Trial Outcomes & Findings for Japanese Phase II Study of SB-497115-GR in Hepatitis C Virus Infected Patients (NCT NCT01636778)

NCT ID: NCT01636778

Last Updated: 2016-03-01

Results Overview

Participants were assessed for a shift from a baseline platelet count of \<80 Gi/L to a count \>=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

From Baseline up to Week 9 in Part 1

Results posted on

2016-03-01

Participant Flow

Participants with chronic hepatitis C (CHC) or compensated liver cirrhosis, who cannot start polyethylene glycol (Peg)-interferon (IFN)/ribavirin (RBV) therapy due to thrombocytopenia (platelet count \<80 giga (10\^9) cells per liter (Gi/L).

The total study duration was a maximum of 88 weeks, which consisted of a Screening Period of less than or equal to 45 days, the Pre-Antiviral Treatment Period (Part 1) from 1 up to 9 weeks and the Antiviral Treatment Period (Part 2) of 48 weeks and Follow-up Period of 24 weeks.

Participant milestones

Participant milestones
Measure
Eltrombopag Dose Escalation: Part 1
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Eltrombopag + Antiviral Therapy: Part 2
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to \&gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Eltrombopag + Antiviral Therapy: Follow-up Period After Part
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Pre-Antiviral Treatment Period (Part 1)
STARTED
45
0
0
Pre-Antiviral Treatment Period (Part 1)
COMPLETED
41
0
0
Pre-Antiviral Treatment Period (Part 1)
NOT COMPLETED
4
0
0
Antiviral Treatment Period (Part 2)
STARTED
0
41
0
Antiviral Treatment Period (Part 2)
COMPLETED
0
31
0
Antiviral Treatment Period (Part 2)
NOT COMPLETED
0
10
0
Follow-up Period After Part 2
STARTED
0
0
41
Follow-up Period After Part 2
COMPLETED
0
0
37
Follow-up Period After Part 2
NOT COMPLETED
0
0
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Eltrombopag Dose Escalation: Part 1
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Eltrombopag + Antiviral Therapy: Part 2
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to \&gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Eltrombopag + Antiviral Therapy: Follow-up Period After Part
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Pre-Antiviral Treatment Period (Part 1)
Protocol Violation
3
0
0
Pre-Antiviral Treatment Period (Part 1)
Protocol-Defined Stopping Criteria
1
0
0
Antiviral Treatment Period (Part 2)
Adverse Event
0
7
0
Antiviral Treatment Period (Part 2)
Protocol Violation
0
1
0
Antiviral Treatment Period (Part 2)
Physician Decision
0
2
0
Follow-up Period After Part 2
Other
0
0
1
Follow-up Period After Part 2
Not entered FU period after withdrawal
0
0
1
Follow-up Period After Part 2
Withdrawal by Subject
0
0
2

Baseline Characteristics

Japanese Phase II Study of SB-497115-GR in Hepatitis C Virus Infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Diagnosis
Chronic hepatitis C
23 Participants
n=5 Participants
Diagnosis
Liver cirrosis
22 Participants
n=5 Participants
HCV genotype
1a
0 Participants
n=5 Participants
HCV genotype
1b
33 Participants
n=5 Participants
HCV genotype
2a
6 Participants
n=5 Participants
HCV genotype
2b
5 Participants
n=5 Participants
HCV genotype
Others
1 Participants
n=5 Participants
Child-Pugh Class
A (Score 5 - 6)
44 Participants
n=5 Participants
Age, Continuous
57.8 Years
STANDARD_DEVIATION 9.65 • n=5 Participants
Sex: Female, Male
Female
30 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian - Japanese Heritage
45 Participants
n=5 Participants
Child-Pugh Class
B (Score 7 - 9)
1 Participants
n=5 Participants
Child-Pugh Class
C (Score > 9)
0 Participants
n=5 Participants
Number of Participants with or without previous IFN use
Naïve
24 Participants
n=5 Participants
Number of Participants with or without previous IFN use
Experienced
21 Participants
n=5 Participants
Baseline alanine transaminase (ALT)
78.2 IU/L
STANDARD_DEVIATION 47.82 • n=5 Participants
Baseline Hepatitis C Virus (HCV) RNA
6.41 Log IU/mL
STANDARD_DEVIATION 0.706 • n=5 Participants
Baseline platelet counts
<50 Gi Platelets/L
8 Participants
n=5 Participants
Baseline platelet counts
>=50 Gi Platelets/L
37 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From Baseline up to Week 9 in Part 1

Population: Full Analysis Set 1 (FAS1) Population: all participants enrolled in Part 1.

Participants were assessed for a shift from a baseline platelet count of \<80 Gi/L to a count \>=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1
43 Participants

PRIMARY outcome

Timeframe: From Antiviral Baseline to up to Week 48 in Part 2

Population: Full Analysis Set 2 (FAS2) Population: all participants enrolled in Part 2.

Participants were assessed for continuously maintaining platelet counts \>=50 Gi/L during Part 2. Platelet counts were measured by blood draw.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2
36 Participants

SECONDARY outcome

Timeframe: Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1

Population: FAS1 Population.

Platelet counts were measured by blood draw

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Median Platelet Count at the Indicated Time Points in Part 1
Baseline, n=45
63.0 10^9 Cells Per Liter (Gi/L)
Interval 34.0 to 78.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 1, n=43
74.0 10^9 Cells Per Liter (Gi/L)
Interval 36.0 to 108.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 2, n=36
100.0 10^9 Cells Per Liter (Gi/L)
Interval 43.0 to 248.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 3, n=17
97.0 10^9 Cells Per Liter (Gi/L)
Interval 48.0 to 153.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 4, n=9
104.0 10^9 Cells Per Liter (Gi/L)
Interval 48.0 to 137.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 5, n=4
87.0 10^9 Cells Per Liter (Gi/L)
Interval 49.0 to 132.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 6, n=3
83.0 10^9 Cells Per Liter (Gi/L)
Interval 53.0 to 93.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 7, n=3
97.0 10^9 Cells Per Liter (Gi/L)
Interval 56.0 to 103.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 8, n=2
79.0 10^9 Cells Per Liter (Gi/L)
Interval 63.0 to 95.0
Median Platelet Count at the Indicated Time Points in Part 1
Week 9, n=1
100.0 10^9 Cells Per Liter (Gi/L)
Interval 100.0 to 100.0
Median Platelet Count at the Indicated Time Points in Part 1
Withdrawal, n=4
96 10^9 Cells Per Liter (Gi/L)
Interval 48.0 to 115.0

SECONDARY outcome

Timeframe: From Baseline up to Week 9 in Part 1

Population: FAS1 Population: all participants enrolled in Part 1.

Participants were assessed for achieving platelet counts \>=100 Gi/L during Part 1. Platelet counts were measured by blood draw.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=43 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Time in Weeks to Achieve Platelet Count >= 100 Gi/L
Within 2 Weeks
11 Participants
Time in Weeks to Achieve Platelet Count >= 100 Gi/L
Within 4 Weeks
25 Participants
Time in Weeks to Achieve Platelet Count >= 100 Gi/L
Within 6 Weeks
5 Participants
Time in Weeks to Achieve Platelet Count >= 100 Gi/L
Within 8 Weeks
1 Participants
Time in Weeks to Achieve Platelet Count >= 100 Gi/L
Within 9 Weeks
0 Participants
Time in Weeks to Achieve Platelet Count >= 100 Gi/L
Greater than 9 Weeks
1 Participants

SECONDARY outcome

Timeframe: Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2

Population: FAS2 Population.

Platelet counts were measured by blood draw

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Median Platelet Count at the Indicated Time Points in Part 2
Withdrawal, n=10
102.0 Gi/L
Interval 54.0 to 207.0
Median Platelet Count at the Indicated Time Points in Part 2
Antiviral Baseline, n=41
114.0 Gi/L
Interval 100.0 to 248.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 1, n=40
106.5 Gi/L
Interval 50.0 to 431.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 2, n=40
118.0 Gi/L
Interval 58.0 to 309.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 4, n=37
89.0 Gi/L
Interval 43.0 to 126.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 6, n=36
86.0 Gi/L
Interval 38.0 to 130.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 8, n=36
79.5 Gi/L
Interval 53.0 to 130.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 12, n=36
80.5 Gi/L
Interval 55.0 to 161.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 16, n=36
79.5 Gi/L
Interval 49.0 to 128.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 20, n=36
75.5 Gi/L
Interval 54.0 to 119.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 24, n=36
76.5 Gi/L
Interval 29.0 to 128.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 28, n=34
75.0 Gi/L
Interval 49.0 to 128.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 32, n=34
73.0 Gi/L
Interval 30.0 to 161.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 36, n=34
76.0 Gi/L
Interval 43.0 to 148.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 40, n=33
80.0 Gi/L
Interval 48.0 to 135.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 44, n=31
79.0 Gi/L
Interval 37.0 to 172.0
Median Platelet Count at the Indicated Time Points in Part 2
Week 48, n=31
82.0 Gi/L
Interval 49.0 to 170.0

SECONDARY outcome

Timeframe: Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2

Population: FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 are excluded from this analysis.

Platelet counts were measured by blood draw at specified timepoints.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=34 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, n=34
86.5 Gi/L
Interval 36.0 to 184.0
Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2
FU Week 4, n=34
82.5 Gi/L
Interval 43.0 to 645.0
Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2
FU Week 12, n=34
70.0 Gi/L
Interval 37.0 to 154.0
Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, n=31
63.0 Gi/L
Interval 41.0 to 145.0

SECONDARY outcome

Timeframe: From Antiviral Baseline to up to Week 48 in Part 2

Population: FAS2 Population: all participants enrolled in Part 2.

Participants were assessed for platelet counts during antiviral therapy in Part 2. Platelet counts were measured by blood draw.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Minimum Platelet Count on Antiviral Therapy
<25 Gi/L
0 Participants
Minimum Platelet Count on Antiviral Therapy
>=25 to <50 Gi/L
5 Participants
Minimum Platelet Count on Antiviral Therapy
>=50 to <100 Gi/L
34 Participants
Minimum Platelet Count on Antiviral Therapy
>=100 to <150 Gi/L
2 Participants
Minimum Platelet Count on Antiviral Therapy
>=150 to <200 Gi/L
0 Participants
Minimum Platelet Count on Antiviral Therapy
>=200 to <400 Gi/L
0 Participants
Minimum Platelet Count on Antiviral Therapy
>= 400 Gi/L
0 Participants

SECONDARY outcome

Timeframe: From Baseline up to Week 9 in Part 1

Population: FAS1 Population: all participants enrolled in Part 1.

Participants received eltrombopag at escalating dosages until a platelet count of \>=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy
Eltrombopag 0 mg
1 Participants
Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy
Eltrombopag 12.5 mg
25 Participants
Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy
Eltrombopag 25 mg
13 Participants
Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy
Eltrombopag 37.5 mg
0 Participants
Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy
Eltrombopag 50 mg
2 Participants
Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy
Did not initiate antiviral therapy
4 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Antiviral Therapy Dose Reductions in Part 2
7 DR
3 Participants
Number of Antiviral Therapy Dose Reductions in Part 2
8 DR
1 Participants
Number of Antiviral Therapy Dose Reductions in Part 2
10 DR
2 Participants
Number of Antiviral Therapy Dose Reductions in Part 2
0 DR
8 Participants
Number of Antiviral Therapy Dose Reductions in Part 2
1 DR
9 Participants
Number of Antiviral Therapy Dose Reductions in Part 2
2 DR
10 Participants
Number of Antiviral Therapy Dose Reductions in Part 2
3 DR
3 Participants
Number of Antiviral Therapy Dose Reductions in Part 2
4 DR
2 Participants
Number of Antiviral Therapy Dose Reductions in Part 2
5 DR
1 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2a were analyzed.

Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=16 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2
0 DR
4 Participants
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2
1 DR
6 Participants
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2
2 DR
4 Participants
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2
3 DR
1 Participants
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2
>3 DR
1 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2b were analyzed.

Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=25 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2
0 DR
16 Participants
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2
1 DR
2 Participants
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2
2 DR
4 Participants
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2
3 DR
0 Participants
Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2
>3 DR
3 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2
0 DR
14 Participants
Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2
1 DR
12 Participants
Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2
2 DR
9 Participants
Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2
3 DR
3 Participants
Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2
>3 DR
3 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Time to First Dose Reduction of Antiviral Therapy in Part 2
Peg-IFN alfa-2a dose reduction, n=12
9.44 weeks
Standard Deviation 12.556
Time to First Dose Reduction of Antiviral Therapy in Part 2
Peg-IFN alfa-2b dose reduction, n=9
6.22 weeks
Standard Deviation 6.944
Time to First Dose Reduction of Antiviral Therapy in Part 2
RBV dose reduction, n=27
9.16 weeks
Standard Deviation 6.611

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Who Discontinued Antiviral Therapy in Part 2
8 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.

Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=16 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2
1 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.

Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=25 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2
7 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Achieving Adherence to Antiviral Therapy in Part 2
32 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.

Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=16 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2
14 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.

Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=25 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2
18 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With Sustained Virologic Response (SVR) in Part 2
9 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2
RVR
6 Participants
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2
eRVR
5 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2
EVR
28 Participants
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2
cEVR
18 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: FAS2 Population.

ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2
19 Participants

SECONDARY outcome

Timeframe: Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2

Population: FAS2 Population.

The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Serum HCV RNA at the Indicated Time Points In Part 2
Week 24, n=36
2.46 Log international unit per milliliter
Standard Deviation 1.876
Mean Serum HCV RNA at the Indicated Time Points In Part 2
Screening, n=41
6.41 Log international unit per milliliter
Standard Deviation 0.726
Mean Serum HCV RNA at the Indicated Time Points In Part 2
Antiviral Baseline, n=41
6.37 Log international unit per milliliter
Standard Deviation 0.767
Mean Serum HCV RNA at the Indicated Time Points In Part 2
Week 4, n=37
3.77 Log international unit per milliliter
Standard Deviation 1.741
Mean Serum HCV RNA at the Indicated Time Points In Part 2
Week 12, n=36
2.52 Log international unit per milliliter
Standard Deviation 1.734
Mean Serum HCV RNA at the Indicated Time Points In Part 2
Week 36, n=34
2.69 Log international unit per milliliter
Standard Deviation 2.177
Mean Serum HCV RNA at the Indicated Time Points In Part 2
Week 48, n=31
2.63 Log international unit per milliliter
Standard Deviation 2.275
Mean Serum HCV RNA at the Indicated Time Points In Part 2
Withdrawal, n=10
3.87 Log international unit per milliliter
Standard Deviation 2.275

SECONDARY outcome

Timeframe: FU Baseline, FU Week 12 and FU Week 24 after Part 2

Population: FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 were excluded from this analysis.

The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=34 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2
FU Week 12, n=34
5.04 Log international unit per milliliter
Standard Deviation 2.551
Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, n=34
3.10 Log international unit per milliliter
Standard Deviation 2.422
Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, n=31
4.82 Log international unit per milliliter
Standard Deviation 2.436

SECONDARY outcome

Timeframe: From Baseline up to week 9 in Part 1

Population: Safety Population 1 (SP1) : consisted of all participants who were enrolled in Part 1 and received at least one dose of eltrombopag.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
Any AE
13 Participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
Any SAE
0 Participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
Fatal AE
0 Participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
Drug-related AE
4 Participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
AE leading to withdrawal
0 Participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
SAE leading to withdrawal
0 Participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1
On-going AE at the endo of study/withdrawal
1 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48 in Part 2

Population: Safety Population 2 (SP2): consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With Any AE and Any SAE in Part 2
Any AE
41 Participants
Number of Participants With Any AE and Any SAE in Part 2
Any SAE
3 Participants
Number of Participants With Any AE and Any SAE in Part 2
Fatal AE
0 Participants
Number of Participants With Any AE and Any SAE in Part 2
Drug-related AE
41 Participants
Number of Participants With Any AE and Any SAE in Part 2
AE leading to withdrawal
9 Participants
Number of Participants With Any AE and Any SAE in Part 2
SAE leading to withdrawal
3 Participants
Number of Participants With Any AE and Any SAE in Part 2
On-going AE at the end of study/withdrawal
34 Participants

SECONDARY outcome

Timeframe: From FU Baseline up to FU Week 24 after Part 2

Population: SP2 Population

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
Any AE
25 Participants
Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
Any SAE
4 Participants
Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
Fatal AE
0 Participants
Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
Drug-related AE
6 Participants
Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
AE leading to withdrawal
0 Participants
Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
SAE leading to withdrawal
0 Participants
Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2
On-going AE at the end of study/withdrawal
16 Participants

SECONDARY outcome

Timeframe: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24

Population: SP1

Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 1, n=38
0.9 Millimeter of mercury (mmHg)
Standard Deviation 9.86
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 2, n=30
-1.7 Millimeter of mercury (mmHg)
Standard Deviation 12.42
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 3, n=11
2.8 Millimeter of mercury (mmHg)
Standard Deviation 11.07
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 4, n=6
-2.8 Millimeter of mercury (mmHg)
Standard Deviation 9.79
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 5, n=3
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 9.54
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 6, n=3
-4.0 Millimeter of mercury (mmHg)
Standard Deviation 3.00
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 7, n=3
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 5.69
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 8, n=2
12.0 Millimeter of mercury (mmHg)
Standard Deviation 15.56
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Week 9, n=1
3.0 Millimeter of mercury (mmHg)
Standard Deviation NA
Forty subjects in Part1 achieved platelet counts \>=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Withdrawal, n=4
13.5 Millimeter of mercury (mmHg)
Standard Deviation 13.96
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Follow Up, week 4, n=3
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 8.54
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Follow Up, week 12, n=3
9.0 Millimeter of mercury (mmHg)
Standard Deviation 8.89
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
SBP, Follow Up, week 24, n=3
2.7 Millimeter of mercury (mmHg)
Standard Deviation 10.07
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 1, n=38
-0.5 Millimeter of mercury (mmHg)
Standard Deviation 8.81
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 2, n=30
-2.1 Millimeter of mercury (mmHg)
Standard Deviation 8.04
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 3, n=11
-1.6 Millimeter of mercury (mmHg)
Standard Deviation 7.98
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 4, n=6
-1.7 Millimeter of mercury (mmHg)
Standard Deviation 8.04
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 5, n=3
-7.3 Millimeter of mercury (mmHg)
Standard Deviation 9.87
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 6, n=3
-3.3 Millimeter of mercury (mmHg)
Standard Deviation 7.64
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 7, n=3
-9.0 Millimeter of mercury (mmHg)
Standard Deviation 7.00
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 8, n=2
6.0 Millimeter of mercury (mmHg)
Standard Deviation 14.14
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Week 9, n=1
-10.0 Millimeter of mercury (mmHg)
Standard Deviation NA
Forty subjects in Part1 achieved platelet counts \>=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, Withdrawal, n=4
5.8 Millimeter of mercury (mmHg)
Standard Deviation 12.09
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, FU Week 4, n=3
0.3 Millimeter of mercury (mmHg)
Standard Deviation 5.51
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, FU Week 12, n=3
4.0 Millimeter of mercury (mmHg)
Standard Deviation 10.39
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period
DBP, FU Week 24, n=3
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 1.53

SECONDARY outcome

Timeframe: Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2

Population: SP2: consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.

Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 6, n=36
-3.9 mmHg
Standard Deviation 13.09
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Antiviral Baseline, n=40
0.2 mmHg
Standard Deviation 13.99
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 1, n=40
-5.9 mmHg
Standard Deviation 10.37
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 2, n=40
-8.7 mmHg
Standard Deviation 13.35
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 4, n=37
-5.2 mmHg
Standard Deviation 13.69
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 8, n=36
-6.0 mmHg
Standard Deviation 14.53
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 12, n=36
-5.7 mmHg
Standard Deviation 13.08
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 16, n=36
-5.5 mmHg
Standard Deviation 16.52
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 20, n=36
-4.4 mmHg
Standard Deviation 15.18
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 24, n=36
-2.1 mmHg
Standard Deviation 15.70
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 28, n=34
-6.3 mmHg
Standard Deviation 15.76
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 32, n=34
-5.2 mmHg
Standard Deviation 17.60
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 36, n=34
-5.6 mmHg
Standard Deviation 15.36
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 40, n=33
-5.1 mmHg
Standard Deviation 13.47
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 44, n=31
-4.6 mmHg
Standard Deviation 16.60
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, Week 48, n=31
-2.9 mmHg
Standard Deviation 12.37
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
SBP, withdrawal, n=10
0.5 mmHg
Standard Deviation 17.26
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Antiviral Baseline, n=40
-0.4 mmHg
Standard Deviation 6.35
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 1, n=40
-3.5 mmHg
Standard Deviation 9.28
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 2, n=40
-4.0 mmHg
Standard Deviation 9.59
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 4, n=37
-3.5 mmHg
Standard Deviation 9.81
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 6, n=36
-3.9 mmHg
Standard Deviation 9.16
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 8, n=36
-6.0 mmHg
Standard Deviation 9.62
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 12, n=36
-5.9 mmHg
Standard Deviation 10.07
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 16, n=36
-4.7 mmHg
Standard Deviation 9.94
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 20, n=36
-5.7 mmHg
Standard Deviation 11.17
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 24, n=36
-4.5 mmHg
Standard Deviation 12.34
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 28, n=34
-7.9 mmHg
Standard Deviation 11.48
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 32, n=34
-7.1 mmHg
Standard Deviation 11.97
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 36, n=34
-5.4 mmHg
Standard Deviation 9.96
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 40, n=33
-6.8 mmHg
Standard Deviation 9.69
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 44, n=31
-5.8 mmHg
Standard Deviation 12.18
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, Week 48, n=31
-3.8 mmHg
Standard Deviation 8.36
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2
DBP, withdrawal, n=10
-2.4 mmHg
Standard Deviation 8.24

SECONDARY outcome

Timeframe: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2

Population: SP2 Population.

Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=40 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
SBP, FU Baseline, n=40
126.5 mmHg
Standard Deviation 11.30
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
SBP, FU Week 4, n=40
125.4 mmHg
Standard Deviation 11.74
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
SBP, Week 12, n=40
126.7 mmHg
Standard Deviation 10.86
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
SBP, Week 24, n=37
128.4 mmHg
Standard Deviation 12.68
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
DBP, FU Baseline, n=40
73.8 mmHg
Standard Deviation 8.85
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
DBP, FU Week 4, n=40
74.3 mmHg
Standard Deviation 8.91
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
DBP, FU Week 12, n=40
76.2 mmHg
Standard Deviation 9.40
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2
DBP, FU Week 24, n=37
75.7 mmHg
Standard Deviation 9.48

SECONDARY outcome

Timeframe: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24

Population: SP1 Population.

The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 1, n=38
0.1 Beats per minute (bpm)
Standard Deviation 7.07
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 2, n=30
-0.1 Beats per minute (bpm)
Standard Deviation 7.42
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 3, n=11
0.1 Beats per minute (bpm)
Standard Deviation 4.50
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 4, n=6
2.8 Beats per minute (bpm)
Standard Deviation 4.07
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 5, n=3
0.3 Beats per minute (bpm)
Standard Deviation 7.37
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 6, n=3
2.0 Beats per minute (bpm)
Standard Deviation 5.29
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 7, n=3
3.0 Beats per minute (bpm)
Standard Deviation 7.00
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 8, n=2
-1.0 Beats per minute (bpm)
Standard Deviation 5.66
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Week 9, n=1
-4.0 Beats per minute (bpm)
Standard Deviation NA
Forty subjects in Part1 achieved platelet counts \>=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
Withdrawal, n=4
2.8 Beats per minute (bpm)
Standard Deviation 8.30
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 4, n=3
0.7 Beats per minute (bpm)
Standard Deviation 12.66
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 12, n=3
3.7 Beats per minute (bpm)
Standard Deviation 9.07
Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 24, n=3
2.0 Beats per minute (bpm)
Standard Deviation 9.54

SECONDARY outcome

Timeframe: Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2

Population: SP2 Population.

The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 40, n=33
5.2 bpm
Standard Deviation 8.20
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 44, n=31
5.2 bpm
Standard Deviation 7.11
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 48, n=31
3.6 bpm
Standard Deviation 7.18
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Antiviral Baseline, n=40
0.4 bpm
Standard Deviation 7.56
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 1, n=40
-3.5 bpm
Standard Deviation 9.51
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 2, n=40
1.0 bpm
Standard Deviation 9.57
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 4, n=37
3.9 bpm
Standard Deviation 9.29
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 6, n=36
5.9 bpm
Standard Deviation 9.78
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 8, n=36
4.7 bpm
Standard Deviation 10.60
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 12, n=36
5.8 bpm
Standard Deviation 10.34
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 16, n=36
6.2 bpm
Standard Deviation 9.91
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 20, n=36
4.5 bpm
Standard Deviation 10.54
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 24, n=36
4.5 bpm
Standard Deviation 9.79
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 28, n=34
5.6 bpm
Standard Deviation 9.85
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 32, n=34
3.6 bpm
Standard Deviation 8.80
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Week 36, n=34
4.7 bpm
Standard Deviation 9.07
Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2
Withdrawal, n=10
5.1 bpm
Standard Deviation 11.86

SECONDARY outcome

Timeframe: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2

Population: SP2 Population.

The heart rate was measured in participants at the indicated time points.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=40 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, n=40
78.3 bpm
Standard Deviation 8.77
Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2
FU Week 4, n=40
79.5 bpm
Standard Deviation 9.38
Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2
FU Week 12, n=40
74.0 bpm
Standard Deviation 8.64
Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, n=37
74.6 bpm
Standard Deviation 9.58

SECONDARY outcome

Timeframe: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24

Population: SP1 Population.

The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 1, n=38
0.09 Kilogram (kg)
Standard Deviation 0.807
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 2, n=30
0.05 Kilogram (kg)
Standard Deviation 1.239
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 3, n=11
0.75 Kilogram (kg)
Standard Deviation 1.196
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 4, n=6
1.15 Kilogram (kg)
Standard Deviation 0.931
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 5, n=3
1.00 Kilogram (kg)
Standard Deviation 1.400
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 6, n=3
1.03 Kilogram (kg)
Standard Deviation 0.723
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 7, n=3
0.57 Kilogram (kg)
Standard Deviation 1.159
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 8, n=2
0.15 Kilogram (kg)
Standard Deviation 1.909
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Week 9, n=1
0.20 Kilogram (kg)
Standard Deviation NA
Forty subjects in Part1 achieved platelet counts \>=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
Withdrawal, n=4
0.30 Kilogram (kg)
Standard Deviation 1.519
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 4, n=3
0.90 Kilogram (kg)
Standard Deviation 1.212
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 12, n=3
0.93 Kilogram (kg)
Standard Deviation 3.009
Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 24, n=3
1.17 Kilogram (kg)
Standard Deviation 2.894

SECONDARY outcome

Timeframe: Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2

Population: SP2 Population.

The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Antivital Baseline, n=40
0.04 kg
Standard Deviation 1.336
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 1, n=40
-0.95 kg
Standard Deviation 1.131
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 2, n=40
-1.14 kg
Standard Deviation 1.314
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 4, n=37
-1.04 kg
Standard Deviation 1.060
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 6, n=36
-1.05 kg
Standard Deviation 1.344
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 8, n=36
-1.28 kg
Standard Deviation 1.581
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 12, n=36
-1.73 kg
Standard Deviation 1.887
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 16, n=36
-2.13 kg
Standard Deviation 2.175
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 20, n=36
-2.49 kg
Standard Deviation 2.265
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 24, n=36
-3.11 kg
Standard Deviation 2.488
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 28, n=34
-3.00 kg
Standard Deviation 3.104
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 32, n=34
-3.16 kg
Standard Deviation 3.100
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 36, n=34
-3.43 kg
Standard Deviation 3.188
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 40, n=33
-3.61 kg
Standard Deviation 3.000
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 44, n=31
-3.39 kg
Standard Deviation 3.018
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Week 48, n=31
-3.76 kg
Standard Deviation 2.950
Mean Change From Baseline in Weight at the Indicated Time Points in Part 2
Withdrawal, n=10
-3.04 kg
Standard Deviation 3.584

SECONDARY outcome

Timeframe: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2

Population: SP2 Population

The weight of participants was recorded at the indicated time points.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=40 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Weight at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, n=40
55.77 kg
Standard Deviation 11.403
Mean Weight at the Indicated Time Points During Follow-up Period After Part 2
FU Week 4, n=40
56.37 kg
Standard Deviation 11.627
Mean Weight at the Indicated Time Points During Follow-up Period After Part 2
FU Week 12, n=40
57.05 kg
Standard Deviation 11.841
Mean Weight at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, n=37
57.84 kg
Standard Deviation 12.478

SECONDARY outcome

Timeframe: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24

Population: SP1 Population.

The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 3, n=11
0.06 Degrees centigrade
Standard Deviation 0.284
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 1, n=38
-0.04 Degrees centigrade
Standard Deviation 0.439
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 2, n=30
0.03 Degrees centigrade
Standard Deviation 0.445
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 4, n=6
0.07 Degrees centigrade
Standard Deviation 0.367
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 5, n=3
-0.07 Degrees centigrade
Standard Deviation 0.153
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 6, n=3
-0.10 Degrees centigrade
Standard Deviation 0.173
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 7, n=3
-0.40 Degrees centigrade
Standard Deviation 0.100
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 8, n=2
-0.50 Degrees centigrade
Standard Deviation 0.141
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Week 9, n=1
-1.10 Degrees centigrade
Standard Deviation NA
Forty subjects in Part1 achieved platelet counts \>=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
Withdrawal, n=4
-0.18 Degrees centigrade
Standard Deviation 0.171
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 4, n=3
0.07 Degrees centigrade
Standard Deviation 0.153
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 12, n=3
-0.23 Degrees centigrade
Standard Deviation 0.493
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period
FU Week 24, n=3
-0.17 Degrees centigrade
Standard Deviation 0.306

SECONDARY outcome

Timeframe: Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2

Population: SP2 Population.

The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Withdrawal, n=10
0.38 Degrees centigrade
Standard Deviation 0.724
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Antiviral Baseline, n=41
0.08 Degrees centigrade
Standard Deviation 0.662
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 1, n=40
0.09 Degrees centigrade
Standard Deviation 0.398
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 2, n=40
0.17 Degrees centigrade
Standard Deviation 0.459
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 4, n=37
0.16 Degrees centigrade
Standard Deviation 0.439
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 6, n=36
0.19 Degrees centigrade
Standard Deviation 0.499
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 8, n=36
0.22 Degrees centigrade
Standard Deviation 0.426
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 12, n=36
0.28 Degrees centigrade
Standard Deviation 0.440
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 16, n=36
0.22 Degrees centigrade
Standard Deviation 0.392
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 20, n=36
0.20 Degrees centigrade
Standard Deviation 0.386
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 24, n=36
0.26 Degrees centigrade
Standard Deviation 0.422
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 28, n=34
0.27 Degrees centigrade
Standard Deviation 0.424
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 32, n=34
0.21 Degrees centigrade
Standard Deviation 0.435
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 36, n=34
0.22 Degrees centigrade
Standard Deviation 0.462
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 40, n=33
0.26 Degrees centigrade
Standard Deviation 0.374
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 44, n=31
0.20 Degrees centigrade
Standard Deviation 0.492
Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2
Week 48, n=31
0.15 Degrees centigrade
Standard Deviation 0.498

SECONDARY outcome

Timeframe: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2

Population: SP2 Population

The Body temperature of participants was recorded at the indicated time points..

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=40 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, n=40
36.44 Degrees centigrade
Standard Deviation 0.417
Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2
FU Week 4, n=40
36.37 Degrees centigrade
Standard Deviation 0.360
Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2
FU Week 12, n=40
36.29 Degrees centigrade
Standard Deviation 0.350
Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, n=37
36.90 Degrees centigrade
Standard Deviation 0.377

SECONDARY outcome

Timeframe: Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24

Population: SP1 Population.

The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 1, n=38
0.03 kilogram per meters squared (kg/m^2)
Standard Deviation 0.302
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 2, n=30
0.02 kilogram per meters squared (kg/m^2)
Standard Deviation 0.457
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 3, n=11
0.26 kilogram per meters squared (kg/m^2)
Standard Deviation 0.415
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 4, n=6
0.39 kilogram per meters squared (kg/m^2)
Standard Deviation 0.325
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 5, n=3
0.36 kilogram per meters squared (kg/m^2)
Standard Deviation 0.504
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 6, n=3
0.36 kilogram per meters squared (kg/m^2)
Standard Deviation 0.248
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 7, n=3
0.20 kilogram per meters squared (kg/m^2)
Standard Deviation 0.417
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 8, n=2
0.04 kilogram per meters squared (kg/m^2)
Standard Deviation 0.704
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Week 9, n=1
0.08 kilogram per meters squared (kg/m^2)
Standard Deviation NA
Forty subjects in Part1 achieved platelet counts \>=100 Gi/L until Week 7 and progressed to Part2. Four subjects were withdrawn before Week 9. The number of subject at Week 9 in Part 1 was one; therefore the SD cannot be calculated.
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
Withdrawal, n=4
0.09 kilogram per meters squared (kg/m^2)
Standard Deviation 0.572
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
FU, Week 4, n=3
0.34 kilogram per meters squared (kg/m^2)
Standard Deviation 0.432
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
FU, Week 12, n=3
0.36 kilogram per meters squared (kg/m^2)
Standard Deviation 1.084
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc
FU, Week 24, n=3
0.41 kilogram per meters squared (kg/m^2)
Standard Deviation 1.042

SECONDARY outcome

Timeframe: Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2

Population: SP2 Population.

The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Antiviral Baseline, n=40
0.01 kg/m^2
Standard Deviation 0.476
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 1, n=40
-0.37 kg/m^2
Standard Deviation 0.408
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 2, n=40
-0.44 kg/m^2
Standard Deviation 0.495
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 4, n=37
-0.41 kg/m^2
Standard Deviation 0.424
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 6, n=36
-0.42 kg/m^2
Standard Deviation 0.534
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 8, n=36
-0.51 kg/m^2
Standard Deviation 0.624
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 12, n=36
-0.70 kg/m^2
Standard Deviation 0.723
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 16, n=36
-0.86 kg/m^2
Standard Deviation 0.844
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 20, n=36
-1.01 kg/m^2
Standard Deviation 0.891
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 24, n=36
-1.25 kg/m^2
Standard Deviation 0.965
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 28, n=34
-1.21 kg/m^2
Standard Deviation 1.212
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 32, n=34
-1.28 kg/m^2
Standard Deviation 1.228
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 36, n=34
-1.38 kg/m^2
Standard Deviation 1.264
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 40, n=33
-1.45 kg/m^2
Standard Deviation 1.200
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 44, n=31
-1.36 kg/m^2
Standard Deviation 1.174
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Week 48, n=31
-1.50 kg/m^2
Standard Deviation 1.146
Mean Change From Baseline in BMI at the Indicated Time Points in Part 2
Withdrawal, n=10
-1.23 kg/m^2
Standard Deviation 1.529

SECONDARY outcome

Timeframe: FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2

Population: SP2 Population

The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=40 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Mean BMI at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, n=40
21.89 kilogram per meters squared (kg/m^2)
Standard Deviation 3.486
Mean BMI at the Indicated Time Points During Follow-up Period After Part 2
FU Week 4, n=40
22.11 kilogram per meters squared (kg/m^2)
Standard Deviation 3.474
Mean BMI at the Indicated Time Points During Follow-up Period After Part 2
FU Week 12, n=40
22.37 kilogram per meters squared (kg/m^2)
Standard Deviation 3.531
Mean BMI at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, n=37
22.54 kilogram per meters squared (kg/m^2)
Standard Deviation 3.521

SECONDARY outcome

Timeframe: From Baseline up to Week 9

Population: SP1 Population.

Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Creatinine:Increase to G1
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Sodium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALT: Increase to G2
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALT: Increase to G3
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALT: Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
AST:Any Grade Increase
9 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
AST:Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
AST:Increase to G2
5 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
AST:Increase to G3
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
AST:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Total Bilirubin:Any Grade Increase
8 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Total Bilirubin:Increase to G1
6 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Total Bilirubin:Increase to G2
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Total Bilirubin:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Total Bilirubin:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Calcium:Any Grade Increase
5 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Calcium:Increase to G1
5 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Calcium:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Calcium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Calcium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Creatinine:Any Grade Increase
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Creatinine:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Creatinine:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Creatinine:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Potassium:Any Grade Increase
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Potassium:Increase to G1
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Potassium:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Potassium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Potassium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Sodium:Any Grade Increase
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Sodium:Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Sodium:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Sodium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Albumin: Any Grade Increase
5 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Albumin: Increase to G1
5 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Albumin: Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Albumin: Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Albumin: Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALP: Any Grade Increase
4 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALP: Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALP: Increase to G2
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALP: Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALP: Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALT: Any Grade Increase
5 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
ALT: Increase to G1
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Uric Acid:Any Grade Increase
6 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Uric acid:Increase to G1
5 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Uric acid:Increase to G2
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Uric acid:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1
Uric acid:Increase to G4
0 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48

Population: SP2 Population.

Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Albumin:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Albumin:Any Grade Increase
18 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Albumin:Increase to G1
15 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Albumin:Increase to G2
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Albumin:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALP:Any Grade Increase
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALP:Increase to G1
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALP:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALP:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALP:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALT:Any Grade Increase
14 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALT:Increase to G1
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALT:Increase to G2
6 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALT:Increase to G3
6 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
ALT:Increase to G4
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
AST:Any Grade Increase
22 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
AST:Increase to G1
4 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
AST:Increase to G2
11 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
AST:Increase to G3
6 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
AST:Increase to G4
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Total Bilirubin:Any Grade Increase
20 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Total Bilirubin:Increase to G1
7 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Total Bilirubin:Increase to G2
9 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Total Bilirubin:Increase to G3
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Total Bilirubin:Increase to G4
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Calcium:Any Grade Increase
31 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Calcium:Increase to G1
25 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Calcium:Increase to G2
6 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Calcium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Calcium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Creatinine:Any Grade Increase
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Creatinine:Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Creatinine:Increase to G2
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Creatinine:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Creatinine:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Potassium:Any Grade Increase
8 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Potassium:Increase to G1
8 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Potassium:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Potassium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Potassium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Sodium:Any Grade Increase
7 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Sodium:Increase to G1
7 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Sodium:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Sodium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Sodium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Uric acid:Any Grade Increase
13 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Uric acid:Increase to G1
9 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Uric acid:Increase to G2
4 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Uric acid:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2
Uric acid:Increase to G4
0 Participants

SECONDARY outcome

Timeframe: From FU Week 4 to FU Week 24

Population: SP2 Population.

Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=40 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Albumin:Any Grade Increase
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Albumin:Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Albumin:Increase to G2
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Albumin:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Albumin:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALP:Any Grade Increase
5 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALP:Increase to G1
4 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALP:Increase to G2
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALP:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALP:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALT:Any Grade Increase
9 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALT:Increase to G1
4 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALT:Increase to G2
4 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALT:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
ALT:Increase to G4
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
AST:Any Grade Increase
10 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
AST:Increase to G1
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
AST:Increase to G2
6 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
AST:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
AST:Increase to G4
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Total Bilirubin:Any Grade Increase
4 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Total Bilirubin:Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Total Bilirubin:Increase to G2
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Total Bilirubin:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Total Bilirubin:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium:Any Grade Increase
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium:Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium serum high: Any Grade Increase
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium, serum high: Increase to G1
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium, serum high: Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium, serum high: Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium, serum high: Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium serum low: Any Grade Increase
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium, serum low: Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium, serum low: Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium, serum low: Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Calcium, serum low: Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Creatinine: Any Grade Increase
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Creatinine: Increase to G1
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Creatinine: Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Creatinine: Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Creatinine: Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium:Any Grade Increase
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium:Increase to G1
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum high:Any Grade Increase
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum high:Increase to G1
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum high:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum high:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum high:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum low:Any Grade Increase
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum low:Increase to G1
3 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum low:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum low:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Potassium, serum low:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium:Any Grade Increase
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium:Increase to G1
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum high:Any Grade Increase
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum high:Increase to G1
1 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum high:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum high:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum high:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum low:Any Grade Increase
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum low:Increase to G1
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum low:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum low:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Sodium, serum low:Increase to G4
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Uric acid:Any Grade Increase
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Uric acid:Increase to G1
2 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Uric acid:Increase to G2
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Uric acid:Increase to G3
0 Participants
Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2
Uric acid:Increase to G4
0 Participants

SECONDARY outcome

Timeframe: From Baseline up to Week 9

Population: SP1 Population.

Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Hemoglobin:Any Grade Increase
1 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Hemoglobin:Increase to G1
1 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Hemoglobin:Increase to G2
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Hemoglobin:Increase to G3
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Hemoglobin:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Lymphocytes:Any Grade Increase
4 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Lymphocytes:Increase to G1
1 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Lymphocytes:Increase to G2
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Lymphocytes:Increase to G3
3 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Lymphocytes:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Total Neutrophils:Any Grade Increase
8 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Total Neutrophils:Increase to G1
6 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Total Neutrophils:Increase to G2
2 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Total Neutrophils:Increase to G3
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Total Neutrophils:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Platelet count:Any Grade Increase
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Platelet count:Increase to G1
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Platelet count:Increase to G2
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Platelet count:Increase to G3
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
Platelet count:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
White Blood Cell count:Any Grade Increase
7 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
White Blood Cell count:Increase to G1
7 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
White Blood Cell count:Increase to G2
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
White Blood Cell count:Increase to G3
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1
White Blood Cell count:Increase to G4
0 Participants

SECONDARY outcome

Timeframe: From Antiviral Baseline up to Week 48

Population: SP2 Population.

Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Hemoglobin:Any Grade Increase
38 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Hemoglobin:Increase to G1
3 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Hemoglobin:Increase to G2
11 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Hemoglobin:Increase to G3
24 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Hemoglobin:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Lymphocytes:Any Grade Increase
26 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Lymphocytes:Increase to G1
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Lymphocytes:Increase to G2
6 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Lymphocytes:Increase to G3
12 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Lymphocytes:Increase to G4
8 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Total Neutrophils:Any Grade Increase
38 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Total Neutrophils:Increase to G1
8 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Total Neutrophils:Increase to G2
10 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Total Neutrophils:Increase to G3
16 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Total Neutrophils:Increase to G4
4 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Platelet count:Any Grade Increase
5 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Platelet count:Increase to G1
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Platelet count:Increase to G2
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Platelet count:Increase to G3
5 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
Platelet count:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
White Blood Cell count:Any Grade Increase
38 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
White Blood Cell count:Increase to G1
10 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
White Blood Cell count:Increase to G2
18 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
White Blood Cell count:Increase to G3
9 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2
White Blood Cell count:Increase to G4
1 Participants

SECONDARY outcome

Timeframe: From FU Week 4 to FU Week 24

Population: SP2 Population,

Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=40 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Hemoglobin:Any Grade Increase
2 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Hemoglobin:Increase to G1
2 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Hemoglobin:Increase to G2
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Hemoglobin:Increase to G3
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Hemoglobin:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Lymphocytes:Any Grade Increase
2 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Lymphocytes:Increase to G1
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Lymphocytes:Increase to G2
2 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Lymphocytes:Increase to G3
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Lymphocytes:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Total Neutrophils:Any Grade Increase
7 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Total Neutrophils:Increase to G1
3 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Total Neutrophils:Increase to G2
4 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Total Neutrophils:Increase to G3
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Total Neutrophils:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Platelet count:Any Grade Increase
15 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Platelet count:Increase to G1
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Platelet count:Increase to G2
8 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Platelet count:Increase to G3
7 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
Platelet count:Increase to G4
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
White Blood Cell count:Any Grade Increase
6 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
White Blood Cell count:Increase to G1
3 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
White Blood Cell count:Increase to G2
3 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
White Blood Cell count:Increase to G3
0 Participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2
White Blood Cell count:Increase to G4
0 Participants

SECONDARY outcome

Timeframe: Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24

Population: SP1 Population.

Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, pH, 5.5, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, USG, 1.025, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UU, 0.1, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UB, Neg, n=4
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UOB, Neg, n=4
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UG, 0.5, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UG, Neg, n=4
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UK, Neg, n=4
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, pH, 6, n=4
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, pH, 6.5, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, pH, 8, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UP, Neg, n=4
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, USG, 1.008, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, USG, 1.01, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, USG, 1.018, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, UK, Neg, n=3
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, pH, 7, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UB, (-), n=45
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UB, Neg., n=45
39 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UOB, 1+, n=45
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UOB, 2+, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UOB, 3+, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UOB, (-), n=45
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UOB, Neg., n=45
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UOB, trace., n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UG, (-), n=45
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UG, 0.5, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UG, Neg., n=45
37 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UK, (-), n=45
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UK, Neg., n=45
38 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, pH, 5, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, pH, 5.5, n=45
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, pH, 6, n=45
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, pH, 6.5, n=45
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, pH, 7, n=45
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, pH, 7.5, n=45
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UP, 1+., n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UP, (-), n=45
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UP, Neg., n=45
35 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UP, trace, n=45
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UU, 1+, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UU, (-), n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UU, 0.1, n=45
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UU, 1, n=45
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UU, 2, n=45
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UU, trace, n=45
19 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, UU, normal, n=45
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.005, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.006, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.007, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.008, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.009, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.01, n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.011, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.012, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.013, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.014, n=45
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.015, n=45
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.017, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.018, n=45
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.019, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.02, n=45
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.021, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.022, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.024, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.025, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.026, n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Screening, USG, 1.03, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UB, (-), n=45
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UB, Neg., n=45
39 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UOB, 1+, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UOB, 2+, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UOB, 3+, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UOB, (-), n=45
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UOB, Neg., n=45
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UOB, trace., n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UG, 2+, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UG, (-), n=45
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UG, 0.1, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UG, 0.5, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UG, Neg., n=45
35 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UK, (-), n=45
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UK, Neg., n=45
38 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, pH, 5, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, pH, 5.5, n=45
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, pH, 6, n=45
13 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, pH, 6.5, n=45
11 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, pH, 7, n=45
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, pH, 7.5, n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, pH, 8, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UP, 1+., n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UP, (-), n=45
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UP, Neg., n=45
36 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UP, trace, n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UU, 1+, n=45
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UU, (-), n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UU, 0.1, n=45
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UU, 1, n=45
10 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UU, 2, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UU, trace, n=45
15 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, UU, normal, n=45
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.003, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.005, n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.006, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.007, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.009, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.01, n=45
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.011, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.012, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.013, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.014, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.015, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.016, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.017, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.018, n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.019, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.02, n=45
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.021, n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.022, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.023, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.025, n=45
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.028, n=45
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Baseline, USG, 1.03, n=45
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 1, UB, Neg, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 1, UOB, Neg, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 1, UG, Neg, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 1, UK, Neg, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 1, pH, 7.5, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 1, UP, trace, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 1, USG, 1.021, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 1, UU, trace, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UB, Neg, n=3
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UOB, Neg, n=3
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UG, 0.25, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UG, Neg, n=3
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UK, Neg, n=3
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, pH, 6, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, pH, 6.5, n=3
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UP, Neg, n=3
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, USG, 1.016, Neg, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, USG, 1.019, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, USG, 1.02, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UU, 0.1, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UU, trace, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 2, UU, normal, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, UB, Neg, n=2
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, UOB, Neg, n=2
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, UG, >=1.0, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, UG, Neg, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, UK, Neg, n=2
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, pH, 6, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, pH, 6.5, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, UP, Neg, n=2
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, USG, 1.015, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, USG, 1.02, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, UU, 0.1, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 3, UU, 4, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UB, Neg, n=5
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UOB, Neg, n=5
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UG, >=1.0, n=5
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UG, Neg, n=5
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UK, Neg, n=5
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, pH, 5.5, n=5
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, pH, 6, n=5
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, pH, 6.5, n=5
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UP, Neg, n=5
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, USG, 1.015, n=5
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, USG, 1.02, n=5
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, USG, 1.025, n=5
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, USG, 1.026, n=5
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UU, 1, n=5
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UU, 2, n=5
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 4, UU, trace, n=5
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 7, UB, Neg, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 7, UOB, Neg, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 7, UG, 0.5, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 7, UK, Neg, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 7, pH, 7, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 7, UP, Neg, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 7, USG, 1.02, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 7, UU, 2, n=1
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UB, Neg, n=2
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UOB, Neg, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UOB, trace, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UG, 0.1 n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UG, Neg, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UK, Neg, n=2
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, pH, 6, n=2
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UP, Neg, n=2
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, USG, 1.023, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Week 8, UU, trace, n=2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, USG, 1.025, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UU, 1+, n=4
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UU, 0.1, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
Withdrawal, UU, 1, n=4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU, Week 24, UB, Neg, n=3
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, UOB, 1+, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, UOB, Neg, n=3
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, UG, Neg, n=3
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, pH, 6, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, UP, Neg, n=3
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, USG, 1.004, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, USG, 1.01, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, USG, 1.02, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, UU, 0.1, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, UU, 1, n=3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period
FU Week 24, UU, trace, n=3
1 Participants

SECONDARY outcome

Timeframe: Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal

Population: SP2 Population.

Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=41 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.025, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.026, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UU, 1+, n=41
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UU, 0.1, n=41
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UU, 4, n=41
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UK, Neg, n=37
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, Neg, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, 1+, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, 1+, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UG, 0.1, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, pH, 7.5, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UP, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UP, Neg, n=31
27 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.005, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.011, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.016, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.018, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.019, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.02, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.022, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.024, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.027, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, 2+, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, 1, n=31
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, 4, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UP, Neg, n=31
26 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, pH, 7, n=10
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.005, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.006, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.007, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.027, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UU, 1, n=41
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UU, 2, n=41
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UU, Neg, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UU, trace, n=41
16 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UU, normal, n=41
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UB, (-), n=37
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UB, Neg, n=37
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UOB, 2+, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UOB, (-), n=37
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UOB, Neg, n=37
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UG, (-), n=37
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UG, 0.1, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UG, Neg, n=37
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UK, (-), n=37
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, pH, 5, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, pH, 5.5, n=37
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, pH, 6, n=37
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, pH, 6.5, n=37
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, pH, 7, n=37
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, pH, 7.5, n=37
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, pH, 8, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UP, (-), n=37
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UP, Neg, n=37
28 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UP, trace, n=37
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.004, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.005, n=37
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.006, n=37
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.008, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.01, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.011, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.012, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.013, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.014, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.015, n=37
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.016, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.017, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.019, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.02, n=37
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.021, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.022, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, USG, 1.025, n=37
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, 1+, n=37
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, 0.1, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, 1, n=37
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.008, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, 2, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, 4, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, 8, n=37
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, Neg, n=37
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, trace, n=37
15 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 4, UU, normal, n=37
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UB, (-), n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UB, 2, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UB, Neg, n=36
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UOB, 1+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UOB, 2+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UOB, (-), n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UOB, Neg, n=36
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UG, 1+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UG, (-), n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UG, >=1.0, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UG, Neg, n=36
29 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UK, (-), n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UK, Neg, n=36
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UK, trace, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, pH, 5, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, pH, 5.5, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, pH, 6, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, pH, 6.5, n=36
13 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, pH, 7, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, pH, 7.5, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, pH, 8, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UP, 1+, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UP, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UP, Neg, n=36
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UP, trace, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.001, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.003, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.004, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.005, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.008, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.01, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.012, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.013, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.014, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.015, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.016, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.018, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.019, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.02, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.023, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, 1.025, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, <=1.005, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, USG, >=1.030, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, 1+, n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, (-), n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, 0.1, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, 1, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, 2, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, 4, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, Neg, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, trace, n=36
11 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 8, UU, normal, n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UB, (-), n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UB, Neg, n=36
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.009, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UOB, (-), n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UOB, Neg, n=36
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UG, (-), n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UG, 0.25, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UG, Neg, n=36
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UK, (-), n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UK, 0, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UK, Neg, n=36
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, pH, 5, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, pH, 5.5, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, pH, 6, n=36
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, pH, 6.5, n=36
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, pH, 7, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, pH, 7.5, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UP, 1+, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UP, (-), n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UP, Neg, n=36
26 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UP, trace, n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.01, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.012, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.014, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.015, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.016, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.017, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.018, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.019, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.02, n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.021, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.022, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, USG, 1.026, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UU, 1+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UU, 0.1, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UU, 1, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UU, 2, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UU, 4, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UU, Neg, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UU, trace, n=36
15 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 12, UU, normal, n=36
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UB, (-), n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UB, Neg, n=36
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UOB, 1+, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UOB, Neg, n=36
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UG, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UG, Neg, n=36
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UG, trace, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UOB, 2+, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UK, Neg, n=31
29 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UOB, 3+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UOB, (-), n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UOB, Neg, n=36
27 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UG, (-), n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UG, 0.25, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UG, Neg, n=36
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UK, (-), n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UK, Neg, n=36
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UK, trace, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, pH, 5, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, pH, 5.5, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, pH, 6, n=36
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, pH, 6.5, n=36
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, pH, 7, n=36
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, pH, 7.5, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UP, 1+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UP, (-), n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UP, Neg, n=36
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UP, trace, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.005, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.006, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.007, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.008, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.009, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.01, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.014, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.015, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.016, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.017, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.018, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.019, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.02, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.021, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.022, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.023, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.025, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, USG, 1.027, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UU, 1+, n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UU, 2+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UU, 0.1, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UU, 1, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UU, 4, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UU, Neg, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UU, trace, n=36
11 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 16, UU, normal, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UB, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UB, Neg, n=36
34 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UOB, 1+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UOB, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UK, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UK, Neg, n=36
34 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, pH, 5, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, pH, 5.5, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, pH, 6, n=36
10 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, pH, 6.5, n=36
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, pH, 7, n=36
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, pH, 7.5, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UP, 1+, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UP, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UP, Neg, n=36
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UP, trace, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.004, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.005, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.006, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.007, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.009, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.01, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.013, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.014, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.015, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.016, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.017, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.018, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.019, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.02, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.021, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.025, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, 1.029, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, USG, <=1.005, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, 1+, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, 2+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, 0.1, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, 1, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, 4, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, 8, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, trace, n=36
13 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 20, UU, normal, n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UB, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UB, Neg, n=36
34 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UOB, 1+, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UOB, 3+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UOB, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UOB, Neg, n=36
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UOB, trace, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UG, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UG, 0.1, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UG, Neg, n=36
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UK, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UK, Neg, n=36
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UK, trace, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, pH, 5, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, pH, 5.5, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, pH, 6, n=36
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, pH, 6.5, n=36
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, pH, 7, n=36
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, pH, 7.5, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, pH, 8.5, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UP, (-), n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UP, Neg, n=36
28 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UP, trace, n=36
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.008, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.009, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.01, n=36
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.011, n=36
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.012, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.013, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.014, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.015, n=36
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.016, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.017, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.018, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.019, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.021, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.022, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.023, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.025, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, 1.03, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, USG, <=1.005, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, 1+, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, 3+, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, 0.1, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, 1, n=36
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, 2, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, 4, n=36
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, Neg, n=36
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, trace, n=36
13 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 24, UU, normal, n=36
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UB, 1+, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UB, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UB, Neg, n=34
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UOB, 1+, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UOB, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UOB, Neg, n=34
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UOB, trace, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UG, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UG, 0.5, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UG, Neg, n=34
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UK, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UK, Neg, n=34
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UK, trace, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, pH, 5.5, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, pH, 6, n=34
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, pH, 6.5, n=34
11 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, pH, 7, n=34
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, pH, 7.5, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, pH, 8, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UP, 1+, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UP, Neg, n=34
27 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UP, trace, n=34
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.005, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.007, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.008, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.009, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.011, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.012, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.013, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.015, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.016, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.017, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.018, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.019, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.02, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.022, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.023, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.024, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.025, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, 1.027, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, USG, <=1.005, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UU, 1+, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UU, 0.1, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UU, 1, n=34
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UU, 2, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UU, 4, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UU, Neg, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UU, trace, n=34
11 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 28, UU, normal, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UB, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UB, Neg, n=34
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UOB, 1+, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UOB, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UOB, Neg, n=34
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UG, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UG, Neg, n=34
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UK, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UK, Neg, n=34
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UK, trace, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, pH, 5, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, pH, 5.5, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, pH, 6, n=34
14 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, pH, 6.5, n=34
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, pH, 7, n=34
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, pH, 7.5, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UP, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UP, Neg, n=34
29 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UP, trace, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.005, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.006, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.007, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.01, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.011, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.012, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.014, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.015, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.016, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.018, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.019, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.02, n=34
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.021, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.022, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, USG, 1.024, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UK, trace, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, 1+, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, 0.1, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, 1, n=34
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, pH, 5.5, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, 3, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, 4, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, 8, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, Neg, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, trace, n=34
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 32, UU, normal, n=34
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UB, 1+, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UB, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UB, Neg, n=34
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UOB, 2+, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UOB, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UOB, Neg, n=34
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UG, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UG, Neg, n=34
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UK, 1+, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UK, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UK, Neg, n=34
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, pH, 5, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, pH, 6, n=31
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, pH, 5.5, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, pH, 6, n=34
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, pH, 6.5, n=31
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, pH, 6.5, n=34
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, pH, 7, n=34
10 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, pH, 7.5, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UP, 1+, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UP, (-), n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UP, Neg, n=34
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UP, trace, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.005, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.007, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.008, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.009, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.01, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.011, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.012, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.013, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.015, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UB, Neg, n=31
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UB, (-), n=41
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UB, Neg., n=41
36 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UOB, 1+, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UOB, (-), n=41
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UOB, Neg., n=41
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UOB, trace., n=41
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UG, 1+, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UG, 2+, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UG, (-), n=41
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UG, 0.25, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UG, 0.5, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UG, >=1.0, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UG, Neg., n=41
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UK, (-), n=41
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UK, Neg., n=41
35 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UK, trace, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, pH, 5, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, pH, 5.5, n=41
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, pH, 6, n=41
11 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, pH, 6.5, n=41
12 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, pH, 7, n=41
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, pH, 7.5, n=41
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, pH, 8.5, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UP, (-), n=41
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UP, Neg, n=41
34 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, UP, trace, n=41
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.005, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.006, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.01, n=41
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.011, n=41
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.012, n=41
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.013, n=41
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.014, n=41
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.015, n=41
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.016, n=41
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.017, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.018, n=41
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.019, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.02, n=41
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.021, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.022, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.023, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Antiviral Baseline, USG, 1.024, n=41
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.016, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.018, n=34
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.02, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.021, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.023, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.024, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, 1.03, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, USG, <=1.005, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, 0.1, n=34
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, 1, n=34
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, 2, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, 3, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, 4, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, Neg, n=34
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, trace, n=34
14 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 36, UU, normal, n=34
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UB, (-), n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UB, Neg, n=33
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UOB, 2+, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UOB, 3+, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UOB, (-), n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UOB, Neg, n=33
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UG, (-), n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UG, Neg, n=33
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UK, (-), n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UK, Neg, n=33
31 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UK, trace, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, pH, 5.5, n=33
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, pH, 6, n=33
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, pH, 6.5, n=33
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, pH, 7, n=33
10 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, pH, 7.5, n=33
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UP, (-), n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UG, Neg, n=31
29 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UP, Neg, n=33
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UP, trace, n=33
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.003, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.004, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.005, n=33
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.006, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.007, n=33
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.01, n=33
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.011, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.012, n=33
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.013, n=33
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.014, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.015, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.016, n=33
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.018, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.019, n=33
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.02, n=33
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.022, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.023, n=33
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.024, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, USG, 1.025, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, 0.1, n=33
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, 1, n=33
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, 2, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, 3, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, 4, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, Neg, n=33
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, trace, n=33
13 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 40, UU, normal, n=33
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UB, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UB, Neg, n=31
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UOB, 2+, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UOB, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UK, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UOB, Neg, n=31
28 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UG, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UOB, 3+, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UOB, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UOB, Neg, n=31
29 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UG, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, pH, 7, n=31
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UP, trace, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.007, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.008, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.01, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.012, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.015, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.017, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UG, Neg, n=31
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UK, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UK, Neg, n=31
30 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.021, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, pH, 5.5, n=31
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, pH, 6, n=31
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, pH, 6.5, n=31
14 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, pH, 7, n=31
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, pH, 8, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UP, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UP, 10, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UP, trace, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.005, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.007, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.009, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.025, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.01, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.011, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.012, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.013, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.014, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.015, n=31
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.016, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.017, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, USG, 1.03, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, 1+, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, 0.1, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.018, n=31
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.019, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.02, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.025, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, 2, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, Neg, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, trace, n=31
11 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.027, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, USG, 1.03, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UU, 1+, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UU, 0.1, n=31
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UU, 1, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UU, 2, n=31
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UU, 3, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UU, Neg, n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UU, trace, n=31
14 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UU, normal, n=31
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UB, 1+, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UB, (-), n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UB, Neg, n=10
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UOB, 1+, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UOB, (-), n=10
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UOB, Neg, n=10
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UG, (-), n=10
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UG, Neg, n=10
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UK, (-), n=10
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UK, Neg, n=10
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, pH, 5, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, pH, 6, n=10
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, pH, 6.5, n=10
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UP, Neg, n=10
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UP, trace, n=10
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.002, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 44, UU, normal, n=31
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.009, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.01, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.017, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.018, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Week 48, UB, (-), n=31
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.019, n=10
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.021, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.023, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, USG, 1.025, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UU, 1+, n=10
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UU, 1, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UU, Neg, n=10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UU, trace, n=10
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2
Withdrawal, UU, normal, n=10
3 Participants

SECONDARY outcome

Timeframe: FU Baseline and FU Week 24

Population: SP2 Population.

Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=37 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UP, trace
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.015
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.025
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UU, 1
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UU, 4
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UU, <1.0
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UU, Neg
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UU, Trace
18 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FUWeek 24, UU, normal
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UB, (-)
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UB, Neg.
34 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UOB, 1+
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UOB, 3+
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UOB, (-)
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UOB, Neg.
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UG, (-)
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UG, Neg
34 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UK, (-)
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UK, Neg.
34 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, pH, 5
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, pH, 5.5
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, pH, 6
10 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, pH, 6.5
13 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, pH, 7
8 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, pH, 8
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UP, (-)
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UP, 10
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UP, Neg
27 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.002
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.005
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.007
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.009
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.01
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.011
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.012
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.013
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.014
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.016
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.017
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.018
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.019
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.02
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.021
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.024
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.025
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.027
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, USG, 1.03
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UU, 1+
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UU, 0.1
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UU, 1
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UU, 2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UU, 3
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UU, Neg
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UU, trace
17 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Baseline, UU, normal
6 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UB, (-)
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UB, Neg.
35 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UOB, 1+
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UOB, 3+
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UOB, (-)
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UOB, Neg.
26 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UOB, Trace
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UG, 1+
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UG, (-)
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UG, 0.2
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FUWeek 24, UG, Neg
33 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UK, (-)
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UK, Neg.
34 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UK, Trace.
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, pH, 5
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, pH, 5.5
9 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, pH, 6
7 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, pH, 6.5
10 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, pH, 7
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, pH, 7.5
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UP, (-)
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UP, Neg
32 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UP, Trace
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.004
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.005
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.008
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.01
5 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.011
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.012
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.013
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.015
3 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.016
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.017
4 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.018
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.019
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.02
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.021
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.022
2 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.023
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, USG, 1.024
1 Participants
Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2
FU Week 24, UU, 0.1
5 Participants

SECONDARY outcome

Timeframe: Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal

Population: SP1 Population.

The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Screening, normal, n=45
31 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Screening, abnormal-NCS, n=45
14 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Screening, abnormal-CS, n=45
0 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Antiviral Baseline, normal, n=41
26 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Antiviral Baseline, abnormal-NCS, n=41
14 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Antiviral Baseline, abnormal-CS, n=41
1 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 12, normal, n=36
29 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 12, abnormal-NCS, n=36
7 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 12, abnormal-CS, n=36
0 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 24, normal, n=36
29 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 24, abnormal-NCS, n=36
7 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 24, abnormal-CS, n=36
0 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 36, normal, n=34
24 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 36, abnormal-NCS, n=34
10 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 36, abnormal-CS, n=34
0 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 48, normal, n=31
19 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 48, abnormal-NCS, n=31
12 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Part 2, week 48, abnormal-CS, n=31
0 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Withdrawal, normal, n=14
10 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Withdrawal, abnormal-NCS, n=14
4 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Withdrawal, abnormal-CS, n=14
0 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Worst ECG post Baseline, normal, n=41
24 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Worst ECG post Baseline, abnormal-NCS, n=41
17 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points
Worst ECG post Baseline, abnormal-CS, n=41
0 Participants

SECONDARY outcome

Timeframe: FU Baseline and FU Week 24

Population: SP2 Population.

The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=37 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2
FU Baseline, normal
24 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2
FU Baseline, abnormal-NCS
13 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2
FU Baseline, abnormal-CS
0 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2
FU Week 24, normal
31 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2
FU Week 24, abnormal-NCS
6 Participants
Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2
FU Week 24, abnormal-CS
0 Participants

SECONDARY outcome

Timeframe: Baseline; Week 24, Week 48, Withdrawal/Completion

Population: SP1 Population. Only those participants available at the specified time points were analyzed (n=X).

Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Baseline, masses suspicious for HCC detected, n=45
0 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Baseline, ascites detected, n=45
0 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Baseline, portal vein thrombosis detected, n=45
0 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Baseline, measureable spleen breadth, n=45
43 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Baseline, OCSF, n=45
8 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 24, masses suspicious for HCC detected, n=36
1 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 24, ascites detected, n=36
1 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 24, portal vein thrombosis detected, n=36
0 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 24, measureable spleen breadth, n=36
34 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 24, OCSF, n=36
4 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 48, masses suspicious for HCC detected, n=29
0 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 48, ascites detected, n=29
1 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 48, portal vein thrombosis detected, n=29
0 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 48, measureable spleen breadth, n=29
29 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
Week 48, OCSF, n=29
3 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
WD/comp, masses suspicious for HCC detected, n=37
2 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
WD/comp, ascites detected, n=37
2 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
WD/comp, portal vein thrombosis detected, n=37
0 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
WD/comp, measureable spleen breadth, n=37
37 Participants
Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points
WD/comp, OCSF, n=37
6 Participants

SECONDARY outcome

Timeframe: FU Week 24

Population: SP2 Population.

Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=36 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
FU Week 24, masses suspicious for HCC detected,
1 Participants
Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
FU Week 24, ascites detected
1 Participants
Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
FU Week 24, portal vein thrombosis detected
0 Participants
Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
FU Week 24, measureable spleen breadth
36 Participants
Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
FU Week 24, OCSF
4 Participants

SECONDARY outcome

Timeframe: Baseline; Week 24, Week 48, Withdrawal/Completion

Population: SP1 Population. Only those participants available at the specified time points were analyzed (n=X).

Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=45 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
Baseline, spleen length, n=45
11.5 Centimeters (cm)
Standard Deviation 2.63
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
Baseline, spleen width (breadth), n=43
4.7 Centimeters (cm)
Standard Deviation 1.25
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
Week 24, spleen length, n=36
11.5 Centimeters (cm)
Standard Deviation 2.34
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
Week 24, spleen width (breadth), n=34
4.9 Centimeters (cm)
Standard Deviation 1.21
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
Week 48, spleen length, n=29
11.6 Centimeters (cm)
Standard Deviation 2.27
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
Week 48, spleen width (breadth), n=29
4.5 Centimeters (cm)
Standard Deviation 0.87
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
WD/comp, spleen length, n=37
11.7 Centimeters (cm)
Standard Deviation 2.67
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study
WD/comp, spleen width (breadth), n=37
4.5 Centimeters (cm)
Standard Deviation 0.93

SECONDARY outcome

Timeframe: FU Week 24

Population: SP2 Population.

Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).

Outcome measures

Outcome measures
Measure
Eltrombopag Dose Escalation: Part 1
n=36 Participants
Participants with an initial platelet count of \<80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \<100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
FU Week 24, spleen length
11.0 Cm
Standard Deviation 2.61
Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2
FU Week 24, spleen width (breadth)
4.4 Cm
Standard Deviation 1.32

Adverse Events

Eltrombopag Dose Escalation: Part 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Eltrombopag + Antiviral Therapy: Part 2

Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths

Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2

Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Eltrombopag Dose Escalation: Part 1
n=45 participants at risk
Participants with an initial platelet count of \&lt;80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \&lt;100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \&lt;100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \&gt;=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \&gt;=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Eltrombopag + Antiviral Therapy: Part 2
n=41 participants at risk
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to \&gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
n=41 participants at risk
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Hepatobiliary disorders
Liver injury
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Investigations
Myeloblast percentage increased
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
4.9%
2/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Blood and lymphatic system disorders
Thrombocytosis
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Infections and infestations
Herpes zoster
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Nervous system disorders
Trigeminal neuralgia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
2.4%
1/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.

Other adverse events

Other adverse events
Measure
Eltrombopag Dose Escalation: Part 1
n=45 participants at risk
Participants with an initial platelet count of \&lt;80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \&lt;100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained \&lt;100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \&gt;=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts \&gt;=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
Eltrombopag + Antiviral Therapy: Part 2
n=41 participants at risk
Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to \&gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2
n=41 participants at risk
Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
Blood and lymphatic system disorders
Anaemia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
53.7%
22/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
41.5%
17/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
19.5%
8/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
17.1%
7/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
39.0%
16/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
34.1%
14/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
31.7%
13/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
17.1%
7/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
9.8%
4/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Stomatitis
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
29.3%
12/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
14.6%
6/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Nausea
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
14.6%
6/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Diarrhoea
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
9.8%
4/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Constipation
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Dental caries
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Toothache
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Varices oesophageal
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Vomiting
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
General disorders
Pyrexia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
58.5%
24/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
General disorders
Malaise
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
26.8%
11/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Gastrointestinal disorders
Fatigue
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
9.8%
4/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
General disorders
Injection site erythema
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
9.8%
4/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
General disorders
Injection site pruritus
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
9.8%
4/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
General disorders
Injection site reaction
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
22.0%
9/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
17.1%
7/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Nervous system disorders
Headache
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
31.7%
13/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Nervous system disorders
Dysgeusia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Nervous system disorders
Dizziness
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
9.8%
4/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Eye disorders
Retinal haemorrhage
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
17.1%
7/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Eye disorders
Retinopathy
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
14.6%
6/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Eye disorders
Retinal exudates
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Investigations
White blood cell count decreased
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
17.1%
7/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Investigations
Weight decreased
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
14.6%
6/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Investigations
Neutrophil count decreased
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Investigations
Haemoglobin decreased
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
9.8%
4/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Investigations
Alanine aminotransferase increased
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Investigations
Aspartate aminotransferase increased
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Infections and infestations
Nasopharyngitis
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
22.0%
9/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Infections and infestations
Cystitis
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
9.8%
4/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Infections and infestations
Enteritis infectious
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
22.0%
9/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
7.3%
3/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
14.6%
6/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Psychiatric disorders
Insomnia
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
14.6%
6/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/45 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
12.2%
5/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.
0.00%
0/41 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to a maximun of 81 weeks).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants enrolled in the Pre-Antiviral Treatment Period and Antivital Treatment Period, who received at least one dose of eltrombopag.

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