measured by blood draw. |
Countries
Japan
Participant flow
Recruitment details
Participants with chronic hepatitis C (CHC) or compensated liver cirrhosis, who cannot start polyethylene glycol (Peg)-interferon (IFN)/ribavirin (RBV) therapy due to thrombocytopenia (platelet count \<80 giga (10\^9) cells per liter (Gi/L).
Pre-assignment details
The total study duration was a maximum of 88 weeks, which consisted of a Screening Period of less than or equal to 45 days, the Pre-Antiviral Treatment Period (Part 1) from 1 up to 9 weeks and the Antiviral Treatment Period (Part 2) of 48 weeks and Follow-up Period of 24 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Eltrombopag Dose Escalation: Part 1 Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Antiviral Treatment Period (Part 2) | Adverse Event | 0 | 7 | 0 |
| Antiviral Treatment Period (Part 2) | Physician Decision | 0 | 2 | 0 |
| Antiviral Treatment Period (Part 2) | Protocol Violation | 0 | 1 | 0 |
| Follow-up Period After Part 2 | Not entered FU period after withdrawal | 0 | 0 | 1 |
| Follow-up Period After Part 2 | Other | 0 | 0 | 1 |
| Follow-up Period After Part 2 | Withdrawal by Subject | 0 | 0 | 2 |
| Pre-Antiviral Treatment Period (Part 1) | Protocol-Defined Stopping Criteria | 1 | 0 | 0 |
| Pre-Antiviral Treatment Period (Part 1) | Protocol Violation | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Eltrombopag Dose Escalation: Part 1 |
|---|---|
| Age, Continuous | 57.8 Years STANDARD_DEVIATION 9.65 |
| Baseline alanine transaminase (ALT) | 78.2 IU/L STANDARD_DEVIATION 47.82 |
| Baseline Hepatitis C Virus (HCV) RNA | 6.41 Log IU/mL STANDARD_DEVIATION 0.706 |
| Baseline platelet counts <50 Gi Platelets/L | 8 Participants |
| Baseline platelet counts >=50 Gi Platelets/L | 37 Participants |
| Child-Pugh Class A (Score 5 - 6) | 44 Participants |
| Child-Pugh Class B (Score 7 - 9) | 1 Participants |
| Child-Pugh Class C (Score > 9) | 0 Participants |
| Diagnosis Chronic hepatitis C | 23 Participants |
| Diagnosis Liver cirrosis | 22 Participants |
| HCV genotype 1a | 0 Participants |
| HCV genotype 1b | 33 Participants |
| HCV genotype 2a | 6 Participants |
| HCV genotype 2b | 5 Participants |
| HCV genotype Others | 1 Participants |
| Number of Participants with or without previous IFN use Experienced | 21 Participants |
| Number of Participants with or without previous IFN use Naïve | 24 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 45 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 41 / 41 | 6 / 41 |
| serious Total, serious adverse events | 0 / 45 | 3 / 41 | 4 / 41 |
Outcome results
Primary
Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1
Participants were assessed for a shift from a baseline platelet count of \<80 Gi/L to a count \>=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.
Time frame: From Baseline up to Week 9 in Part 1
Population: Full Analysis Set 1 (FAS1) Population: all participants enrolled in Part 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1 | 43 Participants |
Primary
Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2
Participants were assessed for continuously maintaining platelet counts \>=50 Gi/L during Part 2. Platelet counts were measured by blood draw.
Time frame: From Antiviral Baseline to up to Week 48 in Part 2
Population: Full Analysis Set 2 (FAS2) Population: all participants enrolled in Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2 | 36 Participants |
95% CI: [74, 96]
Secondary
Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy
Participants received eltrombopag at escalating dosages until a platelet count of \>=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw.
Time frame: From Baseline up to Week 9 in Part 1
Population: FAS1 Population: all participants enrolled in Part 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | Eltrombopag 25 mg | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | Eltrombopag 0 mg | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | Eltrombopag 12.5 mg | 25 Participants |
| Eltrombopag Dose Escalation: Part 1 | Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | Eltrombopag 37.5 mg | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | Eltrombopag 50 mg | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy | Did not initiate antiviral therapy | 4 Participants |
Secondary
Mean BMI at the Indicated Time Points During Follow-up Period After Part 2
The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.
Time frame: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Population: SP2 Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean BMI at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 4, n=40 | 22.11 kilogram per meters squared (kg/m^2) | Standard Deviation 3.474 |
| Eltrombopag Dose Escalation: Part 1 | Mean BMI at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 12, n=40 | 22.37 kilogram per meters squared (kg/m^2) | Standard Deviation 3.531 |
| Eltrombopag Dose Escalation: Part 1 | Mean BMI at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, n=37 | 22.54 kilogram per meters squared (kg/m^2) | Standard Deviation 3.521 |
| Eltrombopag Dose Escalation: Part 1 | Mean BMI at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, n=40 | 21.89 kilogram per meters squared (kg/m^2) | Standard Deviation 3.486 |
Secondary
Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2
The Body temperature of participants was recorded at the indicated time points..
Time frame: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Population: SP2 Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 4, n=40 | 36.37 Degrees centigrade | Standard Deviation 0.36 |
| Eltrombopag Dose Escalation: Part 1 | Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, n=40 | 36.44 Degrees centigrade | Standard Deviation 0.417 |
| Eltrombopag Dose Escalation: Part 1 | Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 12, n=40 | 36.29 Degrees centigrade | Standard Deviation 0.35 |
| Eltrombopag Dose Escalation: Part 1 | Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, n=37 | 36.90 Degrees centigrade | Standard Deviation 0.377 |
Secondary
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline.
Time frame: Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Population: SP2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Antiviral Baseline, n=40 | 0.4 bpm | Standard Deviation 7.56 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 1, n=40 | -3.5 bpm | Standard Deviation 9.51 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 2, n=40 | 1.0 bpm | Standard Deviation 9.57 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 4, n=37 | 3.9 bpm | Standard Deviation 9.29 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 6, n=36 | 5.9 bpm | Standard Deviation 9.78 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 8, n=36 | 4.7 bpm | Standard Deviation 10.6 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 12, n=36 | 5.8 bpm | Standard Deviation 10.34 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 16, n=36 | 6.2 bpm | Standard Deviation 9.91 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 20, n=36 | 4.5 bpm | Standard Deviation 10.54 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 24, n=36 | 4.5 bpm | Standard Deviation 9.79 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 28, n=34 | 5.6 bpm | Standard Deviation 9.85 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 32, n=34 | 3.6 bpm | Standard Deviation 8.8 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 36, n=34 | 4.7 bpm | Standard Deviation 9.07 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 40, n=33 | 5.2 bpm | Standard Deviation 8.2 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 44, n=31 | 5.2 bpm | Standard Deviation 7.11 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Week 48, n=31 | 3.6 bpm | Standard Deviation 7.18 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2 | Withdrawal, n=10 | 5.1 bpm | Standard Deviation 11.86 |
Secondary
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time frame: Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Population: SP2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 12, n=36 | -0.70 kg/m^2 | Standard Deviation 0.723 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 16, n=36 | -0.86 kg/m^2 | Standard Deviation 0.844 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Antiviral Baseline, n=40 | 0.01 kg/m^2 | Standard Deviation 0.476 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 1, n=40 | -0.37 kg/m^2 | Standard Deviation 0.408 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 2, n=40 | -0.44 kg/m^2 | Standard Deviation 0.495 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 4, n=37 | -0.41 kg/m^2 | Standard Deviation 0.424 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 6, n=36 | -0.42 kg/m^2 | Standard Deviation 0.534 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 8, n=36 | -0.51 kg/m^2 | Standard Deviation 0.624 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 20, n=36 | -1.01 kg/m^2 | Standard Deviation 0.891 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 24, n=36 | -1.25 kg/m^2 | Standard Deviation 0.965 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 28, n=34 | -1.21 kg/m^2 | Standard Deviation 1.212 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 32, n=34 | -1.28 kg/m^2 | Standard Deviation 1.228 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 36, n=34 | -1.38 kg/m^2 | Standard Deviation 1.264 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 40, n=33 | -1.45 kg/m^2 | Standard Deviation 1.2 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 44, n=31 | -1.36 kg/m^2 | Standard Deviation 1.174 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Week 48, n=31 | -1.50 kg/m^2 | Standard Deviation 1.146 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in BMI at the Indicated Time Points in Part 2 | Withdrawal, n=10 | -1.23 kg/m^2 | Standard Deviation 1.529 |
Secondary
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time frame: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24
Population: SP1 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 1, n=38 | 0.03 kilogram per meters squared (kg/m^2) | Standard Deviation 0.302 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 2, n=30 | 0.02 kilogram per meters squared (kg/m^2) | Standard Deviation 0.457 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 3, n=11 | 0.26 kilogram per meters squared (kg/m^2) | Standard Deviation 0.415 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 4, n=6 | 0.39 kilogram per meters squared (kg/m^2) | Standard Deviation 0.325 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 5, n=3 | 0.36 kilogram per meters squared (kg/m^2) | Standard Deviation 0.504 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 6, n=3 | 0.36 kilogram per meters squared (kg/m^2) | Standard Deviation 0.248 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 7, n=3 | 0.20 kilogram per meters squared (kg/m^2) | Standard Deviation 0.417 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 8, n=2 | 0.04 kilogram per meters squared (kg/m^2) | Standard Deviation 0.704 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Week 9, n=1 | 0.08 kilogram per meters squared (kg/m^2) | — |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | Withdrawal, n=4 | 0.09 kilogram per meters squared (kg/m^2) | Standard Deviation 0.572 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | FU, Week 4, n=3 | 0.34 kilogram per meters squared (kg/m^2) | Standard Deviation 0.432 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | FU, Week 12, n=3 | 0.36 kilogram per meters squared (kg/m^2) | Standard Deviation 1.084 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc | FU, Week 24, n=3 | 0.41 kilogram per meters squared (kg/m^2) | Standard Deviation 1.042 |
Secondary
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time frame: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24
Population: SP1 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 1, n=38 | -0.04 Degrees centigrade | Standard Deviation 0.439 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 12, n=3 | -0.23 Degrees centigrade | Standard Deviation 0.493 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 24, n=3 | -0.17 Degrees centigrade | Standard Deviation 0.306 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 2, n=30 | 0.03 Degrees centigrade | Standard Deviation 0.445 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 3, n=11 | 0.06 Degrees centigrade | Standard Deviation 0.284 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 4, n=6 | 0.07 Degrees centigrade | Standard Deviation 0.367 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 5, n=3 | -0.07 Degrees centigrade | Standard Deviation 0.153 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 6, n=3 | -0.10 Degrees centigrade | Standard Deviation 0.173 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 7, n=3 | -0.40 Degrees centigrade | Standard Deviation 0.1 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 8, n=2 | -0.50 Degrees centigrade | Standard Deviation 0.141 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Week 9, n=1 | -1.10 Degrees centigrade | — |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | Withdrawal, n=4 | -0.18 Degrees centigrade | Standard Deviation 0.171 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 4, n=3 | 0.07 Degrees centigrade | Standard Deviation 0.153 |
Secondary
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time frame: Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Population: SP2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Antiviral Baseline, n=41 | 0.08 Degrees centigrade | Standard Deviation 0.662 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 1, n=40 | 0.09 Degrees centigrade | Standard Deviation 0.398 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 2, n=40 | 0.17 Degrees centigrade | Standard Deviation 0.459 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 4, n=37 | 0.16 Degrees centigrade | Standard Deviation 0.439 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 6, n=36 | 0.19 Degrees centigrade | Standard Deviation 0.499 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 8, n=36 | 0.22 Degrees centigrade | Standard Deviation 0.426 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 12, n=36 | 0.28 Degrees centigrade | Standard Deviation 0.44 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 16, n=36 | 0.22 Degrees centigrade | Standard Deviation 0.392 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 20, n=36 | 0.20 Degrees centigrade | Standard Deviation 0.386 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 24, n=36 | 0.26 Degrees centigrade | Standard Deviation 0.422 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 28, n=34 | 0.27 Degrees centigrade | Standard Deviation 0.424 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 32, n=34 | 0.21 Degrees centigrade | Standard Deviation 0.435 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 36, n=34 | 0.22 Degrees centigrade | Standard Deviation 0.462 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 40, n=33 | 0.26 Degrees centigrade | Standard Deviation 0.374 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 44, n=31 | 0.20 Degrees centigrade | Standard Deviation 0.492 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Week 48, n=31 | 0.15 Degrees centigrade | Standard Deviation 0.498 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 | Withdrawal, n=10 | 0.38 Degrees centigrade | Standard Deviation 0.724 |
Secondary
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time frame: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24
Population: SP1 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 5, n=3 | 0.3 Beats per minute (bpm) | Standard Deviation 7.37 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 6, n=3 | 2.0 Beats per minute (bpm) | Standard Deviation 5.29 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 1, n=38 | 0.1 Beats per minute (bpm) | Standard Deviation 7.07 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 2, n=30 | -0.1 Beats per minute (bpm) | Standard Deviation 7.42 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 3, n=11 | 0.1 Beats per minute (bpm) | Standard Deviation 4.5 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 4, n=6 | 2.8 Beats per minute (bpm) | Standard Deviation 4.07 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 7, n=3 | 3.0 Beats per minute (bpm) | Standard Deviation 7 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 8, n=2 | -1.0 Beats per minute (bpm) | Standard Deviation 5.66 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Week 9, n=1 | -4.0 Beats per minute (bpm) | — |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | Withdrawal, n=4 | 2.8 Beats per minute (bpm) | Standard Deviation 8.3 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 4, n=3 | 0.7 Beats per minute (bpm) | Standard Deviation 12.66 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 12, n=3 | 3.7 Beats per minute (bpm) | Standard Deviation 9.07 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 24, n=3 | 2.0 Beats per minute (bpm) | Standard Deviation 9.54 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time frame: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24
Population: SP1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 1, n=38 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 9.86 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 6, n=3 | -4.0 Millimeter of mercury (mmHg) | Standard Deviation 3 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 2, n=30 | -1.7 Millimeter of mercury (mmHg) | Standard Deviation 12.42 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 3, n=11 | 2.8 Millimeter of mercury (mmHg) | Standard Deviation 11.07 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 4, n=6 | -2.8 Millimeter of mercury (mmHg) | Standard Deviation 9.79 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 5, n=3 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 9.54 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 7, n=3 | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 5.69 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 8, n=2 | 12.0 Millimeter of mercury (mmHg) | Standard Deviation 15.56 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Week 9, n=1 | 3.0 Millimeter of mercury (mmHg) | — |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Withdrawal, n=4 | 13.5 Millimeter of mercury (mmHg) | Standard Deviation 13.96 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Follow Up, week 4, n=3 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 8.54 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Follow Up, week 12, n=3 | 9.0 Millimeter of mercury (mmHg) | Standard Deviation 8.89 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | SBP, Follow Up, week 24, n=3 | 2.7 Millimeter of mercury (mmHg) | Standard Deviation 10.07 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 1, n=38 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 8.81 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 2, n=30 | -2.1 Millimeter of mercury (mmHg) | Standard Deviation 8.04 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 3, n=11 | -1.6 Millimeter of mercury (mmHg) | Standard Deviation 7.98 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 4, n=6 | -1.7 Millimeter of mercury (mmHg) | Standard Deviation 8.04 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 5, n=3 | -7.3 Millimeter of mercury (mmHg) | Standard Deviation 9.87 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 6, n=3 | -3.3 Millimeter of mercury (mmHg) | Standard Deviation 7.64 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 7, n=3 | -9.0 Millimeter of mercury (mmHg) | Standard Deviation 7 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 8, n=2 | 6.0 Millimeter of mercury (mmHg) | Standard Deviation 14.14 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Week 9, n=1 | -10.0 Millimeter of mercury (mmHg) | — |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, Withdrawal, n=4 | 5.8 Millimeter of mercury (mmHg) | Standard Deviation 12.09 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, FU Week 4, n=3 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 5.51 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, FU Week 12, n=3 | 4.0 Millimeter of mercury (mmHg) | Standard Deviation 10.39 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period | DBP, FU Week 24, n=3 | -0.3 Millimeter of mercury (mmHg) | Standard Deviation 1.53 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline
Time frame: Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Population: SP2: consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Antiviral Baseline, n=40 | 0.2 mmHg | Standard Deviation 13.99 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 44, n=31 | -5.8 mmHg | Standard Deviation 12.18 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 1, n=40 | -5.9 mmHg | Standard Deviation 10.37 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 2, n=40 | -8.7 mmHg | Standard Deviation 13.35 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 4, n=37 | -5.2 mmHg | Standard Deviation 13.69 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 6, n=36 | -3.9 mmHg | Standard Deviation 13.09 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 8, n=36 | -6.0 mmHg | Standard Deviation 14.53 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 12, n=36 | -5.7 mmHg | Standard Deviation 13.08 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 16, n=36 | -5.5 mmHg | Standard Deviation 16.52 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 20, n=36 | -4.4 mmHg | Standard Deviation 15.18 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 24, n=36 | -2.1 mmHg | Standard Deviation 15.7 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 28, n=34 | -6.3 mmHg | Standard Deviation 15.76 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 32, n=34 | -5.2 mmHg | Standard Deviation 17.6 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 36, n=34 | -5.6 mmHg | Standard Deviation 15.36 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 40, n=33 | -5.1 mmHg | Standard Deviation 13.47 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 44, n=31 | -4.6 mmHg | Standard Deviation 16.6 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, Week 48, n=31 | -2.9 mmHg | Standard Deviation 12.37 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | SBP, withdrawal, n=10 | 0.5 mmHg | Standard Deviation 17.26 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Antiviral Baseline, n=40 | -0.4 mmHg | Standard Deviation 6.35 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 1, n=40 | -3.5 mmHg | Standard Deviation 9.28 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 2, n=40 | -4.0 mmHg | Standard Deviation 9.59 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 4, n=37 | -3.5 mmHg | Standard Deviation 9.81 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 6, n=36 | -3.9 mmHg | Standard Deviation 9.16 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 8, n=36 | -6.0 mmHg | Standard Deviation 9.62 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 12, n=36 | -5.9 mmHg | Standard Deviation 10.07 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 16, n=36 | -4.7 mmHg | Standard Deviation 9.94 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 20, n=36 | -5.7 mmHg | Standard Deviation 11.17 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 24, n=36 | -4.5 mmHg | Standard Deviation 12.34 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 28, n=34 | -7.9 mmHg | Standard Deviation 11.48 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 32, n=34 | -7.1 mmHg | Standard Deviation 11.97 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 36, n=34 | -5.4 mmHg | Standard Deviation 9.96 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 40, n=33 | -6.8 mmHg | Standard Deviation 9.69 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, Week 48, n=31 | -3.8 mmHg | Standard Deviation 8.36 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2 | DBP, withdrawal, n=10 | -2.4 mmHg | Standard Deviation 8.24 |
Secondary
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time frame: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24
Population: SP1 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 24, n=3 | 1.17 Kilogram (kg) | Standard Deviation 2.894 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 1, n=38 | 0.09 Kilogram (kg) | Standard Deviation 0.807 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 2, n=30 | 0.05 Kilogram (kg) | Standard Deviation 1.239 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 3, n=11 | 0.75 Kilogram (kg) | Standard Deviation 1.196 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 4, n=6 | 1.15 Kilogram (kg) | Standard Deviation 0.931 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 5, n=3 | 1.00 Kilogram (kg) | Standard Deviation 1.4 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 6, n=3 | 1.03 Kilogram (kg) | Standard Deviation 0.723 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 7, n=3 | 0.57 Kilogram (kg) | Standard Deviation 1.159 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 8, n=2 | 0.15 Kilogram (kg) | Standard Deviation 1.909 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Week 9, n=1 | 0.20 Kilogram (kg) | — |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | Withdrawal, n=4 | 0.30 Kilogram (kg) | Standard Deviation 1.519 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 4, n=3 | 0.90 Kilogram (kg) | Standard Deviation 1.212 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period | FU Week 12, n=3 | 0.93 Kilogram (kg) | Standard Deviation 3.009 |
Secondary
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time frame: Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Population: SP2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Antivital Baseline, n=40 | 0.04 kg | Standard Deviation 1.336 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 1, n=40 | -0.95 kg | Standard Deviation 1.131 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 2, n=40 | -1.14 kg | Standard Deviation 1.314 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 4, n=37 | -1.04 kg | Standard Deviation 1.06 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 6, n=36 | -1.05 kg | Standard Deviation 1.344 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 8, n=36 | -1.28 kg | Standard Deviation 1.581 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 12, n=36 | -1.73 kg | Standard Deviation 1.887 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 16, n=36 | -2.13 kg | Standard Deviation 2.175 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 20, n=36 | -2.49 kg | Standard Deviation 2.265 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 24, n=36 | -3.11 kg | Standard Deviation 2.488 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 28, n=34 | -3.00 kg | Standard Deviation 3.104 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 32, n=34 | -3.16 kg | Standard Deviation 3.1 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 36, n=34 | -3.43 kg | Standard Deviation 3.188 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 40, n=33 | -3.61 kg | Standard Deviation 3 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 44, n=31 | -3.39 kg | Standard Deviation 3.018 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Week 48, n=31 | -3.76 kg | Standard Deviation 2.95 |
| Eltrombopag Dose Escalation: Part 1 | Mean Change From Baseline in Weight at the Indicated Time Points in Part 2 | Withdrawal, n=10 | -3.04 kg | Standard Deviation 3.584 |
Secondary
Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2
The heart rate was measured in participants at the indicated time points.
Time frame: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Population: SP2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, n=40 | 78.3 bpm | Standard Deviation 8.77 |
| Eltrombopag Dose Escalation: Part 1 | Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 4, n=40 | 79.5 bpm | Standard Deviation 9.38 |
| Eltrombopag Dose Escalation: Part 1 | Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 12, n=40 | 74.0 bpm | Standard Deviation 8.64 |
| Eltrombopag Dose Escalation: Part 1 | Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, n=37 | 74.6 bpm | Standard Deviation 9.58 |
Secondary
Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2
The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2
Time frame: FU Baseline, FU Week 12 and FU Week 24 after Part 2
Population: FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 were excluded from this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 12, n=34 | 5.04 Log international unit per milliliter | Standard Deviation 2.551 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, n=34 | 3.10 Log international unit per milliliter | Standard Deviation 2.422 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, n=31 | 4.82 Log international unit per milliliter | Standard Deviation 2.436 |
Secondary
Mean Serum HCV RNA at the Indicated Time Points In Part 2
The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal.
Time frame: Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2
Population: FAS2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Screening, n=41 | 6.41 Log international unit per milliliter | Standard Deviation 0.726 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Antiviral Baseline, n=41 | 6.37 Log international unit per milliliter | Standard Deviation 0.767 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Week 4, n=37 | 3.77 Log international unit per milliliter | Standard Deviation 1.741 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Week 12, n=36 | 2.52 Log international unit per milliliter | Standard Deviation 1.734 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Week 24, n=36 | 2.46 Log international unit per milliliter | Standard Deviation 1.876 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Week 36, n=34 | 2.69 Log international unit per milliliter | Standard Deviation 2.177 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Week 48, n=31 | 2.63 Log international unit per milliliter | Standard Deviation 2.275 |
| Eltrombopag Dose Escalation: Part 1 | Mean Serum HCV RNA at the Indicated Time Points In Part 2 | Withdrawal, n=10 | 3.87 Log international unit per milliliter | Standard Deviation 2.275 |
Secondary
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed.
Time frame: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Population: SP2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | SBP, FU Baseline, n=40 | 126.5 mmHg | Standard Deviation 11.3 |
| Eltrombopag Dose Escalation: Part 1 | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | SBP, FU Week 4, n=40 | 125.4 mmHg | Standard Deviation 11.74 |
| Eltrombopag Dose Escalation: Part 1 | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | SBP, Week 12, n=40 | 126.7 mmHg | Standard Deviation 10.86 |
| Eltrombopag Dose Escalation: Part 1 | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | SBP, Week 24, n=37 | 128.4 mmHg | Standard Deviation 12.68 |
| Eltrombopag Dose Escalation: Part 1 | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | DBP, FU Baseline, n=40 | 73.8 mmHg | Standard Deviation 8.85 |
| Eltrombopag Dose Escalation: Part 1 | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | DBP, FU Week 4, n=40 | 74.3 mmHg | Standard Deviation 8.91 |
| Eltrombopag Dose Escalation: Part 1 | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | DBP, FU Week 12, n=40 | 76.2 mmHg | Standard Deviation 9.4 |
| Eltrombopag Dose Escalation: Part 1 | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2 | DBP, FU Week 24, n=37 | 75.7 mmHg | Standard Deviation 9.48 |
Secondary
Mean Weight at the Indicated Time Points During Follow-up Period After Part 2
The weight of participants was recorded at the indicated time points.
Time frame: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2
Population: SP2 Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Mean Weight at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, n=40 | 55.77 kg | Standard Deviation 11.403 |
| Eltrombopag Dose Escalation: Part 1 | Mean Weight at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 4, n=40 | 56.37 kg | Standard Deviation 11.627 |
| Eltrombopag Dose Escalation: Part 1 | Mean Weight at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 12, n=40 | 57.05 kg | Standard Deviation 11.841 |
| Eltrombopag Dose Escalation: Part 1 | Mean Weight at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, n=37 | 57.84 kg | Standard Deviation 12.478 |
Secondary
Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2
Platelet counts were measured by blood draw at specified timepoints.
Time frame: Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2
Population: FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 are excluded from this analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, n=34 | 86.5 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 4, n=34 | 82.5 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 12, n=34 | 70.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, n=31 | 63.0 Gi/L |
Secondary
Median Platelet Count at the Indicated Time Points in Part 1
Platelet counts were measured by blood draw
Time frame: Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1
Population: FAS1 Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Baseline, n=45 | 63.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 1, n=43 | 74.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 2, n=36 | 100.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 3, n=17 | 97.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 4, n=9 | 104.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 5, n=4 | 87.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 6, n=3 | 83.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 7, n=3 | 97.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 8, n=2 | 79.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Week 9, n=1 | 100.0 10^9 Cells Per Liter (Gi/L) |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 1 | Withdrawal, n=4 | 96 10^9 Cells Per Liter (Gi/L) |
Secondary
Median Platelet Count at the Indicated Time Points in Part 2
Platelet counts were measured by blood draw
Time frame: Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2
Population: FAS2 Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Antiviral Baseline, n=41 | 114.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 1, n=40 | 106.5 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 2, n=40 | 118.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 4, n=37 | 89.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 28, n=34 | 75.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 6, n=36 | 86.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 8, n=36 | 79.5 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 12, n=36 | 80.5 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 16, n=36 | 79.5 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 20, n=36 | 75.5 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 24, n=36 | 76.5 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 32, n=34 | 73.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 36, n=34 | 76.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 40, n=33 | 80.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 44, n=31 | 79.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Week 48, n=31 | 82.0 Gi/L |
| Eltrombopag Dose Escalation: Part 1 | Median Platelet Count at the Indicated Time Points in Part 2 | Withdrawal, n=10 | 102.0 Gi/L |
Secondary
Minimum Platelet Count on Antiviral Therapy
Participants were assessed for platelet counts during antiviral therapy in Part 2. Platelet counts were measured by blood draw.
Time frame: From Antiviral Baseline to up to Week 48 in Part 2
Population: FAS2 Population: all participants enrolled in Part 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Minimum Platelet Count on Antiviral Therapy | <25 Gi/L | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Minimum Platelet Count on Antiviral Therapy | >=25 to <50 Gi/L | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Minimum Platelet Count on Antiviral Therapy | >=50 to <100 Gi/L | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Minimum Platelet Count on Antiviral Therapy | >=100 to <150 Gi/L | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Minimum Platelet Count on Antiviral Therapy | >=150 to <200 Gi/L | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Minimum Platelet Count on Antiviral Therapy | >=200 to <400 Gi/L | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Minimum Platelet Count on Antiviral Therapy | >= 400 Gi/L | 0 Participants |
Secondary
Number of Antiviral Therapy Dose Reductions in Part 2
Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 0 DR | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 1 DR | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 2 DR | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 3 DR | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 4 DR | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 5 DR | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 7 DR | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 8 DR | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Antiviral Therapy Dose Reductions in Part 2 | 10 DR | 2 Participants |
Secondary
Number of Participants Achieving Adherence to Antiviral Therapy in Part 2
Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Achieving Adherence to Antiviral Therapy in Part 2 | 32 Participants |
Secondary
Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2
Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2 | 14 Participants |
Secondary
Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2
Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2 | 18 Participants |
Secondary
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.
Time frame: Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal
Population: SP1 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Screening, abnormal-CS, n=45 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Antiviral Baseline, normal, n=41 | 26 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 12, normal, n=36 | 29 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 24, abnormal-CS, n=36 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 36, abnormal-CS, n=34 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 48, abnormal-NCS, n=31 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Withdrawal, normal, n=14 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Worst ECG post Baseline, normal, n=41 | 24 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Screening, normal, n=45 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Screening, abnormal-NCS, n=45 | 14 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Antiviral Baseline, abnormal-NCS, n=41 | 14 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Antiviral Baseline, abnormal-CS, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 12, abnormal-NCS, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 12, abnormal-CS, n=36 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 24, normal, n=36 | 29 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 24, abnormal-NCS, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 36, normal, n=34 | 24 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 36, abnormal-NCS, n=34 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 48, normal, n=31 | 19 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Part 2, week 48, abnormal-CS, n=31 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Withdrawal, abnormal-NCS, n=14 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Withdrawal, abnormal-CS, n=14 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Worst ECG post Baseline, abnormal-NCS, n=41 | 17 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points | Worst ECG post Baseline, abnormal-CS, n=41 | 0 Participants |
Secondary
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2
The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.
Time frame: FU Baseline and FU Week 24
Population: SP2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | FU Baseline, abnormal-NCS | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | FU Week 24, normal | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | FU Baseline, normal | 24 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | FU Baseline, abnormal-CS | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | FU Week 24, abnormal-NCS | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2 | FU Week 24, abnormal-CS | 0 Participants |
Secondary
Number of Participants Who Discontinued Antiviral Therapy in Part 2
Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Who Discontinued Antiviral Therapy in Part 2 | 8 Participants |
Secondary
Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2
Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2 | 1 Participants |
Secondary
Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2
Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2 | 7 Participants |
Secondary
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).
Time frame: Baseline; Week 24, Week 48, Withdrawal/Completion
Population: SP1 Population. Only those participants available at the specified time points were analyzed (n=X).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 24, measureable spleen breadth, n=36 | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Baseline, masses suspicious for HCC detected, n=45 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Baseline, ascites detected, n=45 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Baseline, portal vein thrombosis detected, n=45 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Baseline, measureable spleen breadth, n=45 | 43 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Baseline, OCSF, n=45 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 24, masses suspicious for HCC detected, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 24, ascites detected, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 24, portal vein thrombosis detected, n=36 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 24, OCSF, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 48, masses suspicious for HCC detected, n=29 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 48, ascites detected, n=29 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 48, portal vein thrombosis detected, n=29 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 48, measureable spleen breadth, n=29 | 29 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | Week 48, OCSF, n=29 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | WD/comp, masses suspicious for HCC detected, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | WD/comp, ascites detected, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | WD/comp, portal vein thrombosis detected, n=37 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | WD/comp, measureable spleen breadth, n=37 | 37 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points | WD/comp, OCSF, n=37 | 6 Participants |
Secondary
Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).
Time frame: FU Week 24
Population: SP2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24, measureable spleen breadth | 36 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24, OCSF | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24, masses suspicious for HCC detected, | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24, ascites detected | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24, portal vein thrombosis detected | 0 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Time frame: From Baseline up to week 9 in Part 1
Population: Safety Population 1 (SP1) : consisted of all participants who were enrolled in Part 1 and received at least one dose of eltrombopag.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | Any AE | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | Any SAE | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | Fatal AE | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | Drug-related AE | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | AE leading to withdrawal | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | SAE leading to withdrawal | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1 | On-going AE at the endo of study/withdrawal | 1 Participants |
Secondary
Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Time frame: From FU Baseline up to FU Week 24 after Part 2
Population: SP2 Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | Any AE | 25 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | Any SAE | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | Fatal AE | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | Drug-related AE | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | AE leading to withdrawal | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | SAE leading to withdrawal | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2 | On-going AE at the end of study/withdrawal | 16 Participants |
Secondary
Number of Participants With Any AE and Any SAE in Part 2
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: Safety Population 2 (SP2): consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE in Part 2 | Any AE | 41 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE in Part 2 | Any SAE | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE in Part 2 | Fatal AE | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE in Part 2 | Drug-related AE | 41 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE in Part 2 | AE leading to withdrawal | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE in Part 2 | SAE leading to withdrawal | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Any AE and Any SAE in Part 2 | On-going AE at the end of study/withdrawal | 34 Participants |
Secondary
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2
EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2 | EVR | 28 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2 | cEVR | 18 Participants |
Secondary
Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2
ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2 | 19 Participants |
Secondary
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2
RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2 | RVR | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2 | eRVR | 5 Participants |
Secondary
Number of Participants With Sustained Virologic Response (SVR) in Part 2
Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With Sustained Virologic Response (SVR) in Part 2 | 9 Participants |
Secondary
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2
Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2a were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2 | 0 DR | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2 | 1 DR | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2 | 2 DR | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2 | 3 DR | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2 | >3 DR | 1 Participants |
Secondary
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2
Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2b were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2 | 0 DR | 16 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2 | 1 DR | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2 | 2 DR | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2 | 3 DR | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2 | >3 DR | 3 Participants |
Secondary
Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2
Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2 | 0 DR | 14 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2 | 1 DR | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2 | 2 DR | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2 | 3 DR | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2 | >3 DR | 3 Participants |
Secondary
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time frame: From FU Week 4 to FU Week 24
Population: SP2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Albumin:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium, serum high: Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium, serum high: Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum low:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum high:Any Grade Increase | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Albumin:Any Grade Increase | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Albumin:Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Albumin:Increase to G2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Albumin:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALP:Any Grade Increase | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALP:Increase to G1 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALP:Increase to G2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALP:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALP:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALT:Any Grade Increase | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALT:Increase to G1 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALT:Increase to G2 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALT:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | ALT:Increase to G4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | AST:Any Grade Increase | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | AST:Increase to G1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | AST:Increase to G2 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | AST:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | AST:Increase to G4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Total Bilirubin:Any Grade Increase | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Total Bilirubin:Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Total Bilirubin:Increase to G2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Total Bilirubin:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Total Bilirubin:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium:Any Grade Increase | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium:Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium serum high: Any Grade Increase | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium, serum high: Increase to G1 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium, serum high: Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium serum low: Any Grade Increase | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium, serum low: Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium, serum low: Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium, serum low: Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Calcium, serum low: Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Creatinine: Any Grade Increase | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Creatinine: Increase to G1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Creatinine: Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Creatinine: Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Creatinine: Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium:Any Grade Increase | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium:Increase to G1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum high:Any Grade Increase | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum high:Increase to G1 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum high:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum high:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum high:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum low:Any Grade Increase | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum low:Increase to G1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum low:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Potassium, serum low:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium:Any Grade Increase | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium:Increase to G1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum high:Increase to G1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum high:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum high:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum high:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum low:Any Grade Increase | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum low:Increase to G1 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum low:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum low:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Sodium, serum low:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Uric acid:Any Grade Increase | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Uric acid:Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Uric acid:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Uric acid:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2 | Uric acid:Increase to G4 | 0 Participants |
Secondary
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time frame: From Antiviral Baseline up to Week 48
Population: SP2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALT:Increase to G2 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Albumin:Any Grade Increase | 18 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Albumin:Increase to G1 | 15 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Albumin:Increase to G2 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Albumin:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Albumin:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALP:Any Grade Increase | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALP:Increase to G1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALP:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALP:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALP:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALT:Any Grade Increase | 14 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALT:Increase to G1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALT:Increase to G3 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | ALT:Increase to G4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | AST:Any Grade Increase | 22 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | AST:Increase to G1 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | AST:Increase to G2 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | AST:Increase to G3 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | AST:Increase to G4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Total Bilirubin:Any Grade Increase | 20 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Total Bilirubin:Increase to G1 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Total Bilirubin:Increase to G2 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Total Bilirubin:Increase to G3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Total Bilirubin:Increase to G4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Calcium:Any Grade Increase | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Calcium:Increase to G1 | 25 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Calcium:Increase to G2 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Calcium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Calcium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Creatinine:Any Grade Increase | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Creatinine:Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Creatinine:Increase to G2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Creatinine:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Creatinine:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Potassium:Any Grade Increase | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Potassium:Increase to G1 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Potassium:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Potassium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Potassium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Sodium:Any Grade Increase | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Sodium:Increase to G1 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Sodium:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Sodium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Sodium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Uric acid:Any Grade Increase | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Uric acid:Increase to G1 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Uric acid:Increase to G2 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Uric acid:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2 | Uric acid:Increase to G4 | 0 Participants |
Secondary
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time frame: From Baseline up to Week 9
Population: SP1 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALT: Increase to G3 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | AST:Increase to G2 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Total Bilirubin:Increase to G1 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Calcium:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Uric acid:Increase to G2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Albumin: Any Grade Increase | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Albumin: Increase to G1 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Albumin: Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Albumin: Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Albumin: Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALP: Any Grade Increase | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALP: Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALP: Increase to G2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALP: Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALP: Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALT: Any Grade Increase | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALT: Increase to G1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALT: Increase to G2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | ALT: Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | AST:Any Grade Increase | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | AST:Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | AST:Increase to G3 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | AST:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Total Bilirubin:Any Grade Increase | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Total Bilirubin:Increase to G2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Total Bilirubin:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Total Bilirubin:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Calcium:Any Grade Increase | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Calcium:Increase to G1 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Calcium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Calcium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Creatinine:Any Grade Increase | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Creatinine:Increase to G1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Creatinine:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Creatinine:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Creatinine:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Potassium:Any Grade Increase | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Potassium:Increase to G1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Potassium:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Potassium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Potassium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Sodium:Any Grade Increase | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Sodium:Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Sodium:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Sodium:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Sodium:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Uric Acid:Any Grade Increase | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Uric acid:Increase to G1 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Uric acid:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1 | Uric acid:Increase to G4 | 0 Participants |
Secondary
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time frame: From Baseline up to Week 9
Population: SP1 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Platelet count:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Platelet count:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Hemoglobin:Any Grade Increase | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Hemoglobin:Increase to G1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Hemoglobin:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Hemoglobin:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Hemoglobin:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Lymphocytes:Any Grade Increase | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Lymphocytes:Increase to G1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Lymphocytes:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Lymphocytes:Increase to G3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Lymphocytes:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Total Neutrophils:Any Grade Increase | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Total Neutrophils:Increase to G1 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Total Neutrophils:Increase to G2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Total Neutrophils:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Total Neutrophils:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Platelet count:Any Grade Increase | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Platelet count:Increase to G1 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | Platelet count:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | White Blood Cell count:Any Grade Increase | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | White Blood Cell count:Increase to G1 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | White Blood Cell count:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | White Blood Cell count:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1 | White Blood Cell count:Increase to G4 | 0 Participants |
Secondary
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time frame: From Antiviral Baseline up to Week 48
Population: SP2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Lymphocytes:Increase to G3 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Hemoglobin:Any Grade Increase | 38 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Hemoglobin:Increase to G1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Hemoglobin:Increase to G2 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Hemoglobin:Increase to G3 | 24 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Hemoglobin:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Lymphocytes:Any Grade Increase | 26 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Lymphocytes:Increase to G1 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Lymphocytes:Increase to G2 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Lymphocytes:Increase to G4 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Total Neutrophils:Any Grade Increase | 38 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Total Neutrophils:Increase to G1 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Total Neutrophils:Increase to G2 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Total Neutrophils:Increase to G3 | 16 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Total Neutrophils:Increase to G4 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Platelet count:Any Grade Increase | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Platelet count:Increase to G1 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Platelet count:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Platelet count:Increase to G3 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | Platelet count:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | White Blood Cell count:Any Grade Increase | 38 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | White Blood Cell count:Increase to G1 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | White Blood Cell count:Increase to G2 | 18 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | White Blood Cell count:Increase to G3 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2 | White Blood Cell count:Increase to G4 | 1 Participants |
Secondary
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time frame: From FU Week 4 to FU Week 24
Population: SP2 Population,
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Hemoglobin:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Total Neutrophils:Any Grade Increase | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Total Neutrophils:Increase to G1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Hemoglobin:Any Grade Increase | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Hemoglobin:Increase to G1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Hemoglobin:Increase to G2 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Hemoglobin:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Lymphocytes:Any Grade Increase | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Lymphocytes:Increase to G1 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Lymphocytes:Increase to G2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Lymphocytes:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Lymphocytes:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Total Neutrophils:Increase to G2 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Total Neutrophils:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Total Neutrophils:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Platelet count:Any Grade Increase | 15 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Platelet count:Increase to G1 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Platelet count:Increase to G2 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Platelet count:Increase to G3 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | Platelet count:Increase to G4 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | White Blood Cell count:Any Grade Increase | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | White Blood Cell count:Increase to G1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | White Blood Cell count:Increase to G2 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | White Blood Cell count:Increase to G3 | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2 | White Blood Cell count:Increase to G4 | 0 Participants |
Secondary
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.
Time frame: FU Baseline and FU Week 24
Population: SP2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UG, Neg | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.002 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.024 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UU, 1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UK, (-) | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, pH, 5 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, pH, 6.5 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.004 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.019 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UB, (-) | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UB, Neg. | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UOB, 1+ | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UOB, 3+ | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UOB, (-) | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UOB, Neg. | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UG, (-) | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UK, (-) | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UK, Neg. | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, pH, 5 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, pH, 5.5 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, pH, 6 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, pH, 6.5 | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, pH, 7 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, pH, 8 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UP, (-) | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UP, 10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UP, Neg | 27 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UP, trace | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.005 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.007 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.009 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.01 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.011 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.012 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.013 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.014 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.015 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.016 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.017 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.018 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.019 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.02 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.021 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.025 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.027 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, USG, 1.03 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UU, 1+ | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UU, 0.1 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UU, 2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UU, 3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UU, Neg | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UU, trace | 17 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Baseline, UU, normal | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UB, (-) | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UB, Neg. | 35 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UOB, 1+ | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UOB, 3+ | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UOB, (-) | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UOB, Neg. | 26 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UOB, Trace | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UG, 1+ | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UG, (-) | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UG, 0.2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FUWeek 24, UG, Neg | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UK, Neg. | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UK, Trace. | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, pH, 5.5 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, pH, 6 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, pH, 7 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, pH, 7.5 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UP, (-) | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UP, Neg | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UP, Trace | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.005 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.008 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.01 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.011 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.012 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.013 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.015 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.016 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.017 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.018 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.02 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.021 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.022 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.023 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.024 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, USG, 1.025 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UU, 0.1 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UU, 1 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UU, 4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UU, <1.0 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UU, Neg | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FU Week 24, UU, Trace | 18 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2 | FUWeek 24, UU, normal | 8 Participants |
Secondary
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.
Time frame: Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24
Population: SP1 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UOB, 1+, n=45 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UG, 0.5, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UP, 1+., n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UU, trace, n=45 | 19 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.026, n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UK, (-), n=45 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, pH, 7, n=45 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UU, 1, n=45 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.007, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.023, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 1, UU, trace, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, USG, 1.016, Neg, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, USG, 1.025, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, USG, 1.01, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UB, (-), n=45 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UB, Neg., n=45 | 39 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UOB, 2+, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UOB, 3+, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UOB, (-), n=45 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UOB, Neg., n=45 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UOB, trace., n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UG, (-), n=45 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UG, Neg., n=45 | 37 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UK, (-), n=45 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UK, Neg., n=45 | 38 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, pH, 5, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, pH, 5.5, n=45 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, pH, 6, n=45 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, pH, 6.5, n=45 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, pH, 7, n=45 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, pH, 7.5, n=45 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UP, (-), n=45 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UP, Neg., n=45 | 35 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UP, trace, n=45 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UU, 1+, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UU, (-), n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UU, 0.1, n=45 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UU, 1, n=45 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UU, 2, n=45 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, UU, normal, n=45 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.005, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.006, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.007, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.008, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.009, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.01, n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.011, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.012, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.013, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.014, n=45 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.015, n=45 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.017, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.018, n=45 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.019, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.02, n=45 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.021, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.022, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.024, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.025, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Screening, USG, 1.03, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UB, (-), n=45 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UB, Neg., n=45 | 39 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, pH, 5.5, n=45 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UOB, 1+, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UOB, 2+, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UOB, 3+, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UOB, (-), n=45 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, pH, 6, n=45 | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UOB, Neg., n=45 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UOB, trace., n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UG, 2+, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UG, (-), n=45 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UG, 0.1, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UG, 0.5, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UG, Neg., n=45 | 35 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UK, Neg., n=45 | 38 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, pH, 5, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, pH, 6.5, n=45 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, pH, 7.5, n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, pH, 8, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UP, 1+., n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UP, (-), n=45 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UP, Neg., n=45 | 36 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UP, trace, n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UU, 1+, n=45 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UU, (-), n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UU, 0.1, n=45 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UU, 2, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UU, trace, n=45 | 15 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, UU, normal, n=45 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.003, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.005, n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.006, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.009, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.01, n=45 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.011, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.012, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.013, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.014, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.015, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.016, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.017, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.018, n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.019, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.02, n=45 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.021, n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.022, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.025, n=45 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.028, n=45 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Baseline, USG, 1.03, n=45 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 1, UB, Neg, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 1, UOB, Neg, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 1, UG, Neg, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 1, UK, Neg, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 1, pH, 7.5, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 1, UP, trace, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 1, USG, 1.021, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UB, Neg, n=3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UOB, Neg, n=3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UG, 0.25, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UU, normal, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UG, Neg, n=3 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, pH, 6.5, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UK, Neg, n=3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, pH, 6, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, pH, 6.5, n=3 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UP, Neg, n=3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, USG, 1.019, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, USG, 1.02, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UU, 0.1, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 2, UU, trace, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, UB, Neg, n=2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, UOB, Neg, n=2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, UG, >=1.0, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, UG, Neg, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, UK, Neg, n=2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, pH, 6, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, UP, Neg, n=2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, USG, 1.015, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, USG, 1.02, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, UU, 0.1, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 3, UU, 4, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UB, Neg, n=5 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UOB, Neg, n=5 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UG, >=1.0, n=5 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UG, Neg, n=5 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UK, Neg, n=5 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, pH, 5.5, n=5 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, pH, 6, n=5 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, pH, 6.5, n=5 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UP, Neg, n=5 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, USG, 1.015, n=5 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, USG, 1.02, n=5 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, USG, 1.025, n=5 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, USG, 1.026, n=5 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UU, 1, n=5 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UU, 2, n=5 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 4, UU, trace, n=5 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 7, UB, Neg, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 7, UOB, Neg, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 7, UG, 0.5, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 7, UK, Neg, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 7, pH, 7, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 7, UP, Neg, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 7, USG, 1.02, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 7, UU, 2, n=1 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UB, Neg, n=2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UOB, Neg, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UOB, trace, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UG, 0.1 n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UG, Neg, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UK, Neg, n=2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, pH, 6, n=2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UP, Neg, n=2 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, USG, 1.023, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UU, 0.1, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Week 8, UU, trace, n=2 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UB, Neg, n=4 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UOB, Neg, n=4 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UG, 0.5, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UG, Neg, n=4 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UK, Neg, n=4 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, pH, 6, n=4 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, pH, 6.5, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UU, 0.1, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, pH, 8, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UP, Neg, n=4 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, USG, 1.008, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, USG, 1.01, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, USG, 1.018, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, USG, 1.025, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UU, 1+, n=4 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | Withdrawal, UU, 1, n=4 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU, Week 24, UB, Neg, n=3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, UOB, 1+, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, UOB, Neg, n=3 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, UG, Neg, n=3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, UK, Neg, n=3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, pH, 5.5, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, pH, 6, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, pH, 7, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, UP, Neg, n=3 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, USG, 1.004, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, USG, 1.02, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, UU, 0.1, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, UU, 1, n=3 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period | FU Week 24, UU, trace, n=3 | 1 Participants |
Secondary
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.
Time frame: Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal
Population: SP2 Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UOB, 1+, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UG, >=1.0, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, pH, 6, n=41 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UK, (-), n=37 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.004, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.013, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.016, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UB, (-), n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UOB, 2+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UK, Neg, n=36 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UP, 1+, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.015, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.023, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UG, Neg, n=36 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UB, (-), n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.015, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.027, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UU, 1, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UB, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UP, Neg, n=34 | 29 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.012, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UOB, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, pH, 5, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UOB, 2+, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.022, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, 3, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UU, trace, n=10 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UB, (-), n=41 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UB, Neg., n=41 | 36 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UOB, (-), n=41 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UOB, Neg., n=41 | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UOB, trace., n=41 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UG, 1+, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UG, 2+, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UG, (-), n=41 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UG, 0.25, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UG, 0.5, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UG, Neg., n=41 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UK, (-), n=41 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UK, Neg., n=41 | 35 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UK, trace, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, pH, 5, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, pH, 5.5, n=41 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, pH, 6.5, n=41 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, pH, 7, n=41 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, pH, 7.5, n=41 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, pH, 8.5, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UP, (-), n=41 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UP, Neg, n=41 | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UP, trace, n=41 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.005, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.006, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.01, n=41 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.011, n=41 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.012, n=41 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.013, n=41 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.014, n=41 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.015, n=41 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.016, n=41 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.017, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.018, n=41 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.019, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.02, n=41 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.021, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.022, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.023, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.024, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.025, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.026, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, USG, 1.027, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UU, 1+, n=41 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UU, 0.1, n=41 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UU, 1, n=41 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UU, 2, n=41 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UU, 4, n=41 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UU, Neg, n=41 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UU, trace, n=41 | 16 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Antiviral Baseline, UU, normal, n=41 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UB, (-), n=37 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UB, Neg, n=37 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UOB, 2+, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UOB, (-), n=37 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UOB, Neg, n=37 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UG, (-), n=37 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UG, 0.1, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UG, Neg, n=37 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UK, Neg, n=37 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, pH, 5, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, pH, 5.5, n=37 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, pH, 6, n=37 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, pH, 6.5, n=37 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, pH, 7, n=37 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, pH, 7.5, n=37 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, pH, 8, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UP, (-), n=37 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UP, Neg, n=37 | 28 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UP, trace, n=37 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.005, n=37 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.006, n=37 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.008, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.01, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.011, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.012, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.014, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.015, n=37 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.017, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.019, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.02, n=37 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.021, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.022, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, USG, 1.025, n=37 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, 1+, n=37 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, 0.1, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, 1, n=37 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, 2, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, 4, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, 8, n=37 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, Neg, n=37 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, trace, n=37 | 15 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 4, UU, normal, n=37 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UB, 2, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UB, Neg, n=36 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UOB, 1+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UOB, (-), n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UOB, Neg, n=36 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UG, 1+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UG, (-), n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UG, >=1.0, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UG, Neg, n=36 | 29 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UK, (-), n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UK, trace, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, pH, 5, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, pH, 5.5, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, pH, 6, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, pH, 6.5, n=36 | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, pH, 7, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, pH, 7.5, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, pH, 8, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UP, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UP, Neg, n=36 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UP, trace, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.001, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.003, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.004, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.005, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.008, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.01, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.012, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.013, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.014, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.016, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.018, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.019, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.02, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, 1.025, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, <=1.005, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, USG, >=1.030, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, 1+, n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, (-), n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, 0.1, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, 1, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, 2, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, 4, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, Neg, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, trace, n=36 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 8, UU, normal, n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UB, (-), n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UB, Neg, n=36 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UOB, (-), n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UOB, Neg, n=36 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UG, (-), n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UG, 0.25, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UK, (-), n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UK, 0, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UK, Neg, n=36 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, pH, 5, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, pH, 5.5, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, pH, 6, n=36 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, pH, 6.5, n=36 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, pH, 7, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, pH, 7.5, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UP, 1+, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UP, (-), n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UP, Neg, n=36 | 26 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UP, trace, n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.005, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.006, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.007, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.008, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.009, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.01, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.012, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.014, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.015, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.016, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.017, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.018, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.019, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.02, n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.021, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.022, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, USG, 1.026, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UU, 1+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UU, 0.1, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UU, 1, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UU, 2, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UU, 4, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UU, Neg, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UU, trace, n=36 | 15 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 12, UU, normal, n=36 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UB, Neg, n=36 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UOB, 1+, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UOB, 2+, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UOB, 3+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UOB, (-), n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UOB, Neg, n=36 | 27 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UG, (-), n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UG, 0.25, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UG, Neg, n=36 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UK, (-), n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UK, Neg, n=36 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UK, trace, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, pH, 5, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, pH, 5.5, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, pH, 6, n=36 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, pH, 6.5, n=36 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, pH, 7, n=36 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, pH, 7.5, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UP, 1+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UP, (-), n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UP, Neg, n=36 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UP, trace, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.005, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.006, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.007, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.008, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.009, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.01, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.014, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.016, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.017, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.018, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.019, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.02, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.021, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.022, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.023, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, USG, 1.025, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UU, 1+, n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UU, 2+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UU, 0.1, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UU, 4, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UU, Neg, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UU, trace, n=36 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 16, UU, normal, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UB, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UB, Neg, n=36 | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UOB, 1+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UOB, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UOB, Neg, n=36 | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UG, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UG, Neg, n=36 | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UG, trace, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UK, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UK, Neg, n=36 | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, pH, 5, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, pH, 5.5, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, pH, 6, n=36 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, pH, 6.5, n=36 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, pH, 7, n=36 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, pH, 7.5, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UP, 1+, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UP, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UP, Neg, n=36 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UP, trace, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.004, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.005, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.006, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.007, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.009, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.01, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.013, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.014, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.015, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.016, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.017, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.018, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.019, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.02, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.021, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.025, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, 1.029, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, USG, <=1.005, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, 1+, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, 2+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, 0.1, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, 1, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, 4, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, 8, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, Neg, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, trace, n=36 | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 20, UU, normal, n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UB, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UB, Neg, n=36 | 34 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UOB, 1+, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UOB, 3+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UOB, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UOB, Neg, n=36 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UOB, trace, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UG, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UG, 0.1, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UG, Neg, n=36 | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UK, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UK, Neg, n=36 | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UK, trace, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, pH, 5, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, pH, 5.5, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, pH, 6, n=36 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, pH, 6.5, n=36 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, pH, 7, n=36 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, pH, 7.5, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, pH, 8.5, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UP, (-), n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UP, Neg, n=36 | 28 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UP, trace, n=36 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.008, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.009, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.01, n=36 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.011, n=36 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.012, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.013, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.014, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.015, n=36 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.016, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.017, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.018, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.019, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.021, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.022, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.023, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.025, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, 1.03, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, USG, <=1.005, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, 1+, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, 3+, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, 0.1, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, 1, n=36 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, 2, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, 4, n=36 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, Neg, n=36 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, trace, n=36 | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 24, UU, normal, n=36 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UB, 1+, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UB, Neg, n=34 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UOB, 1+, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UOB, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UOB, Neg, n=34 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UOB, trace, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UG, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UG, 0.5, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UG, Neg, n=34 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UK, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UK, Neg, n=34 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UK, trace, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, pH, 5.5, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, pH, 6, n=34 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, pH, 6.5, n=34 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, pH, 7, n=34 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, pH, 7.5, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, pH, 8, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UP, 1+, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UP, Neg, n=34 | 27 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UP, trace, n=34 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.005, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.007, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.008, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.009, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.011, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.012, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.013, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.015, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.016, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.017, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.018, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.019, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.02, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.022, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.023, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.024, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.025, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, 1.027, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, USG, <=1.005, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UU, 1+, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UU, 0.1, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UU, 1, n=34 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UU, 2, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UU, 4, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UU, Neg, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UU, trace, n=34 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 28, UU, normal, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UB, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UB, Neg, n=34 | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UOB, 1+, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UOB, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UOB, Neg, n=34 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UG, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UG, Neg, n=34 | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UK, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UK, Neg, n=34 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UK, trace, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, pH, 5, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, pH, 5.5, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, pH, 6, n=34 | 14 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, pH, 6.5, n=34 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, pH, 7, n=34 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, pH, 7.5, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UP, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UP, trace, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.005, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.006, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.007, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.01, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.011, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.014, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.015, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.016, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.018, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.019, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.02, n=34 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.021, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.022, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, USG, 1.024, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, 1+, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, 0.1, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, 1, n=34 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, 3, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, 4, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, 8, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, Neg, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, trace, n=34 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 32, UU, normal, n=34 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UB, 1+, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UB, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UB, Neg, n=34 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UOB, 2+, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UOB, Neg, n=34 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UG, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UG, Neg, n=34 | 33 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UK, 1+, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UK, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UK, Neg, n=34 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, pH, 5.5, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, pH, 6, n=34 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, pH, 6.5, n=34 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, pH, 7, n=34 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, pH, 7.5, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UP, 1+, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UP, (-), n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UP, Neg, n=34 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UP, trace, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.005, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.007, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.008, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.009, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.01, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.011, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.012, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.013, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.015, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.016, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.018, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.02, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.021, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.023, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.024, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, 1.03, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, USG, <=1.005, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, 1+, n=34 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, 0.1, n=34 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, 1, n=34 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, 2, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, 3, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, 4, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, Neg, n=34 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, trace, n=34 | 14 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 36, UU, normal, n=34 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UB, (-), n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UB, Neg, n=33 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UOB, 3+, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UOB, (-), n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UOB, Neg, n=33 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UG, (-), n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UG, Neg, n=33 | 32 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UK, (-), n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UK, Neg, n=33 | 31 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UK, trace, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, pH, 5.5, n=33 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, pH, 6, n=33 | 9 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, pH, 6.5, n=33 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, pH, 7, n=33 | 10 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, pH, 7.5, n=33 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UP, (-), n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UP, Neg, n=33 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UP, trace, n=33 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.003, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.004, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.005, n=33 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.006, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.007, n=33 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.01, n=33 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.011, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.012, n=33 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.013, n=33 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.014, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.015, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.016, n=33 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.018, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.019, n=33 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.02, n=33 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.023, n=33 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.024, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, USG, 1.025, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, 1+, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, 0.1, n=33 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, 1, n=33 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, 2, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, 4, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, Neg, n=33 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, trace, n=33 | 13 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 40, UU, normal, n=33 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UB, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UB, Neg, n=31 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UOB, 2+, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UOB, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UOB, Neg, n=31 | 28 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UG, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UG, 0.1, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UG, Neg, n=31 | 29 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UK, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UK, Neg, n=31 | 29 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UK, trace, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, pH, 5.5, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, pH, 6, n=31 | 12 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, pH, 6.5, n=31 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, pH, 7, n=31 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, pH, 7.5, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UP, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UP, Neg, n=31 | 27 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UP, trace, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.005, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.007, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.008, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.01, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.011, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.012, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.015, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.016, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.017, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.018, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.019, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.02, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.021, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.022, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.024, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.025, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.027, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, USG, 1.03, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, 1+, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, 2+, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, 0.1, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, 1, n=31 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, 2, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, 4, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, Neg, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, trace, n=31 | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 44, UU, normal, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UB, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UB, Neg, n=31 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UOB, 3+, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UOB, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UOB, Neg, n=31 | 29 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UG, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UG, Neg, n=31 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UK, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UK, Neg, n=31 | 30 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, pH, 5.5, n=31 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, pH, 6, n=31 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, pH, 6.5, n=31 | 14 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, pH, 7, n=31 | 6 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, pH, 8, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UP, (-), n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UP, 10, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UP, Neg, n=31 | 26 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UP, trace, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.005, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.007, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.009, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.01, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.011, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.012, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.013, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.014, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.015, n=31 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.016, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.017, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.018, n=31 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.019, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.02, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.025, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.027, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, USG, 1.03, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UU, 1+, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UU, 0.1, n=31 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UU, 1, n=31 | 3 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UU, 2, n=31 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UU, 3, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UU, Neg, n=31 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UU, trace, n=31 | 14 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Week 48, UU, normal, n=31 | 4 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UB, 1+, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UB, (-), n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UB, Neg, n=10 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UOB, 1+, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UOB, (-), n=10 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UOB, Neg, n=10 | 7 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UG, (-), n=10 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UG, Neg, n=10 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UK, (-), n=10 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UK, Neg, n=10 | 8 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, pH, 5, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, pH, 6, n=10 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, pH, 6.5, n=10 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, pH, 7, n=10 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UP, Neg, n=10 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UP, trace, n=10 | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.002, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.009, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.01, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.017, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.018, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.019, n=10 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.021, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.023, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, USG, 1.025, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UU, 1+, n=10 | 2 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UU, 1, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UU, Neg, n=10 | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2 | Withdrawal, UU, normal, n=10 | 3 Participants |
Secondary
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).
Time frame: FU Week 24
Population: SP2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24, spleen length | 11.0 Cm | Standard Deviation 2.61 |
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2 | FU Week 24, spleen width (breadth) | 4.4 Cm | Standard Deviation 1.32 |
Secondary
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).
Time frame: Baseline; Week 24, Week 48, Withdrawal/Completion
Population: SP1 Population. Only those participants available at the specified time points were analyzed (n=X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Week 24, spleen length, n=36 | 11.5 Centimeters (cm) | Standard Deviation 2.34 |
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Week 24, spleen width (breadth), n=34 | 4.9 Centimeters (cm) | Standard Deviation 1.21 |
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Week 48, spleen width (breadth), n=29 | 4.5 Centimeters (cm) | Standard Deviation 0.87 |
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | WD/comp, spleen length, n=37 | 11.7 Centimeters (cm) | Standard Deviation 2.67 |
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Baseline, spleen length, n=45 | 11.5 Centimeters (cm) | Standard Deviation 2.63 |
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Baseline, spleen width (breadth), n=43 | 4.7 Centimeters (cm) | Standard Deviation 1.25 |
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | Week 48, spleen length, n=29 | 11.6 Centimeters (cm) | Standard Deviation 2.27 |
| Eltrombopag Dose Escalation: Part 1 | Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study | WD/comp, spleen width (breadth), n=37 | 4.5 Centimeters (cm) | Standard Deviation 0.93 |
Secondary
Time in Weeks to Achieve Platelet Count >= 100 Gi/L
Participants were assessed for achieving platelet counts \>=100 Gi/L during Part 1. Platelet counts were measured by blood draw.
Time frame: From Baseline up to Week 9 in Part 1
Population: FAS1 Population: all participants enrolled in Part 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Time in Weeks to Achieve Platelet Count >= 100 Gi/L | Within 2 Weeks | 11 Participants |
| Eltrombopag Dose Escalation: Part 1 | Time in Weeks to Achieve Platelet Count >= 100 Gi/L | Within 4 Weeks | 25 Participants |
| Eltrombopag Dose Escalation: Part 1 | Time in Weeks to Achieve Platelet Count >= 100 Gi/L | Within 6 Weeks | 5 Participants |
| Eltrombopag Dose Escalation: Part 1 | Time in Weeks to Achieve Platelet Count >= 100 Gi/L | Within 8 Weeks | 1 Participants |
| Eltrombopag Dose Escalation: Part 1 | Time in Weeks to Achieve Platelet Count >= 100 Gi/L | Within 9 Weeks | 0 Participants |
| Eltrombopag Dose Escalation: Part 1 | Time in Weeks to Achieve Platelet Count >= 100 Gi/L | Greater than 9 Weeks | 1 Participants |
Secondary
Time to First Dose Reduction of Antiviral Therapy in Part 2
Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction.
Time frame: From Antiviral Baseline up to Week 48 in Part 2
Population: FAS2 Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag Dose Escalation: Part 1 | Time to First Dose Reduction of Antiviral Therapy in Part 2 | Peg-IFN alfa-2a dose reduction, n=12 | 9.44 weeks | Standard Deviation 12.556 |
| Eltrombopag Dose Escalation: Part 1 | Time to First Dose Reduction of Antiviral Therapy in Part 2 | Peg-IFN alfa-2b dose reduction, n=9 | 6.22 weeks | Standard Deviation 6.944 |
| Eltrombopag Dose Escalation: Part 1 | Time to First Dose Reduction of Antiviral Therapy in Part 2 | RBV dose reduction, n=27 | 9.16 weeks | Standard Deviation 6.611 |