Purpura, Thrombocytopaenic, Idiopathic
Conditions
Keywords
Immune (idiopathic) thrombocytopenic purpura (ITP), bone marrow fibers, eltrombopag olamine, thrombopoietin receptor agonist
Brief summary
A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.
Detailed description
This is a phase IV, open-label safety study, designed to determine baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP)and to evaluate the long-term effect of eltrombopag on bone marrow reticulin and/or collagen fibers. The duration of the screening period is up to 8 weeks. Eltrombopag will be administered for at least 2-years followed by a 4-week follow-up period. Bone marrow biopsies will be performed at screening, after 1-year and 2-years of eltrombopag treatment, and at early withdrawal of treatment. The screening bone marrow biopsy should be performed within 8 weeks of planned start of study medication and the bone marrow biopsy block must be available for central laboratory processing.
Interventions
Thrombopoietin receptor agonist
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have signed and dated a written informed consent and be able to understand and comply with protocol requirements and instructions. * Adults (≥18 years) diagnosed with chronic ITP according to the American Society for Hematology/British Committee for Standards in Hematology (ASH/BCSH) guidelines \[George, 1996; BCSH, 2003; Provan, 2009\]. In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other disease causative of thrombocytopenia (e.g., pseudo thrombocytopenia, myelofibrosis). The physical examination should not suggest any disease, which may cause thrombocytopenia other than ITP. * Subjects must be physically eligible for serial bone marrow biopsies and must have a bone marrow biopsy performed during screening, and be willing to remain on the study for at least 2 years with annual bone marrow biopsies. * Subjects, who previously received eltrombopag or romiplostim, must have completed treatment with these therapies at least 6 months prior to the screening bone marrow biopsy. * Subjects must have the following clinical chemistry values: * ALT and AST \< 2xULN; * Bilirubin \<1.5xULN (except for Gilbert's Syndrome); * Subjects are practicing an acceptable method of contraception as specified in the protocol. * In France, subjects will be eligible for inclusion in this study, only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
* Subjects with any clinically relevant abnormality, other than ITP, or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g., thrombocytopenia is secondary to another disease). * Subjects with any concurrent malignant disease and/or a recent history of cancer treatment with systemic chemotherapy and/or radiotherapy. Exception: Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * Subjects with any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any family history of arterial or venous thrombosis. * Subjects with screening bone marrow fibers of either MF Grade 3 using European Consensus scale or Grade 4 using Bauermeister scale. * Subjects with a QTc \>450 msec or \> 480 msec for subjects with Bundle Branch Block. * Female subjects who are nursing or pregnant (positive serum or urine β-human chorionic gonadotrophin (β-hCG) pregnancy test) at screening. * Subjects treated with an investigational drug (other than a thrombopopoetin-receptor (TPO-R) agonist) within 30 days or five half-lives (whichever is longer) preceding the first dose of eltrombopag in the study. (For romiplostim or eltrombopag, see inclusion criterion #4). * Subjects treated with any TPO-R agonist other than romiplostim or eltrombopag. * Subjects with recent history of alcohol/drug abuse as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Positive or Negative Collagen Level at 2 Year | 2 years | The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. |
| Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | Baseline and 1 year | The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. |
| Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | Baseline and 2 years | The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. |
| Number of Participants With a Positive or Negative Collagen Level at 1 Year | 1 year | The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. |
| Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline | Baseline | The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis \[MF\]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. |
| Number of Participants With a Positive or Negative Collagen Level at Baseline | Baseline | The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) | Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during. |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) | On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; \>1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; \>30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations. |
| Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) | Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during. |
Countries
Czechia, France, Germany, Hong Kong, Hungary, India, Italy, Pakistan, Russia, South Korea, United States
Participant flow
Pre-assignment details
A total of 167 participants were enrolled and received at least one dose of study medication. The 5 enrolled participants from center 082877 were excluded from the analysis due to the following: serious good clinical practice (GCP) findings related to informed consent, source documents and investigator study oversight.
Participants by arm
| Arm | Count |
|---|---|
| Eltrombopag Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response. | 162 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 22 |
| Overall Study | Lack of Efficacy | 11 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Eltrombopag |
|---|---|
| Age, Continuous | 43.1 Years STANDARD_DEVIATION 16.31 |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 47 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 32 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 81 Participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 114 / 162 |
| serious Total, serious adverse events | 42 / 162 |
Outcome results
Primary
Number of Participants With a Positive or Negative Collagen Level at 1 Year
The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.
Time frame: 1 year
Population: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 1 Year | Negative to Negative | 120 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 1 Year | Negative to Positive | 5 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 1 Year | Positive to Negative | 0 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 1 Year | Positive to Positive | 0 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 1 Year | Missing to Negative | 2 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 1 Year | Missing to Positive | 0 Participants |
Primary
Number of Participants With a Positive or Negative Collagen Level at 2 Year
The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.
Time frame: 2 years
Population: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 2 Year | Negative to Negative | 90 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 2 Year | Negative to Positive | 1 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 2 Year | Positive to Negative | 0 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 2 Year | Positive to Positive | 0 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 2 Year | Missing to Negative | 2 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at 2 Year | Missing to Positive | 0 Participants |
Primary
Number of Participants With a Positive or Negative Collagen Level at Baseline
The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Time frame: Baseline
Population: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at Baseline | Negative | 159 Participants |
| Eltrombopag | Number of Participants With a Positive or Negative Collagen Level at Baseline | Positive | 0 Participants |
Primary
Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline
The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis \[MF\]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Time frame: Baseline
Population: All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877. Participants with bone marrow biopsy data available in the relevant time period were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline | MF-0 | 150 Participants |
| Eltrombopag | Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline | MF-1 | 9 Participants |
| Eltrombopag | Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline | MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline | MF-3 | 0 Participants |
Primary
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Time frame: Baseline and 2 years
Population: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-0 to MF-0 | 79 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-0 to MF-1 | 9 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-0 to MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-0 to MF-3 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-1 to MF-0 | 2 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-1 to MF-1 | 1 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-1 to MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-1 to MF-3 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-2 to MF-0 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-2 to MF-1 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-2 to MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-2 to MF-3 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-3 to MF-0 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-3 to MF-1 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-3 to MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | MF-3 to MF-3 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | Missing to MF-0 | 2 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | Missing to MF-1 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | Missing to MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years | Missing to MF-3 | 0 Participants |
Primary
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Time frame: Baseline and 1 year
Population: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-0 to MF-0 | 82 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-0 to MF-1 | 33 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-0 to MF-2 | 2 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-0 to MF-3 | 2 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-1 to MF-0 | 3 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-1 to MF-1 | 2 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-1 to MF-2 | 1 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-1 to MF-3 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-2 to MF-0 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-2 to MF-1 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-2 to MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-2 to MF-3 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-3 to MF-0 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-3 to MF-1 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-3 to MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | MF-3 to MF-3 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | Missing to MF-0 | 2 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | Missing to MF-1 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | Missing to MF-2 | 0 Participants |
| Eltrombopag | Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year | Missing to MF-3 | 0 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy
On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; \>1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; \>30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.
Time frame: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)
Population: ATS Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | Any AE, on-therapy + 1 day | 141 Participants |
| Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | Any SAE, on-therapy + 1 day | 41 Participants |
| Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | Any AE, >1 to 30 days post therapy | 12 Participants |
| Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | Any SAE, >1 to 30 days post therapy | 5 Participants |
| Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | Any AE, >30 days post therapy | 9 Participants |
| Eltrombopag | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy | Any SAE, >30 days post therapy | 1 Participants |
Secondary
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.
Time frame: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)
Population: ATS Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Albumin, G0, n=162 | 151 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Albumin, G1, n=162 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Albumin, G2, n=162 | 6 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Albumin, G3, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Albumin, G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALP, G0, n=162 | 125 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALP, G1, n=162 | 35 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALP, G2, n=162 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALP, G3, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALP, G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALT, G0, n=162 | 109 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALT, G1, n=162 | 37 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALT, G2, n=162 | 8 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALT, G3, n=162 | 7 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | ALT, G4, n=162 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | AST, G0, n=162 | 99 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | AST, G1, n=162 | 48 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | AST, G2, n=162 | 8 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | AST, G3, n=162 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | AST, G4, n=162 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Total bilirubin, G0, n=162 | 103 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Total bilirubin, G1, n=162 | 40 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Total bilirubin, G2, n=162 | 17 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Total bilirubin, G3, n=162 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Total bilirubin, G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypercalcemia), G0, n=162 | 159 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypercalcemia), G1, n=162 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypercalcemia), G2, n=162 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypercalcemia), G3, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypercalcemia), G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypocalcemia), G0, n=162 | 92 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypocalcemia), G1, n=162 | 57 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypocalcemia), G2, n=162 | 12 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypocalcemia), G3, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Calcium (hypocalcemia), G4, n=162 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hyperkalemia), G0, n=162 | 138 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hyperkalemia), G1, n=162 | 14 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hyperkalemia), G2, n=162 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hyperkalemia), G3, n=162 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hyperkalemia), G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hypokalemia), G0, n=162 | 123 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hypokalemia), G1, n=162 | 35 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hypokalemia), G2, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hypokalemia), G3, n=162 | 4 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Potassium (hypokalemia), G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hypernatremia), G0, n=162 | 138 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hypernatremia), G1, n=162 | 20 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hypernatremia), G2, n=162 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hypernatremia), G3, n=162 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hypernatremia), G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hyponatremia), G0, n=162 | 137 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hyponatremia), G1, n=162 | 21 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hyponatremia), G2, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hyponatremia), G3, n=162 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Sodium (hyponatremia), G4, n=162 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Inorganic phosphorus, G0, n=162 | 100 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Inorganic phosphorus, G1, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Inorganic phosphorus, G2, n=162 | 52 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Inorganic phosphorus, G3, n=162 | 10 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Inorganic phosphorus, G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Creatinine, G0, n=162 | 149 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Creatinine, G1, n=162 | 8 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Creatinine, G2, n=162 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Creatinine, G3, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study | Creatinine, G4, n=162 | 2 Participants |
Secondary
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.
Time frame: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)
Population: ATS Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (increased), G0, n=162 | 143 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (increased), G1, n=162 | 17 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (increased), G2, n=162 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (increased), G3, n=162 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (increased), G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (anemia), G0, n=162 | 55 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (anemia), G1, n=162 | 63 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (anemia), G2, n=162 | 31 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (anemia), G3, n=162 | 13 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Hemoglobin (anemia), G4, n=162 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (increased), G0, n=161 | 122 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (increased), G1, n=161 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (increased), G2, n=161 | 39 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (increased), G3, n=161 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (increased), G4, n=161 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (decreased), G0, n=161 | 86 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (decreased), G1, n=161 | 36 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (decreased), G2, n=161 | 26 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (decreased), G3, n=161 | 13 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Lymphocyte count (decreased), G4, n=161 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Total ANC, G0, n=161 | 140 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Total ANC, G1, n=161 | 12 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Total ANC, G2, n=161 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Total ANC, G3, n=161 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Total ANC, G4, n=161 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Platelet count, G0, n=162 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Platelet count, G1, n=162 | 8 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Platelet count, G2, n=162 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Platelet count, G3, n=162 | 26 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | Platelet count, G4, n=162 | 123 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | WBC, G0, n=162 | 135 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | WBC, G1, n=162 | 21 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | WBC, G2, n=162 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | WBC, G3, n=162 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study | WBC, G4, n=162 | 0 Participants |