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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001129-15 | EudraCT Number |
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In the context of COVID-19 pandemic, the benefit / risk ratio of the participation of a patient with pancytopenia could be compromised. The decision of this premature termination was not the consequence of any safety reason inherent to the drug.
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The purpose of this study was to evaluate the efficacy of eltrombopag for poor graft function (PGF) on overall hematologic response (partial and complete), as determined by platelet, hemoglobin and neutrophil counts by 16 weeks after the initiation of eltrombopag in patients with poor graft function after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
This was an open-label, single-arm phase II study, in which participants diagnosed with PGF after allo-HSCT were treated with eltrombopag up to week 36 or until the participant's premature withdrawal.
The study consisted of the following periods:
Participants who discontinued eltrombopag because efficacy, continued in the study and attended the scheduled visits of Treatment Period as per protocol. If loss of response occurred, eltrombopag was reintroduced at the last effective dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrombopag | Experimental | Patients received eltrombopag orally once daily up to 36 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | Eltrombopag was provided as 50 mg or 25 mg film-coated tablets for oral use administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematologic Response Rate by 16 Weeks After the Initiation of Eltrombopag | Hematologic response rate was defined as the percentage of participants who met the criteria of either complete response (CR) or partial response (PR) by Week 16. PR was defined when any of the following: Platelet count ≥ 20000/microliter(μL) (with platelet transfusion independence), absolute neutrophil count (ANC) ≥1000/μL (when pretreatment ANC was <1000/μL) and/or hemoglobin (Hb) ≥100 gram(g)/ liter(L) (when pretreatment Hb was <100g/L) (with red blood cells transfusion independence), confirmed in two blood tests separated a minimum of 7 days. CR was defined when all of the following: platelet count ≥100000/μL, ANC ≥1500/μL (when pretreatment ANC was <1000/μL) and Hb ≥110 g/L (when pretreatment Hb was <100g/L), confirmed in two blood tests separated a minimum of 7 days. Participants who discontinued before Week 16 were considered as responders if, in the last evaluation, they had PR or CR. The 95% Confidence Interval (CI) was the binomial exact CI based on Clopper-Pearson method. | Baseline up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had a Response in the Neutrophil Lineage | Percentage of participants who had a response (partial or complete) in the neutrophil lineage. A partial response in the neutrophil lineage was defined as absolute neutrophil count (ANC) ≥1000/ µL (when pretreatment ANC was <1000/μL) confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the neutrophil lineage was defined as ANC ≥ 1500/ µL (when pretreatment ANC was <1000/μL) confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method |
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Inclusion Criteria:
Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must provide written, signed and dated informed consent form before any study assessment is performed
Male of female patients ≥ 18 years of age
Patients diagnosed with primary or secondary poor graft function (PGF) defined as two or more cytopenias after day +30 post-transplant (re-tested in a peripheral blood analysis at screening):
Presence of donor chimerism >90% in screening visit
Karnofsky status ≥90% (Karnofsky assessment must be performed within 7 days prior to Day 1)
Exclusion Criteria:
Pregnant or nursing (lactating women).
Evidence of active acute or chronic graft versus host disease (GVHD).
Evidence of any active malignancy.
Subjects who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive in screening visit.
Cytogenetic abnormality in chromosome 7 present before the allo-HSC.
Evidence of any clonal abnormality on cytogenetics (in bone marrow analysis).
As a consequence, patients with dry tap bone marrow aspiration are NOT eligible.
Evidence of bone marrow involvement or progression of the underlying disease assessed by the applicable methods in each case.
Evidence of thrombotic microangiopathy.
Evidence of possible causes of cytopenia other than PGF (active infections, myelotoxic drugs, hypersplenism…).
Prior use of any thrombopoietin receptor (TPO-R) agonists for PGF.
AST or ALT levels >3 x ULN.
Creatinine level ≥1.5 x ULN.
Total bilirubin level ≥1.5 x ULN.
Previous thromboembolic event (other than line-related upper extremity thrombosis)
Hypersensitivity to eltrombopag or its components.
Clinically significant ECG abnormality history or current diagnosis of cardiac disease indicating significant risk of safety for subjects participating in the study such as uncontrolled or significant cardiac disease or impaired cardiac function including any of the following:
Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
Patient with liver cirrhosis.
Risk factors for Torsade de Pointes including uncorrected hypokalemia or hypomagnesemia.
Subjects with any serious and/ or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with patient´s safety, obtaining informed consent or compliance with the study procedures as per investigator discretion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Plain Language Trial Summary | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A total of 25 participants were screened in this study of which 15 failed screening and 10 participants were enrolled in the study.
The study was conducted across 7 centers in 1 country (Spain).
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| ID | Title | Description |
|---|---|---|
| FG000 | Eltrombopag | Participants received eltrombopag orally once daily up to 36 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Eltrombopag | Participants received eltrombopag orally once daily up to 36 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hematologic Response Rate by 16 Weeks After the Initiation of Eltrombopag | Hematologic response rate was defined as the percentage of participants who met the criteria of either complete response (CR) or partial response (PR) by Week 16. PR was defined when any of the following: Platelet count ≥ 20000/microliter(μL) (with platelet transfusion independence), absolute neutrophil count (ANC) ≥1000/μL (when pretreatment ANC was <1000/μL) and/or hemoglobin (Hb) ≥100 gram(g)/ liter(L) (when pretreatment Hb was <100g/L) (with red blood cells transfusion independence), confirmed in two blood tests separated a minimum of 7 days. CR was defined when all of the following: platelet count ≥100000/μL, ANC ≥1500/μL (when pretreatment ANC was <1000/μL) and Hb ≥110 g/L (when pretreatment Hb was <100g/L), confirmed in two blood tests separated a minimum of 7 days. Participants who discontinued before Week 16 were considered as responders if, in the last evaluation, they had PR or CR. The 95% Confidence Interval (CI) was the binomial exact CI based on Clopper-Pearson method. | All participants to whom study treatment was assigned. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to Week 16 |
From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eltrombopag (On-treatment) | AEs during on-treatment period (up to 30 days post-treatment) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast pain | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2019 | Nov 3, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2020 | Nov 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| Week 16, 20, 24, 30 and 36 |
| Percentage of Participants Who Had a Response in the Platelet Lineage | Percentage of participants who had a response (partial or complete) in the platelet lineage. A partial response in the platelet lineage was defined as platelet count ≥20000/µL (with platelet transfusion independence) confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the platelet lineage was defined as platelet count ≥ 100000/µL confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | Week 16, 20, 24, 30 and 36 |
| Percentage of Participants Who Had a Response in the Hemoglobin Lineage | Percentage of participants who had a response (partial or complete) in the hemoglobin (Hb) lineage. A partial response in the Hb lineage was defined as Hb ≥100 g/L (when pretreatment Hb was <100g/L) (with RBC transfusion independence), confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the Hb lineage was defined as Hb≥ 110 g/L (when pretreatment Hb was <100g/L) confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | Week 16, 20, 24, 30 and 36 |
| Hematologic Response Rate at Week 24 and 36 | Hematologic response rate was defined as the percentage of participants who met the criteria of either complete response (CR) or partial response (PR) at 24 weeks and 36 weeks after the initiation of eltrombopag. PR was defined when any of the following: Platelet count ≥20000/microliter (μL) (with platelet transfusion independence), absolute neutrophil count (ANC) ≥1000/μL (when pretreatment ANC was <1000/μL) and/or hemoglobin (Hb) ≥100 gram (g)/ liter (L) (when pretreatment Hb was <100g/L) (with red blood cells transfusion independence), confirmed in two blood tests separated a minimum of 7 days. CR was defined when all three of the following: platelet count ≥100000/μL, ANC ≥1500/μL (when pretreatment ANC was <1000/μL) and Hb ≥110 g/L (when pretreatment Hb was <100g/L), confirmed in two blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | Week 24 and 36 |
| Percentage of Participants Who Were Previously Platelet Transfusion-dependent and Did no Longer Require Platelet Transfusions After the Initiation of Eltrombopag | Percentage of participants who received at least one platelet transfusion before starting treatment and who did no longer require platelet transfusion before and after the first 16 weeks of treatment. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | From start of treatment to end of treatment, assessed up to 36 weeks |
| Percentage of Participants Who Were Previously Red Blood Cells Transfusion-dependent and Did no Longer Require Red Blood Cells Transfusions | Percentage of participants who received at least one red blood cells transfusion before starting treatment and who did no longer require red blood cells transfusion before and after the first 16 weeks of treatment. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | From start of treatment to end of treatment, assessed up to 36 weeks |
| Duration of Transfusion Independence | Duration of transfusion independence defined as the period of time where participants did not receive any platelet or red blood cells transfusions during the treatment period | From start of treatment to end of treatment, assessed up to 36 weeks |
| Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Erythropoietin (EPO) Therapy | Percentage of participants who discontinued or reduced by ≥50% from baseline the use of concomitant EPO therapy while receiving eltrombopag. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | From start of treatment to end of treatment, assessed up to Week 36 |
| Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Granulocyte Colony-stimulating Factor (G-CSF) Therapy | Percentage of participants who discontinued or reduced by ≥50% from baseline the use of concomitant G-CSF therapy while receiving eltrombopag. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | From start of treatment to end of treatment, assessed up to Week 36 |
| Overall Survival (OS) | OS defined as the time from the date of inclusion until the date of death due to any cause was calculated using Kaplan-Meier estimated. All patients who discontinued from the study, regardless the reason of discontinuation, were followed for survival, unless they withdrew their consent, died or were lost-to follow-up, in which case were censored at the last contact. | From start of treatment until the date of death, assessed up to 40 weeks |
| Overall Survival Rate at 24 and 36 Weeks | Overall survival rate defined as the rate estimate of the percentage of participants who were alive at 24 and 36 weeks. All patients who discontinued from the study, regardless the reason of discontinuation, were followed for survival at Week 24 and 36, unless they withdrew their consent, died or were lost-to follow-up, in which case were censored at the last contact. | Week 24 and 36 |
| Palma de Mallorca |
| Balearic Islands |
| 07120 |
| Spain |
| Novartis Investigative Site | Donostia / San Sebastian | Basque Country | 20080 | Spain |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | Vigo | Pontevedra | 36212 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46010 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Relapse |
|
| Physician Decision |
|
| Physician Decision and Adverse Event |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Eltrombopag | Participants received eltrombopag orally once daily up to 36 weeks. |
|
|
| Secondary | Percentage of Participants Who Had a Response in the Neutrophil Lineage | Percentage of participants who had a response (partial or complete) in the neutrophil lineage. A partial response in the neutrophil lineage was defined as absolute neutrophil count (ANC) ≥1000/ µL (when pretreatment ANC was <1000/μL) confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the neutrophil lineage was defined as ANC ≥ 1500/ µL (when pretreatment ANC was <1000/μL) confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method | All participants to whom study treatment was assigned and pretreatment ANC was <1000 µL. Number analyzed signified number of participants that reached the study week. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 16, 20, 24, 30 and 36 |
|
|
|
| Secondary | Percentage of Participants Who Had a Response in the Platelet Lineage | Percentage of participants who had a response (partial or complete) in the platelet lineage. A partial response in the platelet lineage was defined as platelet count ≥20000/µL (with platelet transfusion independence) confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the platelet lineage was defined as platelet count ≥ 100000/µL confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | All participants to whom study treatment was assigned. Number analyzed signified number of participants that reached the study week. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16, 20, 24, 30 and 36 |
|
|
|
| Secondary | Percentage of Participants Who Had a Response in the Hemoglobin Lineage | Percentage of participants who had a response (partial or complete) in the hemoglobin (Hb) lineage. A partial response in the Hb lineage was defined as Hb ≥100 g/L (when pretreatment Hb was <100g/L) (with RBC transfusion independence), confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the Hb lineage was defined as Hb≥ 110 g/L (when pretreatment Hb was <100g/L) confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | All participants to whom study treatment was assigned and pretreatment Hb <100g/L. Number analyzed signified number of participants that reached the study week. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16, 20, 24, 30 and 36 |
|
|
|
| Secondary | Hematologic Response Rate at Week 24 and 36 | Hematologic response rate was defined as the percentage of participants who met the criteria of either complete response (CR) or partial response (PR) at 24 weeks and 36 weeks after the initiation of eltrombopag. PR was defined when any of the following: Platelet count ≥20000/microliter (μL) (with platelet transfusion independence), absolute neutrophil count (ANC) ≥1000/μL (when pretreatment ANC was <1000/μL) and/or hemoglobin (Hb) ≥100 gram (g)/ liter (L) (when pretreatment Hb was <100g/L) (with red blood cells transfusion independence), confirmed in two blood tests separated a minimum of 7 days. CR was defined when all three of the following: platelet count ≥100000/μL, ANC ≥1500/μL (when pretreatment ANC was <1000/μL) and Hb ≥110 g/L (when pretreatment Hb was <100g/L), confirmed in two blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | All participants to whom study treatment was assigned. Number analyzed signified number of participants that reached the study week. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 and 36 |
|
|
|
| Secondary | Percentage of Participants Who Were Previously Platelet Transfusion-dependent and Did no Longer Require Platelet Transfusions After the Initiation of Eltrombopag | Percentage of participants who received at least one platelet transfusion before starting treatment and who did no longer require platelet transfusion before and after the first 16 weeks of treatment. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | All participants to whom study treatment was assigned and who received at least one platelet transfusion before starting treatment. Number analyzed signified number of participants with evaluable data for this outcome measure at specified time points | Posted | Number | 95% Confidence Interval | Percentage of participants | From start of treatment to end of treatment, assessed up to 36 weeks |
|
|
|
| Secondary | Percentage of Participants Who Were Previously Red Blood Cells Transfusion-dependent and Did no Longer Require Red Blood Cells Transfusions | Percentage of participants who received at least one red blood cells transfusion before starting treatment and who did no longer require red blood cells transfusion before and after the first 16 weeks of treatment. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | All participants to whom study treatment was assigned and who received at least one red blood cells transfusion before starting treatment. Number analyzed signified number of participants with evaluable data for this outcome measure at specified time points | Posted | Number | 95% Confidence Interval | Percentage of participants | From start of treatment to end of treatment, assessed up to 36 weeks |
|
|
|
| Secondary | Duration of Transfusion Independence | Duration of transfusion independence defined as the period of time where participants did not receive any platelet or red blood cells transfusions during the treatment period | All participants to whom study treatment was assigned. | Posted | Mean | Standard Deviation | Days | From start of treatment to end of treatment, assessed up to 36 weeks |
|
|
|
| Secondary | Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Erythropoietin (EPO) Therapy | Percentage of participants who discontinued or reduced by ≥50% from baseline the use of concomitant EPO therapy while receiving eltrombopag. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | All participants to whom study treatment was assigned with evaluable data for this outcome measure | Posted | Number | 95% Confidence Interval | Percentage of participants | From start of treatment to end of treatment, assessed up to Week 36 |
|
|
|
| Secondary | Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Granulocyte Colony-stimulating Factor (G-CSF) Therapy | Percentage of participants who discontinued or reduced by ≥50% from baseline the use of concomitant G-CSF therapy while receiving eltrombopag. The 95% CI was the binomial exact CI based on Clopper-Pearson method. | All participants to whom study treatment was assigned with evaluable data for this outcome measure | Posted | Number | 95% Confidence Interval | Percentage of participants | From start of treatment to end of treatment, assessed up to Week 36 |
|
|
|
| Secondary | Overall Survival (OS) | OS defined as the time from the date of inclusion until the date of death due to any cause was calculated using Kaplan-Meier estimated. All patients who discontinued from the study, regardless the reason of discontinuation, were followed for survival, unless they withdrew their consent, died or were lost-to follow-up, in which case were censored at the last contact. | All participants to whom study treatment was assigned. | Posted | Median | Standard Error | Weeks | From start of treatment until the date of death, assessed up to 40 weeks |
|
|
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| Secondary | Overall Survival Rate at 24 and 36 Weeks | Overall survival rate defined as the rate estimate of the percentage of participants who were alive at 24 and 36 weeks. All patients who discontinued from the study, regardless the reason of discontinuation, were followed for survival at Week 24 and 36, unless they withdrew their consent, died or were lost-to follow-up, in which case were censored at the last contact. | All participants to whom study treatment was assigned. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 and 36 |
|
|
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| Post-Hoc | All Collected Deaths | On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of eltrombopag. Post-treament survival follow-up deaths were collected from day 31 after last dose of study medication to end of study. Participants who completed treatment with study drug as planned at Week 36, were followed up until Week 40 and deaths that occurred within that time frame were counted as on-treatment. For all participants who discontinued from eltrombopag, post-treatment deaths due to any cause were collected after the on-treatment period until end of survival follow-up period. | All participants to whom study treatment was assigned. | Posted | Count of Participants | Participants | On-treatment deaths: Up to 40 weeks. Post-treatment survival follow-up deaths: up to 40 weeks |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| 10 |
| 10 |
| EG001 | Eltrombopag (Post-treatment Survival Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period | 2 | 7 | 0 | 0 | 0 | 0 |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Chimerism | Congenital, familial and genetic disorders | MedDRA 23.1 | Systematic Assessment |
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| Epstein-Barr virus infection reactivation | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypogammaglobulinaemia | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Iron overload | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Ovarian Cyst | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Breast operation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Hypoglobulinaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Papiloma excision | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Finger amputation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Urine analysis abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Clostridium test positive | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
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