Trial Outcomes & Findings for Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag (NCT NCT01147809)

Last Updated: 2016-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)

Results posted on

2016-04-18

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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).	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).
Phase I (168 Days) STARTED	3	9	4	10	0	0
Phase I (168 Days) COMPLETED	2	8	2	5	0	0
Phase I (168 Days) NOT COMPLETED	1	1	2	5	0	0
Phase II (168 Days) STARTED	0	0	0	0	23	52
Phase II (168 Days) Ongoing	0	0	0	0	1	0
Phase II (168 Days) COMPLETED	0	0	0	0	7	19
Phase II (168 Days) NOT COMPLETED	0	0	0	0	16	33

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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).	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).
Phase I (168 Days) Adverse Event	0	0	0	1	0	0
Phase I (168 Days) Lost to Follow-up	1	0	0	1	0	0
Phase I (168 Days) Physician Decision	0	1	2	0	0	0
Phase I (168 Days) Withdrawal by Subject	0	0	0	3	0	0
Phase II (168 Days) Adverse Event	0	0	0	0	3	6
Phase II (168 Days) Protocol Violation	0	0	0	0	0	1
Phase II (168 Days) Physician Decision	0	0	0	0	5	11
Phase II (168 Days) Withdrawal by Subject	0	0	0	0	7	15
Phase II (168 Days) Ongoing	0	0	0	0	1	0

Baseline Characteristics

Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: 21-Day Cycle Placebo n=3 Participants 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.	Phase I: 21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	Phase I: 28-Day Cycle Placebo n=4 Participants 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.	Phase I: 28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.	Phase II: Placebo n=23 Participants 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).	Phase II: Eltrombopag 100 mg n=52 Participants 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).	Total n=101 Participants Total of all reporting groups
Age, Continuous	53.3 Years STANDARD_DEVIATION 3.79 • n=93 Participants	53.8 Years STANDARD_DEVIATION 11.27 • n=4 Participants	61.8 Years STANDARD_DEVIATION 22.82 • n=27 Participants	65.6 Years STANDARD_DEVIATION 8.41 • n=483 Participants	64.4 Years STANDARD_DEVIATION 9.96 • n=36 Participants	66.3 Years STANDARD_DEVIATION 8.98 • n=10 Participants	64.1 Years STANDARD_DEVIATION 10.56 • n=115 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	7 Participants n=4 Participants	3 Participants n=27 Participants	3 Participants n=483 Participants	13 Participants n=36 Participants	23 Participants n=10 Participants	50 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	7 Participants n=483 Participants	10 Participants n=36 Participants	29 Participants n=10 Participants	51 Participants n=115 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race/Ethnicity, Customized White	2 Participants n=93 Participants	8 Participants n=4 Participants	3 Participants n=27 Participants	8 Participants n=483 Participants	22 Participants n=36 Participants	52 Participants n=10 Participants	95 Participants n=115 Participants
Race/Ethnicity, Customized Central/South Asian Heritage	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Japanese/East Asian Heritage/South East Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants

PRIMARY outcome

Timeframe: From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)

Population: Safety Population

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
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 Any AE Pre-therapy	3 Participants	8 Participants	4 Participants	9 Participants
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 Any SAE Pre-therapy	1 Participants	0 Participants	0 Participants	1 Participants
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 Any AE On-therapy+30 days	3 Participants	9 Participants	3 Participants	10 Participants
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 Any SAE On-therapy+30 days	1 Participants	5 Participants	1 Participants	2 Participants
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 Any SAE Post-therapy	0 Participants	0 Participants	0 Participants	1 Participants
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 >=Grade 3 AEs On-therapy+30 days	2 Participants	7 Participants	2 Participants	3 Participants
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 Liver AEs On-therapy+30 days	0 Participants	2 Participants	0 Participants	2 Participants
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 Renal AEs On-therapy+30 days	0 Participants	3 Participants	2 Participants	0 Participants
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 Thromboembolic events On-therapy+30 days	0 Participants	2 Participants	0 Participants	1 Participants
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 Cardiac AEs On-therapy+30 days	0 Participants	1 Participants	1 Participants	1 Participants
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 Neutropenia On-therapy+30 days	3 Participants	4 Participants	2 Participants	5 Participants
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 Any AE Post-therapy	0 Participants	0 Participants	0 Participants	3 Participants
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 Treatment-related AEs On-therapy+30 days	2 Participants	3 Participants	1 Participants	6 Participants
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 Anemia On-therapy+30 days	1 Participants	4 Participants	1 Participants	4 Participants
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 Thrombocytopenia On-therapy+30 days	2 Participants	3 Participants	3 Participants	3 Participants
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 Leukopenia On-therapy+30 days	1 Participants	2 Participants	2 Participants	3 Participants
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 Thrombocytosis On-therapy+30 days	2 Participants	2 Participants	1 Participants	2 Participants
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 Platelet count increased On-therapy+30 days	0 Participants	0 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: After Baseline (C1D1), on-treatment and 30 day follow-up

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Lymphocytes (Increased), Grade 0, n=3,9,4,10	3 Participants	8 Participants	4 Participants	10 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Lymphocytes (Increased), Grade 2, n=3,9,4,10	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Lymphocytes (Decreased), Grade 1, n=3,9,4,10	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I PLT, Grade 4, n=3,9,4,10	2 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I WBC, Grade 0, n=3,9,4,10	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Hemoglobin (Increased), Grade 0, n=3,9,4,10	3 Participants	9 Participants	4 Participants	10 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Hemoglobin (Anemia), Grade 1, n=3,9,4,10	2 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Hemoglobin (Anemia), Grade 2, n=3,9,4,10	0 Participants	6 Participants	2 Participants	4 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Hemoglobin (Anemia), Grade 3, n=3,9,4,10	1 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I WBC, Grade 1, n=3,9,4,10	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I WBC, Grade 2, n=3,9,4,10	2 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I WBC, Grade 3, n=3,9,4,10	1 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I WBC, Grade 4, n=3,9,4,10	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Lymphocytes (Decreased), Grade 0, n=3,9,4,10	1 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Lymphocytes (Decreased), Grade 2, n=3,9,4,10	1 Participants	1 Participants	1 Participants	4 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Lymphocytes (Decreased), Grade 3, n=3,9,4,10	1 Participants	5 Participants	3 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Lymphocytes (Decreased), Grade 4, n=3,9,4,10	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Total ANC, Grade 0, n=1,2,1,2	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I Total ANC, Grade 1, n=1,2,1,2	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I PLT, Grade 0, n=3,9,4,10	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I PLT, Grade 1, n=3,9,4,10	0 Participants	1 Participants	1 Participants	3 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I PLT, Grade 2, n=3,9,4,10	0 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I PLT, Grade 3, n=3,9,4,10	1 Participants	2 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: After Baseline (C1D1), on-treatment and 30 day follow-up

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I TB, Grade 0, n=3,9,4,10	3 Participants	5 Participants	3 Participants	8 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Glu (hypoglycemia), Grade 1, n=3,9,4,10	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I K (hyperkalemia), Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Alb, Grade 0, n=3,9,4,10	2 Participants	4 Participants	0 Participants	4 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Alb, Grade 1, n=3,9,4,10	1 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Alb, Grade 2, n=3,9,4,10	0 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Alb, Grade 3, n=3,9,4,10	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I ALP, Grade 0, n=3,9,4,10	2 Participants	3 Participants	3 Participants	6 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I ALP, Grade 1, n=3,9,4,10	1 Participants	5 Participants	1 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I ALP, Grade 2, n=3,9,4,10	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I ALP, Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I ALT, Grade 0, n=3,9,4,10	2 Participants	3 Participants	3 Participants	4 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I ALT, Grade 1, n=3,9,4,10	1 Participants	4 Participants	1 Participants	5 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I ALT, Grade 2, n=3,9,4,10	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I ALT, Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I AST, Grade 0, n=3,9,4,10	2 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I AST, Grade 1, n=3,9,4,10	1 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I AST, Grade 2, n=3,9,4,10	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I AST, Grade 3, n=3,9,4,10	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I TB, Grade 1, n=3,9,4,10	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I TB, Grade 2, n=3,9,4,10	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I TB, Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Ca (hypercalcemia), Grade 0, n=3,9,4,10	3 Participants	8 Participants	4 Participants	10 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Ca (hypercalcemia), Grade 1, n=3,9,4,10	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Ca (hypercalcemia), Grade 2, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Ca (hypercalcemia), Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Ca (hypocalcemia), Grade 0, n=3,9,4,10	2 Participants	7 Participants	3 Participants	9 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Ca (hypocalcemia), Grade 1, n=3,9,4,10	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Ca (hypocalcemia), Grade 2, n=3,9,4,10	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Ca (hypocalcemia), Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Creatinine, Grade 0, n=3,9,4,10	3 Participants	7 Participants	4 Participants	9 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Creatinine, Grade 1, n=3,9,4,10	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Creatinine, Grade 2, n=3,9,4,10	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Creatinine, Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Glu (hyperglycemia), Grade 0, n=3,9,4,10	2 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Glu (hyperglycemia), Grade 1, n=3,9,4,10	0 Participants	4 Participants	2 Participants	4 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Glu (hyperglycemia), Grade 2, n=3,9,4,10	1 Participants	2 Participants	1 Participants	4 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Glu (hyperglycemia), Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Glu (hypoglycemia), Grade 0, n=3,9,4,10	3 Participants	8 Participants	4 Participants	8 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Glu (hypoglycemia), Grade 2, n=3,9,4,10	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Glu (hypoglycemia), Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I K (hyperkalemia), Grade 0, n=3,9,4,10	1 Participants	8 Participants	3 Participants	9 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I K (hyperkalemia), Grade 1, n=3,9,4,10	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I K (hyperkalemia), Grade 2, n=3,9,4,10	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I K (hypokalemia), Grade 0, n=3,9,4,10	2 Participants	5 Participants	3 Participants	7 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I K (hypokalemia), Grade 1, n=3,9,4,10	1 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I K (hypokalemia), Grade 2, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I K (hypokalemia), Grade 3, n=3,9,4,10	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Na (hypernatremia), Grade 0, n=3,9,4,10	2 Participants	9 Participants	3 Participants	10 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Na (hypernatremia), Grade 1, n=3,9,4,10	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Na (hypernatremia), Grade 2, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Na (hypernatremia), Grade 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Na (hyponatremia), Grade 0, n=3,9,4,10	2 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Na (hyponatremia), Grade 1, n=3,9,4,10	1 Participants	4 Participants	0 Participants	5 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Na (hyponatremia), Grade 2, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I Na (hyponatremia), Grade 3, n=3,9,4,10	0 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: After Baseline (C1D1), on-treatment and 30 day follow-up

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I	0 Participants	3 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Screening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C4D1, Score 2, n=2,6,1,7	0 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C5D1, Score 3, n=1,3,1,4	0 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C6D1, Score 2, n=1,1,1,4	0 Participants	0 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D15, Score 3, n=0,1,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C3D1, Score 0, n=2,6,2,7	1 Participants	2 Participants	2 Participants	4 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C3D1, Score 1, n=2,6,2,7	1 Participants	2 Participants	0 Participants	3 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C3D1, Score 2, n=2,6,2,7	0 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I Screening, Score 0, n=3,9,4,10	3 Participants	5 Participants	1 Participants	3 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I Screening, Score 1, n=3,9,4,10	0 Participants	3 Participants	3 Participants	7 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I Screening, Score 2, n=3,9,4,10	0 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I Screening, Score 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C1D1, Score 0, n=3,9,4,10	3 Participants	5 Participants	2 Participants	3 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C1D1, Score 1, n=3,9,4,10	0 Participants	3 Participants	2 Participants	7 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C1D1, Score 2, n=3,9,4,10	0 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C1D1, Score 3, n=3,9,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D1, Score 0, n=3,8,4,10	1 Participants	3 Participants	2 Participants	2 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D1, Score 1, n=3,8,4,10	1 Participants	4 Participants	1 Participants	8 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D1, Score 2, n=3,8,4,10	1 Participants	1 Participants	1 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D1, Score 3, n=3,8,4,10	0 Participants	0 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D8, Score 0, n=1,0,1,0	1 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D8, Score 1, n=1,0,1,0	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D8, Score 2, n=1,0,1,0	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	1 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D8, Score 3, n=1,0,1,0	1 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D15, Score 0, n=0,1,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D15, Score 1, n=0,1,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	1 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C2D15, Score 2, n=0,1,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	1 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C3D1, Score 3, n=2,6,2,7	0 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C4D1, Score 0, n=2,6,1,7	1 Participants	1 Participants	0 Participants	4 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C4D1, Score 1, n=2,6,1,7	1 Participants	3 Participants	1 Participants	3 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C4D1, Score 3, n=2,6,1,7	0 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C4D22, Score 0, n=0,0,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C4D22, Score 1, n=0,0,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C4D22, Score 2, n=0,0,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	1 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C4D22, Score 3, n=0,0,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C5D1, Score 0, n=1,3,1,4	0 Participants	0 Participants	0 Participants	2 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C5D1, Score 1, n=1,3,1,4	1 Participants	1 Participants	1 Participants	2 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C5D1, Score 2, n=1,3,1,4	0 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C5D8, Score 0, n=0,1,0,0	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C5D8, Score 1, n=0,1,0,0	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C5D8, Score 2, n=0,1,0,0	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C5D8, Score 3, n=0,1,0,0	NA Participants Zero participants were analyzed; therefore, a value was not available.	1 Participants	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C6D1, Score 0, n=1,1,1,4	0 Participants	1 Participants	0 Participants	2 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C6D1, Score 1, n=1,1,1,4	1 Participants	0 Participants	1 Participants	2 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C6D1, Score 3, n=1,1,1,4	0 Participants	0 Participants	0 Participants	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C6D15, Score 0, n=0,0,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C6D15, Score 1, n=0,0,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	1 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C6D15, Score 2, n=0,0,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I C6D15, Score 3, n=0,0,0,1	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	NA Participants Zero participants were analyzed; therefore, a value was not available.	0 Participants

PRIMARY outcome

Timeframe: C2D4, C2D8, C5D8, C6D15

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I No change or insignificant change n=3,9,3,8	3 Participants	8 Participants	3 Participants	7 Participants
Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I CSC: unfavorable, n=3,9,3,8	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 (averaged across cycles 1 to 6)

Population: Intent-to Treat (ITT) Population: all randomized participants.

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=48 Participants 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.	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.	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.
Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II	193.34 Giga (10^9) cells per liter (Gi/L) Geometric Coefficient of Variation 54.5	246.20 Giga (10^9) cells per liter (Gi/L) Geometric Coefficient of Variation 49.8	—	—

SECONDARY outcome

Timeframe: C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1,C4D8, C4D15, C5D1,C5D8, C5D15, C6D1,C6D8 and C6D15

Population: Safety Population

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).

Outcome measures

SECONDARY outcome

Timeframe: Day 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I G+Cb, Day 1, n=1,3,0,0	296.80 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined	275.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation 144.253	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I G+Cb, Day 8, n=1,3,0,0	235.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined	232.10 Giga (10^9) cells per liter (G cells/L) Standard Deviation 77.329	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I G+Cis, Day 1, n=2,6,0,0	322.50 Giga (10^9) cells per liter (G cells/L) Standard Deviation 82.731	526.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation 86.408	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I G+Cis, Day 8, n=2,6,0,0	326.85 Giga (10^9) cells per liter (G cells/L) Standard Deviation 119.006	296.75 Giga (10^9) cells per liter (G cells/L) Standard Deviation 119.342	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I Gm, Day1, n=0,0,4,9	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	309.20 Giga (10^9) cells per liter (G cells/L) Standard Deviation 123.133	442.79 Giga (10^9) cells per liter (G cells/L) Standard Deviation 114.593
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I Gm, Day8, n=0,0,4,10	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	204.20 Giga (10^9) cells per liter (G cells/L) Standard Deviation 80.822	355.09 Giga (10^9) cells per liter (G cells/L) Standard Deviation 148.539
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I Gm, Day15, n=0,0,3,10	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	75.37 Giga (10^9) cells per liter (G cells/L) Standard Deviation 18.292	164.24 Giga (10^9) cells per liter (G cells/L) Standard Deviation 94.905

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Platelet Count Nadir for Each Chemotherapy Cycle in Phase I Cycle 1, n=3,9,4,10	30.67 Giga (10^9) cells per liter (G cells/L) Standard Deviation 20.404	106.56 Giga (10^9) cells per liter (G cells/L) Standard Deviation 113.338	60.50 Giga (10^9) cells per liter (G cells/L) Standard Deviation 22.664	99.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation 75.700
Platelet Count Nadir for Each Chemotherapy Cycle in Phase I Cycle 2, n=2,9,4,10	66.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation 9.899	122.44 Giga (10^9) cells per liter (G cells/L) Standard Deviation 115.794	103.50 Giga (10^9) cells per liter (G cells/L) Standard Deviation 62.952	135.50 Giga (10^9) cells per liter (G cells/L) Standard Deviation 73.951
Platelet Count Nadir for Each Chemotherapy Cycle in Phase I Cycle 3, n=2,7,2,7	47.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation 4.243	88.29 Giga (10^9) cells per liter (G cells/L) Standard Deviation 71.807	78.50 Giga (10^9) cells per liter (G cells/L) Standard Deviation 43.134	151.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation 111.946
Platelet Count Nadir for Each Chemotherapy Cycle in Phase I Cycle 4, n=2,6,1,7	76.50 Giga (10^9) cells per liter (G cells/L) Standard Deviation 4.950	87.50 Giga (10^9) cells per liter (G cells/L) Standard Deviation 79.173	86.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	142.86 Giga (10^9) cells per liter (G cells/L) Standard Deviation 91.908
Platelet Count Nadir for Each Chemotherapy Cycle in Phase I Cycle 5, n=1,2,1,4	14.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	148.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation 182.434	75.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	113.25 Giga (10^9) cells per liter (G cells/L) Standard Deviation 34.683
Platelet Count Nadir for Each Chemotherapy Cycle in Phase I Cycle 6, n=1,1,1,4	24.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	13.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	110.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	122.75 Giga (10^9) cells per liter (G cells/L) Standard Deviation 63.163

SECONDARY outcome

Timeframe: All assessments from Cycle 2 Day 1 to last assessment in Cycle 6

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I	260.97 Giga (10^9) cells per liter (G cells/L) Standard Deviation 67.581	307.59 Giga (10^9) cells per liter (G cells/L) Standard Deviation 95.110	183.68 Giga (10^9) cells per liter (G cells/L) Standard Deviation 55.366	291.18 Giga (10^9) cells per liter (G cells/L) Standard Deviation 99.718

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
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 Grade 1, n=3,9,4,10	0 Participants	2 Participants	1 Participants	3 Participants
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 Grade 2, n=3,9,4,10	0 Participants	3 Participants	1 Participants	4 Participants
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 Grade 3, n=3,9,4,10	1 Participants	1 Participants	1 Participants	0 Participants
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 Grade 4, n=3,9,4,10	1 Participants	2 Participants	0 Participants	0 Participants
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 Grade 0 / None, n=3,9,4,10	1 Participants	1 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Cycle 2 to Cycle 6

Population: Safety Population. Participants experiencing thrombocytopenia with subsequent increase in platelet count to \>=150Gi/L are included.

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=2 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=8 Participants 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.	28-Day Cycle Placebo n=3 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=7 Participants 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.
Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts	11.0 Days Standard Deviation 4.24	10.6 Days Standard Deviation 5.63	14.7 Days Standard Deviation 7.77	13.4 Days Standard Deviation 5.06

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I Cycle 1, n=3,9,4,10	15.7 Days Standard Deviation 0.58	11.4 Days Standard Deviation 5.53	13.8 Days Standard Deviation 6.13	13.8 Days Standard Deviation 4.73
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I Cycle 2, n=2,9,4,10	15.0 Days Standard Deviation 1.41	12.9 Days Standard Deviation 4.68	14.0 Days Standard Deviation 5.72	19.2 Days Standard Deviation 4.42
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I Cycle 3, n=2,7,2,7	15.0 Days Standard Deviation 1.41	12.9 Days Standard Deviation 3.02	23.5 Days Standard Deviation 0.71	17.6 Days Standard Deviation 4.50
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I Cycle 4, n=2,6,1,7	14.0 Days Standard Deviation 0.00	13.5 Days Standard Deviation 3.33	14.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined	17.4 Days Standard Deviation 6.16
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I Cycle 5, n=1,2,1,4	15.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined	11.5 Days Standard Deviation 6.36	14.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined	21.5 Days Standard Deviation 1.00
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I Cycle 6, n=1,1,1,4	16.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined	14.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined	23.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined	15.5 Days Standard Deviation 5.20

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<100Gi/L to >=100Gi/L), Cycle 6, n=0,1,0,0	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	7.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<150Gi/L to >=150Gi/L), Cycle 1, n=3,7,4,8	5.3 Days Standard Deviation 0.58	7.6 Days Standard Deviation 2.57	7.0 Days Standard Deviation 0.00	8.5 Days Standard Deviation 3.46
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<150Gi/L to >=150Gi/L), Cycle 2, n=2,4,3,5	6.5 Days Standard Deviation 2.12	7.8 Days Standard Deviation 2.99	9.0 Days Standard Deviation 4.36	9.4 Days Standard Deviation 4.28
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<150Gi/L to >=150Gi/L), Cycle 3, n=1,6,1,5	7.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	8.0 Days Standard Deviation 2.97	7.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	6.2 Days Standard Deviation 1.10
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<150Gi/L to >=150Gi/L), Cycle 4, n=1,4,1,4	8.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	7.8 Days Standard Deviation 4.27	14.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	8.3 Days Standard Deviation 3.95
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<150Gi/L to >=150Gi/L), Cycle 5, n=1,0,1,3	5.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	14.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	4.7 Days Standard Deviation 2.52
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<150Gi/L to >=150Gi/L), Cycle 6, n=0,0,1,0	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	5.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<100Gi/L to >=100Gi/L), Cycle 1, n=3,6,4,7	5.3 Days Standard Deviation 0.58	7.2 Days Standard Deviation 2.56	7.0 Days Standard Deviation 0.00	7.7 Days Standard Deviation 2.87
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<100Gi/L to >=100Gi/L), Cycle 2, n=2,5,3,4	6.5 Days Standard Deviation 2.12	6.6 Days Standard Deviation 3.65	6.0 Days Standard Deviation 4.00	7.0 Days Standard Deviation 5.10
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<100Gi/L to >=100Gi/L), Cycle 3, n=1,4,0,2	7.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	8.5 Days Standard Deviation 3.70	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	6.0 Days Standard Deviation 1.41
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<100Gi/L to >=100Gi/L), Cycle 4, n=1,4,1,2	2.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	6.5 Days Standard Deviation 5.20	14.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	5.0 Days Standard Deviation 2.83
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts TR(<100Gi/L to >=100Gi/L), Cycle 5, n=1,1,1,1	5.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	5.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	9.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	7.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: Safety Population

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).

Outcome measures

SECONDARY outcome

Timeframe: All time on chemotherapy treatment

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=1 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=3 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I	1 Participants	2 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
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 Pulmonary embolism On-therapy+30 days	0 Participants	1 Participants	—	—
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 Portal vein thrombosis On-therapy+30 days	1 Participants	0 Participants	—	—
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 Any AE Pre Therapy	0 Participants	1 Participants	—	—
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 Any SAE Pre Therapy	0 Participants	0 Participants	—	—
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 Any AE On Therapy+30 days	23 Participants	48 Participants	—	—
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 Any SAE On Therapy+30 days	12 Participants	16 Participants	—	—
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 Any AE Post Therapy	4 Participants	2 Participants	—	—
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 Any SAE Post Therapy	2 Participants	1 Participants	—	—
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 Blood/lymphatic system disorders On-therapy+30 day	21 Participants	40 Participants	—	—
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 Thrombocytopenia On-therapy+30 days	11 Participants	19 Participants	—	—
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 Anemia On-therapy+30 days	16 Participants	26 Participants	—	—
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 Neutopenia On-therapy+30 days	13 Participants	21 Participants	—	—
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 Gastrointestinal disorders On-therapy+30 days	12 Participants	25 Participants	—	—
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 Blood Creatinine increased On-therapy+30 days	3 Participants	2 Participants	—	—
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 Vascular discorders On-therapy+30 days	2 Participants	6 Participants	—	—
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 Cardiac disorders On-therapy+30 days	1 Participants	3 Participants	—	—
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 Deaths On-therapy+30 days	9 Participants	13 Participants	—	—

SECONDARY outcome

Timeframe: 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

Population: ITT Population: Participants with at least one visit within the cycle.

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=12 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=35 Participants 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.	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.	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.
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 Grade 0	11 Participants	34 Participants	—	—
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 Grade 1	1 Participants	0 Participants	—	—
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 Grade 2	0 Participants	0 Participants	—	—
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 Grade 3	0 Participants	0 Participants	—	—
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 Grade 4	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Screening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuation

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Number of Participants Requiring a Platelet Transfusion in Phase II Cycle 1	0 Participants	4 Participants	—	—
Number of Participants Requiring a Platelet Transfusion in Phase II Cycle 2	2 Participants	3 Participants	—	—
Number of Participants Requiring a Platelet Transfusion in Phase II Cycle 3	0 Participants	2 Participants	—	—
Number of Participants Requiring a Platelet Transfusion in Phase II Cycle 4	1 Participants	1 Participants	—	—
Number of Participants Requiring a Platelet Transfusion in Phase II Cycle 5	0 Participants	0 Participants	—	—
Number of Participants Requiring a Platelet Transfusion in Phase II Cycle 6	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: ITT Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II Gemcitabine, 21-day cycle, n=11,22	5 Participants	7 Participants	—	—
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II Carboplatin, 21-day cycle, n=4,12	4 Participants	5 Participants	—	—
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II Cisplatin, 21-day cycle, n=7,9	1 Participants	2 Participants	—	—
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II Gemcitabine, 28-day cycle, n=12,30	4 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II Gemcitabine, 21-day cycle, n=11,22	7 Participants	6 Participants	—	—
Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II Carboplatin, 21-day cycle, n=4,12	2 Participants	2 Participants	—	—
Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II Cisplatin, 21-day cycle, n=7,9	0 Participants	3 Participants	—	—
Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II Gemcitabine, 28-day cycle, n=12,30	8 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II Cycle 1, n=23,48	96.6 Dose Intensity (%) Standard Deviation 10.65	97.9 Dose Intensity (%) Standard Deviation 6.19	—	—
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II Cycle 2, n=19,37	113.1 Dose Intensity (%) Standard Deviation 33.91	97.8 Dose Intensity (%) Standard Deviation 24.99	—	—
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II Cycle 3, n=13,26	102.6 Dose Intensity (%) Standard Deviation 42.20	98.7 Dose Intensity (%) Standard Deviation 35.77	—	—
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II Cycle 4, n=11,19	96.6 Dose Intensity (%) Standard Deviation 27.65	90.7 Dose Intensity (%) Standard Deviation 30.00	—	—
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II Cycle 5, n=6,12	102.2 Dose Intensity (%) Standard Deviation 31.88	81.3 Dose Intensity (%) Standard Deviation 25.39	—	—
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II Cycle 6, n=5,7	84.4 Dose Intensity (%) Standard Deviation 21.92	65.2 Dose Intensity (%) Standard Deviation 25.48	—	—
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II Cycle 1-6, n=23,49	98.5 Dose Intensity (%) Standard Deviation 18.26	94.6 Dose Intensity (%) Standard Deviation 15.71	—	—

SECONDARY outcome

Timeframe: After baseline (C1D1), on-treatment and 30 day follow-up

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Increased), Grade 0, n=23,52	23 Participants	52 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Increased), Grade 1, n=23,52	0 Participants	0 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Increased), Grade 2, n=23,52	0 Participants	0 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Increased), Grade 3, n=23,52	0 Participants	0 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Increased), Grade 4, n=23,52	0 Participants	0 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Anemia), Grade 0, n=23,52	0 Participants	4 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Anemia), Grade 1, n=23,52	4 Participants	16 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Anemia), Grade 2, n=23,52	13 Participants	16 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Anemia), Grade 3, n=23,52	6 Participants	16 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Hb (Anemia), Grade 4, n=23,52	0 Participants	0 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Increased), Grade 0, n=23,52	22 Participants	47 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Increased), Grade 1, n=23,52	0 Participants	0 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Increased), Grade 2, n=23,52	1 Participants	2 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Increased), Grade 3, n=23,52	0 Participants	1 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Increased), Grade 4, n=23,52	0 Participants	0 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Decreased), Grade 0, n=23,52	1 Participants	7 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Decreased), Grade 1, n=23,52	3 Participants	10 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Decreased), Grade 2, n=23,52	8 Participants	14 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Decreased), Grade 3, n=23,52	9 Participants	16 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Lym (Decreased), Grade 4, n=23,52	2 Participants	3 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Total ANC, Grade 0, n=23,52	4 Participants	16 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Total ANC, Grade 1, n=23,52	1 Participants	4 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Total ANC, Grade2, n=23,52	3 Participants	17 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Total ANC, Grade 3, n=23,52	10 Participants	10 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Total ANC, Grade 4, n=23,52	5 Participants	3 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Platelet count, Grade 0, n=23,52	0 Participants	7 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Platelet count, Grade 1, n=23,52	4 Participants	9 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Platelet count, Grade 2, n=23,52	3 Participants	9 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Platelet count, Grade 3, n=23,52	6 Participants	15 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II Platelet count, Grade 4, n=23,52	10 Participants	12 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II WBC count, Grade 0, n=23,52	4 Participants	14 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II WBC count, Grade 1, n=23,52	3 Participants	10 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II WBC count, Grade 2, n=23,52	8 Participants	17 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II WBC count, Grade 3, n=23,52	6 Participants	11 Participants	—	—
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II WBC count, Grade 4, n=23,52	2 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 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

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
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 Al, Any grade increase, n=23,51	10 participants	22 participants	—	—
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 Al, Increase to Grade 3, n=23,51	0 participants	2 participants	—	—
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 Al, Increase to Grade 4, n=23,51	0 participants	0 participants	—	—
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 ALP, Any grade increase, n=23,52	11 participants	16 participants	—	—
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 ALP, Increase to Grade 3, n=23,52	1 participants	2 participants	—	—
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 ALP, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 ALT, Any grade increase, n=23,52	12 participants	16 participants	—	—
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 ALT, Increase to Grade 3, n=23,52	3 participants	2 participants	—	—
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 ALT, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 AST, Any grade increase, n=23,52	11 participants	15 participants	—	—
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 AST, Increase to Grade 3, n=23,52	3 participants	2 participants	—	—
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 AST, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 TB, Any grade increase, n=23,52	5 participants	11 participants	—	—
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 TB, Increase to Grade 3, n=23,52	3 participants	2 participants	—	—
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 TB, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 CaHy, Any grade increase, n=23,51	0 participants	1 participants	—	—
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 CaHy, Increase to Grade 3, n=23,51	0 participants	0 participants	—	—
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 CaHy, Increase to Grade 4, n=23,51	0 participants	0 participants	—	—
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 CaHo, Any grade increase, n=23,51	3 participants	10 participants	—	—
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 CaHo, Increase to Grade 3, n=23,51	1 participants	2 participants	—	—
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 CaHo, Increase to Grade 4, n=23,51	0 participants	0 participants	—	—
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 Creatinine, Any grade increase, n=23,52	5 participants	11 participants	—	—
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 Creatinine, Increase to Grade 3, n=23,52	1 participants	0 participants	—	—
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 Creatinine, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 GluHy, Any grade increase, n=23,52	13 participants	31 participants	—	—
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 GluHy, Increase to Grade 3, n=23,52	2 participants	3 participants	—	—
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 GluHy, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 GluHo, Any grade increase, n=23,52	2 participants	4 participants	—	—
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 GluHo, Increase to Grade 3, n=23,52	0 participants	0 participants	—	—
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 GluHo, Increase to Grade 4, n=23,52	1 participants	0 participants	—	—
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 NaHy, Any grade increase, n=23,52	0 participants	2 participants	—	—
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 NaHy, Increase to Grade 3, n=23,52	0 participants	0 participants	—	—
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 NaHy, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 NaHo, Any grade increase, n=23,52	4 participants	15 participants	—	—
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 NaHo, Increase to Grade 3, n=23,52	1 participants	1 participants	—	—
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 NaHo, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 KHy, Any grade increase, n=23,52	4 participants	10 participants	—	—
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 KHy, Increase to Grade 3, n=23,52	1 participants	1 participants	—	—
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 KHy, Increase to Grade 4, n=23,52	0 participants	0 participants	—	—
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 KHo, Any grade increase, n=23,52	5 participants	11 participants	—	—
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 KHo, Increase to Grade 3, n=23,52	1 participants	4 participants	—	—
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 KHo, Increase to Grade 4, n=23,52	0 participants	1 participants	—	—

SECONDARY outcome

Timeframe: 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

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II	5 participants	11 participants	—	—

SECONDARY outcome

Timeframe: Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1 and C17D1

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C2D1, Score 1, n=19,36	13 participants	18 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C2D1, Score 2, n=19,36	2 participants	2 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C3D1, Score 0, n=13,27	3 participants	9 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C4D1, Score 1, n=11,19	7 participants	10 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C4D1, Score 2, n=11,19	0 participants	1 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C5D1, Score 0, n=6,12	2 participants	5 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C5D1, Score 1, n=6,12	4 participants	6 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C5D1, Score 2, n=6,12	0 participants	1 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C3D1, Score 1, n=13,27	9 participants	16 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C3D1, Score 2, n=13,27	1 participants	2 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C4D1, Score 0, n=11,19	4 participants	8 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II Screening, Score 0, n=23,52	3 participants	19 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II Screening, Score 1, n=23,52	19 participants	32 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II Screening, Score 2, n=23,52	1 participants	1 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C1D1, Score 0, n=23,49	4 participants	20 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C1D1, Score 1, n=23,49	17 participants	28 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C1D1, Score 2, n=23,49	0 participants	1 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C1D1, Unknown, n=23,49	2 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C2D1, Score 0, n=19,36	4 participants	16 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C6D1, Score 0, n=6,7	2 participants	3 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C6D1, Score 1, n=6,7	4 participants	4 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C7D1, Score 0, n=3,2	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C7D1, Score 1, n=3,2	2 participants	2 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C8D1, Score 0, n=2,1	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C8D1, Score 1, n=2,1	1 participants	1 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C9D1, Score 1, n=2,1	2 participants	1 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C10D1, Score1 n=2,0	2 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C11D1, Score 1, n=2,0	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C11D1, Score 2, n=2,0	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C12D1, Score 1, n=2,0	2 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C13D1, Score 0, n=2,0	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C13D1, Score 1, n=2,0	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C14D1, Score 0, n=2,0	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C14D1, Score 1, n=2,0	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C15D1, Score 1, n=2,0	2 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C16D1, Score 0, n=1,0	1 participants	0 participants	—	—
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II C17D1, Score 2, n=1,0	1 participants	0 participants	—	—

SECONDARY outcome

Timeframe: C1D4

Population: Safety Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II CSC favorable, n=22,45	0 participants	2 participants	—	—
Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II No change or insignificant change, n=22,45	20 participants	42 participants	—	—
Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II CSC: unfavorable, n=22,45	2 participants	1 participants	—	—

SECONDARY outcome

Timeframe: Day 8 (averaged across cycles 1 to 6)

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=20 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=42 Participants 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.	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.	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.
Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II	162.18 Giga (10^9) cells per liter (G cells/L) Geometric Coefficient of Variation 74.2	180.65 Giga (10^9) cells per liter (G cells/L) Geometric Coefficient of Variation 59.1	—	—

SECONDARY outcome

Timeframe: Day 15 (averaged across cycles 1 to 6)

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=9 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=22 Participants 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.	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.	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.
Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II	95.10 Giga (10^9) cells per liter (G cells/L) Geometric Coefficient of Variation 23.3	95.29 Giga (10^9) cells per liter (G cells/L) Geometric Coefficient of Variation 52.1	—	—

SECONDARY outcome

Timeframe: Day 1, Day 8, Day 15 (all averaged across cycles 1 to 6)

Population: ITT Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II Day1, n=23,48	221.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 128.23	272.9 Giga (10^9) cells per liter (G cells/L) Standard Deviation 120.92	—	—
Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II Day 8, n=20,42	201.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 143.75	207.4 Giga (10^9) cells per liter (G cells/L) Standard Deviation 110.93	—	—
Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II Day 15, n=9,22	97.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 24.82	106.7 Giga (10^9) cells per liter (G cells/L) Standard Deviation 54.73	—	—

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: ITT Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Platelet Count Nadir for Each Chemotherapy Cycle in Phase II Cycle 1, n=23,48	68.3 Giga (10^9) cells per liter (G cells/L) Standard Deviation 47.74	77.2 Giga (10^9) cells per liter (G cells/L) Standard Deviation 76.43	—	—
Platelet Count Nadir for Each Chemotherapy Cycle in Phase II Cycle 2, n=19,37	61.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 35.82	68.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 48.92	—	—
Platelet Count Nadir for Each Chemotherapy Cycle in Phase II Cycle 3, n=13,26	71.6 Giga (10^9) cells per liter (G cells/L) Standard Deviation 53.80	84.7 Giga (10^9) cells per liter (G cells/L) Standard Deviation 60.03	—	—
Platelet Count Nadir for Each Chemotherapy Cycle in Phase II Cycle 4, n=11, 19	89.7 Giga (10^9) cells per liter (G cells/L) Standard Deviation 116.73	86.9 Giga (10^9) cells per liter (G cells/L) Standard Deviation 56.11	—	—
Platelet Count Nadir for Each Chemotherapy Cycle in Phase II Cycle 5, n=6,11	51.7 Giga (10^9) cells per liter (G cells/L) Standard Deviation 12.23	83.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 58.63	—	—
Platelet Count Nadir for Each Chemotherapy Cycle in Phase II Cycle 6, n=5,5	69.6 Giga (10^9) cells per liter (G cells/L) Standard Deviation 62.76	136.6 Giga (10^9) cells per liter (G cells/L) Standard Deviation 151.88	—	—

SECONDARY outcome

Timeframe: All assessments from Cycle 1 Day 1 to last assessment in Cycle 6

Population: ITT Population:Participants with platelet count data in at least one cycle in the study.

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=48 Participants 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.	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.	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.
Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II	153.00 Giga (10^9) cells per liter (G cells/L) Standard Deviation 96.079	189.48 Giga (10^9) cells per liter (G cells/L) Standard Deviation 79.583	—	—

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=50 Participants 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.	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.	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.
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II Grade 1	4 Participants	9 Participants	—	—
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II Grade 2	3 Participants	9 Participants	—	—
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II Grade 3	8 Participants	15 Participants	—	—
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II Grade 4	8 Participants	12 Participants	—	—
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II None	0 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: ITT Population: Participants with at least one period of thrombocytopenia where duration could be calculated.

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.

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=45 Participants 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.	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.	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.
Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II	32.6 Days Standard Deviation 20.31	23.5 Days Standard Deviation 18.68	—	—

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: ITT Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 1, n=23,48	14.7 Days Standard Deviation 4.85	15.7 Days Standard Deviation 6.12	—	—
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 2, n=19,37	15.1 Days Standard Deviation 4.41	15.4 Days Standard Deviation 3.62	—	—
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 3, n=13,26	15.8 Days Standard Deviation 5.64	14.3 Days Standard Deviation 4.76	—	—
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 4, n=11,19	15.4 Days Standard Deviation 5.48	14.7 Days Standard Deviation 5.19	—	—
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 5, n=6,11	15.5 Days Standard Deviation 6.38	13.8 Days Standard Deviation 4.45	—	—
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 6, n=5,5	13.6 Days Standard Deviation 7.37	10.4 Days Standard Deviation 6.31	—	—
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 7,n=2,2	15.0 Days Standard Deviation 0.00	7.5 Days Standard Deviation 0.71	—	—
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 8, n=2,1	12.5 Days Standard Deviation 3.54	8.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	—	—
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II Cycle 9, n=2,0	12.5 Days Standard Deviation 3.54	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	—	—

SECONDARY outcome

Timeframe: Cycle 1 to Cycle 6

Population: ITT Population

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).

Outcome measures

Outcome measures
Measure	21-Day Cycle Placebo n=23 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=52 Participants 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.	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.	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.
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 1, n=17, 32	8.1 Days Standard Deviation 3.15	8.5 Days Standard Deviation 3.70	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 1, n=12, 29	9.3 Days Standard Deviation 3.89	9.1 Days Standard Deviation 3.26	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 2, n=13, 24	9.9 Days Standard Deviation 3.64	8.3 Days Standard Deviation 2.56	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 2, n=11, 21	10.5 Days Standard Deviation 4.50	9.0 Days Standard Deviation 3.31	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 3, n=9, 12	10.1 Days Standard Deviation 5.01	8.8 Days Standard Deviation 3.16	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 3, n=7, 14	10.4 Days Standard Deviation 5.74	9.6 Days Standard Deviation 3.43	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 4, n=8, 10	10.0 Days Standard Deviation 5.63	10.9 Days Standard Deviation 4.77	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 4, n=5, 11	10.2 Days Standard Deviation 6.65	10.6 Days Standard Deviation 5.39	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 5, n=5,6	7.8 Days Standard Deviation 1.10	8.8 Days Standard Deviation 4.79	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 5, n=2,4	8.0 Days Standard Deviation 0.00	7.3 Days Standard Deviation 1.50	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 6, n=2,2	10.5 Days Standard Deviation 6.36	8.5 Days Standard Deviation 0.71	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 6, n=2,1	10.5 Days Standard Deviation 6.36	8.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 7, n=1,1	15.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	22.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 7, n=1,1	15.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	22.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 8, n=1,1	14.0 Days Standard Deviation 1.41	20.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 8, n=1,0	15.0 Days Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<100Gi/L to >=100Gi/L), Cycle 9, n=2,	14.0 Days Standard Deviation 11.31	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	—	—
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II TR(<150Gi/L to >=150Gi/L), Cycle 9, n=0,	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Days Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	—	—

Adverse Events

Phase I: 21-Day Cycle Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase I: 21-Day Cycle Eltrombopag

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Phase I: 28-Day Cycle Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase I: 28-Day Cycle Eltrombopag 100 mg

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Phase II: Placebo

Serious events: 13 serious events

Other events: 22 other events

Deaths: 0 deaths

Phase II: Eltrombopag

Serious events: 17 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: 21-Day Cycle Placebo n=3 participants at risk 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.	Phase I: 21-Day Cycle Eltrombopag n=9 participants at risk 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.	Phase I: 28-Day Cycle Placebo n=4 participants at risk 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.	Phase I: 28-Day Cycle Eltrombopag 100 mg n=10 participants at risk 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.	Phase II: Placebo n=23 participants at risk 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).	Phase II: Eltrombopag n=52 participants at risk 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).
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	7.7% 4/52 • 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.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	8.7% 2/23 • 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.	1.9% 1/52 • 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.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Cardiac disorders Cardiac failure congestive	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Cardiac disorders Myocardial infarction	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Gastrointestinal disorders Nausea	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
General disorders General physical health deterioration	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Hepatobiliary disorders Cholestasis	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Hepatobiliary disorders Jaundice	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	3.8% 2/52 • 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.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Immune system disorders Hypersensitivity	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Infections and infestations Arthritis infective	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Infections and infestations Bacterial sepsis	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Infections and infestations Cellulitis	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Infections and infestations Diverticulitis	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Infections and infestations Pneumonia	33.3% 1/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	5.8% 3/52 • 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.
Infections and infestations Respiratory tract infection	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Infections and infestations Sepsis	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Infections and infestations Tracheobronchitis	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Infections and infestations Viral infection	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Investigations Alanine aminotransferase increased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Investigations Blood bilirubin increased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	8.7% 2/23 • 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.	0.00% 0/52 • 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.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	3.8% 2/52 • 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.
Nervous system disorders Hypoglycaemic coma	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Psychiatric disorders Confusional state	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Renal and urinary disorders Calculus urinary	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Renal and urinary disorders Renal failure acute	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	8.7% 2/23 • 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.	0.00% 0/52 • 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	1.9% 1/52 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • 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.	0.00% 0/9 • 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.	25.0% 1/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	33.3% 1/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	1.9% 1/52 • 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.
General disorders Device damage	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	0.00% 0/52 • 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.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	0.00% 0/52 • 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.
Investigations Platelet count decreased	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	0.00% 0/52 • 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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	33.3% 1/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	0.00% 0/52 • 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.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • 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.	22.2% 2/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	0.00% 0/52 • 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.
Nervous system disorders Seizure cluster	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	0.00% 0/23 • 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.	0.00% 0/52 • 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.
Renal and urinary disorders Oliguria	0.00% 0/3 • 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.	0.00% 0/9 • 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.	25.0% 1/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	0.00% 0/52 • 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.

Other adverse events

Other adverse events
Measure	Phase I: 21-Day Cycle Placebo n=3 participants at risk 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.	Phase I: 21-Day Cycle Eltrombopag n=9 participants at risk 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.	Phase I: 28-Day Cycle Placebo n=4 participants at risk 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.	Phase I: 28-Day Cycle Eltrombopag 100 mg n=10 participants at risk 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.	Phase II: Placebo n=23 participants at risk 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).	Phase II: Eltrombopag n=52 participants at risk 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).
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • 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.	44.4% 4/9 • 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.	75.0% 3/4 • 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.	50.0% 5/10 • 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.	65.2% 15/23 • 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.	46.2% 24/52 • 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.
Blood and lymphatic system disorders Leukopenia	66.7% 2/3 • 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.	22.2% 2/9 • 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.	50.0% 2/4 • 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.	30.0% 3/10 • 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.	8.7% 2/23 • 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.	17.3% 9/52 • 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.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	21.7% 5/23 • 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.	13.5% 7/52 • 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.
Blood and lymphatic system disorders Neutropenia	100.0% 3/3 • 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.	55.6% 5/9 • 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.	50.0% 2/4 • 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.	60.0% 6/10 • 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.	56.5% 13/23 • 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.	40.4% 21/52 • 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.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 3/3 • 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.	33.3% 3/9 • 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.	100.0% 4/4 • 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.	50.0% 5/10 • 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.	43.5% 10/23 • 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.	34.6% 18/52 • 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.
Blood and lymphatic system disorders Thrombocytosis	66.7% 2/3 • 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.	22.2% 2/9 • 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.	25.0% 1/4 • 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.	20.0% 2/10 • 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.	8.7% 2/23 • 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.	7.7% 4/52 • 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • 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.	11.1% 1/9 • 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.	25.0% 1/4 • 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.	10.0% 1/10 • 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.	13.0% 3/23 • 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.	13.5% 7/52 • 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.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	7.7% 4/52 • 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.
Gastrointestinal disorders Constipation	0.00% 0/3 • 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.	44.4% 4/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	17.4% 4/23 • 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.	7.7% 4/52 • 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.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • 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.	0.00% 0/9 • 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.	25.0% 1/4 • 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.	10.0% 1/10 • 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.	17.4% 4/23 • 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.	9.6% 5/52 • 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.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	7.7% 4/52 • 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.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	0.00% 0/23 • 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.	9.6% 5/52 • 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.
Gastrointestinal disorders Nausea	33.3% 1/3 • 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.	66.7% 6/9 • 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.	25.0% 1/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	19.2% 10/52 • 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.
Gastrointestinal disorders Vomiting	33.3% 1/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	30.0% 3/10 • 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.	13.0% 3/23 • 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.	9.6% 5/52 • 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.
General disorders Asthenia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	17.4% 4/23 • 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.	15.4% 8/52 • 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.
General disorders Fatigue	33.3% 1/3 • 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.	11.1% 1/9 • 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.	50.0% 2/4 • 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.	30.0% 3/10 • 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.	13.0% 3/23 • 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.	25.0% 13/52 • 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.
General disorders Oedema peripheral	0.00% 0/3 • 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.	11.1% 1/9 • 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.	50.0% 2/4 • 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.	20.0% 2/10 • 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.	4.3% 1/23 • 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.	9.6% 5/52 • 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.
General disorders Pain	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	3.8% 2/52 • 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.
General disorders Peripheral swelling	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	21.7% 5/23 • 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.	5.8% 3/52 • 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.
General disorders Pyrexia	33.3% 1/3 • 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.	11.1% 1/9 • 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.	50.0% 2/4 • 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.	0.00% 0/10 • 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.	17.4% 4/23 • 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.	5.8% 3/52 • 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.
Infections and infestations Bronchitis	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	21.7% 5/23 • 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.	0.00% 0/52 • 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.
Investigations Alanine aminotransferase increased	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	9.6% 5/52 • 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.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	5.8% 3/52 • 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.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	20.0% 2/10 • 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.	13.0% 3/23 • 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.	7.7% 4/52 • 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.
Investigations Blood bilirubin increased	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	4.3% 1/23 • 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.	5.8% 3/52 • 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.
Investigations Blood creatinine increased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	13.0% 3/23 • 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.	3.8% 2/52 • 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.
Investigations Lymphocyte count decreased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	13.0% 3/23 • 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.	11.5% 6/52 • 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.
Investigations Neutrophil count decreased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	13.0% 3/23 • 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.	5.8% 3/52 • 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.
Investigations Platelet count decreased	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	21.7% 5/23 • 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.	11.5% 6/52 • 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.
Investigations White blood cell count decreased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	30.0% 3/10 • 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.	13.0% 3/23 • 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.	7.7% 4/52 • 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.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • 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.	11.1% 1/9 • 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.	25.0% 1/4 • 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.	20.0% 2/10 • 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.	26.1% 6/23 • 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.	13.5% 7/52 • 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.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	13.0% 3/23 • 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.	1.9% 1/52 • 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.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	7.7% 4/52 • 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.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • 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.	11.1% 1/9 • 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.	25.0% 1/4 • 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.	10.0% 1/10 • 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.	4.3% 1/23 • 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.	13.5% 7/52 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	21.7% 5/23 • 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.	3.8% 2/52 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	8.7% 2/23 • 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.	13.5% 7/52 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	8.7% 2/23 • 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.	0.00% 0/52 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	4.3% 1/23 • 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.	9.6% 5/52 • 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.
Nervous system disorders Dizziness	0.00% 0/3 • 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.	0.00% 0/9 • 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.	50.0% 2/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	1.9% 1/52 • 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.
Nervous system disorders Polyneuropathy	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	8.7% 2/23 • 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.	1.9% 1/52 • 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.
Psychiatric disorders Depression	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	7.7% 4/52 • 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.
Psychiatric disorders Insomnia	0.00% 0/3 • 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.	22.2% 2/9 • 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.	50.0% 2/4 • 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.	0.00% 0/10 • 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.	17.4% 4/23 • 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.	7.7% 4/52 • 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	3.8% 2/52 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	9.6% 5/52 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • 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.	11.1% 1/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	1.9% 1/52 • 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.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	10.0% 1/10 • 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.	8.7% 2/23 • 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.	1.9% 1/52 • 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.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • 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.	0.00% 0/9 • 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.	25.0% 1/4 • 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.	10.0% 1/10 • 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.	4.3% 1/23 • 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.	0.00% 0/52 • 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.
Metabolism and nutrition disorders Hyperglycamia	33.3% 1/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	0.00% 0/10 • 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.	4.3% 1/23 • 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.	3.8% 2/52 • 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.
Nervous system disorders headache	0.00% 0/3 • 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.	22.2% 2/9 • 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.	25.0% 1/4 • 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.	20.0% 2/10 • 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.	4.3% 1/23 • 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.	3.8% 2/52 • 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.
Investigations Platelet count increased	0.00% 0/3 • 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.	0.00% 0/9 • 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.	0.00% 0/4 • 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.	30.0% 3/10 • 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.	4.3% 1/23 • 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.	1.9% 1/52 • 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.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C1 D1, n=3,9,4,9	239.3 Giga (10^9) cells per liter (G cells/L) Standard Deviation 75.87	244.8 Giga (10^9) cells per liter (G cells/L) Standard Deviation 48.47	223.8 Giga (10^9) cells per liter (G cells/L) Standard Deviation 79.96	207.7 Giga (10^9) cells per liter (G cells/L) Standard Deviation 65.51
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C1 D8, n=3,6,3,9	180.7 Giga (10^9) cells per liter (G cells/L) Standard Deviation 65.03	143.8 Giga (10^9) cells per liter (G cells/L) Standard Deviation 33.88	144.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 44.17	135.6 Giga (10^9) cells per liter (G cells/L) Standard Deviation 52.52
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C1 D15, n=0,0,2, 6	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	135.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 84.85	97.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 39.15
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C2 D1, n=2,9,4,8	443.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 168.29	545.8 Giga (10^9) cells per liter (G cells/L) Standard Deviation 131.66	284.8 Giga (10^9) cells per liter (G cells/L) Standard Deviation 84.11	473.3 Giga (10^9) cells per liter (G cells/L) Standard Deviation 117.07
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C2 D8, n=2,7,3,9	221.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 94.75	335.6 Giga (10^9) cells per liter (G cells/L) Standard Deviation 134.06	163.3 Giga (10^9) cells per liter (G cells/L) Standard Deviation 35.30	333.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 146.59
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C2 D15, n=0,0,2,6	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	80.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 0.71	142.7 Giga (10^9) cells per liter (G cells/L) Standard Deviation 63.14
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C3 D1, n=2,5,2,7	464.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 36.77	484.6 Giga (10^9) cells per liter (G cells/L) Standard Deviation 188.16	290.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 180.31	435.4 Giga (10^9) cells per liter (G cells/L) Standard Deviation 145.57
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C3 D8, n=2,6,2,5	285.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 39.60	292.2 Giga (10^9) cells per liter (G cells/L) Standard Deviation 161.11	293.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 199.40	465.2 Giga (10^9) cells per liter (G cells/L) Standard Deviation 260.20
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C3 D15, n=0,0,2,5	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	92.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 45.25	183.4 Giga (10^9) cells per liter (G cells/L) Standard Deviation 119.12
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C4 D1, n=1,6,1,6	298.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	394.7 Giga (10^9) cells per liter (G cells/L) Standard Deviation 154.28	609.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	388.3 Giga (10^9) cells per liter (G cells/L) Standard Deviation 166.07
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C4 D8, n=1,5,1,6	261.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	249.8 Giga (10^9) cells per liter (G cells/L) Standard Deviation 122.29	335.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	366.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 143.75
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C4 D15, n=0,0,1,6	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	86.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	169.8 Giga (10^9) cells per liter (G cells/L) Standard Deviation 120.56
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C5 D1, n=1,2,1,4	245.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	529.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 340.12	337.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	406.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 174.89
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C5 D8, n=1,1,1,4	144.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	123.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	311.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	403.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 195.31
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C5 D15, n=0,0,1,4	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	75.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	140.5 Giga (10^9) cells per liter (G cells/L) Standard Deviation 42.93
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C6 D1, n=1,1,1,3	512.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	123.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	440.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	360.3 Giga (10^9) cells per liter (G cells/L) Standard Deviation 133.45
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C6 D8, n=1,1,0,3	251.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	137.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	428.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 210.71
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I C6 D15, n=0,0,1,2	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	NA Giga (10^9) cells per liter (G cells/L) Standard Deviation NA Zero participants were analyzed; therefore, a value was not available.	113.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	101.0 Giga (10^9) cells per liter (G cells/L) Standard Deviation 48.08

Measure	21-Day Cycle Placebo n=3 Participants 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.	21-Day Cycle Eltrombopag 100 mg n=9 Participants 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.	28-Day Cycle Placebo n=4 Participants 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.	28-Day Cycle Eltrombopag 100 mg n=10 Participants 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.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Gemcitabine, Cycle 1, n=2,5,0,0	100.0 Dose Intensity (%) Standard Deviation 0.00	99.8 Dose Intensity (%) Standard Deviation 0.45	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Gemcitabine, Cycle 2, n=1,5,0,0	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	92.8 Dose Intensity (%) Standard Deviation 24.83	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Gemcitabine, Cycle 3, n=1,4,0,0	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	104.3 Dose Intensity (%) Standard Deviation 8.50	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Gemcitabine, Cycle 4, n=1,3,0,0	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	83.3 Dose Intensity (%) Standard Deviation 28.87	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Cisplatin, Cycle 1, n=2,6,0,0	100.0 Dose Intensity (%) Standard Deviation 0.00	100.3 Dose Intensity (%) Standard Deviation 1.03	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Cisplatin, Cycle 2, n=1,6,0,0	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	102.8 Dose Intensity (%) Standard Deviation 6.05	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Cisplatin, Cycle 3, n=1,5,0,0	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	93.8 Dose Intensity (%) Standard Deviation 24.34	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Cisplatin, Cycle 4, n=1,4,0,0	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	100.3 Dose Intensity (%) Standard Deviation 0.96	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cis, Cisplatin, Cycle 5, n=0,1,0,0	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	50 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Gemcitabine, Cycle 1, n=1,2,0,0	99.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	100.0 Dose Intensity (%) Standard Deviation 0.00	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Gemcitabine, Cycle 2, n=1,2,0,0	99.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	88.5 Dose Intensity (%) Standard Deviation 17.68	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Gemcitabine, Cycle 3, n=1,2,0,0	99.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	100.0 Dose Intensity (%) Standard Deviation 0.00	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Gemcitabine, Cycle 4, n=1,2,0,0	49.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	99.5 Dose Intensity (%) Standard Deviation 0.71	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Gemcitabine, Cycle 5, n=1,1,0,0	99.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	74.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Gemcitabine, Cycle 6, n=1,1,0,0	99.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	74.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Carboplatin, Cycle 1, n=1,3,0,0	101.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	88.7 Dose Intensity (%) Standard Deviation 14.05	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Carboplatin, Cycle 2, n=1,3,0,0	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	103.0 Dose Intensity (%) Standard Deviation 5.20	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Carboplatin, Cycle 3, n=1,2,0,0	93.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	105.0 Dose Intensity (%) Standard Deviation 5.66	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Carboplatin, Cycle 4, n=1,2,0,0	91.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	107.5 Dose Intensity (%) Standard Deviation 2.12	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Carboplatin, Cycle 5, n=1,1,0,0	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	71.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I G+Cb, Carboplatin, Cycle 6, n=1,1,0,0	87.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	79.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I Gemcitabine, Cycle 1, n=0,0,1,7	NA Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	94.7 Dose Intensity (%) Standard Deviation 6.75
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I Gemcitabine, Cycle 2, n=0,0,1,7	NA Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	85.0 Dose Intensity (%) Standard Deviation 17.48
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I Gemcitabine, Cycle 3, n=0,0,1,4	NA Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	100.0 Dose Intensity (%) Standard Deviation NA There was only one participant analyzed; therefore, SD could not be determined.	79.5 Dose Intensity (%) Standard Deviation 21.44
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I Gemcitabine, Cycle 4, n=0,0,0,4	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	94.8 Dose Intensity (%) Standard Deviation 4.11
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I Gemcitabine, Cycle 5, n=0,0,0,3	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	93.7 Dose Intensity (%) Standard Deviation 3.79
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I Gemcitabine, Cycle 6, n=0,0,0,3	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	NA Dose Intensity (%) Standard Deviation NA Zero participants were analyzed; therefore, mean and SD were not available.	72.7 Dose Intensity (%) Standard Deviation 17.01