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GSK decision
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The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo, once daily, oral |
|
| Active | Active Comparator | 75 mg, once daily, oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | 75 mg, once daily, oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures | A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure. | Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures | The WHO Bleeding Scale was used to assess bleeding during the study. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality). |
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Inclusion Criteria:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
Childbearing potential, has a negative urine and/or serum pregnancy test at screening, and within the 24 hour period prior to the first dose of investigational product and uses one of the following acceptable methods of contraception:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294-0005 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22913681 | Derived | Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D; ELEVATE Study Group. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. N Engl J Med. 2012 Aug 23;367(8):716-24. doi: 10.1056/NEJMoa1110709. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo |
| FG001 | Eltrombopag 75 mg | Eltrombopag 75 mg administered orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
placebo, once daily, oral |
|
| Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
| Number of Participants With the Indicated Number of Platelet Transfusions Administered | Platelet transfusion use was documented at every visit throughout the study from screening until the 4-week (30-day) post-procedure follow-up visit or at the time of participant withdrawal from the study. | Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
| Median Platelet Count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 Day Follow-up; Early Withdrawal; and Maximum Post-baseline | Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable). | Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline |
| Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline | Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable). | Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline |
| Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category | An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect or an ocular event of clinical concern. Medical or scientific judgement is exercised in deciding whether reporting is appropriate in other situations. | Screening to Procedure +30 day follow-up or early withdrawal |
| Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant | Screening to Procedure +30 day follow-up or early withdrawal |
| Number of Participants With the Indicated Event Relating to Vision | The progression of pre-existing cataracts was measured by the use of slit lamp examination. Decrease in visual acuity is defined as the loss of 3 or more lines of visual acuity in either eye (0.3 log minimal angle of resolution [logMAR], 15 letters on the standard Early Treatment Diabetic Retinopathy Study chart). | Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit) |
| Number of Participants With Renal Function Abnormality | Renal function abnormality was defined by threshold values for: serum creatinine: change from baseline of >=0.3 and <0.5 milligrams (mg)/deciliter (dL) (>=26.6 and <44.3 micromoles [umol]/L) or change from baseline of >=0.5 mg/dL (>=44.3 umol/L); microscopic urine analysis: cellular casts pathologic (as defined by local standards of microscopic urine analysis); urine protein/creatinine ratio (UP/CR): >0.5 mg/mg; Glomerular Filtration Rate (GFR) as determined by the Cockcroft-Gault formula and urine dipstick test. | Screening to Procedure +30 day follow-up or early withdrawal |
| Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results | A 12-lead ECG was obtained in duplicate at screening, baseline, Day 15, and withdrawal from the study. Participants rested supine for 5 minutes before the 12-lead ECG was recorded. A 30 second rhythm strip was obtained, and the ECG was calibrated, labelled, and initialled by the person performing the recording. A written, interpretive assessment detailing clinical significance was produced, dated, and signed off by the physician at the site. | Screening, Baseline, Day 15, and Withdrawal |
| Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau) | AUC(0-tau) is the area under a concentration versus time curve between dose interval following repeat dosing. It is a measure of systemic drug exposure. | Day 14 |
| Pharmacokinetics (PK) of Eltrombopag, Cmax | Cmax is the steady state peak plasma concentration of a drug observed after its administration. | Day 14 |
| Pharmacokinetics (PK) of Eltrombopag, t1/2 | t1/2 is the half life of a drug based on its terminal phase. Half life is defined as the time necessary to halve the plasma concentration. | Day 14 |
| Pharmacokinetics (PK) of Eltrombopag, CL/F | CL/F is the apparent plasma clearance, where CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. Total clearance is the volume of blood cleared of the drug by the various elimination processes (metabolism and excretion) per unit time. | Day 14 |
| Mean Number of Days Spent in the Hospital | The number of days spent in the hospital was analyzed as an indication of medical resource utilization throughout the study. | Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
| Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures | The number of unscheduled events was analyzed as an indication of medical resource utilization throughout the study. | Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205-7199 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | San Diego | California | 92103-8707 | United States |
| GSK Investigational Site | San Francisco | California | 94115 | United States |
| GSK Investigational Site | Denver | Colorado | 80262 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20307 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32224 | United States |
| GSK Investigational Site | Miami | Florida | 33125 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70112 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21202 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Burlington | Massachusetts | 01805 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Valhalla | New York | 10595 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28203 | United States |
| GSK Investigational Site | Durham | North Carolina | 27715 | United States |
| GSK Investigational Site | Portland | Oregon | 97239 | United States |
| GSK Investigational Site | Hershey | Pennsylvania | 17033-0850 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29425 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37232 | United States |
| GSK Investigational Site | Dallas | Texas | 75235 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22908 | United States |
| GSK Investigational Site | Falls Church | Virginia | 22046 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Richmond | Virginia | 23298 | United States |
| GSK Investigational Site | Capital Fefderal | Buenos Aires | Argentina |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1181ACI | Argentina |
| GSK Investigational Site | Derqui, Pilar | Buenos Aires | B1629AHJ | Argentina |
| GSK Investigational Site | Rosario | Santa Fe Province | S2002KDR | Argentina |
| GSK Investigational Site | Buenos Aires | 1264 | Argentina |
| GSK Investigational Site | Brussels | 1070 | Belgium |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Calgary | Alberta | T2N 4Z6 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M6H 3M1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2X 3J4 | Canada |
| GSK Investigational Site | Clermont Ferrand Cédex 1 | 63058 | France |
| GSK Investigational Site | Lyon | 69288 | France |
| GSK Investigational Site | Lyon | 69437 | France |
| GSK Investigational Site | Marseille | 13385 | France |
| GSK Investigational Site | Montpellier | 34295 | France |
| GSK Investigational Site | Nice | 06202 | France |
| GSK Investigational Site | Paris | 75014 | France |
| GSK Investigational Site | Paris | 75571 | France |
| GSK Investigational Site | Paris | 75651 | France |
| GSK Investigational Site | Villejuif | 94804 | France |
| GSK Investigational Site | Jaipur | 302004 | India |
| GSK Investigational Site | Mumbai | 400 016 | India |
| GSK Investigational Site | Mumbai | 400020 | India |
| GSK Investigational Site | Bari | Apulia | 70124 | Italy |
| GSK Investigational Site | San Giovanni Rotondo (FG) | Apulia | 71013 | Italy |
| GSK Investigational Site | Avellino | Campania | 83100 | Italy |
| GSK Investigational Site | Naples | Campania | 80123 | Italy |
| GSK Investigational Site | Bologna | Emilia-Romagna | 40138 | Italy |
| GSK Investigational Site | Rome | Lazio | 00133 | Italy |
| GSK Investigational Site | Rome | Lazio | 00168 | Italy |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20122 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20132 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20162 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10126 | Italy |
| GSK Investigational Site | Palermo | Sicily | 90127 | Italy |
| GSK Investigational Site | Padova | Veneto | 35128 | Italy |
| GSK Investigational Site | Lahore | 54000 | Pakistan |
| GSK Investigational Site | Lahore | 54600 | Pakistan |
| GSK Investigational Site | Chorzów | 41-500 | Poland |
| GSK Investigational Site | Lubin | 59-301 | Poland |
| GSK Investigational Site | Słupsk | 76-200 | Poland |
| GSK Investigational Site | Warsaw | 01-201 | Poland |
| GSK Investigational Site | Wroclaw | 50-367 | Poland |
| GSK Investigational Site | Saint Petersburg | 194044 | Russia |
| GSK Investigational Site | Samara | 443011 | Russia |
| GSK Investigational Site | Smolensk | 214006 | Russia |
| GSK Investigational Site | Yekaterinburg | 620102 | Russia |
| GSK Investigational Site | Busan | 614-735 | South Korea |
| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Seoul | 135-710 | South Korea |
| GSK Investigational Site | Seoul | 138-736 | South Korea |
| GSK Investigational Site | Barakaldo | 48903 | Spain |
| GSK Investigational Site | Barcelona | 08003 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | L'Hospitalet de Llobregat | 08907 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Oviedo | 33006 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Valencia | 46009 | Spain |
| GSK Investigational Site | Valencia | 46014 | Spain |
| GSK Investigational Site | Valladolid | 47012 | Spain |
| GSK Investigational Site | Douliu | 640 | Taiwan |
| GSK Investigational Site | Kaohsiung City | 807 | Taiwan |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Taipei | 112 | Taiwan |
| GSK Investigational Site | Taoyuan | Taiwan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo |
| BG001 | Eltrombopag 75 mg | Eltrombopag 75 mg administered orally once daily |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Number of participants categorized into the indicated Child-Pugh (CP) Class | The CP score (ranging from 5 to 15; 5=mild, 15=severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess liver disease severity. A CP score of 5 or 6 is classified as Class A (mild), a score of 7-9 is classified as Class B (moderate), and a score >=10 is classified as Class C (severe). Participants with a CP score <10 were enrolled in the study. The number of participants analyzed is 140 for placebo and 135 for Eltrombopag; not all participants were compliant and had their baseline CP score measured. | Number | participants |
| |||||||||||||||
| Model for End-Stage Liver Disease (MELD) Score at Baseline | MELD uses the following formula to calculate a participant's likelihood of dying within 3 months from liver disease: 3.8 x log (e) (bilirubin milligrams [mg]/deciliter [dL]) + 11.2 x log (e) (international ratio for prothrombin time) + 9.6 log (e) (creatinine mg/dL). Scores range from 6 (least ill) to 40 (most ill): 40 or more, 71.3% mortality; 30-39, 52.6% mortality; 20-29, 19.6% mortality; 10-19, 6.0% mortality; <9, 1.9% mortality. The number of participants analyzed is 140 for placebo and 135 for Eltrombopag; not all participants were compliant and had their baseline MELD score measured. | Median | Full Range | scores on a scale |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures | A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure. | Intent-to-Treat (ITT) Population: all participants who were randomized to treatment | Posted | Number | participants | Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
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| Secondary | Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures | The WHO Bleeding Scale was used to assess bleeding during the study. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality). | ITT Population | Posted | Number | participants | Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
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| Secondary | Number of Participants With the Indicated Number of Platelet Transfusions Administered | Platelet transfusion use was documented at every visit throughout the study from screening until the 4-week (30-day) post-procedure follow-up visit or at the time of participant withdrawal from the study. | ITT Population | Posted | Number | participants | Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
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| Secondary | Median Platelet Count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 Day Follow-up; Early Withdrawal; and Maximum Post-baseline | Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable). | ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study. | Posted | Median | Full Range | Gi/L | Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline |
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| Secondary | Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline | Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable). | ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study. | Posted | Number | participants | Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline |
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| Secondary | Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category | An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect or an ocular event of clinical concern. Medical or scientific judgement is exercised in deciding whether reporting is appropriate in other situations. | Safety population: all randomized participants who received at least one dose of study medication | Posted | Number | participants | Screening to Procedure +30 day follow-up or early withdrawal |
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| Secondary | Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant | Safety Population | Posted | Number | participants | Screening to Procedure +30 day follow-up or early withdrawal |
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| Secondary | Number of Participants With the Indicated Event Relating to Vision | The progression of pre-existing cataracts was measured by the use of slit lamp examination. Decrease in visual acuity is defined as the loss of 3 or more lines of visual acuity in either eye (0.3 log minimal angle of resolution [logMAR], 15 letters on the standard Early Treatment Diabetic Retinopathy Study chart). | Safety Population: all randomized participants who received at least one dose of study medication. Data are missing for some participants. | Posted | Number | participants | Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit) |
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| Secondary | Number of Participants With Renal Function Abnormality | Renal function abnormality was defined by threshold values for: serum creatinine: change from baseline of >=0.3 and <0.5 milligrams (mg)/deciliter (dL) (>=26.6 and <44.3 micromoles [umol]/L) or change from baseline of >=0.5 mg/dL (>=44.3 umol/L); microscopic urine analysis: cellular casts pathologic (as defined by local standards of microscopic urine analysis); urine protein/creatinine ratio (UP/CR): >0.5 mg/mg; Glomerular Filtration Rate (GFR) as determined by the Cockcroft-Gault formula and urine dipstick test. | Safety Population | Posted | Number | participants | Screening to Procedure +30 day follow-up or early withdrawal |
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| Secondary | Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results | A 12-lead ECG was obtained in duplicate at screening, baseline, Day 15, and withdrawal from the study. Participants rested supine for 5 minutes before the 12-lead ECG was recorded. A 30 second rhythm strip was obtained, and the ECG was calibrated, labelled, and initialled by the person performing the recording. A written, interpretive assessment detailing clinical significance was produced, dated, and signed off by the physician at the site. | Safety Population. Data were missing for some participants. | Posted | Number | participants | Screening, Baseline, Day 15, and Withdrawal |
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| Secondary | Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau) | AUC(0-tau) is the area under a concentration versus time curve between dose interval following repeat dosing. It is a measure of systemic drug exposure. | PK Subpopulation: all participants who were treated with eltrombopag and provided evaluable PK samples | Posted | Geometric Mean | 95% Confidence Interval | hour*micrograms (ug)/milliliter (mL) | Day 14 |
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| Secondary | Pharmacokinetics (PK) of Eltrombopag, Cmax | Cmax is the steady state peak plasma concentration of a drug observed after its administration. | PK Subpopulation | Posted | Geometric Mean | 95% Confidence Interval | ug/mL | Day 14 |
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| Secondary | Pharmacokinetics (PK) of Eltrombopag, t1/2 | t1/2 is the half life of a drug based on its terminal phase. Half life is defined as the time necessary to halve the plasma concentration. | PK Subpopulation | Posted | Geometric Mean | 95% Confidence Interval | hours | Day 14 |
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| Secondary | Pharmacokinetics (PK) of Eltrombopag, CL/F | CL/F is the apparent plasma clearance, where CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. Total clearance is the volume of blood cleared of the drug by the various elimination processes (metabolism and excretion) per unit time. | PK Subpopulation | Posted | Geometric Mean | 95% Confidence Interval | Liters/hour | Day 14 |
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| Secondary | Mean Number of Days Spent in the Hospital | The number of days spent in the hospital was analyzed as an indication of medical resource utilization throughout the study. | ITT Population. Data are missing for some participants. | Posted | Mean | Standard Deviation | days | Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
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| Secondary | Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures | The number of unscheduled events was analyzed as an indication of medical resource utilization throughout the study. | ITT Population. Data are missing for some participants. | Posted | Mean | Standard Deviation | unscheduled events | Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 |
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Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to the end of Week 7).
The Safety Population, comprised of all randomized participants who received at least one dose of study medication, was used for the collection of AEs and SAEs.
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 | Placebo | Matching placebo | 17 | 145 | 35 | 145 | ||
| EG001 | Eltrombopag 75 mg | Eltrombopag 75 mg administered orally once daily | 19 | 143 | 40 | 143 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Appendix disorder | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Colitis ischaemia | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Visual accuity reduced | Eye disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA, v12.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA, v12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, v12.1 | Systematic Assessment |
| |
| Gastroenteristis | Infections and infestations | MedDRA, v12.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA, v12.1 | Systematic Assessment |
| |
| Peritonitis acute | Infections and infestations | MedDRA, v12.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA, v12.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Chronic hepatic failure | Hepatobiliary disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Hepatic hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Acute myocardial infaction | Cardiac disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA, v12.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, v12.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA, v12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, v12.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D015658 | HIV Infections |
| D013921 | Thrombocytopenia |
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| D008107 | Liver Diseases |
| D006509 | Hepatitis B |
| C537560 | Jacobs syndrome |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D012897 | Slow Virus Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C520809 | eltrombopag |
Not provided
Not provided
Not provided
| Male |
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| African American/African Heritage |
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| Native Hawaiian/Other Pacific Islander and White |
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