Immune Thrombocytopenic Purpura (ITP)
Conditions
Keywords
Thrombocytopenic, Immune, Platelets, Bleeding, ITP, eltrombopag, ETB115, induce sustained response off treatment, refractory or relapsed, first-line steroids
Brief summary
The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.
Detailed description
Protocol Amendment 01 added a follow-up period of 12 months for patients with sustained response off treatment at month 12 to obtain further data on response duration. The starting dose was eltrombopag 50 mg daily (25 mg daily for Asian patients and 12.5 mg daily for Japanese patients in Japan). The starting dose for this study was consistent with the dosing guidelines approved for eltrombopag use in ITP. An increase of eltrombopag dose up to 75 mg was allowed for patients who did not respond to standard-dosage treatment and to reduce the risk of bleeding. The rationale for this increased dose was to use the minimal efficacious dosage of eltrombopag in order to achieve a platelet count ≥ 100×10\^9/L and maintain it around 100×10\^9/L (no counts below 70×10\^9/L) for 2 months in order to allow patients to start the eltrombopag tapering and withdrawal process. Patients who reached a platelet count of \>= 100 × 10\^9/L and maintained counts around 100×10\^9/L for 2 months with no platelet count \< 70 × 10\^9/L were eligible for tapering-off and treatment discontinuation, which occurred via 25 mg reduction every 2 weeks up to 25 mg on alternate days for 2 weeks until treatment discontinuation. Patients who successfully discontinue eltrombopag and maintained platelet count \>= 30 × 10\^9/L in the absence of bleeding or use of rescue therapy were followed to month 12. If a relapse (defined as platelet count \<30 × 10\^9/L) occurred during the 12-month treatment period, they were offered a new course of eltrombopag treatment within this timeframe at the appropriate starting dose. If a patient relapsed in the post 12-month follow-up period, no further attempts for tapering and achieving sustained response off treatment were made. The taper-off scheme followed recommendations within the current established dosing regimen for when to consider dose adjustment.
Interventions
DRUGeltrombopag
12.5, 25, 50 and 75 mg tablets for oral use once daily
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent must be obtained prior to participation in the study 2. Patients ≥ 18 years old 3. Patients with a confirmed diagnosis of primary ITP, who are not responsive or in relapse after a first line of steroid therapy ± intravenous immunoglobulin (IVIG) (used as a rescue therapy) 4. Platelet count \< 30×10\^9/L and assessed as needing treatment (per physician's discretion
Exclusion criteria
1. ITP patients previously treated with any ITP second-line therapies, thrombopoietin receptor (TPO-R) agonists for ITP, except steroids / IVIG 2. Patients who relapsed more than one year after the end of first-line full course of steroid therapy 3. Patients with a diagnosis of secondary thrombocytopenia 4. Patients who have life threatening bleeding complications per investigator discretion 5. Patients who had a deep vein thrombosis or arterial thrombosis in the 6 months preceding enrollment 6. Serum creatinine ≥ 1.5 mg/dL 7. Total bilirubin \> 1.5 × upper limit of normal (ULN) 8. Aspartate transaminase (AST) \> 3.0 × ULN 9. Alanine transaminase (ALT) \> 3.0 × ULN 10. Patients who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive 11. Patients with hepatic impairment (Child-Pugh score \> 5) 12. Patients who have active malignancy 13. Patients with any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures per investigator discretion 14. History or current diagnosis of cardiac disease indicating significant risk of safety for Patients participating in the study 15. Patients with known active or uncontrolled infections not responding to appropriate therapy 16. Patients with evidence of current alcohol/drug abuse 17. Women of child-bearing potential and sexually active males unwilling to use adequate contraception during the study 18. Female Patients who are nursing or pregnant (positive serum or urine B-human chorionic gonadotrophin (B-hCG) pregnancy test) at screening or pre-dose on Day 1 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Response Off Treatment (SRoT) by 12 Months | Month 12 | Sustained response off treatment (SRoT) was defined as: reaching platelet count \>= 100×10\^9/L (complete response \[CR\]) and then maintaining platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L), AND then tapering off the drug until treatment discontinuation while maintaining platelet count \>= 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy until month 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Median Duration of Sustained Response Off Treatment (SRoT) for Participants With Sustained Response Off Treatment at Month 12 and Who Enter 12 Months Follow-up Period | From last dose of eltrombopag to relapse, assessed up to month 24 | Sustained response off treatment (SRoT) was defined as: reaching platelet count \>= 100×10\^9/L (complete response \[CR\]) and then maintaining platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L), AND then tapering off the drug until treatment discontinuation while maintaining platelet count \>= 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy. Patients with SRoT until month 12 who entered follow-up and did not relapse by cut-off date/Month 24 were censored at the earliest of discontinuation date/death date/Month 24 platelet assessment date/cutoff date. Patients with SRoT until Month 12 patients who did not enter or do not yet have data in follow-up phase are censored at their Month 12 platelet assessment date. |
| Estimated Median Duration of Sustained Response Off Treatment (SRot) for All Patients | From last dose of eltrombopag to month 24 | Patients who tapered and discontinued successfully, or did not relapse/die by cutoff date /month 24 were censored at the earliest of discontinuation date/death date/month 24 platelet assessment date/cutoff date. |
| Percentage of Participants With Sustained Response Off Treatment Until Month 24 | Month 15, 18, 21 and 24 | Sustained response off treatment is defined as reach platelet count ≥ 100×10\^9/L (complete response \[CR\]) and then maintain platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy |
| Percentage of Participants With Early Response Within First Month | By 1 month | Early response is defined as reaching a platelet count \>= 50×10\^9/L at least once within the first month (month 1) without bleeding events and no rescue therapy. |
| Percentage of Participants With Recovery Response in Case of Loss of Response During or After Tapering of Eltrombopag Until Month 24 | Up to month 24 | Recovery response is defined as platelet count \>=30×10\^9/L after eltrombopag is re-introduced, in case of loss of response (\< 30×10\^9/L and/or bleeding event) without bleeding events and no rescue therapy. |
| Relative Change From Baseline in Platelet Count Over Time | Baseline, month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | Relative change (%) is the absolute change divided by the platelet counts at baseline and multiplied by 100. |
| Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | From first time of reaching the level to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | Platelet counts level is defined as having platelet counts \>=30×10\^9/L without bleeding events and no rescue therapy. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue©) is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities over the past 7 days. FACIT-fatigue is scored using a 4-point Likert scale. Items are scored as follows: 4 = Not At All; 3 = A Little Bit; 2 = Somewhat; 1 = Quite A Bit; 0 = Very Much, EXCEPT items #7 and #8 which are reversed scored. Score range from 0-52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life (less fatigue). |
| Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | FACT-Th6 instrument is used to measure worry/concern about bleeding and bruising, and the impact of this worry/concern on physical and social activity (Cella 2006). FACT-Th6 is a 6-item subset of the more detailed FACT-Th, which is an 18-item subscale of the validated FACT that specifically measures concerns related to thrombocytopenia in the past 7 days. The FACT-Th6 is scored using a 5-level Likert scale (0=not at all to 4=very much) and is calculated by summing scores for the 6-items; therefore, scores can range from 0-24, with higher scores representing better HRQoL |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Median Duration of Sustained Response Off Treatment (SRoT) After Treatment Discontinuation for Participants With Sustained Response Off Treatment | From last dose of eltrombopag to month 12 | Sustained response off treatment (SRoT) was defined as: reaching platelet count \>= 100×10\^9/L (complete response \[CR\]) and then maintaining platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L), AND then tapering off the drug until treatment discontinuation while maintaining platelet count \>= 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy until month 12. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
| Percentage of Participants With Worst Post-baseline Value in Functional Assessment of Cancer Therapy-G (GP5) | Baseline to end of treatment visit, assessed up to 12 months for non-responders and up to 24 months for responders | The GP5 is a single question used to assess the overall bothersomeness of treatment side effects. The GP5 is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bothersomeness from treatment side effects. |
| Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Baseline to month 12 (End of Treatment Visit for non-responders) and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement. |
| Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders | The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL. |
Countries
Austria, Brazil, Chile, France, Greece, Italy, Japan, Mexico, Oman, Russia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
This study was conducted in 32 investigative sites in 15 countries:1 (Austria), 3 (Brazil), 2 (Chile), 2 (France), 2 (Greece), 2 (Italy), 1 (Japan), 2 (Mexico), 1 (Oman), 2 (Russia), 7 (Spain), 1 (Switzerland), 3 (Turkey), 1 (UK), 2 (USA).
Participants by arm
| Arm | Count |
|---|---|
| Eltrombopag Participants were treated with eltrombopag to induce sustained response off treatment to reach a target platelet count of \>=100×10\^9/L (CR), after 1st line steroids had failed. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Death | 3 |
| Overall Study | Lack of Efficacy | 10 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | New therapy for study indication | 6 |
| Overall Study | Patient Decision (Patient Changed Her Address) | 1 |
| Overall Study | Patient Decision (Personal Reasons) | 1 |
| Overall Study | Physician Decision (Patient non-compliant) | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Eltrombopag |
|---|---|
| Age, Continuous | 48.1 Years STANDARD_DEVIATION 19.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 95 Participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 41 Participants |
| Time since initial diagnosis | 366.37 Days STANDARD_DEVIATION 911.42 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 105 | 1 / 102 |
| other Total, other adverse events | 64 / 105 | 0 / 0 |
| serious Total, serious adverse events | 21 / 105 | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Sustained Response Off Treatment (SRoT) by 12 Months
Sustained response off treatment (SRoT) was defined as: reaching platelet count \>= 100×10\^9/L (complete response \[CR\]) and then maintaining platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L), AND then tapering off the drug until treatment discontinuation while maintaining platelet count \>= 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy until month 12.
Time frame: Month 12
Population: Full Analysis Set, which included all patients who received at least one dose of eltrombopag.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag | Percentage of Participants With Sustained Response Off Treatment (SRoT) by 12 Months | 30.5 Percentage of participants |
p-value: <0.0001Clopper Pearson test
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire
FACT-Th6 instrument is used to measure worry/concern about bleeding and bruising, and the impact of this worry/concern on physical and social activity (Cella 2006). FACT-Th6 is a 6-item subset of the more detailed FACT-Th, which is an 18-item subscale of the validated FACT that specifically measures concerns related to thrombocytopenia in the past 7 days. The FACT-Th6 is scored using a 5-level Likert scale (0=not at all to 4=very much) and is calculated by summing scores for the 6-items; therefore, scores can range from 0-24, with higher scores representing better HRQoL
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | 3 Months | 3.80 Unit on a scale | Standard Deviation 5.13 |
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | 6 Months | 4.35 Unit on a scale | Standard Deviation 6.312 |
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | 9 Months | 5.60 Unit on a scale | Standard Deviation 6.114 |
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | 12 Months | 5.62 Unit on a scale | Standard Deviation 6.505 |
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | 15 Months | 5.44 Unit on a scale | Standard Deviation 8.949 |
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | 18 Months | 7.04 Unit on a scale | Standard Deviation 7.654 |
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | 21 Months | 7.32 Unit on a scale | Standard Deviation 7.351 |
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | 24 Months | 7.08 Unit on a scale | Standard Deviation 7.048 |
| Eltrombopag | Change From Baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) Questionnaire | end of treatment visit | 4.15 Unit on a scale | Standard Deviation 6.631 |
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue©) is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities over the past 7 days. FACIT-fatigue is scored using a 4-point Likert scale. Items are scored as follows: 4 = Not At All; 3 = A Little Bit; 2 = Somewhat; 1 = Quite A Bit; 0 = Very Much, EXCEPT items #7 and #8 which are reversed scored. Score range from 0-52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life (less fatigue).
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | 3 Months | 5.42 Unit on a scale | Standard Deviation 9.7 |
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | 6 Months | 6.15 Unit on a scale | Standard Deviation 8.779 |
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | 9 Months | 6.89 Unit on a scale | Standard Deviation 9.291 |
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | 12 Months | 7.90 Unit on a scale | Standard Deviation 9.064 |
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | 15 Months | 7.12 Unit on a scale | Standard Deviation 11.72 |
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | 18 Months | 8.87 Unit on a scale | Standard Deviation 11.644 |
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | 21 Months | 8.80 Unit on a scale | Standard Deviation 11.112 |
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | 24 Months | 8.69 Unit on a scale | Standard Deviation 10.635 |
| Eltrombopag | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionaire | end of treatment visit | 5.40 Unit on a scale | Standard Deviation 10.116 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | 3 Months | 7.55 Unit on a scale | Standard Deviation 24.199 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | 6 Months | 2.75 Unit on a scale | Standard Deviation 24.636 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | 9 Months | 3.82 Unit on a scale | Standard Deviation 21.507 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | 12 Months | 7.53 Unit on a scale | Standard Deviation 25.547 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | 15 Months | 1.96 Unit on a scale | Standard Deviation 36.697 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | 18 Months | 13.61 Unit on a scale | Standard Deviation 26.662 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | 21 Months | 3.00 Unit on a scale | Standard Deviation 20.967 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | 24 Months | 9.27 Unit on a scale | Standard Deviation 29.09 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Bodily Pain (BP) Score | end of treatment visit | 5.19 Unit on a scale | Standard Deviation 29.46 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | 3 Months | 4.12 Unit on a scale | Standard Deviation 18.894 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | 6 Months | 5.39 Unit on a scale | Standard Deviation 20.646 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | 9 Months | 7.40 Unit on a scale | Standard Deviation 17.99 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | 12 Months | 7.62 Unit on a scale | Standard Deviation 18.42 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | 15 Months | 11.17 Unit on a scale | Standard Deviation 20.47 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | 18 Months | 14.78 Unit on a scale | Standard Deviation 26.801 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | 21 Months | 14.36 Unit on a scale | Standard Deviation 25.541 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | 24 Months | 13.92 Unit on a scale | Standard Deviation 19.577 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: General Health (GH) Score | end of treatment visit | 3.80 Unit on a scale | Standard Deviation 18.122 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | 3 Months | 2.34 Unit on a scale | Standard Deviation 8.443 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | 6 Months | 2.85 Unit on a scale | Standard Deviation 9.451 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | 9 Months | 4.52 Unit on a scale | Standard Deviation 7.815 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | 12 Months | 5.33 Unit on a scale | Standard Deviation 8.719 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | 15 Months | 3.28 Unit on a scale | Standard Deviation 11.083 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | 18 Months | 7.12 Unit on a scale | Standard Deviation 11.312 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | 21 Months | 7.18 Unit on a scale | Standard Deviation 11.143 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | 24 Months | 6.87 Unit on a scale | Standard Deviation 9.081 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Component Summary (MCS) Score | end of treatment visit | 3.53 Unit on a scale | Standard Deviation 9.002 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | 3 Months | 6.74 Unit on a scale | Standard Deviation 15.775 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | 6 Months | 6.97 Unit on a scale | Standard Deviation 18.149 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | 9 Months | 9.78 Unit on a scale | Standard Deviation 15.074 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | 12 Months | 10.26 Unit on a scale | Standard Deviation 16.125 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | 15 Months | 7.08 Unit on a scale | Standard Deviation 22.259 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | 18 Months | 15.22 Unit on a scale | Standard Deviation 22.334 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | 21 Months | 14.32 Unit on a scale | Standard Deviation 20.948 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | 24 Months | 12.50 Unit on a scale | Standard Deviation 17.103 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Mental Health (MH) Score | end of treatment visit | 6.82 Unit on a scale | Standard Deviation 17.058 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | 21 Months | 6.65 Unit on a scale | Standard Deviation 8.017 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | 24 Months | 6.63 Unit on a scale | Standard Deviation 9.627 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | end of treatment visit | 3.30 Unit on a scale | Standard Deviation 9.728 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | 3 Months | 3.46 Unit on a scale | Standard Deviation 7.445 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | 6 Months | 2.72 Unit on a scale | Standard Deviation 8.165 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | 9 Months | 3.92 Unit on a scale | Standard Deviation 7.608 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | 12 Months | 4.85 Unit on a scale | Standard Deviation 8.946 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | 15 Months | 4.37 Unit on a scale | Standard Deviation 11.754 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Component Summary (PCS) Score | 18 Months | 6.77 Unit on a scale | Standard Deviation 9.95 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | 3 Months | 8.48 Unit on a scale | Standard Deviation 23.842 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | 6 Months | 10.90 Unit on a scale | Standard Deviation 26.069 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | 9 Months | 12.67 Unit on a scale | Standard Deviation 28.074 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | 12 Months | 14.31 Unit on a scale | Standard Deviation 28.767 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | 15 Months | 11.87 Unit on a scale | Standard Deviation 37.469 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | 18 Months | 19.35 Unit on a scale | Standard Deviation 33.449 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | 21 Months | 24.09 Unit on a scale | Standard Deviation 31.983 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | 24 Months | 16.54 Unit on a scale | Standard Deviation 35.882 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Physical Functioning (PF) Score | end of treatment visit | 9.00 Unit on a scale | Standard Deviation 29.376 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | 3 Months | 4.42 Unit on a scale | Standard Deviation 22.371 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | 6 Months | 6.15 Unit on a scale | Standard Deviation 23.27 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | 9 Months | 8.89 Unit on a scale | Standard Deviation 22.361 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | 12 Months | 10.20 Unit on a scale | Standard Deviation 23.26 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | 15 Months | 4.86 Unit on a scale | Standard Deviation 27.022 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | 18 Months | 13.04 Unit on a scale | Standard Deviation 26.211 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | 21 Months | 16.29 Unit on a scale | Standard Deviation 25.52 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | 24 Months | 16.03 Unit on a scale | Standard Deviation 20.128 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Emotional (RE) Score | end of treatment visit | 7.25 Unit on a scale | Standard Deviation 22.078 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | 3 Months | 13.26 Unit on a scale | Standard Deviation 22.958 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | 6 Months | 9.43 Unit on a scale | Standard Deviation 27.066 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | 9 Months | 17.36 Unit on a scale | Standard Deviation 24.165 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | 12 Months | 19.94 Unit on a scale | Standard Deviation 29.232 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | 15 Months | 15.89 Unit on a scale | Standard Deviation 37.454 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | 18 Months | 22.55 Unit on a scale | Standard Deviation 32.68 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | 21 Months | 27.27 Unit on a scale | Standard Deviation 33.604 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | 24 Months | 29.81 Unit on a scale | Standard Deviation 32.849 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Role Physical (RP) Score | end of treatment visit | 15.88 Unit on a scale | Standard Deviation 33.332 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | 3 Months | 6.06 Unit on a scale | Standard Deviation 24.143 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | 6 Months | 7.17 Unit on a scale | Standard Deviation 26.951 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | 9 Months | 10.00 Unit on a scale | Standard Deviation 22.863 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | 12 Months | 16.38 Unit on a scale | Standard Deviation 26.408 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | 15 Months | 14.58 Unit on a scale | Standard Deviation 30.986 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | 18 Months | 26.63 Unit on a scale | Standard Deviation 24.514 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | 21 Months | 20.45 Unit on a scale | Standard Deviation 26.318 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | 24 Months | 25.96 Unit on a scale | Standard Deviation 22.617 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Social Functioning (SF) Score | end of treatment visit | 11.18 Unit on a scale | Standard Deviation 26.236 |
Secondary
Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role emotional (SE), role physical (RP), social role functioning (SF) and vitality (VT)) which can be aggregated to derive a physical-component summary (PCS) score and a mental-component score (MCS). The SF-36 is scored using norm-based scoring procedures: each sub-scale score ranges from 0 to 10, and the composite score ranges from 0 to 100. Higher scores indicative of better HRQoL.
Time frame: Baseline to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | 3 Months | 7.48 Unit on a scale | Standard Deviation 18.418 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | 6 Months | 6.45 Unit on a scale | Standard Deviation 20.696 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | 9 Months | 12.78 Unit on a scale | Standard Deviation 20.982 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | 12 Months | 14.33 Unit on a scale | Standard Deviation 22.398 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | 15 Months | 8.33 Unit on a scale | Standard Deviation 26.237 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | 18 Months | 12.23 Unit on a scale | Standard Deviation 27.918 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | 21 Months | 17.33 Unit on a scale | Standard Deviation 26.087 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | 24 Months | 11.06 Unit on a scale | Standard Deviation 24.705 |
| Eltrombopag | Change From Baseline in Short Form 36 Health Survey (SF-36v2) Questionnaire: Vitality (VT) Score | end of treatment visit | 8.97 Unit on a scale | Standard Deviation 22.503 |
Secondary
Estimated Median Duration of Sustained Response Off Treatment (SRot) for All Patients
Patients who tapered and discontinued successfully, or did not relapse/die by cutoff date /month 24 were censored at the earliest of discontinuation date/death date/month 24 platelet assessment date/cutoff date.
Time frame: From last dose of eltrombopag to month 24
Population: Full Analysis Set. No data collected for this endpoint.
Secondary
Estimated Median Duration of Sustained Response Off Treatment (SRoT) for Participants With Sustained Response Off Treatment at Month 12 and Who Enter 12 Months Follow-up Period
Sustained response off treatment (SRoT) was defined as: reaching platelet count \>= 100×10\^9/L (complete response \[CR\]) and then maintaining platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L), AND then tapering off the drug until treatment discontinuation while maintaining platelet count \>= 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy. Patients with SRoT until month 12 who entered follow-up and did not relapse by cut-off date/Month 24 were censored at the earliest of discontinuation date/death date/Month 24 platelet assessment date/cutoff date. Patients with SRoT until Month 12 patients who did not enter or do not yet have data in follow-up phase are censored at their Month 12 platelet assessment date.
Time frame: From last dose of eltrombopag to relapse, assessed up to month 24
Population: Full Analysis Set. No data collected for this endpoint.
Secondary
Median Duration of Sustained Response Off Treatment (SRoT) After Treatment Discontinuation for Participants With Sustained Response Off Treatment
Sustained response off treatment (SRoT) was defined as: reaching platelet count \>= 100×10\^9/L (complete response \[CR\]) and then maintaining platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L), AND then tapering off the drug until treatment discontinuation while maintaining platelet count \>= 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy until month 12.
Time frame: From last dose of eltrombopag to month 12
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eltrombopag | Median Duration of Sustained Response Off Treatment (SRoT) After Treatment Discontinuation for Participants With Sustained Response Off Treatment | 33.3 Weeks |
Secondary
Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9)
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.
Time frame: Baseline to month 12 (End of Treatment Visit for non-responders) and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Global Satisfaction change from BL at 12 months | 17.78 Unit on a scale | Standard Deviation 29.201 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Global Satisfaction change from BL at 24 months | 17.69 Unit on a scale | Standard Deviation 26.11 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Global Satisfaction change from BL at end of treatment visit | 9.96 Unit on a scale | Standard Deviation 33.966 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Effectiveness change from BL at 12 months | 18.82 Unit on a scale | Standard Deviation 33.809 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Effectiveness change from BL at 24 months | 17.99 Unit on a scale | Standard Deviation 29.913 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Effectiveness change from BL at end of treatment visit | 14.14 Unit on a scale | Standard Deviation 36.673 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Convenience change from BL at 12 months | 17.69 Unit on a scale | Standard Deviation 30.758 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Convenience change from BL at 24 months | 19.05 Unit on a scale | Standard Deviation 25.189 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Convenience change from BL at end of treatment visit | 15.07 Unit on a scale | Standard Deviation 30.253 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Total score change from BL at 12 months | 54.29 Unit on a scale | Standard Deviation 78.218 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Total score change from BL at 24 months | 54.72 Unit on a scale | Standard Deviation 75.463 |
| Eltrombopag | Overall Change of Treatment Satisfaction Using Treatment Satisfaction Questionnaire (TSQM-9) | Total score change from BL at end of treatment visit | 39.17 Unit on a scale | Standard Deviation 86.449 |
Secondary
Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24
Platelet counts level is defined as having platelet counts \>=30×10\^9/L without bleeding events and no rescue therapy.
Time frame: From first time of reaching the level to month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to month 21 | 13.3 Percentage of participants |
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to month 3 | 49.5 Percentage of participants |
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to month 6 | 38.1 Percentage of participants |
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to month 9 | 28.6 Percentage of participants |
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to month 12 | 28.6 Percentage of participants |
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to month 15 | 20.0 Percentage of participants |
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to month 18 | 17.1 Percentage of participants |
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to month 24 | 14.3 Percentage of participants |
| Eltrombopag | Percentage of Participants Who Maintain Platelet Counts Level Within 12 Months and Every 3 Months Until Month 24 | maintain platelet counts level from the first time of reaching that level to end of treatment visit | 31.4 Percentage of participants |
Secondary
Percentage of Participants With Early Response Within First Month
Early response is defined as reaching a platelet count \>= 50×10\^9/L at least once within the first month (month 1) without bleeding events and no rescue therapy.
Time frame: By 1 month
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eltrombopag | Percentage of Participants With Early Response Within First Month | 76.2 Percentage of participants |
Secondary
Percentage of Participants With Recovery Response in Case of Loss of Response During or After Tapering of Eltrombopag Until Month 24
Recovery response is defined as platelet count \>=30×10\^9/L after eltrombopag is re-introduced, in case of loss of response (\< 30×10\^9/L and/or bleeding event) without bleeding events and no rescue therapy.
Time frame: Up to month 24
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Percentage of Participants With Recovery Response in Case of Loss of Response During or After Tapering of Eltrombopag Until Month 24 | Participants with loss of response | 11.4 Percentage of participants |
| Eltrombopag | Percentage of Participants With Recovery Response in Case of Loss of Response During or After Tapering of Eltrombopag Until Month 24 | Participants with recovery response | 6.7 Percentage of participants |
Secondary
Percentage of Participants With Sustained Response Off Treatment Until Month 24
Sustained response off treatment is defined as reach platelet count ≥ 100×10\^9/L (complete response \[CR\]) and then maintain platelet counts around 100×10\^9/L for 2 months (no counts below 70×10\^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10\^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy
Time frame: Month 15, 18, 21 and 24
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eltrombopag | Percentage of Participants With Sustained Response Off Treatment Until Month 24 | Month 15 | 21 Participants |
| Eltrombopag | Percentage of Participants With Sustained Response Off Treatment Until Month 24 | Month 18 | 18 Participants |
| Eltrombopag | Percentage of Participants With Sustained Response Off Treatment Until Month 24 | Month 21 | 14 Participants |
| Eltrombopag | Percentage of Participants With Sustained Response Off Treatment Until Month 24 | Month 24 | 15 Participants |
Secondary
Percentage of Participants With Worst Post-baseline Value in Functional Assessment of Cancer Therapy-G (GP5)
The GP5 is a single question used to assess the overall bothersomeness of treatment side effects. The GP5 is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bothersomeness from treatment side effects.
Time frame: Baseline to end of treatment visit, assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eltrombopag | Percentage of Participants With Worst Post-baseline Value in Functional Assessment of Cancer Therapy-G (GP5) | Rating 0 | 51 Participants |
| Eltrombopag | Percentage of Participants With Worst Post-baseline Value in Functional Assessment of Cancer Therapy-G (GP5) | Rating 1 | 15 Participants |
| Eltrombopag | Percentage of Participants With Worst Post-baseline Value in Functional Assessment of Cancer Therapy-G (GP5) | Rating 2 | 10 Participants |
| Eltrombopag | Percentage of Participants With Worst Post-baseline Value in Functional Assessment of Cancer Therapy-G (GP5) | Rating 3 | 2 Participants |
| Eltrombopag | Percentage of Participants With Worst Post-baseline Value in Functional Assessment of Cancer Therapy-G (GP5) | Rating 4 | 5 Participants |
| Eltrombopag | Percentage of Participants With Worst Post-baseline Value in Functional Assessment of Cancer Therapy-G (GP5) | Missing | 22 Participants |
Secondary
Relative Change From Baseline in Platelet Count Over Time
Relative change (%) is the absolute change divided by the platelet counts at baseline and multiplied by 100.
Time frame: Baseline, month 3, 6, 9, 12 (End of Treatment Visit for non-responders), 15, 18, 21 and 24 (End of Treatment Visit for responders), assessed up to 12 months for non-responders and up to 24 months for responders
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | 9 Months | 1396.68 Percentage of change | Standard Deviation 3238.68 |
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | 3 Months | 1384.29 Percentage of change | Standard Deviation 3383.702 |
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | 6 Months | 1313.10 Percentage of change | Standard Deviation 3459.616 |
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | 12 Months | 1464.95 Percentage of change | Standard Deviation 3509.964 |
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | 15 Months | 1622.19 Percentage of change | Standard Deviation 3712.156 |
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | 18 Months | 1664.90 Percentage of change | Standard Deviation 3718.191 |
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | 21 Months | 2527.20 Percentage of change | Standard Deviation 5098.612 |
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | 24 Months | 1691.68 Percentage of change | Standard Deviation 3611.977 |
| Eltrombopag | Relative Change From Baseline in Platelet Count Over Time | end of treatment visit | 1213.91 Percentage of change | Standard Deviation 2952.719 |
Post Hoc
All Collected Deaths
On-treatment deaths were reported from the date of first dose of eltrombopag to 30 days after the date of the last non-zero dose of eltrombopag for patients who discontinued on or before month 12 (i.e., non-responders). For patients ongoing at month 12, the on-treatment period lasted until the cut-off date for the primary analysis (22-Oct-2021; approximately 35 months), as a patient could restart treatment at any time during study. Post-treatment deaths were collected in the post treatment period from 31 days after last dose of study medication until the cut-off date for the primary analysis (22-Oct-2021; approximately 35 months). These are not considered Adverse Events.
Time frame: On-treatment deaths: Up to approximately 35 months. Post-treatment deaths: Up to approximately 35 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eltrombopag | All Collected Deaths | On-treatment deaths | 3 Participants |
| Eltrombopag | All Collected Deaths | Post-treatment deaths | 1 Participants |
| Eltrombopag | All Collected Deaths | All deaths | 4 Participants |