Median Platelet Count at the Indicated Time Points During the OL Phase
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease · Source last updated 2013-11-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEDIAN
Unit
Gi/L
Interval / dispersion
Full Range
Time frame
OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)
What was measured
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
Analysis population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.
Groups in this outcome
Eltrombopag: OL Phase
Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Eltrombopag: OL Phase
712
Reported measurements
Baseline, n=712
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
59.00
Not reported
3.00
98.34
Not reported
Day 1, n=620
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
59.00
Not reported
5.00
108.00
Not reported
Week 1, n=703
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
77.00
Not reported
7.00
226.00
Not reported
Week 2, n=426
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
89.00
Not reported
11.00
389.58
Not reported
Week 3, n=179
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
83.00
Not reported
11.00
335.00
Not reported
Week 4, n=98
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
83.00
Not reported
12.00
310.00
Not reported
Week 5, n=56
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
77.00
Not reported
16.00
379.00
Not reported
Week 6, n=35
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
79.00
Not reported
24.00
436.00
Not reported
Week 7, n=29
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
77.00
Not reported
30.00
187.90
Not reported
Week 8, n=18
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
83.00
Not reported
37.00
135.00
Not reported
Week 9, n=7
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
70.00
Not reported
38.00
113.00
Not reported
Antiviral Baseline, n=48
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
130.00
Not reported
90.00
291.00
Not reported
End of Treatment/Withdrawal, n=18
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
63.00
Not reported
6.00
331.97
Not reported
Last on Treatment, n=30
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
75.00
Not reported
6.00
249.56
Not reported
4 Week Follow-Up, n=15
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
44.00
Not reported
4.00
248.85
Not reported
12 Week Follow-Up, n=16
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
38.00
Not reported
19.00
86.00
Not reported
24 Week Follow-Up, n=15
Values in Gi/L · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Eltrombopag: OL Phase
38.00
Not reported
9.00
79.00
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
3.00
upper Limit
98.34
value
59.00
title
Baseline, n=712
categories
measurements
group Id
OG000
lower Limit
5.00
upper Limit
108.00
value
59.00
title
Day 1, n=620
categories
measurements
group Id
OG000
lower Limit
7.00
upper Limit
226.00
value
77.00
title
Week 1, n=703
categories
measurements
group Id
OG000
lower Limit
11.00
upper Limit
389.58
value
89.00
title
Week 2, n=426
categories
measurements
group Id
OG000
lower Limit
11.00
upper Limit
335.00
value
83.00
title
Week 3, n=179
categories
measurements
group Id
OG000
lower Limit
12.00
upper Limit
310.00
value
83.00
title
Week 4, n=98
categories
measurements
group Id
OG000
lower Limit
16.00
upper Limit
379.00
value
77.00
title
Week 5, n=56
categories
measurements
group Id
OG000
lower Limit
24.00
upper Limit
436.00
value
79.00
title
Week 6, n=35
categories
measurements
group Id
OG000
lower Limit
30.00
upper Limit
187.90
value
77.00
title
Week 7, n=29
categories
measurements
group Id
OG000
lower Limit
37.00
upper Limit
135.00
value
83.00
title
Week 8, n=18
categories
measurements
group Id
OG000
lower Limit
38.00
upper Limit
113.00
value
70.00
title
Week 9, n=7
categories
measurements
group Id
OG000
lower Limit
90.00
upper Limit
291.00
value
130.00
title
Antiviral Baseline, n=48
denoms
counts
group Id
OG000
value
712
units
Participants
description
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
dispersion Type
Full Range
groups
description
Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
id
OG000
title
Eltrombopag: OL Phase
param Type
MEDIAN
population Description
Safety Population. Only those participants contributing data at the indicated time points were analyzed.
reporting Status
POSTED
time Frame
OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)
title
Median Platelet Count at the Indicated Time Points During the OL Phase
Triangle