Safety and Efficacy Study for Solid Tumor Patients Treate... | NCT01147809 | Trialant
NCT01147809
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Apr 18, 2016Estimated
Enrollment
130Actual
Phase
Phase 2
Conditions
Thrombocytopaenia
Interventions
Eltrombopag olamine
Placebo
Countries
United States
Belgium
Canada
Czechia
Finland
Germany
Greece
Hungary
India
Ireland
Israel
Italy
Poland
Protocol Section
Identification Module
NCT ID
NCT01147809
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
112765
Secondary IDs
Not provided
Brief Title
Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag
Official Title
A Randomized, Blinded, Placebo-controlled, Two-Phase, Sequential Cohort, Dose Finding Study to Assess the Safety and Efficacy of an Oral Thrombopoietin Receptor Agonist, Eltrombopag (SB-497115-GR), Administered to Patients With Solid Tumors Receiving Gemcitabine Monotherapy or the Combination of Gemcitabine Plus Carboplatin or Cisplatin
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Mar 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2010
Primary Completion Date
Jan 2015Actual
Completion Date
Mar 2015Actual
First Submitted Date
May 20, 2010
First Submission Date that Met QC Criteria
Jun 17, 2010
First Posted Date
Jun 22, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 27, 2015
Results First Submitted that Met QC Criteria
Mar 17, 2016
Results First Posted Date
Apr 18, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 17, 2016
Last Update Posted Date
Apr 18, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin. Phase I of the study will examine safety and tolerability of various doses of eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful benefit(s) to thrombocytopenic patients by improving platelet numbers.
Other: Placebo Placebo tablets with no active pharmaceutical ingredient
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Eltrombopag olamine
Drug
thrombopoietin receptor agonist
Eltrombopag
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I
AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event 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, or, is a congenital anomaly/birth defect.
From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I
Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), lymphocytes (decreased), total absolute neutrophil count (ANC), platelets (PLT) and white blood cells (WBC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participant available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
After Baseline (C1D1), on-treatment and 30 day follow-up
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I
Secondary Outcomes
Measure
Description
Time Frame
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I
Pre-chemotherapy platelet count is defined for Cycle 1 as the platelet count (from central laboratory data) immediately preceding the first dose of chemotherapy within Cycle 1. For all subsequent cycles it is defined as the platelet count (from central laboratory data) immediately preceding, but limited to within 2 days prior to the first dose of chemotherapy at Day 1. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at the following time points: Group A; Days 1 and 8 of Cycles 1 to 6. Group B; Days 1, 8 and 15 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:Inclusion Criteria Subjects eligible for enrolment in Phase I and II of the study must meet all of the following criteria:
Signed written informed consent.
Age ≥ 18 years.
Subjects with confirmed solid tumor and scheduled to receive at least two cycles of either gemcitabine monotherapy OR gemcitabine in combination with carboplatin or cisplatin at the same dosages and schedule in the study. Novel anticancer agents (e.g. bevacizumab, erlotinib) may be allowed if considered a standard treatment by the investigator. Subjects with only ONE current diagnosis of primary solid tumor will be allowed into the study.
Note: For patients scheduled to receive any novel anticancer agents (e.g. bevacizumab, erlotinib), consultation and approval from the GSK medical monitor should occur before the subject is enrolled into the study.
Life expectancy of at least 3 months, in the opinion of the investigator.
ECOG-Zubrod performance status ≤ 2
For Phase I: Pre-chemotherapy platelet count ≤ 300 Gi/L in the screening period before the subject start their first planned cycle of treatment with gemcitabine monotherapy OR gemcitabine in combination with carboplatin or cisplatin in the study.
For Phase II (Part 1 and 2): Subjects must meet one of the following platelet count entry criteria:
Subjects have not started the first cycle in this disease setting and have a platelet count < 150 Gi/L in the screening period as measured within 3 days before Day -5, OR
Subjects started chemotherapy for this disease setting and had platelet count < 150 Gi/L on Day 1 in the preceding cycle before entry into the study, OR
Platelet count < 100 Gi/L at Day 8 in the preceding cycle before entry into the study, OR
Platelet count < 100 Gi/L at Day 15 in the preceding cycle before entry into the study (for subjects receiving Gemcitabine monotherapy) Note: For any of these platelet counts, a repeated platelet count may be allowed only once to ensure that the subject meets the above platelet count criteria and the latest count will be taken for the assessment of eligibility to the study..
Subjects with previous chemotherapy treatment in a previous disease setting are allowed provided they have recovered from chemotherapy related toxicity except alopecia (and the lab parameters mentioned in Inclusion criteria in #9).
Adequate organ function during screening period defined by the criteria below (adequate baseline organ function):
SYSTEM LABORATORY VALUES
Hematologic
Platelets, see Inclusion criteria
ANC (absolute neutrophil count) ≥1.5 × 109/L
Hemoglobin ≥9 g/dL
Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) Within 80 to 120% of the normal range
Hepatic
Albumin ≥2.5 g/dL
Serum bilirubin ≤1.5 x ULN AST and ALT
3 × ULN without liver metastases
5 × ULN if documented liver metastases
Renal
Serum Creatinine ≤ 1.2 x ULN
Subjects with AST, ALT or bilirubin values outside the range(s) in the table due to Gilbert's syndrome or asymptomatic gall stones are not excluded.
Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to randomization and agree to use effective contraception, during the study and for 4 weeks following the last dose of investigational product.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from 2 weeks prior to randomization until 13 weeks after the last dose of study treatment.
Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Lactating females.
Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), unstable angina, or subjects with a QTc >450 msec (QTc >480 msec for subjects with Bundle Branch Block) at study entry, or myocardial infarction within the preceding 6 months. Subjects with a34 pacemaker or defibrillator are not excluded provided that their cardiac function is within normal ranges.
Note: For patients with pre-existing NYHA Grade II cardiovascular disease, the investigator should consult with GSK medical monitor before enrolling the subject into the study.
Patients with known factor V leiden, antiphospholipid antibody syndrome, prothrombin gene mutations, ATIII deficiency, protein C deficiency, protein S deficiency OR recent history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the preceding 6 months.
Note: for patients with known risk factors for thromboembolism e.g., diabetes, hypercholesterolemia, recent major surgery etc., the investigator should consult with GSK medical monitor before enrolling the patient into the study and all risk factors should be documented in the CRF.
Prior surgery within two weeks before study randomization or radiotherapy (RT) within four weeks before study randomization. Subjects with prior surgery or RT are not permitted into the study unless they have completely recovered from surgery and/or acute RT toxicity except for alopecia.
Note: Note: patients with minor surgeries or outpatient procedures (e.g. insertion of central venous catheter) are immediately allowed in the study provided that there were no complications from the procedure or surgery.
History of prior radiotherapy to more than 20% bone marrow bearing sites.
History of platelet agglutination abnormality, platelet disorders or dysfunction or bleeding disorder that prevents reliable measurement of platelet counts.
Subjects with a history of CNS metastases or clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan unless properly treated. Subjects with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to randomization will be excluded.
Treated brain metastases are defined
Having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed.
Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician.
Note: if subject has performed a CT scan immediately prior to the screening period and CT could not be repeated, an MRI should be performed in the screening period to exclude the development of brain metastases and/or the progression of the pre-existing brain metastatic lesion(s).
Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational product in the study. Concurrent participation in another interventional clinical trial or administration of any investigational drug during the study is also not permitted.
A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Investigator or GSK Medical Monitor is due to drugs chemically related to eltrombopag or excipients (e.g. mannitol).
Subjects with known Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV). Subjects with Gilbert's Syndrome are permitted into the study.
Winer ES, Safran H, Karaszewska B, Richards DA, Hartner L, Forget F, Ramlau R, Kumar K, Mayer B, Johnson BM, Messam CA, Mostafa Kamel Y. Eltrombopag with gemcitabine-based chemotherapy in patients with advanced solid tumors: a randomized phase I study. Cancer Med. 2015 Jan;4(1):16-26. doi: 10.1002/cam4.326. Epub 2014 Aug 28.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 108 par. were randomized, of which 101 par. received at least 1 dose of study drug. A maximum of 6 cycles (with some exceptions) of chemotherapy with eltrombopag/placebo were allowed in each phase (either 21-day or 28-day cycle) followed by the 30 day Follow-up visit.
Recruitment Details
Participants (par.) with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin were eligible for enrollment into the study. The study comprised of 2 phases (I & II), with eligible par. being randomized to receive placebo or eltrombopag in each phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase I: 21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Periods
Title
Milestones
Reasons Not Completed
Phase I (168 Days)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Supportive Care
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
InvestigatorOutcomes Assessor
Placebo
Other
Placebo tablets with no active pharmaceutical ingredient
Placebo
Clinical chemistry laboratory parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Clinical chemistry laboratory parameters included albumin (Alb), urea/blood urea nitrogen (BUN), creatinine, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB) and international normalized ratio/Prothrombin time (PT). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
After Baseline (C1D1), on-treatment and 30 day follow-up
Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I
The number of participants with at least 1 change from Baseline in creatinine, with an increase >=26.5 UMOL/L are reported. Creatinine clearance is estimated using the Cockcroft-Gault formula which is a method to approximate kidney function. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1.
After Baseline (C1D1), on-treatment and 30 day follow-up
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I
ECOG-Zubrod scores for the performance status are defined as follows: Score 0: Fully active, 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: ambulatory and capable of all self-care but unable to carry out any work activities, 3: capable of only limited self-care, 4: completely disabled, 5: dead. The data is presented for the participants with the ECOG performance score at the indicated time points during the study.
Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I
A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and post-dose on C2D4. Three further ECGs were carried out at C2D8, C5D8 and C6D15. Change in ECG findings were categorized as 'Clinically significant change: favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Any time post-Baseline is defined by counting the participants under the worst result experienced post-Baseline. The best to worst order is 'Clinically significant change: favorable', 'No change or insignificant change', and then 'Clinically significant change (CSC): unfavorable. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
C2D4, C2D8, C5D8, C6D15
Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II
Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each participant across Cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), Baseline loge(platelet count) and part of study (part 1 or 2 of phase II). Only those participants available at indicated time points were analyzed (represented by n=X,X).
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I
Within-subject platelet count for each participant was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the participant had data. The average within a treatment group was calculated by summing up the values from each participant within the treatment group and dividing it by the number of participants. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 2 to 6 are summarized. Blood samples were collected on Days 1 and 8 of Cycles 2 to 6 for Group A and on Days 1, 8 and 15 from Cycles 2 to 6 for Group B to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Day 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)
Platelet Count Nadir for Each Chemotherapy Cycle in Phase I
Platelet nadir is defined as the lowest platelet count (from central laboratory data) reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 and 2, at Days 1, 4, 8, 15 and 17 of Cycle 3 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Cycle 1 to Cycle 6
Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I
The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 2 to 6. For 21-Day Cycle, the chemotherapy cycle consisted of 21 days and for 28-Day Cycle, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-Day Cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-Day Cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.
All assessments from Cycle 2 Day 1 to last assessment in Cycle 6
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet Count
As per the CTCAE version 4.0, par. with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; par. with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; par. with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and par. with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Par. experiencing thrombocytopenia (Platelets <150Gi/L) at least once within a cycle are presented in the category title as n=X,X,X,X.
Cycle 1 to Cycle 6
Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts
Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for Group A was 21 days and for Group B was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.
Cycle 2 to Cycle 6
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I
Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Cycle 1 to Cycle 6
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts
Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. Time to recovery (TR) (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22, and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Cycle 1 to Cycle 6
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I
Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: Cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within Cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on electronic case report form (eCRF).
Cycle 1 to Cycle 6
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I
Any delay in a scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants.
All time on chemotherapy treatment
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase II
AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event 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, or, is a congenital anomaly/birth defect.
From first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)
Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase II
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were further classified into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline is defined as the Day 1 assessment or the latest possible screening assessment. Across Cycles 1-6 included all assessments after first dose of chemotherapy up to the end of Cycle 6. Data exclused for participants taking drugs that affect platelet function or anticoagulants, from the time that the medication was started.
Screening, Day -5, Day 1 and 8 of Cycles 1 to 6 of 21-day cycle schedule, Day 1, 8 and 15 of cycles 1 to 6 of 28-day schedule, treatment withdrawal and 30-day follow-up
Number of Participants Requiring a Platelet Transfusion in Phase II
Platelet transfusion was used as a rescue medication for the treatment of thrombocytopenia. Number of participants requiring a platelet transfusion during Cycles 1-6 was summarized and compared between treatment groups using a logistic regression model adjusted for cycle duration. Each cycle included assessments starting at Day 1 of the cycle.
Screening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuation
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II
Any delay in scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants. Number of participants with any delay in dose during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only those participants who actually received chemotherapy are included for the cisplatin and carboplatin components and all participants are included for the gemcitabine components (represented by n=X,X in the category titles).
Cycle 1 to Cycle 6
Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II
Dose reductions are required following potential drug-related toxicities. Number of participants with any dose reduction during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only participants who actually received chemotherapy were included for the cisplatin and carboplatin components. All participants were included for the gemcitabine components.
Cycle 1 to Cycle 6
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II
Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on eCRF. The average chemotherapy dose intensity at Day 1 across Cycles 1 to 6, Day 8 across Cycles 1 to 6 and Day 15 across Cycles 1 to 6 was summarized and compared between treatment groups using an ANCOVA model adjusted for cycle duration and part of the study.
Cycle 1 to Cycle 6
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II
Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included Hemoglobin (Hb) increased, Anemia, Lymphocyte count (Lym), platelet count, White Blood Cell count (WBC) and Total Absolute Neutrophil Count (Total ANC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. participants with missing Baseline value were assumed to have normal Baseline value. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).
After baseline (C1D1), on-treatment and 30 day follow-up
Number of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase II
Clinical chemistry laboratory parameters with a related CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Worst-case grade change of the laboratory parameters at anytime post-Baseline is presented as "Any grade increase", "Increase to Grade 3 or Grade 4". Clinical chemistry laboratory parameters included Albumin (Al), creatinine, AST, ALT, ALP, TB, Calcium hypercalcemia (CaHy)/hypocalcemia (CaHo), Glucose hyperglycemia (GluHy)/hypoglycemia (GluHo), Potassium hypernatremia (KHy)/hyponatremia (KHo) and Sodium hypernatremia (NaHy)/hyponatremia (NaHo). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).
After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up
Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II
Number of participants with at least 1 assessment of change from Baseline in creatinine, with increase >=26.5 UMOL/L are presented. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of IP.
After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II
ECOG-Zubrod scores for the Performance Status were defined as follows: 0: Fully active, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: Ambulatory and capable of all self-care but unable to carry out any work activities, 3: Capable of only limited self-care, 4: Completely disabled, 5 and Unknown: Dead. The data is presented for the participants with the ECOG performance score at different time points during the study. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II
A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and 2 to 6 hours post-dose on C1D4. Change in ECG findings were categorized as 'Clinically significant change (CSC): favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of investigational product. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
C1D4
Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II
Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 8 scheduled platelet count.
Day 8 (averaged across cycles 1 to 6)
Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II
Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 15 scheduled platelet count.
Day 15 (averaged across cycles 1 to 6)
Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II
Within-subject platelet count for each par. was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the par. had data. The average within a treatment group was calculated by summing up the values from each par. within the treatment 21-day cycle dividing it by the number of par. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 1 to 6 are summarized. Blood samples were collected on Day 1 and 8 of Cycles 1 to 6 for 21-day cycle and on Day 1, 8 and 15 from Cycles 1 to 6 for 28-day cycle to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Day 1, Day 8, Day 15 (all averaged across cycles 1 to 6)
Platelet Count Nadir for Each Chemotherapy Cycle in Phase II
Platelet nadir is defined as the lowest platelet count reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Day 1, Day 4, Day 8, Day 15 and Day 17 of Cycles 1 to 6. 28-day cycle; Day 1, Day 4, Day 8, Day 15, Day 22, Day 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).
Cycle 1 to Cycle 6
Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II
The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 1 to 6. Blood samples were collected to estimate platelet count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.
All assessments from Cycle 1 Day 1 to last assessment in Cycle 6
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II
As per the CTCAE version 4.0, participants with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; participants with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; participants with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and participants with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Participants experiencing thrombocytopenia(Platelets <150Gi/L) at least once within cycle are presented in the category title as n=X,X.
Cycle 1 to Cycle 6
Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II
Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for 21-day cycle was 21 days and for 28-day cycle was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.
Cycle 1 to Cycle 6
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II
Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).
Cycle 1 to Cycle 6
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II
Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. TR (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. Blood samples were collected to estimate platelet count at: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22, and 24of Cycles 1 to 6. Time to recover censored if platelet count did not return to >=100/150 Gi/L. Censored results are excluded from calculation of summary statistics. Only those participants available at indicated time points were analyzed (represented by n=X, X).
Cycle 1 to Cycle 6
Hot Springs
Arkansas
71913
United States
GSK Investigational Site
Rancho Cucamonga
California
91730
United States
GSK Investigational Site
Norwich
Connecticut
06360
United States
GSK Investigational Site
Jacksonville
Florida
32256
United States
GSK Investigational Site
New Port Richey
Florida
34655
United States
GSK Investigational Site
Rome
Georgia
30165
United States
GSK Investigational Site
Savannah
Georgia
31405
United States
GSK Investigational Site
Wichita
Kansas
67214
United States
GSK Investigational Site
Bethesda
Maryland
20817
United States
GSK Investigational Site
Rockville
Maryland
20850
United States
GSK Investigational Site
Columbia
Missouri
65201
United States
GSK Investigational Site
Las Vegas
Nevada
89169
United States
GSK Investigational Site
Cherry Hill
New Jersey
08003
United States
GSK Investigational Site
Albany
New York
12206
United States
GSK Investigational Site
Greensboro
North Carolina
27403
United States
GSK Investigational Site
Bend
Oregon
97701
United States
GSK Investigational Site
Philadelphia
Pennsylvania
19106
United States
GSK Investigational Site
Wynnewood
Pennsylvania
19096
United States
GSK Investigational Site
Providence
Rhode Island
02903
United States
GSK Investigational Site
Providence
Rhode Island
02906
United States
GSK Investigational Site
Greenville
South Carolina
29605
United States
GSK Investigational Site
Arlington
Texas
76014
United States
GSK Investigational Site
Austin
Texas
78731
United States
GSK Investigational Site
Bedford
Texas
76022
United States
GSK Investigational Site
Dallas
Texas
75246
United States
GSK Investigational Site
San Antonio
Texas
78217
United States
GSK Investigational Site
Tyler
Texas
75702
United States
GSK Investigational Site
Norfolk
Virginia
23502
United States
GSK Investigational Site
Edmonds
Washington
98026
United States
GSK Investigational Site
Tacoma
Washington
98405
United States
GSK Investigational Site
Vancouver
Washington
98684
United States
GSK Investigational Site
Yakima
Washington
98902
United States
GSK Investigational Site
Charleroi
6000
Belgium
GSK Investigational Site
Leuven
3000
Belgium
GSK Investigational Site
Libramont
6800
Belgium
GSK Investigational Site
Namur
5000
Belgium
GSK Investigational Site
Edmonton
Alberta
T6G 1Z2
Canada
GSK Investigational Site
Toronto
Ontario
M5G 2M9
Canada
GSK Investigational Site
Olomouc
775 20
Czechia
GSK Investigational Site
Prague
100 00
Czechia
GSK Investigational Site
Prague
150 06
Czechia
GSK Investigational Site
Helsinki
00290
Finland
GSK Investigational Site
Tampere
33520
Finland
GSK Investigational Site
Freiburg im Breisgau
Baden-Wurttemberg
79106
Germany
GSK Investigational Site
Augsburg
Bavaria
86150
Germany
GSK Investigational Site
Munich
Bavaria
80335
Germany
GSK Investigational Site
Munich
Bavaria
81241
Germany
GSK Investigational Site
Goslar
Lower Saxony
38642
Germany
GSK Investigational Site
Hanover
Lower Saxony
30171
Germany
GSK Investigational Site
Essen
North Rhine-Westphalia
45122
Germany
GSK Investigational Site
Dresden
Saxony
01127
Germany
GSK Investigational Site
Dresden
Saxony
01307
Germany
GSK Investigational Site
Berlin
State of Berlin
10367
Germany
GSK Investigational Site
Berlin
State of Berlin
14169
Germany
GSK Investigational Site
Athens
115 27
Greece
GSK Investigational Site
Athens
115 28
Greece
GSK Investigational Site
Heraklion, Crete
71100
Greece
GSK Investigational Site
Thessaloniki
564 29
Greece
GSK Investigational Site
Budapest
1529
Hungary
GSK Investigational Site
Győr
9022
Hungary
GSK Investigational Site
Kaposvár
7400
Hungary
GSK Investigational Site
Törökbálint
Hungary
GSK Investigational Site
Zalaegerszeg
8900
Hungary
GSK Investigational Site
Madurai
625107
India
GSK Investigational Site
Pune
411001
India
GSK Investigational Site
Pune
411004
India
GSK Investigational Site
Dublin
4
Ireland
GSK Investigational Site
Dublin
7
Ireland
GSK Investigational Site
Tallaght, Dublin
24
Ireland
GSK Investigational Site
Ashkelon
78306
Israel
GSK Investigational Site
Haifa
34362
Israel
GSK Investigational Site
Jerusalem
91031
Israel
GSK Investigational Site
Kfar Saba
44281
Israel
GSK Investigational Site
Tel Aviv
64239
Israel
GSK Investigational Site
Zrifin
70300
Israel
GSK Investigational Site
Modena
Emilia-Romagna
41100
Italy
GSK Investigational Site
Aviano (PN)
Friuli Venezia Giulia
33081
Italy
GSK Investigational Site
Milan
Lombardy
20133
Italy
GSK Investigational Site
Sassari
Sardinia
07100
Italy
GSK Investigational Site
Pisa
Tuscany
56126
Italy
GSK Investigational Site
Bialystok
15-540
Poland
GSK Investigational Site
Konin
62-500
Poland
GSK Investigational Site
Olsztyn
10-357
Poland
GSK Investigational Site
Poznan
60-569
Poland
GSK Investigational Site
Poznan
61-866
Poland
FG001
Phase I: 21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
FG002
Phase I: 28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
FG003
Phase I: 28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
FG004
Phase II: Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
FG005
Phase II: Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
FG0003 subjects
FG0019 subjects
FG0024 subjects
FG00310 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0002 subjects
FG0018 subjects
FG0022 subjects
FG0035 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0035 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Phase II (168 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00423 subjects
FG00552 subjects
Ongoing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase I: 21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
BG001
Phase I: 21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
BG002
Phase I: 28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
BG003
Phase I: 28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
BG004
Phase II: Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
BG005
Phase II: Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0019
BG0024
BG00310
BG00423
BG00552
BG006101
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00053.3± 3.79
BG00153.8± 11.27
BG00261.8± 22.82
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0017
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
African American/African Heritage
Title
Measurements
BG0001
BG0011
BG002
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 Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I
AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event 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, or, is a congenital anomaly/birth defect.
Safety Population
Posted
Number
Participants
From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG003
Title
Denominators
Categories
Any AE Pre-therapy
Title
Measurements
OG0003
OG0018
OG0024
OG003
Primary
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I
Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), lymphocytes (decreased), total absolute neutrophil count (ANC), platelets (PLT) and white blood cells (WBC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participant available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Safety Population
Posted
Number
Participants
After Baseline (C1D1), on-treatment and 30 day follow-up
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Primary
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I
Clinical chemistry laboratory parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Clinical chemistry laboratory parameters included albumin (Alb), urea/blood urea nitrogen (BUN), creatinine, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB) and international normalized ratio/Prothrombin time (PT). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Safety Population
Posted
Number
Participants
After Baseline (C1D1), on-treatment and 30 day follow-up
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Primary
Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I
The number of participants with at least 1 change from Baseline in creatinine, with an increase >=26.5 UMOL/L are reported. Creatinine clearance is estimated using the Cockcroft-Gault formula which is a method to approximate kidney function. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1.
Safety Population
Posted
Number
Participants
After Baseline (C1D1), on-treatment and 30 day follow-up
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
Primary
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I
ECOG-Zubrod scores for the performance status are defined as follows: Score 0: Fully active, 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: ambulatory and capable of all self-care but unable to carry out any work activities, 3: capable of only limited self-care, 4: completely disabled, 5: dead. The data is presented for the participants with the ECOG performance score at the indicated time points during the study.
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Primary
Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I
A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and post-dose on C2D4. Three further ECGs were carried out at C2D8, C5D8 and C6D15. Change in ECG findings were categorized as 'Clinically significant change: favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Any time post-Baseline is defined by counting the participants under the worst result experienced post-Baseline. The best to worst order is 'Clinically significant change: favorable', 'No change or insignificant change', and then 'Clinically significant change (CSC): unfavorable. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Safety Population
Posted
Number
Participants
C2D4, C2D8, C5D8, C6D15
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Primary
Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II
Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each participant across Cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), Baseline loge(platelet count) and part of study (part 1 or 2 of phase II). Only those participants available at indicated time points were analyzed (represented by n=X,X).
Intent-to Treat (ITT) Population: all randomized participants.
Posted
Geometric Mean
Geometric Coefficient of Variation
Giga (10^9) cells per liter (Gi/L)
Day 1 (averaged across cycles 1 to 6)
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I
Pre-chemotherapy platelet count is defined for Cycle 1 as the platelet count (from central laboratory data) immediately preceding the first dose of chemotherapy within Cycle 1. For all subsequent cycles it is defined as the platelet count (from central laboratory data) immediately preceding, but limited to within 2 days prior to the first dose of chemotherapy at Day 1. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at the following time points: Group A; Days 1 and 8 of Cycles 1 to 6. Group B; Days 1, 8 and 15 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Secondary
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I
Within-subject platelet count for each participant was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the participant had data. The average within a treatment group was calculated by summing up the values from each participant within the treatment group and dividing it by the number of participants. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 2 to 6 are summarized. Blood samples were collected on Days 1 and 8 of Cycles 2 to 6 for Group A and on Days 1, 8 and 15 from Cycles 2 to 6 for Group B to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Safety Population
Posted
Mean
Standard Deviation
Giga (10^9) cells per liter (G cells/L)
Day 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Secondary
Platelet Count Nadir for Each Chemotherapy Cycle in Phase I
Platelet nadir is defined as the lowest platelet count (from central laboratory data) reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 and 2, at Days 1, 4, 8, 15 and 17 of Cycle 3 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Safety Population
Posted
Mean
Standard Deviation
Giga (10^9) cells per liter (G cells/L)
Cycle 1 to Cycle 6
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Secondary
Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I
The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 2 to 6. For 21-Day Cycle, the chemotherapy cycle consisted of 21 days and for 28-Day Cycle, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-Day Cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-Day Cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.
Safety Population
Posted
Mean
Standard Deviation
Giga (10^9) cells per liter (G cells/L)
All assessments from Cycle 2 Day 1 to last assessment in Cycle 6
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg)
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Secondary
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet Count
As per the CTCAE version 4.0, par. with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; par. with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; par. with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and par. with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Par. experiencing thrombocytopenia (Platelets <150Gi/L) at least once within a cycle are presented in the category title as n=X,X,X,X.
Safety Population
Posted
Number
Participants
Cycle 1 to Cycle 6
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Secondary
Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts
Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for Group A was 21 days and for Group B was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.
Safety Population. Participants experiencing thrombocytopenia with subsequent increase in platelet count to >=150Gi/L are included.
Posted
Mean
Standard Deviation
Days
Cycle 2 to Cycle 6
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Secondary
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I
Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Safety Population
Posted
Mean
Standard Deviation
Days
Cycle 1 to Cycle 6
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Secondary
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts
Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. Time to recovery (TR) (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22, and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Safety Population
Posted
Mean
Standard Deviation
Days
Cycle 1 to Cycle 6
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Secondary
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I
Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: Cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within Cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on electronic case report form (eCRF).
Safety Population
Posted
Mean
Standard Deviation
Dose Intensity (%)
Cycle 1 to Cycle 6
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Secondary
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I
Any delay in a scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants.
Safety Population
Posted
Number
Participants
All time on chemotherapy treatment
ID
Title
Description
OG000
21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG001
21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Secondary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase II
AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event 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, or, is a congenital anomaly/birth defect.
Safety Population
Posted
Number
Participants
From first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase II
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were further classified into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline is defined as the Day 1 assessment or the latest possible screening assessment. Across Cycles 1-6 included all assessments after first dose of chemotherapy up to the end of Cycle 6. Data exclused for participants taking drugs that affect platelet function or anticoagulants, from the time that the medication was started.
ITT Population: Participants with at least one visit within the cycle.
Posted
Number
Participants
Screening, Day -5, Day 1 and 8 of Cycles 1 to 6 of 21-day cycle schedule, Day 1, 8 and 15 of cycles 1 to 6 of 28-day schedule, treatment withdrawal and 30-day follow-up
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Secondary
Number of Participants Requiring a Platelet Transfusion in Phase II
Platelet transfusion was used as a rescue medication for the treatment of thrombocytopenia. Number of participants requiring a platelet transfusion during Cycles 1-6 was summarized and compared between treatment groups using a logistic regression model adjusted for cycle duration. Each cycle included assessments starting at Day 1 of the cycle.
ITT Population
Posted
Number
Participants
Screening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuation
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II
Any delay in scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants. Number of participants with any delay in dose during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only those participants who actually received chemotherapy are included for the cisplatin and carboplatin components and all participants are included for the gemcitabine components (represented by n=X,X in the category titles).
ITT Population
Posted
Number
Participants
Cycle 1 to Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II
Dose reductions are required following potential drug-related toxicities. Number of participants with any dose reduction during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only participants who actually received chemotherapy were included for the cisplatin and carboplatin components. All participants were included for the gemcitabine components.
ITT Population
Posted
Number
Participants
Cycle 1 to Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II
Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on eCRF. The average chemotherapy dose intensity at Day 1 across Cycles 1 to 6, Day 8 across Cycles 1 to 6 and Day 15 across Cycles 1 to 6 was summarized and compared between treatment groups using an ANCOVA model adjusted for cycle duration and part of the study.
ITT Population
Posted
Mean
Standard Deviation
Dose Intensity (%)
Cycle 1 to Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II
Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included Hemoglobin (Hb) increased, Anemia, Lymphocyte count (Lym), platelet count, White Blood Cell count (WBC) and Total Absolute Neutrophil Count (Total ANC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. participants with missing Baseline value were assumed to have normal Baseline value. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Safety Population
Posted
Number
Participants
After baseline (C1D1), on-treatment and 30 day follow-up
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Secondary
Number of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase II
Clinical chemistry laboratory parameters with a related CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Worst-case grade change of the laboratory parameters at anytime post-Baseline is presented as "Any grade increase", "Increase to Grade 3 or Grade 4". Clinical chemistry laboratory parameters included Albumin (Al), creatinine, AST, ALT, ALP, TB, Calcium hypercalcemia (CaHy)/hypocalcemia (CaHo), Glucose hyperglycemia (GluHy)/hypoglycemia (GluHo), Potassium hypernatremia (KHy)/hyponatremia (KHo) and Sodium hypernatremia (NaHy)/hyponatremia (NaHo). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Safety Population
Posted
Number
participants
After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II
Number of participants with at least 1 assessment of change from Baseline in creatinine, with increase >=26.5 UMOL/L are presented. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of IP.
Safety Population
Posted
Number
participants
After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II
ECOG-Zubrod scores for the Performance Status were defined as follows: 0: Fully active, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: Ambulatory and capable of all self-care but unable to carry out any work activities, 3: Capable of only limited self-care, 4: Completely disabled, 5 and Unknown: Dead. The data is presented for the participants with the ECOG performance score at different time points during the study. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II
A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and 2 to 6 hours post-dose on C1D4. Change in ECG findings were categorized as 'Clinically significant change (CSC): favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of investigational product. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Safety Population
Posted
Number
participants
C1D4
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II
Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 8 scheduled platelet count.
ITT Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Giga (10^9) cells per liter (G cells/L)
Day 8 (averaged across cycles 1 to 6)
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II
Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 15 scheduled platelet count.
ITT Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Giga (10^9) cells per liter (G cells/L)
Day 15 (averaged across cycles 1 to 6)
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II
Within-subject platelet count for each par. was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the par. had data. The average within a treatment group was calculated by summing up the values from each par. within the treatment 21-day cycle dividing it by the number of par. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 1 to 6 are summarized. Blood samples were collected on Day 1 and 8 of Cycles 1 to 6 for 21-day cycle and on Day 1, 8 and 15 from Cycles 1 to 6 for 28-day cycle to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
ITT Population
Posted
Mean
Standard Deviation
Giga (10^9) cells per liter (G cells/L)
Day 1, Day 8, Day 15 (all averaged across cycles 1 to 6)
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Secondary
Platelet Count Nadir for Each Chemotherapy Cycle in Phase II
Platelet nadir is defined as the lowest platelet count reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Day 1, Day 4, Day 8, Day 15 and Day 17 of Cycles 1 to 6. 28-day cycle; Day 1, Day 4, Day 8, Day 15, Day 22, Day 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).
ITT Population
Posted
Mean
Standard Deviation
Giga (10^9) cells per liter (G cells/L)
Cycle 1 to Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II
The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 1 to 6. Blood samples were collected to estimate platelet count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.
ITT Population:Participants with platelet count data in at least one cycle in the study.
Posted
Mean
Standard Deviation
Giga (10^9) cells per liter (G cells/L)
All assessments from Cycle 1 Day 1 to last assessment in Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II
As per the CTCAE version 4.0, participants with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; participants with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; participants with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and participants with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Participants experiencing thrombocytopenia(Platelets <150Gi/L) at least once within cycle are presented in the category title as n=X,X.
ITT Population
Posted
Number
Participants
Cycle 1 to Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II
Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for 21-day cycle was 21 days and for 28-day cycle was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.
ITT Population: Participants with at least one period of thrombocytopenia where duration could be calculated.
Posted
Mean
Standard Deviation
Days
Cycle 1 to Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II
Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).
ITT Population
Posted
Mean
Standard Deviation
Days
Cycle 1 to Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Secondary
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II
Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. TR (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. Blood samples were collected to estimate platelet count at: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22, and 24of Cycles 1 to 6. Time to recover censored if platelet count did not return to >=100/150 Gi/L. Censored results are excluded from calculation of summary statistics. Only those participants available at indicated time points were analyzed (represented by n=X, X).
ITT Population
Posted
Mean
Standard Deviation
Days
Cycle 1 to Cycle 6
ID
Title
Description
OG000
Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
OG001
Eltrombopag 100 mg
Time Frame
AEs and SAEs were collected from Cycle 1, Day 1 for Phase I; and from the time the first dose of investigational product (IP) is administered for Phase II; up to 30 days following discontinuation of IP.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase I: 21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
1
3
3
3
EG001
Phase I: 21-Day Cycle Eltrombopag
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
5
9
9
9
EG002
Phase I: 28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
1
4
4
4
EG003
Phase I: 28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
2
10
10
10
EG004
Phase II: Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
13
23
22
23
EG005
Phase II: Eltrombopag
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
17
52
47
52
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG0031 affected10 at risk
EG0042 affected23 at risk
EG0054 affected52 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
General physical health deterioration
General disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Hypoglycaemic coma
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Device damage
General disorders
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v.17.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected9 at risk
EG0020 affected4 at risk
EG003
Seizure cluster
Nervous system disorders
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0014 affected9 at risk
EG0023 affected4 at risk
EG0035 affected10 at risk
EG00415 affected23 at risk
EG00524 affected52 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected9 at risk
EG0022 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0003 affected3 at risk
EG0015 affected9 at risk
EG0022 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0003 affected3 at risk
EG0013 affected9 at risk
EG0024 affected4 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected9 at risk
EG0021 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0021 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected9 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0021 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0016 affected9 at risk
EG0021 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0022 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0022 affected4 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Peripheral swelling
General disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0022 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0021 affected4 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0021 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0022 affected4 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected9 at risk
EG0022 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected4 at risk
EG003
Hyperglycamia
Metabolism and nutrition disorders
MedDRA v.17.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
headache
Nervous system disorders
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected9 at risk
EG0021 affected4 at risk
EG003
Platelet count increased
Investigations
MedDRA v.17.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D013921
Thrombocytopenia
Ancestor Terms
ID
Term
D001791
Blood Platelet Disorders
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D000095542
Cytopenia
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
7 subjects
FG00519 subjects
16 subjects
FG00533 subjects
0 subjects
FG0043 subjects
FG0056 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0045 subjects
FG00511 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0047 subjects
FG00515 subjects
Ongoing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
65.6
± 8.41
BG00464.4± 9.96
BG00566.3± 8.98
BG00664.1± 10.56
3
BG0033
BG00413
BG00523
BG00650
Male
BG0002
BG0012
BG0021
BG0037
BG00410
BG00529
BG00651
0
BG0030
BG0041
BG0050
BG0063
White
Title
Measurements
BG0002
BG0018
BG0023
BG0038
BG00422
BG00552
BG00695
Central/South Asian Heritage
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
Japanese/East Asian Heritage/South East Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0032
BG0040
BG0050
BG0062
10
9
Any SAE Pre-therapy
Title
Measurements
OG0001
OG0010
OG0020
OG0031
Any AE On-therapy+30 days
Title
Measurements
OG0003
OG0019
OG0023
OG00310
Any SAE On-therapy+30 days
Title
Measurements
OG0001
OG0015
OG0021
OG0032
Any AE Post-therapy
Title
Measurements
OG0000
OG0010
OG0020
OG0033
Any SAE Post-therapy
Title
Measurements
OG0000
OG0010
OG0020
OG0031
Treatment-related AEs On-therapy+30 days
Title
Measurements
OG0002
OG0013
OG0021
OG0036
>=Grade 3 AEs On-therapy+30 days
Title
Measurements
OG0002
OG0017
OG0022
OG0033
Liver AEs On-therapy+30 days
Title
Measurements
OG0000
OG0012
OG0020
OG0032
Renal AEs On-therapy+30 days
Title
Measurements
OG0000
OG0013
OG0022
OG0030
Thromboembolic events On-therapy+30 days
Title
Measurements
OG0000
OG0012
OG0020
OG0031
Cardiac AEs On-therapy+30 days
Title
Measurements
OG0000
OG0011
OG0021
OG0031
Neutropenia On-therapy+30 days
Title
Measurements
OG0003
OG0014
OG0022
OG0035
Anemia On-therapy+30 days
Title
Measurements
OG0001
OG0014
OG0021
OG0034
Thrombocytopenia On-therapy+30 days
Title
Measurements
OG0002
OG0013
OG0023
OG0033
Leukopenia On-therapy+30 days
Title
Measurements
OG0001
OG0012
OG0022
OG0033
Thrombocytosis On-therapy+30 days
Title
Measurements
OG0002
OG0012
OG0021
OG0032
Platelet count increased On-therapy+30 days
Title
Measurements
OG0000
OG0010
OG0020
OG0033
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
Hemoglobin (Increased), Grade 0, n=3,9,4,10
Title
Measurements
OG0003
OG0019
OG0024
OG00310
Hemoglobin (Anemia), Grade 1, n=3,9,4,10
Title
Measurements
OG0002
OG0011
OG0020
OG003
Hemoglobin (Anemia), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0016
OG0022
OG003
Hemoglobin (Anemia), Grade 3, n=3,9,4,10
Title
Measurements
OG0001
OG0012
OG0022
OG003
Lymphocytes (Increased), Grade 0, n=3,9,4,10
Title
Measurements
OG0003
OG0018
OG0024
OG003
Lymphocytes (Increased), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
Lymphocytes (Decreased), Grade 0, n=3,9,4,10
Title
Measurements
OG0001
OG0011
OG0020
OG003
Lymphocytes (Decreased), Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0012
OG0020
OG003
Lymphocytes (Decreased), Grade 2, n=3,9,4,10
Title
Measurements
OG0001
OG0011
OG0021
OG003
Lymphocytes (Decreased), Grade 3, n=3,9,4,10
Title
Measurements
OG0001
OG0015
OG0023
OG003
Lymphocytes (Decreased), Grade 4, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total ANC, Grade 0, n=1,2,1,2
Title
Measurements
OG0000
OG0012
OG0021
OG003
Total ANC, Grade 1, n=1,2,1,2
Title
Measurements
OG0001
OG0010
OG0020
OG003
PLT, Grade 0, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
PLT, Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0021
OG003
PLT, Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0013
OG0021
OG003
PLT, Grade 3, n=3,9,4,10
Title
Measurements
OG0001
OG0012
OG0022
OG003
PLT, Grade 4, n=3,9,4,10
Title
Measurements
OG0002
OG0012
OG0020
OG003
WBC, Grade 0, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC, Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
WBC, Grade 2, n=3,9,4,10
Title
Measurements
OG0002
OG0012
OG0021
OG003
WBC, Grade 3, n=3,9,4,10
Title
Measurements
OG0001
OG0015
OG0022
OG003
WBC, Grade 4, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
Alb, Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0014
OG0020
OG0034
Alb, Grade 1, n=3,9,4,10
Title
Measurements
OG0001
OG0012
OG0022
OG003
Alb, Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0013
OG0021
OG003
Alb, Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0021
OG003
ALP, Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0013
OG0023
OG003
ALP, Grade 1, n=3,9,4,10
Title
Measurements
OG0001
OG0015
OG0021
OG003
ALP, Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
ALP, Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0013
OG0023
OG003
ALT, Grade 1, n=3,9,4,10
Title
Measurements
OG0001
OG0014
OG0021
OG003
ALT, Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0012
OG0020
OG003
ALT, Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0014
OG0022
OG003
AST, Grade 1, n=3,9,4,10
Title
Measurements
OG0001
OG0013
OG0022
OG003
AST, Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
AST, Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
TB, Grade 0, n=3,9,4,10
Title
Measurements
OG0003
OG0015
OG0023
OG003
TB, Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0012
OG0020
OG003
TB, Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0012
OG0021
OG003
TB, Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ca (hypercalcemia), Grade 0, n=3,9,4,10
Title
Measurements
OG0003
OG0018
OG0024
OG003
Ca (hypercalcemia), Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
Ca (hypercalcemia), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ca (hypercalcemia), Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ca (hypocalcemia), Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0017
OG0023
OG003
Ca (hypocalcemia), Grade 1, n=3,9,4,10
Title
Measurements
OG0001
OG0011
OG0020
OG003
Ca (hypocalcemia), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0021
OG003
Ca (hypocalcemia), Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine, Grade 0, n=3,9,4,10
Title
Measurements
OG0003
OG0017
OG0024
OG003
Creatinine, Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
Creatinine, Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
Creatinine, Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glu (hyperglycemia), Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0013
OG0021
OG003
Glu (hyperglycemia), Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0014
OG0022
OG003
Glu (hyperglycemia), Grade 2, n=3,9,4,10
Title
Measurements
OG0001
OG0012
OG0021
OG003
Glu (hyperglycemia), Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glu (hypoglycemia), Grade 0, n=3,9,4,10
Title
Measurements
OG0003
OG0018
OG0024
OG003
Glu (hypoglycemia), Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glu (hypoglycemia), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
Glu (hypoglycemia), Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
K (hyperkalemia), Grade 0, n=3,9,4,10
Title
Measurements
OG0001
OG0018
OG0023
OG003
K (hyperkalemia), Grade 1, n=3,9,4,10
Title
Measurements
OG0002
OG0011
OG0020
OG003
K (hyperkalemia), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0021
OG003
K (hyperkalemia), Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
K (hypokalemia), Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0015
OG0023
OG003
K (hypokalemia), Grade 1, n=3,9,4,10
Title
Measurements
OG0001
OG0013
OG0021
OG003
K (hypokalemia), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
K (hypokalemia), Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
Na (hypernatremia), Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0019
OG0023
OG003
Na (hypernatremia), Grade 1, n=3,9,4,10
Title
Measurements
OG0001
OG0010
OG0021
OG003
Na (hypernatremia), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Na (hypernatremia), Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Na (hyponatremia), Grade 0, n=3,9,4,10
Title
Measurements
OG0002
OG0014
OG0022
OG003
Na (hyponatremia), Grade 1, n=3,9,4,10
Title
Measurements
OG0001
OG0014
OG0020
OG003
Na (hyponatremia), Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
Na (hyponatremia), Grade 3, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0022
OG003
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
Title
Measurements
OG0000
OG0013
OG0021
OG0032
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
Screening, Score 0, n=3,9,4,10
Title
Measurements
OG0003
OG0015
OG0021
OG0033
Screening, Score 1, n=3,9,4,10
Title
Measurements
OG0000
OG0013
OG0023
OG003
Screening, Score 2, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
Screening, Score 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
C1D1, Score 0, n=3,9,4,10
Title
Measurements
OG0003
OG0015
OG0022
OG003
C1D1, Score 1, n=3,9,4,10
Title
Measurements
OG0000
OG0013
OG0022
OG003
C1D1, Score 2, n=3,9,4,10
Title
Measurements
OG0000
OG0011
OG0020
OG003
C1D1, Score 3, n=3,9,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
C2D1, Score 0, n=3,8,4,10
Title
Measurements
OG0001
OG0013
OG0022
OG003
C2D1, Score 1, n=3,8,4,10
Title
Measurements
OG0001
OG0014
OG0021
OG003
C2D1, Score 2, n=3,8,4,10
Title
Measurements
OG0001
OG0011
OG0021
OG003
C2D1, Score 3, n=3,8,4,10
Title
Measurements
OG0000
OG0010
OG0020
OG003
C2D8, Score 0, n=1,0,1,0
Title
Measurements
OG0001
OG001NAZero participants were analyzed; therefore, a value was not available.
OG0020
OG003
C2D8, Score 1, n=1,0,1,0
Title
Measurements
OG0000
OG001NAZero participants were analyzed; therefore, a value was not available.
OG0020
OG003
C2D8, Score 2, n=1,0,1,0
Title
Measurements
OG0000
OG001NAZero participants were analyzed; therefore, a value was not available.
OG0021
OG003
C2D8, Score 3, n=1,0,1,0
Title
Measurements
OG0001
OG001NAZero participants were analyzed; therefore, a value was not available.
OG0020
OG003
C2D15, Score 0, n=0,1,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG0010
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C2D15, Score 1, n=0,1,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG0010
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C2D15, Score 2, n=0,1,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG0011
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C2D15, Score 3, n=0,1,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG0010
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C3D1, Score 0, n=2,6,2,7
Title
Measurements
OG0001
OG0012
OG0022
OG003
C3D1, Score 1, n=2,6,2,7
Title
Measurements
OG0001
OG0012
OG0020
OG003
C3D1, Score 2, n=2,6,2,7
Title
Measurements
OG0000
OG0011
OG0020
OG003
C3D1, Score 3, n=2,6,2,7
Title
Measurements
OG0000
OG0011
OG0020
OG003
C4D1, Score 0, n=2,6,1,7
Title
Measurements
OG0001
OG0011
OG0020
OG003
C4D1, Score 1, n=2,6,1,7
Title
Measurements
OG0001
OG0013
OG0021
OG003
C4D1, Score 2, n=2,6,1,7
Title
Measurements
OG0000
OG0011
OG0020
OG003
C4D1, Score 3, n=2,6,1,7
Title
Measurements
OG0000
OG0011
OG0020
OG003
C4D22, Score 0, n=0,0,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG001NAZero participants were analyzed; therefore, a value was not available.
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C4D22, Score 1, n=0,0,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG001NAZero participants were analyzed; therefore, a value was not available.
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C4D22, Score 2, n=0,0,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG001NAZero participants were analyzed; therefore, a value was not available.
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C4D22, Score 3, n=0,0,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG001NAZero participants were analyzed; therefore, a value was not available.
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C5D1, Score 0, n=1,3,1,4
Title
Measurements
OG0000
OG0010
OG0020
OG003
C5D1, Score 1, n=1,3,1,4
Title
Measurements
OG0001
OG0011
OG0021
OG003
C5D1, Score 2, n=1,3,1,4
Title
Measurements
OG0000
OG0011
OG0020
OG003
C5D1, Score 3, n=1,3,1,4
Title
Measurements
OG0000
OG0011
OG0020
OG003
C5D8, Score 0, n=0,1,0,0
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG0010
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C5D8, Score 1, n=0,1,0,0
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG0010
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C5D8, Score 2, n=0,1,0,0
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG0010
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C5D8, Score 3, n=0,1,0,0
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG0011
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C6D1, Score 0, n=1,1,1,4
Title
Measurements
OG0000
OG0011
OG0020
OG003
C6D1, Score 1, n=1,1,1,4
Title
Measurements
OG0001
OG0010
OG0021
OG003
C6D1, Score 2, n=1,1,1,4
Title
Measurements
OG0000
OG0010
OG0020
OG003
C6D1, Score 3, n=1,1,1,4
Title
Measurements
OG0000
OG0010
OG0020
OG003
C6D15, Score 0, n=0,0,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG001NAZero participants were analyzed; therefore, a value was not available.
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C6D15, Score 1, n=0,0,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG001NAZero participants were analyzed; therefore, a value was not available.
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C6D15, Score 2, n=0,0,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG001NAZero participants were analyzed; therefore, a value was not available.
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
C6D15, Score 3, n=0,0,0,1
Title
Measurements
OG000NAZero participants were analyzed; therefore, a value was not available.
OG001NAZero participants were analyzed; therefore, a value was not available.
OG002NAZero participants were analyzed; therefore, a value was not available.
OG003
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
No change or insignificant change n=3,9,3,8
Title
Measurements
OG0003
OG0018
OG0023
OG0037
CSC: unfavorable, n=3,9,3,8
Title
Measurements
OG0000
OG0011
OG0020
OG003
Units
Counts
Participants
OG00023
OG00148
Title
Denominators
Categories
Title
Measurements
OG000193.34± 54.5
OG001246.20± 49.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.103
Percent difference
21.1
2-Sided
95
-3.9
52.5
No
Superiority or Other
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
C1 D1, n=3,9,4,9
Title
Measurements
OG000239.3± 75.87
OG001244.8± 48.47
OG002223.8± 79.96
OG003207.7± 65.51
C1 D8, n=3,6,3,9
Title
Measurements
OG000180.7± 65.03
OG001143.8± 33.88
OG002144.0± 44.17
OG003
C1 D15, n=0,0,2, 6
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, a value was not available.
OG001NA± NAZero participants were analyzed; therefore, a value was not available.
OG002135.0± 84.85
OG003
C2 D1, n=2,9,4,8
Title
Measurements
OG000443.0± 168.29
OG001545.8± 131.66
OG002284.8± 84.11
OG003
C2 D8, n=2,7,3,9
Title
Measurements
OG000221.0± 94.75
OG001335.6± 134.06
OG002163.3± 35.30
OG003
C2 D15, n=0,0,2,6
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, a value was not available.
OG001NA± NAZero participants were analyzed; therefore, a value was not available.
OG00280.5± 0.71
OG003
C3 D1, n=2,5,2,7
Title
Measurements
OG000464.0± 36.77
OG001484.6± 188.16
OG002290.5± 180.31
OG003
C3 D8, n=2,6,2,5
Title
Measurements
OG000285.0± 39.60
OG001292.2± 161.11
OG002293.0± 199.40
OG003
C3 D15, n=0,0,2,5
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, a value was not available.
OG001NA± NAZero participants were analyzed; therefore, a value was not available.
OG00292.0± 45.25
OG003
C4 D1, n=1,6,1,6
Title
Measurements
OG000298.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001394.7± 154.28
OG002609.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
C4 D8, n=1,5,1,6
Title
Measurements
OG000261.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001249.8± 122.29
OG002335.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
C4 D15, n=0,0,1,6
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, a value was not available.
OG001NA± NAZero participants were analyzed; therefore, a value was not available.
OG00286.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
C5 D1, n=1,2,1,4
Title
Measurements
OG000245.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001529.5± 340.12
OG002337.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
C5 D8, n=1,1,1,4
Title
Measurements
OG000144.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001123.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002311.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
C5 D15, n=0,0,1,4
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, a value was not available.
OG001NA± NAZero participants were analyzed; therefore, a value was not available.
OG00275.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
C6 D1, n=1,1,1,3
Title
Measurements
OG000512.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001123.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002440.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
C6 D8, n=1,1,0,3
Title
Measurements
OG000251.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001137.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002NA± NAZero participants were analyzed; therefore, a value was not available.
OG003
C6 D15, n=0,0,1,2
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, a value was not available.
OG001NA± NAZero participants were analyzed; therefore, a value was not available.
OG002113.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
OG001
21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
G+Cb, Day 1, n=1,3,0,0
Title
Measurements
OG000296.80± NAThere was only one participant analyzed; therefore, SD could not be determined
OG001275.00± 144.253
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003NA± NAZero participants were analyzed; therefore, mean and SD were not available.
G+Cb, Day 8, n=1,3,0,0
Title
Measurements
OG000235.00± NAThere was only one participant analyzed; therefore, SD could not be determined
OG001232.10± 77.329
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Day 1, n=2,6,0,0
Title
Measurements
OG000322.50± 82.731
OG001526.00± 86.408
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Day 8, n=2,6,0,0
Title
Measurements
OG000326.85± 119.006
OG001296.75± 119.342
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
Gm, Day1, n=0,0,4,9
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG002309.20± 123.133
OG003
Gm, Day8, n=0,0,4,10
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG002204.20± 80.822
OG003
Gm, Day15, n=0,0,3,10
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG00275.37± 18.292
OG003
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
Cycle 1, n=3,9,4,10
Title
Measurements
OG00030.67± 20.404
OG001106.56± 113.338
OG00260.50± 22.664
OG00399.00± 75.700
Cycle 2, n=2,9,4,10
Title
Measurements
OG00066.00± 9.899
OG001122.44± 115.794
OG002103.50± 62.952
OG003
Cycle 3, n=2,7,2,7
Title
Measurements
OG00047.00± 4.243
OG00188.29± 71.807
OG00278.50± 43.134
OG003
Cycle 4, n=2,6,1,7
Title
Measurements
OG00076.50± 4.950
OG00187.50± 79.173
OG00286.00± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
Cycle 5, n=1,2,1,4
Title
Measurements
OG00014.00± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001148.00± 182.434
OG00275.00± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
Cycle 6, n=1,1,1,4
Title
Measurements
OG00024.00± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00113.00± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002110.00± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
Title
Measurements
OG000260.97± 67.581
OG001307.59± 95.110
OG002183.68± 55.366
OG003291.18± 99.718
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
Grade 1, n=3,9,4,10
Title
Measurements
OG0000
OG0012
OG0021
OG0033
Grade 2, n=3,9,4,10
Title
Measurements
OG0000
OG0013
OG0021
OG003
Grade 3, n=3,9,4,10
Title
Measurements
OG0001
OG0011
OG0021
OG003
Grade 4, n=3,9,4,10
Title
Measurements
OG0001
OG0012
OG0020
OG003
Grade 0 / None, n=3,9,4,10
Title
Measurements
OG0001
OG0011
OG0021
OG003
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0002
OG0018
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG00011.0± 4.24
OG00110.6± 5.63
OG00214.7± 7.77
OG00313.4± 5.06
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
Cycle 1, n=3,9,4,10
Title
Measurements
OG00015.7± 0.58
OG00111.4± 5.53
OG00213.8± 6.13
OG00313.8± 4.73
Cycle 2, n=2,9,4,10
Title
Measurements
OG00015.0± 1.41
OG00112.9± 4.68
OG00214.0± 5.72
OG003
Cycle 3, n=2,7,2,7
Title
Measurements
OG00015.0± 1.41
OG00112.9± 3.02
OG00223.5± 0.71
OG003
Cycle 4, n=2,6,1,7
Title
Measurements
OG00014.0± 0.00
OG00113.5± 3.33
OG00214.0± NAThere was only one participant analyzed; therefore, SD could not be determined
OG003
Cycle 5, n=1,2,1,4
Title
Measurements
OG00015.0± NAThere was only one participant analyzed; therefore, SD could not be determined
OG00111.5± 6.36
OG00214.0± NAThere was only one participant analyzed; therefore, SD could not be determined
OG003
Cycle 6, n=1,1,1,4
Title
Measurements
OG00016.0± NAThere was only one participant analyzed; therefore, SD could not be determined
OG00114.0± NAThere was only one participant analyzed; therefore, SD could not be determined
OG00223.0± NAThere was only one participant analyzed; therefore, SD could not be determined
OG003
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
TR(<100Gi/L to >=100Gi/L), Cycle 1, n=3,6,4,7
Title
Measurements
OG0005.3± 0.58
OG0017.2± 2.56
OG0027.0± 0.00
OG0037.7± 2.87
TR(<100Gi/L to >=100Gi/L), Cycle 2, n=2,5,3,4
Title
Measurements
OG0006.5± 2.12
OG0016.6± 3.65
OG0026.0± 4.00
OG003
TR(<100Gi/L to >=100Gi/L), Cycle 3, n=1,4,0,2
Title
Measurements
OG0007.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG0018.5± 3.70
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
TR(<100Gi/L to >=100Gi/L), Cycle 4, n=1,4,1,2
Title
Measurements
OG0002.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG0016.5± 5.20
OG00214.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
TR(<100Gi/L to >=100Gi/L), Cycle 5, n=1,1,1,1
Title
Measurements
OG0005.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG0015.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG0029.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
TR(<100Gi/L to >=100Gi/L), Cycle 6, n=0,1,0,0
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG0017.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
TR(<150Gi/L to >=150Gi/L), Cycle 1, n=3,7,4,8
Title
Measurements
OG0005.3± 0.58
OG0017.6± 2.57
OG0027.0± 0.00
OG003
TR(<150Gi/L to >=150Gi/L), Cycle 2, n=2,4,3,5
Title
Measurements
OG0006.5± 2.12
OG0017.8± 2.99
OG0029.0± 4.36
OG003
TR(<150Gi/L to >=150Gi/L), Cycle 3, n=1,6,1,5
Title
Measurements
OG0007.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG0018.0± 2.97
OG0027.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
TR(<150Gi/L to >=150Gi/L), Cycle 4, n=1,4,1,4
Title
Measurements
OG0008.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG0017.8± 4.27
OG00214.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
TR(<150Gi/L to >=150Gi/L), Cycle 5, n=1,0,1,3
Title
Measurements
OG0005.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG00214.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
TR(<150Gi/L to >=150Gi/L), Cycle 6, n=0,0,1,0
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG0025.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
OG002
28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0003
OG0019
OG0024
OG00310
Title
Denominators
Categories
G+Cis, Gemcitabine, Cycle 1, n=2,5,0,0
Title
Measurements
OG000100.0± 0.00
OG00199.8± 0.45
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003NA± NAZero participants were analyzed; therefore, mean and SD were not available.
G+Cis, Gemcitabine, Cycle 2, n=1,5,0,0
Title
Measurements
OG000100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00192.8± 24.83
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Gemcitabine, Cycle 3, n=1,4,0,0
Title
Measurements
OG000100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001104.3± 8.50
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Gemcitabine, Cycle 4, n=1,3,0,0
Title
Measurements
OG000100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00183.3± 28.87
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Cisplatin, Cycle 1, n=2,6,0,0
Title
Measurements
OG000100.0± 0.00
OG001100.3± 1.03
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Cisplatin, Cycle 2, n=1,6,0,0
Title
Measurements
OG000100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001102.8± 6.05
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Cisplatin, Cycle 3, n=1,5,0,0
Title
Measurements
OG000100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00193.8± 24.34
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Cisplatin, Cycle 4, n=1,4,0,0
Title
Measurements
OG000100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001100.3± 0.96
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cis, Cisplatin, Cycle 5, n=0,1,0,0
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG00150± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Gemcitabine, Cycle 1, n=1,2,0,0
Title
Measurements
OG00099.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001100.0± 0.00
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Gemcitabine, Cycle 2, n=1,2,0,0
Title
Measurements
OG00099.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00188.5± 17.68
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Gemcitabine, Cycle 3, n=1,2,0,0
Title
Measurements
OG00099.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001100.0± 0.00
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Gemcitabine, Cycle 4, n=1,2,0,0
Title
Measurements
OG00049.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00199.5± 0.71
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Gemcitabine, Cycle 5, n=1,1,0,0
Title
Measurements
OG00099.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00174.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Gemcitabine, Cycle 6, n=1,1,0,0
Title
Measurements
OG00099.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00174.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Carboplatin, Cycle 1, n=1,3,0,0
Title
Measurements
OG000101.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00188.7± 14.05
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Carboplatin, Cycle 2, n=1,3,0,0
Title
Measurements
OG000100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001103.0± 5.20
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Carboplatin, Cycle 3, n=1,2,0,0
Title
Measurements
OG00093.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001105.0± 5.66
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Carboplatin, Cycle 4, n=1,2,0,0
Title
Measurements
OG00091.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001107.5± 2.12
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Carboplatin, Cycle 5, n=1,1,0,0
Title
Measurements
OG000100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00171.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
G+Cb, Carboplatin, Cycle 6, n=1,1,0,0
Title
Measurements
OG00087.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00179.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
Gemcitabine, Cycle 1, n=0,0,1,7
Title
Measurements
OG000NA± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG002100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
Gemcitabine, Cycle 2, n=0,0,1,7
Title
Measurements
OG000NA± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG002100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
Gemcitabine, Cycle 3, n=0,0,1,4
Title
Measurements
OG000NA± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG002100.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG003
Gemcitabine, Cycle 4, n=0,0,0,4
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
Gemcitabine, Cycle 5, n=0,0,0,3
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
Gemcitabine, Cycle 6, n=0,0,0,3
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG002NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG003
OG003
28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
Units
Counts
Participants
OG0001
OG0013
OG0024
OG00310
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0022
OG0031
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Any AE Pre Therapy
Title
Measurements
OG0000
OG0011
Any SAE Pre Therapy
Title
Measurements
OG0000
OG0010
Any AE On Therapy+30 days
Title
Measurements
OG00023
OG00148
Any SAE On Therapy+30 days
Title
Measurements
OG00012
OG00116
Any AE Post Therapy
Title
Measurements
OG0004
OG0012
Any SAE Post Therapy
Title
Measurements
OG0002
OG0011
Blood/lymphatic system disorders On-therapy+30 day
Title
Measurements
OG00021
OG00140
Thrombocytopenia On-therapy+30 days
Title
Measurements
OG00011
OG00119
Anemia On-therapy+30 days
Title
Measurements
OG00016
OG00126
Neutopenia On-therapy+30 days
Title
Measurements
OG00013
OG00121
Gastrointestinal disorders On-therapy+30 days
Title
Measurements
OG00012
OG00125
Blood Creatinine increased On-therapy+30 days
Title
Measurements
OG0003
OG0012
Vascular discorders On-therapy+30 days
Title
Measurements
OG0002
OG0016
Cardiac disorders On-therapy+30 days
Title
Measurements
OG0001
OG0013
Pulmonary embolism On-therapy+30 days
Title
Measurements
OG0000
OG0011
Portal vein thrombosis On-therapy+30 days
Title
Measurements
OG0001
OG0010
Deaths On-therapy+30 days
Title
Measurements
OG0009
OG00113
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Units
Counts
Participants
OG00012
OG00135
Title
Denominators
Categories
Grade 0
Title
Measurements
OG00011
OG00134
Grade 1
Title
Measurements
OG0001
OG0010
Grade 2
Title
Measurements
OG0000
OG0010
Grade 3
Title
Measurements
OG0000
OG0010
Grade 4
Title
Measurements
OG0000
OG0011
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG0000
OG0014
Cycle 2
Title
Measurements
OG0002
OG0013
Cycle 3
Title
Measurements
OG0000
OG0012
Cycle 4
Title
Measurements
OG0001
OG0011
Cycle 5
Title
Measurements
OG0000
OG0010
Cycle 6
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Gemcitabine, 21-day cycle, n=11,22
Title
Measurements
OG0005
OG0017
Carboplatin, 21-day cycle, n=4,12
Title
Measurements
OG0004
OG0015
Cisplatin, 21-day cycle, n=7,9
Title
Measurements
OG0001
OG0012
Gemcitabine, 28-day cycle, n=12,30
Title
Measurements
OG0004
OG0014
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Gemcitabine, 21-day cycle, n=11,22
Title
Measurements
OG0007
OG0016
Carboplatin, 21-day cycle, n=4,12
Title
Measurements
OG0002
OG0012
Cisplatin, 21-day cycle, n=7,9
Title
Measurements
OG0000
OG0013
Gemcitabine, 28-day cycle, n=12,30
Title
Measurements
OG0008
OG0018
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Cycle 1, n=23,48
Title
Measurements
OG00096.6± 10.65
OG00197.9± 6.19
Cycle 2, n=19,37
Title
Measurements
OG000113.1± 33.91
OG00197.8± 24.99
Cycle 3, n=13,26
Title
Measurements
OG000102.6± 42.20
OG00198.7± 35.77
Cycle 4, n=11,19
Title
Measurements
OG00096.6± 27.65
OG00190.7± 30.00
Cycle 5, n=6,12
Title
Measurements
OG000102.2± 31.88
OG00181.3± 25.39
Cycle 6, n=5,7
Title
Measurements
OG00084.4± 21.92
OG00165.2± 25.48
Cycle 1-6, n=23,49
Title
Measurements
OG00098.5± 18.26
OG00194.6± 15.71
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Hb (Increased), Grade 0, n=23,52
Title
Measurements
OG00023
OG00152
Hb (Increased), Grade 1, n=23,52
Title
Measurements
OG0000
OG0010
Hb (Increased), Grade 2, n=23,52
Title
Measurements
OG0000
OG0010
Hb (Increased), Grade 3, n=23,52
Title
Measurements
OG0000
OG0010
Hb (Increased), Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
Hb (Anemia), Grade 0, n=23,52
Title
Measurements
OG0000
OG0014
Hb (Anemia), Grade 1, n=23,52
Title
Measurements
OG0004
OG00116
Hb (Anemia), Grade 2, n=23,52
Title
Measurements
OG00013
OG00116
Hb (Anemia), Grade 3, n=23,52
Title
Measurements
OG0006
OG00116
Hb (Anemia), Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
Lym (Increased), Grade 0, n=23,52
Title
Measurements
OG00022
OG00147
Lym (Increased), Grade 1, n=23,52
Title
Measurements
OG0000
OG0010
Lym (Increased), Grade 2, n=23,52
Title
Measurements
OG0001
OG0012
Lym (Increased), Grade 3, n=23,52
Title
Measurements
OG0000
OG0011
Lym (Increased), Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
Lym (Decreased), Grade 0, n=23,52
Title
Measurements
OG0001
OG0017
Lym (Decreased), Grade 1, n=23,52
Title
Measurements
OG0003
OG00110
Lym (Decreased), Grade 2, n=23,52
Title
Measurements
OG0008
OG00114
Lym (Decreased), Grade 3, n=23,52
Title
Measurements
OG0009
OG00116
Lym (Decreased), Grade 4, n=23,52
Title
Measurements
OG0002
OG0013
Total ANC, Grade 0, n=23,52
Title
Measurements
OG0004
OG00116
Total ANC, Grade 1, n=23,52
Title
Measurements
OG0001
OG0014
Total ANC, Grade2, n=23,52
Title
Measurements
OG0003
OG00117
Total ANC, Grade 3, n=23,52
Title
Measurements
OG00010
OG00110
Total ANC, Grade 4, n=23,52
Title
Measurements
OG0005
OG0013
Platelet count, Grade 0, n=23,52
Title
Measurements
OG0000
OG0017
Platelet count, Grade 1, n=23,52
Title
Measurements
OG0004
OG0019
Platelet count, Grade 2, n=23,52
Title
Measurements
OG0003
OG0019
Platelet count, Grade 3, n=23,52
Title
Measurements
OG0006
OG00115
Platelet count, Grade 4, n=23,52
Title
Measurements
OG00010
OG00112
WBC count, Grade 0, n=23,52
Title
Measurements
OG0004
OG00114
WBC count, Grade 1, n=23,52
Title
Measurements
OG0003
OG00110
WBC count, Grade 2, n=23,52
Title
Measurements
OG0008
OG00117
WBC count, Grade 3, n=23,52
Title
Measurements
OG0006
OG00111
WBC count, Grade 4, n=23,52
Title
Measurements
OG0002
OG0010
OG001
Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Al, Any grade increase, n=23,51
Title
Measurements
OG00010
OG00122
Al, Increase to Grade 3, n=23,51
Title
Measurements
OG0000
OG0012
Al, Increase to Grade 4, n=23,51
Title
Measurements
OG0000
OG0010
ALP, Any grade increase, n=23,52
Title
Measurements
OG00011
OG00116
ALP, Increase to Grade 3, n=23,52
Title
Measurements
OG0001
OG0012
ALP, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
ALT, Any grade increase, n=23,52
Title
Measurements
OG00012
OG00116
ALT, Increase to Grade 3, n=23,52
Title
Measurements
OG0003
OG0012
ALT, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
AST, Any grade increase, n=23,52
Title
Measurements
OG00011
OG00115
AST, Increase to Grade 3, n=23,52
Title
Measurements
OG0003
OG0012
AST, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
TB, Any grade increase, n=23,52
Title
Measurements
OG0005
OG00111
TB, Increase to Grade 3, n=23,52
Title
Measurements
OG0003
OG0012
TB, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
CaHy, Any grade increase, n=23,51
Title
Measurements
OG0000
OG0011
CaHy, Increase to Grade 3, n=23,51
Title
Measurements
OG0000
OG0010
CaHy, Increase to Grade 4, n=23,51
Title
Measurements
OG0000
OG0010
CaHo, Any grade increase, n=23,51
Title
Measurements
OG0003
OG00110
CaHo, Increase to Grade 3, n=23,51
Title
Measurements
OG0001
OG0012
CaHo, Increase to Grade 4, n=23,51
Title
Measurements
OG0000
OG0010
Creatinine, Any grade increase, n=23,52
Title
Measurements
OG0005
OG00111
Creatinine, Increase to Grade 3, n=23,52
Title
Measurements
OG0001
OG0010
Creatinine, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
GluHy, Any grade increase, n=23,52
Title
Measurements
OG00013
OG00131
GluHy, Increase to Grade 3, n=23,52
Title
Measurements
OG0002
OG0013
GluHy, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
GluHo, Any grade increase, n=23,52
Title
Measurements
OG0002
OG0014
GluHo, Increase to Grade 3, n=23,52
Title
Measurements
OG0000
OG0010
GluHo, Increase to Grade 4, n=23,52
Title
Measurements
OG0001
OG0010
NaHy, Any grade increase, n=23,52
Title
Measurements
OG0000
OG0012
NaHy, Increase to Grade 3, n=23,52
Title
Measurements
OG0000
OG0010
NaHy, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
NaHo, Any grade increase, n=23,52
Title
Measurements
OG0004
OG00115
NaHo, Increase to Grade 3, n=23,52
Title
Measurements
OG0001
OG0011
NaHo, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
KHy, Any grade increase, n=23,52
Title
Measurements
OG0004
OG00110
KHy, Increase to Grade 3, n=23,52
Title
Measurements
OG0001
OG0011
KHy, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0010
KHo, Any grade increase, n=23,52
Title
Measurements
OG0005
OG00111
KHo, Increase to Grade 3, n=23,52
Title
Measurements
OG0001
OG0014
KHo, Increase to Grade 4, n=23,52
Title
Measurements
OG0000
OG0011
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Title
Measurements
OG0005
OG00111
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Screening, Score 0, n=23,52
Title
Measurements
OG0003
OG00119
Screening, Score 1, n=23,52
Title
Measurements
OG00019
OG00132
Screening, Score 2, n=23,52
Title
Measurements
OG0001
OG0011
C1D1, Score 0, n=23,49
Title
Measurements
OG0004
OG00120
C1D1, Score 1, n=23,49
Title
Measurements
OG00017
OG00128
C1D1, Score 2, n=23,49
Title
Measurements
OG0000
OG0011
C1D1, Unknown, n=23,49
Title
Measurements
OG0002
OG0010
C2D1, Score 0, n=19,36
Title
Measurements
OG0004
OG00116
C2D1, Score 1, n=19,36
Title
Measurements
OG00013
OG00118
C2D1, Score 2, n=19,36
Title
Measurements
OG0002
OG0012
C3D1, Score 0, n=13,27
Title
Measurements
OG0003
OG0019
C3D1, Score 1, n=13,27
Title
Measurements
OG0009
OG00116
C3D1, Score 2, n=13,27
Title
Measurements
OG0001
OG0012
C4D1, Score 0, n=11,19
Title
Measurements
OG0004
OG0018
C4D1, Score 1, n=11,19
Title
Measurements
OG0007
OG00110
C4D1, Score 2, n=11,19
Title
Measurements
OG0000
OG0011
C5D1, Score 0, n=6,12
Title
Measurements
OG0002
OG0015
C5D1, Score 1, n=6,12
Title
Measurements
OG0004
OG0016
C5D1, Score 2, n=6,12
Title
Measurements
OG0000
OG0011
C6D1, Score 0, n=6,7
Title
Measurements
OG0002
OG0013
C6D1, Score 1, n=6,7
Title
Measurements
OG0004
OG0014
C7D1, Score 0, n=3,2
Title
Measurements
OG0001
OG0010
C7D1, Score 1, n=3,2
Title
Measurements
OG0002
OG0012
C8D1, Score 0, n=2,1
Title
Measurements
OG0001
OG0010
C8D1, Score 1, n=2,1
Title
Measurements
OG0001
OG0011
C9D1, Score 1, n=2,1
Title
Measurements
OG0002
OG0011
C10D1, Score1 n=2,0
Title
Measurements
OG0002
OG0010
C11D1, Score 1, n=2,0
Title
Measurements
OG0001
OG0010
C11D1, Score 2, n=2,0
Title
Measurements
OG0001
OG0010
C12D1, Score 1, n=2,0
Title
Measurements
OG0002
OG0010
C13D1, Score 0, n=2,0
Title
Measurements
OG0001
OG0010
C13D1, Score 1, n=2,0
Title
Measurements
OG0001
OG0010
C14D1, Score 0, n=2,0
Title
Measurements
OG0001
OG0010
C14D1, Score 1, n=2,0
Title
Measurements
OG0001
OG0010
C15D1, Score 1, n=2,0
Title
Measurements
OG0002
OG0010
C16D1, Score 0, n=1,0
Title
Measurements
OG0001
OG0010
C17D1, Score 2, n=1,0
Title
Measurements
OG0001
OG0010
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
CSC favorable, n=22,45
Title
Measurements
OG0000
OG0012
No change or insignificant change, n=22,45
Title
Measurements
OG00020
OG00142
CSC: unfavorable, n=22,45
Title
Measurements
OG0002
OG0011
Units
Counts
Participants
OG00020
OG00142
Title
Denominators
Categories
Title
Measurements
OG000162.18± 74.2
OG001180.65± 59.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.407
Percent difference
12.9
2-Sided
95
-15.6
51.1
No
Superiority or Other
Units
Counts
Participants
OG0009
OG00122
Title
Denominators
Categories
Title
Measurements
OG00095.10± 23.3
OG00195.29± 52.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.802
Percent difference
-4.4
2-Sided
95
-33.5
37.4
No
Superiority or Other
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Day1, n=23,48
Title
Measurements
OG000221.0± 128.23
OG001272.9± 120.92
Day 8, n=20,42
Title
Measurements
OG000201.0± 143.75
OG001207.4± 110.93
Day 15, n=9,22
Title
Measurements
OG00097.5± 24.82
OG001106.7± 54.73
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Cycle 1, n=23,48
Title
Measurements
OG00068.3± 47.74
OG00177.2± 76.43
Cycle 2, n=19,37
Title
Measurements
OG00061.5± 35.82
OG00168.5± 48.92
Cycle 3, n=13,26
Title
Measurements
OG00071.6± 53.80
OG00184.7± 60.03
Cycle 4, n=11, 19
Title
Measurements
OG00089.7± 116.73
OG00186.9± 56.11
Cycle 5, n=6,11
Title
Measurements
OG00051.7± 12.23
OG00183.0± 58.63
Cycle 6, n=5,5
Title
Measurements
OG00069.6± 62.76
OG001136.6± 151.88
Units
Counts
Participants
OG00023
OG00148
Title
Denominators
Categories
Title
Measurements
OG000153.00± 96.079
OG001189.48± 79.583
Units
Counts
Participants
OG00023
OG00150
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0004
OG0019
Grade 2
Title
Measurements
OG0003
OG0019
Grade 3
Title
Measurements
OG0008
OG00115
Grade 4
Title
Measurements
OG0008
OG00112
None
Title
Measurements
OG0000
OG0015
Units
Counts
Participants
OG00023
OG00145
Title
Denominators
Categories
Title
Measurements
OG00032.6± 20.31
OG00123.5± 18.68
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
Cycle 1, n=23,48
Title
Measurements
OG00014.7± 4.85
OG00115.7± 6.12
Cycle 2, n=19,37
Title
Measurements
OG00015.1± 4.41
OG00115.4± 3.62
Cycle 3, n=13,26
Title
Measurements
OG00015.8± 5.64
OG00114.3± 4.76
Cycle 4, n=11,19
Title
Measurements
OG00015.4± 5.48
OG00114.7± 5.19
Cycle 5, n=6,11
Title
Measurements
OG00015.5± 6.38
OG00113.8± 4.45
Cycle 6, n=5,5
Title
Measurements
OG00013.6± 7.37
OG00110.4± 6.31
Cycle 7,n=2,2
Title
Measurements
OG00015.0± 0.00
OG0017.5± 0.71
Cycle 8, n=2,1
Title
Measurements
OG00012.5± 3.54
OG0018.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
Cycle 9, n=2,0
Title
Measurements
OG00012.5± 3.54
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
Units
Counts
Participants
OG00023
OG00152
Title
Denominators
Categories
TR(<100Gi/L to >=100Gi/L), Cycle 1, n=17, 32
Title
Measurements
OG0008.1± 3.15
OG0018.5± 3.70
TR(<150Gi/L to >=150Gi/L), Cycle 1, n=12, 29
Title
Measurements
OG0009.3± 3.89
OG0019.1± 3.26
TR(<100Gi/L to >=100Gi/L), Cycle 2, n=13, 24
Title
Measurements
OG0009.9± 3.64
OG0018.3± 2.56
TR(<150Gi/L to >=150Gi/L), Cycle 2, n=11, 21
Title
Measurements
OG00010.5± 4.50
OG0019.0± 3.31
TR(<100Gi/L to >=100Gi/L), Cycle 3, n=9, 12
Title
Measurements
OG00010.1± 5.01
OG0018.8± 3.16
TR(<150Gi/L to >=150Gi/L), Cycle 3, n=7, 14
Title
Measurements
OG00010.4± 5.74
OG0019.6± 3.43
TR(<100Gi/L to >=100Gi/L), Cycle 4, n=8, 10
Title
Measurements
OG00010.0± 5.63
OG00110.9± 4.77
TR(<150Gi/L to >=150Gi/L), Cycle 4, n=5, 11
Title
Measurements
OG00010.2± 6.65
OG00110.6± 5.39
TR(<100Gi/L to >=100Gi/L), Cycle 5, n=5,6
Title
Measurements
OG0007.8± 1.10
OG0018.8± 4.79
TR(<150Gi/L to >=150Gi/L), Cycle 5, n=2,4
Title
Measurements
OG0008.0± 0.00
OG0017.3± 1.50
TR(<100Gi/L to >=100Gi/L), Cycle 6, n=2,2
Title
Measurements
OG00010.5± 6.36
OG0018.5± 0.71
TR(<150Gi/L to >=150Gi/L), Cycle 6, n=2,1
Title
Measurements
OG00010.5± 6.36
OG0018.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
TR(<100Gi/L to >=100Gi/L), Cycle 7, n=1,1
Title
Measurements
OG00015.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00122.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
TR(<150Gi/L to >=150Gi/L), Cycle 7, n=1,1
Title
Measurements
OG00015.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG00122.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
TR(<100Gi/L to >=100Gi/L), Cycle 8, n=1,1
Title
Measurements
OG00014.0± 1.41
OG00120.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
TR(<150Gi/L to >=150Gi/L), Cycle 8, n=1,0
Title
Measurements
OG00015.0± NAThere was only one participant analyzed; therefore, SD could not be determined.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
TR(<100Gi/L to >=100Gi/L), Cycle 9, n=2,
Title
Measurements
OG00014.0± 11.31
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
TR(<150Gi/L to >=150Gi/L), Cycle 9, n=0,
Title
Measurements
OG000NA± NAZero participants were analyzed; therefore, mean and SD were not available.
OG001NA± NAZero participants were analyzed; therefore, mean and SD were not available.
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0042 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0052 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0053 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
1 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0042 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0052 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0042 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0050 affected52 at risk
1 affected
10 at risk
EG0040 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0050 affected52 at risk
3 affected
10 at risk
EG0042 affected23 at risk
EG0059 affected52 at risk
0 affected
10 at risk
EG0045 affected23 at risk
EG0057 affected52 at risk
6 affected
10 at risk
EG00413 affected23 at risk
EG00521 affected52 at risk
5 affected
10 at risk
EG00410 affected23 at risk
EG00518 affected52 at risk
2 affected
10 at risk
EG0042 affected23 at risk
EG0054 affected52 at risk
1 affected
10 at risk
EG0043 affected23 at risk
EG0057 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0054 affected52 at risk
1 affected
10 at risk
EG0044 affected23 at risk
EG0054 affected52 at risk
1 affected
10 at risk
EG0044 affected23 at risk
EG0055 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0054 affected52 at risk
0 affected
10 at risk
EG0040 affected23 at risk
EG0055 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG00510 affected52 at risk
3 affected
10 at risk
EG0043 affected23 at risk
EG0055 affected52 at risk
1 affected
10 at risk
EG0044 affected23 at risk
EG0058 affected52 at risk
3 affected
10 at risk
EG0043 affected23 at risk
EG00513 affected52 at risk
2 affected
10 at risk
EG0041 affected23 at risk
EG0055 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG0052 affected52 at risk
0 affected
10 at risk
EG0045 affected23 at risk
EG0053 affected52 at risk
0 affected
10 at risk
EG0044 affected23 at risk
EG0053 affected52 at risk
0 affected
10 at risk
EG0045 affected23 at risk
EG0050 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG0055 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG0053 affected52 at risk
2 affected
10 at risk
EG0043 affected23 at risk
EG0054 affected52 at risk
1 affected
10 at risk
EG0041 affected23 at risk
EG0053 affected52 at risk
0 affected
10 at risk
EG0043 affected23 at risk
EG0052 affected52 at risk
0 affected
10 at risk
EG0043 affected23 at risk
EG0056 affected52 at risk
0 affected
10 at risk
EG0043 affected23 at risk
EG0053 affected52 at risk
0 affected
10 at risk
EG0045 affected23 at risk
EG0056 affected52 at risk
3 affected
10 at risk
EG0043 affected23 at risk
EG0054 affected52 at risk
2 affected
10 at risk
EG0046 affected23 at risk
EG0057 affected52 at risk
0 affected
10 at risk
EG0043 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0054 affected52 at risk
1 affected
10 at risk
EG0041 affected23 at risk
EG0057 affected52 at risk
0 affected
10 at risk
EG0045 affected23 at risk
EG0052 affected52 at risk
0 affected
10 at risk
EG0042 affected23 at risk
EG0057 affected52 at risk
0 affected
10 at risk
EG0042 affected23 at risk
EG0050 affected52 at risk
1 affected
10 at risk
EG0041 affected23 at risk
EG0055 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0042 affected23 at risk
EG0051 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0054 affected52 at risk
0 affected
10 at risk
EG0044 affected23 at risk
EG0054 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG0052 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG0055 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG0051 affected52 at risk
1 affected
10 at risk
EG0042 affected23 at risk
EG0051 affected52 at risk
1 affected
10 at risk
EG0041 affected23 at risk
EG0050 affected52 at risk
0 affected
10 at risk
EG0041 affected23 at risk
EG0052 affected52 at risk
2 affected
10 at risk
EG0041 affected23 at risk
EG0052 affected52 at risk
3 affected
10 at risk
EG0041 affected23 at risk
EG0051 affected52 at risk
3
4
3
10
0
3
0
4
2
1
0
2
2
3
3
1
1
2
2
2
3
1
5
1
0
6
1
2
1
4
5
0
1
5
3
1
1
8
0
0
2
10
0
0
0
9
0
1
0
9
1
0
0
2
4
4
0
8
1
1
0
9
0
1
0
7
3
0
0
10
0
0
0
5
5
0
0
7
0
0
3
7
0
0
2
8
0
0
NA
Zero participants were analyzed; therefore, a value was not available.
NA
Zero participants were analyzed; therefore, a value was not available.
NA
Zero participants were analyzed; therefore, a value was not available.
NA
Zero participants were analyzed; therefore, a value was not available.
0
1
0
0
4
3
0
0
4
3
0
0
0
0
1
0
2
2
0
0
NA
Zero participants were analyzed; therefore, a value was not available.
NA
Zero participants were analyzed; therefore, a value was not available.
NA
Zero participants were analyzed; therefore, a value was not available.
NA
Zero participants were analyzed; therefore, a value was not available.
2
2
0
0
0
1
0
0
1
135.6
± 52.52
97.5
± 39.15
473.3
± 117.07
333.0
± 146.59
142.7
± 63.14
435.4
± 145.57
465.2
± 260.20
183.4
± 119.12
388.3
± 166.07
366.5
± 143.75
169.8
± 120.56
406.0
± 174.89
403.5
± 195.31
140.5
± 42.93
360.3
± 133.45
428.0
± 210.71
101.0
± 48.08
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
442.79
± 114.593
355.09
± 148.539
164.24
± 94.905
135.50
± 73.951
151.00
± 111.946
142.86
± 91.908
113.25
± 34.683
122.75
± 63.163
4
0
0
3
19.2
± 4.42
17.6
± 4.50
17.4
± 6.16
21.5
± 1.00
15.5
± 5.20
7.0
± 5.10
6.0
± 1.41
5.0
± 2.83
7.0
± NA
There was only one participant analyzed; therefore, SD could not be determined.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
8.5
± 3.46
9.4
± 4.28
6.2
± 1.10
8.3
± 3.95
4.7
± 2.52
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.
NA
± NA
Zero participants were analyzed; therefore, mean and SD were not available.