Trial Outcomes & Findings for Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease (NCT NCT00861601)

Last Updated: 2015-05-12

Results Overview

Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Baseline, Day 15

Results posted on

2015-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Eltrombopag 12.5 mg Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Overall Study STARTED	12	14	12
Overall Study COMPLETED	12	14	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Total n=38 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 10.51 • n=5 Participants	57.7 years STANDARD_DEVIATION 8.69 • n=7 Participants	66.3 years STANDARD_DEVIATION 8.84 • n=5 Participants	61.8 years STANDARD_DEVIATION 9.78 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	12 participants n=5 Participants	14 participants n=7 Participants	12 participants n=5 Participants	38 participants n=4 Participants
Number of participants categorized into the indicated Child-Pugh (CP) Class Class A	8 participants n=5 Participants	8 participants n=7 Participants	7 participants n=5 Participants	23 participants n=4 Participants
Number of participants categorized into the indicated Child-Pugh (CP) Class Class B	4 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	15 participants n=4 Participants
Number of participants categorized into the indicated Child-Pugh (CP) Class Class C	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Day 15

Population: Full Analysis Set (FAS): all enrolled participants, excluding those who received no doses of eltrombopag during the treatment period, those without a baseline platelet assessment, and those without at least one on-therapy (scheduled or unscheduled) platelet assessment.

Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Change From Baseline in Platelet Counts on Day 15	24.8 10^9/Liter Interval 8.2 to 41.4	54.0 10^9/Liter Interval 28.2 to 79.8	60.0 10^9/Liter Interval 29.3 to 90.7

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: FAS

Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)	24.8 10^9/Liter Interval 8.2 to 41.4	54.0 10^9/Liter Interval 28.2 to 79.8	60.0 10^9/Liter Interval 29.3 to 90.7

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: FAS

Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts and Child-Pugh class as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline of Platelet Counts and Child-Pugh Class as Covariates)	24.8 10^9/Liter Interval 8.2 to 41.4	54.0 10^9/Liter Interval 28.2 to 79.8	60.0 10^9/Liter Interval 29.3 to 90.7

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: FAS

Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Percent Change From Baseline in Platelet Counts on Day 15	57.86 Percent change Interval 18.77 to 96.94	134.57 Percent change Interval 81.36 to 187.78	158.45 Percent change Interval 92.32 to 224.59

SECONDARY outcome

Timeframe: Day 1 (Baseline), Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)

Population: FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.

Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Platelet Counts by Treatment Visit Day 1	42.5 10^9/Liter Interval 36.0 to 49.0	38.0 10^9/Liter Interval 19.0 to 48.0	40.0 10^9/Liter Interval 23.0 to 49.0
Platelet Counts by Treatment Visit Day 8	50.5 10^9/Liter Interval 37.0 to 73.0	49.5 10^9/Liter Interval 27.0 to 88.0	52.0 10^9/Liter Interval 32.0 to 87.0
Platelet Counts by Treatment Visit Day 15	66.0 10^9/Liter Interval 37.0 to 126.0	73.0 10^9/Liter Interval 31.0 to 232.0	81.5 10^9/Liter Interval 53.0 to 242.0
Platelet Counts by Treatment Visit Final Assessment Point	66.0 10^9/Liter Interval 37.0 to 126.0	95.5 10^9/Liter Interval 35.0 to 232.0	85.5 10^9/Liter Interval 57.0 to 242.0

SECONDARY outcome

Timeframe: 4 days post-treatment, 8 days post-treatment, and 15 days post-treatment

Platelet counts were measured by blood draw.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=13 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Platelet Counts by Post-Treatment Visit 15 days post-treatment, n=11, 13, 11	65.0 10^9/Liter Interval 36.0 to 157.0	87.0 10^9/Liter Interval 29.0 to 382.0	97.0 10^9/Liter Interval 59.0 to 295.0
Platelet Counts by Post-Treatment Visit 4 days post-treatment, n=12, 13, 11	63.5 10^9/Liter Interval 41.0 to 173.0	100.0 10^9/Liter Interval 38.0 to 271.0	109.0 10^9/Liter Interval 59.0 to 372.0
Platelet Counts by Post-Treatment Visit 8 days post-treatment, n=12, 13, 12	67.5 10^9/Liter Interval 46.0 to 178.0	119.0 10^9/Liter Interval 40.0 to 387.0	120.0 10^9/Liter Interval 66.0 to 376.0

SECONDARY outcome

Timeframe: Day 22

Population: FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count \<80 x 10\^9/Liter on Day 15.

Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=6 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=2 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Platelet Counts at Day 22	—	82.5 10^9/Liter Interval 35.0 to 126.0	72.5 10^9/Liter Interval 57.0 to 88.0

SECONDARY outcome

Timeframe: Baseline, Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)

Population: FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.

Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22. Change from Baseline was calculated as the value at each visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Change From Baseline in Platelet Counts by Treatment Visit Day 8	6.9 10^9/Liter Standard Deviation 9.43	14.6 10^9/Liter Standard Deviation 11.80	15.4 10^9/Liter Standard Deviation 8.96
Change From Baseline in Platelet Counts by Treatment Visit Day 15	24.8 10^9/Liter Standard Deviation 26.13	54.0 10^9/Liter Standard Deviation 44.70	60.0 10^9/Liter Standard Deviation 48.36
Change From Baseline in Platelet Counts by Treatment Visit Final Assessment Point	24.8 10^9/Liter Standard Deviation 26.13	64.0 10^9/Liter Standard Deviation 42.51	61.9 10^9/Liter Standard Deviation 47.77

SECONDARY outcome

Timeframe: 4 days post-treatment, 8 days post-treatment, and 15 days post-treatment

Platelet counts were measured by blood draw. Change from Baseline was calculated as the value at each visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=13 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Change From Baseline in Platelet Counts by Post-Treatment Visit 4 days post-treatment, n=12, 13, 11	33.0 10^9/Liter Standard Deviation 36.36	73.8 10^9/Liter Standard Deviation 50.14	97.6 10^9/Liter Standard Deviation 83.38
Change From Baseline in Platelet Counts by Post-Treatment Visit 8 days post-treatment, n=12, 13, 12	41.5 10^9/Liter Standard Deviation 40.50	100.9 10^9/Liter Standard Deviation 81.96	108.3 10^9/Liter Standard Deviation 81.26
Change From Baseline in Platelet Counts by Post-Treatment Visit 15 days post-treatment, n=11, 13, 11	35.7 10^9/Liter Standard Deviation 36.58	82.2 10^9/Liter Standard Deviation 83.13	83.0 10^9/Liter Standard Deviation 68.31

SECONDARY outcome

Timeframe: Day 15

Population: FAS

A responder was defined as a participant with a platelet count within the target range (\>=80 x 10\^9/Liter) on Day 15.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Percentage of Responders on Day 15	25.0 percentage of responders Interval 5.5 to 57.2	42.9 percentage of responders Interval 17.7 to 71.1	58.3 percentage of responders Interval 27.7 to 84.8

SECONDARY outcome

Timeframe: Day 22

A responder was defined as a participant with a platelet count within the target range (\>=80 x 10\^9/Liter) on Day 22 after receiving eltrombopag for an additional week from Day 15, on which his or her platelet count was \<80 x 10\^9/Liter.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=6 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=2 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Percentage of Responders on Day 22	—	50.0 percentage of responders Interval 11.8 to 88.2	50.0 percentage of responders Interval 1.3 to 98.7

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: FAS. The number of participants categorized as Class A or Class B is given in the category titles.

Change from Baseline was calculated as the Day 15 value minus the Baseline value. The Child-Pugh (CP) score (ranging from 5 to 15, with 5 being mild and 15 being severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5 or 6 is classified as Class A (mild), a score of 7-9 is classified as Class B (moderate), and a score \>=10 is classified as Class C (severe). Participants with a CP score \<10 were enrolled in the study.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Change From Baseline in Platelet Counts on Day 15 by Child-Pugh Class Child-Pugh Class A, n=8, 8, 7	24.4 10^9/Liter Standard Deviation 32.51	44.5 10^9/Liter Standard Deviation 27.02	66.6 10^9/Liter Standard Deviation 60.59
Change From Baseline in Platelet Counts on Day 15 by Child-Pugh Class Child-Pugh Class B, n=4, 6, 5	25.8 10^9/Liter Standard Deviation 5.97	66.7 10^9/Liter Standard Deviation 61.93	50.8 10^9/Liter Standard Deviation 27.23

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: FAS

Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of females and males in each treatment group are illustrated by the "n's" in the category titles.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Change From Baseline in Platelet Counts on Day 15 by Sex Male, n=8, 10, 8	13.6 10^9/Liter Standard Deviation 15.03	42.2 10^9/Liter Standard Deviation 26.96	40.6 10^9/Liter Standard Deviation 23.81
Change From Baseline in Platelet Counts on Day 15 by Sex Female, n=4, 4, 4	47.3 10^9/Liter Standard Deviation 31.16	83.5 10^9/Liter Standard Deviation 69.67	98.8 10^9/Liter Standard Deviation 65.18

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: FAS

Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of participants in each age category are illustrated by the "n's" in the category titles.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=12 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 Participants Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 Participants Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Change From Baseline in Platelet Counts on Day 15 by Age <65 years of age, n=7, 11, 5	19.7 10^9/Liter Standard Deviation 23.34	40.2 10^9/Liter Standard Deviation 24.50	49.8 10^9/Liter Standard Deviation 30.36
Change From Baseline in Platelet Counts on Day 15 by Age >=65 years of age, n=5, 3, 7	32.0 10^9/Liter Standard Deviation 30.82	104.7 10^9/Liter Standard Deviation 71.32	67.3 10^9/Liter Standard Deviation 59.36

SECONDARY outcome

Timeframe: Day 14, Day 15

Population: PK Parameter Population: all participants from whom a PK sample was obtained and analyzed and whose PK parameter data was evaluated. One of the 12 participants took a prohibited medication that might have decreased the absorption of eltrombopag during the treatment period and was hence excluded from the PK Parameter Population.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=11 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Log-transformed Cmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg	3412.999 nanograms/milliliter (ng/ml) Interval 2549.006 to 4569.8448	—	—

SECONDARY outcome

Timeframe: Day 14, Day 15

Population: PK Parameter Population

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=11 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Log-transformed Tmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg	3.444 hours Interval 2.4593 to 4.8226	—	—

SECONDARY outcome

Timeframe: Day 14, Day 15

Population: PK Parameter Population

Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. AUC(0-t)=area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration, and AUC(0-24)=area under the concentration-time curve from 0 (pre-dose) to 24 hours.

Outcome measures

Outcome measures
Measure	Eltrombopag 12.5 mg n=11 Participants Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Log-transformed AUC(0-t) and AUC(0-24) on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg AUC(0-t)	65244.180 hours * ng/ml Interval 46617.4188 to 91313.573	—	—
Log-transformed AUC(0-t) and AUC(0-24) on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg AUC(0-24)	65235.699 hours * ng/ml Interval 46748.123 to 91034.594	—	—

Adverse Events

Eltrombopag 12.5 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Eltrombopag 25 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Eltrombopag 37.5 mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eltrombopag 12.5 mg n=12 participants at risk Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.	Eltrombopag 25 mg n=14 participants at risk Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.	Eltrombopag 37.5 mg n=12 participants at risk Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count \<80 x 10\^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
Gastrointestinal disorders Ascites	0.00% 0/12 • The time period of detecting adverse events (AEs) and serious adverse events (SAEs) was from the start of eltrombopag (Day 1) treatment to 15 days post-treatment.	0.00% 0/14 • The time period of detecting adverse events (AEs) and serious adverse events (SAEs) was from the start of eltrombopag (Day 1) treatment to 15 days post-treatment.	8.3% 1/12 • The time period of detecting adverse events (AEs) and serious adverse events (SAEs) was from the start of eltrombopag (Day 1) treatment to 15 days post-treatment.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

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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