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Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrombopag | Experimental | Eligible subject will receive a starting dose of eltrombopag of 200 milligrams (mg) (100 mg for subjects of East Asian heritage). Dose modifications of eltrombopag will be permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at a safe and effective level (i.e. a level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
| Placebo | Placebo Comparator | Eligible subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | Eltrombopag will be round film-coated tablets containing eltrombopag equivalent to 50 mg (white to off-white), 200 mg and 300 mg (green) of eltrombopag free acid |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy | A subject is defined as being platelet transfusion independent if they received no platelet transfusions within the first 4 cycles of treatment with azacitidine. Subjects who died or withdrew from investigational product within the first four cycles were treated as failures (i.e. not transfusion independent) in the analysis | 4 cycles (Cycle = 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from randomization until death due to any cause and deaths have been presented. Subjects still alive at the time of the analysis and subjects who have withdrawn from the study will be censored at the time of last contact | Randomization until death or end of study, approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hartford | Connecticut | 06105 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30305280 | Derived | Dickinson M, Cherif H, Fenaux P, Mittelman M, Verma A, Portella MSO, Burgess P, Ramos PM, Choi J, Platzbecker U; SUPPORT study investigators. Azacitidine with or without eltrombopag for first-line treatment of intermediate- or high-risk MDS with thrombocytopenia. Blood. 2018 Dec 20;132(25):2629-2638. doi: 10.1182/blood-2018-06-855221. Epub 2018 Oct 10. |
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A total of 356 patients were enrolled in the study and 2 patients did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eltrombopag | Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Azacitidine | Drug | Subcutaneous Injection (IV if local standard) |
|
| Placebo | Drug | Eltrombopag matching placebo tablets |
|
| Placebo | Drug | Eltrombopag matching placebo tablets will be supplied |
|
| Summary of Progression Free Survival From Investigator Assessment (ITT) | Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts | First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years |
| Summary of Progression Free Survival From Central Review (ITT) | Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts | First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years |
| Summary of AML Progression From Investigator Assessment and Central Review (ITT) | Progression to AML in MDS patients with baseline bone marrow blast < 20% was defined as meeting definition of disease progression according to the modified 2006 IWG response criteria for MDS with the additional requirement that bone marrow blast or peripheral blast increases from < 20% at baseline to ≥ 20% postbaseline. Progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts | First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years |
| Best Disease Response From Investigator Assessment (ITT) | Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS | At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first |
| Best Disease Response From Central Review (ITT) | Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS | At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first |
| Hematologic Improvement (HI) in Platelets, Neutrophils, and Hemoglobin Based on the Modified IWG Criteria for MDS (ITT) | HI based on the modified IWG criteria for MDS. HI - Platelets (BL <100Gi/L), response criteria= BL <20: increase to>20 and 100% at least for 56 days or BL >=20: absolute increase of >=30. HI - Neutrophils (BL <1.0 Gi/L), response criteria=100% increase and an absolute increase >0.5 Gi/L over BL for at least 56 days. HI-Hemoglobin (BL <g/dL), response criteria=Hgb increase by >=1.5 g/dL over BL, RBC transfusions(given for Hgb<=9.0) reduced by >=4 per 8w from BL | From Day 1 to 4-week follow-up (samples collected weekly in Cycle 1, Days 1 and 15 in Cycles 2-6 and Day 1 of Cycles >=7) |
| Number of Participants Who Were Platelet Transfusion Independent (ITT Set) | Platelet transfusion independence is defined for each cycle as the number of participants who continue to the end of a cycle without requiring a platelet transfusion | From Day 1 to end of study treatment up to approximately 2 years |
| Bleeding Adverse Events (AEs) >= Grade 3 | Bleeding will be assessed by recording AEs or serious adverse events (SAEs) as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | From Day 1 to 4-week follow-up up to approximately 2 years |
| Number of of Subjects With Azacitidine Dose Delays, Dose Reductions, Interruptions | The proportion of subjects with any delay, reduction or interruption in dosage of Azacitidine excluding those for non-medical reasons will be analyzed | From Day 1 to 4-week follow-up up to approximately 2 years |
| Response Levels in All Domains of Euroquol-5 Dimensions of Health, 3 Response Levels (EQ-5D-3L™) | The EQ-5D is a general health status and health utility measure which captures 5 dimensions of health state: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. (EQ-5D is a trademark of the Stichting EuroQol Group) . C=cycle, D=Day | From Day 1 to 4-week follow-up up to approximately 2 years |
| Functional Assessment of Chronic Disease Therapy-fatigue Subscale (FACIT-Fatigue) (ITT) | The FACIT-Fatigue subscale measures severity and impact of fatigue on functioning and Health Related QoL experienced in the past 7 days. Scale is a 13 item measure of fatigure. Items are scored on a 0-4 response scale ranging from "not at all" to "very much so". All items are summed to create a single fatigure score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatiigue (The FACIT Fatigue Scale is owned by David Cella, Ph.D.) | From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years |
| Medical Resource Utilization (MRU): Event -Hospitalizations Inpatient and Outpatient | MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations | From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years |
| Medical Resource Utilization (MRU): Event and Use of Site Specific Medical Resources - Non-study Laboratory Tests | MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected | From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years |
| Medical Resource Utilization (MRU): Use of Site Specific Medical Resources | MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected | From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years |
| Summary of Post-Hoc Estimates of Steady-state Eltrombopag Cmax and Cmin Pharmacokinetic Parameters for a 50 mg Dose | Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163) | Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose |
| Summary of Post-Hoc Estimates of Steady-state Eltrombopag AUC0 Infinity Pharmacokinetic Parameters for a 50 mg Dose | Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163) | Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose |
| AUC0-infinity -Pharmacokinetic(s) Parameter of Azacitidine | An analysis of variance (ANOVA) on AUC0-infinity. The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + eltrombopag:azacitidine + placebo PK parameter ratios. | Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose |
| Cmax -Pharmacokinetic Parameter of Azacitidine | An analysis of variance (ANOVA) on Cmax . The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + ltrombopag:azacitidine + placebo PK parameter ratios. | Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose |
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| FG001 | Placebo | Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
| Treated |
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| Untreated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eltrombopag | Starting dose is 200 mg (100 mg for East Asian heritage). Dose modifications permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 300 mg (150 mg for East Asian heritage) in order to maintain platelet counts at safe, effective level (level sufficient to avoid platelet transfusions and bleeding events). Subjects will receive Azacitidine 75 mg/meter^2 is administered subcutaneously once daily for 7 days every 28 days, for at least 6 cycles, if tolerated, until they are no longer receiving benefit (at least stable disease), disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle if subject is receiving azacitidine |
| BG001 | Placebo | Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| IPSS risk score | A bone marrow examination for the determination of IPSS was performed during the screening period, or within 3 months prior to randomization. Assessment of bone marrow blasts was to be completed by bone marrow slide review. The patient's IPSS risk category is determined by adding together all of the IPSS scores within the three disease factors (blast cells, chromosomal changes, presence of cytopenias). That number is matched to one of the following four IPSS risk categories: Low, Intermediate-1, Intermediate-2, or High. The higher the score the higher the risk. | Number | participants |
| |||||||||||||||
| Platelet Count | Number | participants |
| ||||||||||||||||
| Platelet transfusion dependence | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy | A subject is defined as being platelet transfusion independent if they received no platelet transfusions within the first 4 cycles of treatment with azacitidine. Subjects who died or withdrew from investigational product within the first four cycles were treated as failures (i.e. not transfusion independent) in the analysis | Intent-to-Treat population, comprised of all randomized patients | Posted | Number | Participants | 4 cycles (Cycle = 28 days) |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization until death due to any cause and deaths have been presented. Subjects still alive at the time of the analysis and subjects who have withdrawn from the study will be censored at the time of last contact | Posted | Number | deaths (events) | Randomization until death or end of study, approximately 2 years |
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| Secondary | Summary of Progression Free Survival From Investigator Assessment (ITT) | Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts | The intent-to-treat (ITT) population included all the patients randomized in the study | Posted | Number | participants | First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years |
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| Secondary | Summary of Progression Free Survival From Central Review (ITT) | Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts | The intent-to-treat (ITT) population included all the patients randomized in the study | Posted | Number | participants | First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years |
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| Secondary | Summary of AML Progression From Investigator Assessment and Central Review (ITT) | Progression to AML in MDS patients with baseline bone marrow blast < 20% was defined as meeting definition of disease progression according to the modified 2006 IWG response criteria for MDS with the additional requirement that bone marrow blast or peripheral blast increases from < 20% at baseline to ≥ 20% postbaseline. Progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts | The intent-to-treat (ITT) population included all the patients randomized in the study | Posted | Number | participants | First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years |
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| Secondary | Best Disease Response From Investigator Assessment (ITT) | Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS | Posted | Number | participant | At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first |
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| Secondary | Best Disease Response From Central Review (ITT) | Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS | Posted | Number | participant | At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first |
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| Secondary | Hematologic Improvement (HI) in Platelets, Neutrophils, and Hemoglobin Based on the Modified IWG Criteria for MDS (ITT) | HI based on the modified IWG criteria for MDS. HI - Platelets (BL <100Gi/L), response criteria= BL <20: increase to>20 and 100% at least for 56 days or BL >=20: absolute increase of >=30. HI - Neutrophils (BL <1.0 Gi/L), response criteria=100% increase and an absolute increase >0.5 Gi/L over BL for at least 56 days. HI-Hemoglobin (BL <g/dL), response criteria=Hgb increase by >=1.5 g/dL over BL, RBC transfusions(given for Hgb<=9.0) reduced by >=4 per 8w from BL | Posted | Number | participants | From Day 1 to 4-week follow-up (samples collected weekly in Cycle 1, Days 1 and 15 in Cycles 2-6 and Day 1 of Cycles >=7) |
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| Secondary | Number of Participants Who Were Platelet Transfusion Independent (ITT Set) | Platelet transfusion independence is defined for each cycle as the number of participants who continue to the end of a cycle without requiring a platelet transfusion | Posted | Number | participants | From Day 1 to end of study treatment up to approximately 2 years |
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| Secondary | Bleeding Adverse Events (AEs) >= Grade 3 | Bleeding will be assessed by recording AEs or serious adverse events (SAEs) as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Posted | Number | participant | From Day 1 to 4-week follow-up up to approximately 2 years |
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| Secondary | Number of of Subjects With Azacitidine Dose Delays, Dose Reductions, Interruptions | The proportion of subjects with any delay, reduction or interruption in dosage of Azacitidine excluding those for non-medical reasons will be analyzed | Posted | Number | participant | From Day 1 to 4-week follow-up up to approximately 2 years |
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| Secondary | Response Levels in All Domains of Euroquol-5 Dimensions of Health, 3 Response Levels (EQ-5D-3L™) | The EQ-5D is a general health status and health utility measure which captures 5 dimensions of health state: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. (EQ-5D is a trademark of the Stichting EuroQol Group) . C=cycle, D=Day | Posted | Number | participant | From Day 1 to 4-week follow-up up to approximately 2 years |
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| Secondary | Functional Assessment of Chronic Disease Therapy-fatigue Subscale (FACIT-Fatigue) (ITT) | The FACIT-Fatigue subscale measures severity and impact of fatigue on functioning and Health Related QoL experienced in the past 7 days. Scale is a 13 item measure of fatigure. Items are scored on a 0-4 response scale ranging from "not at all" to "very much so". All items are summed to create a single fatigure score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatiigue (The FACIT Fatigue Scale is owned by David Cella, Ph.D.) | Posted | Mean | Standard Deviation | scores | From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years |
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| Secondary | Medical Resource Utilization (MRU): Event -Hospitalizations Inpatient and Outpatient | MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations | Posted | Mean | Standard Deviation | days | From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years |
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| Secondary | Medical Resource Utilization (MRU): Event and Use of Site Specific Medical Resources - Non-study Laboratory Tests | MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected | Posted | Number | tests | From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years |
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| Secondary | Medical Resource Utilization (MRU): Use of Site Specific Medical Resources | MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected | Posted | Number | visits | From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years |
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| Secondary | Summary of Post-Hoc Estimates of Steady-state Eltrombopag Cmax and Cmin Pharmacokinetic Parameters for a 50 mg Dose | Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163) | All patients with evaluable eltrombopag dosing, actual sampling time, and eltrombopag concentration data were included in the population PK dataset and analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose |
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| Secondary | Summary of Post-Hoc Estimates of Steady-state Eltrombopag AUC0 Infinity Pharmacokinetic Parameters for a 50 mg Dose | Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163) | All patients with evaluable eltrombopag dosing, actual sampling time, and eltrombopag concentration data were included in the population PK dataset and analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr.μg/mL | Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose |
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| Secondary | AUC0-infinity -Pharmacokinetic(s) Parameter of Azacitidine | An analysis of variance (ANOVA) on AUC0-infinity. The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + eltrombopag:azacitidine + placebo PK parameter ratios. | all patients with evaluable azacitidine dosing, actual sampling time, and azacitidine concentration data were included in the NCA dataset and analysis | Posted | Geometric Mean | Geometric Coefficient of Variation | hr.ng/mL | Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose |
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| Secondary | Cmax -Pharmacokinetic Parameter of Azacitidine | An analysis of variance (ANOVA) on Cmax . The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + ltrombopag:azacitidine + placebo PK parameter ratios. | All patients with evaluable azacitidine dosing, actual sampling time, and azacitidine concentration data were included in the NCA dataset and analysis | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose |
|
Timeframe for AE
AE additional description
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eltrombopag | Eltrombopag | 128 | 177 | 159 | 177 | ||
| EG001 | Placebo | Placebo | 100 | 177 | 153 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Cytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiovascular deconditioning | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Papillary muscle infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pericarditis constrictive | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Small intestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Anal fistula infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Fungal pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pyomyositis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Splenic abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Systemic mycosis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tongue fungal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood osmolarity decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypomania | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Renal tubular disorder | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypersensitivity vasculitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aortic dilatation | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
The IDMC recommended terminating the study for futility (primary) and safety (secondary). Due to early termination of the trial, the final analysis of OS took place at the same time as the final analysis of the primary end point.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novaratis does not prohibit any investigation from publishing. Any publications from a single-site are postposed until the publication of the pooled data (ie. data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharma AG | 862-778-8300 |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D009190 | Myelodysplastic Syndromes |
| C537560 | Jacobs syndrome |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C520809 | eltrombopag |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Male |
|
| East Asian/Japanese/S.E. Asian |
|
| Central/South Asian |
|
| Other |
|
| Missing |
|
| Int - 2 (1.5 - 2.0) |
|
| High Risk (≥ 2.5) |
|
| ≥ 10 - <20 |
|
| ≥ 20 - <50 |
|
| ≥ 50 - <100 |
|
| ≥ 100 |
|
| missing |
|
| No |
|
|
|
|
| Placebo |
Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
|
| Placebo |
Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
|
| OG001 | Placebo | Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
|
|
|
|
|
Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
|
|
|
|
|
|
|
|
|
Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Placebo |
Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
|
|
| Placebo |
Subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive matching placebo daily for the full 28 days each cycle for as long as the subject is receiving azacitidine |
|
|
|