NCT00529568 · OUTCOME

Median Platelet Count at the Indicated Time Points During the OL Phase

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C 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 \<100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<100 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 \>=100 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 \>=100 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	797

Reported measurements

Baseline, n=797

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	59.0	Not reported	12	95	Not reported

Day 1, n=714

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	58.0	Not reported	5	117	Not reported

Week 1, n=791

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	77.0	Not reported	5	223	Not reported

Week 2, n=530

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	93.0	Not reported	9	489	Not reported

Week 3, n=288

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	89.0	Not reported	10	504	Not reported

Week 4, n=161

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	90.0	Not reported	10	280	Not reported

Week 5, n=98

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	92.0	Not reported	9	252	Not reported

Week 6, n=55

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	86.0	Not reported	14	138	Not reported

Week 7, n=35

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	78.0	Not reported	11	136	Not reported

Week 8, n=24

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	87.5	Not reported	15	146	Not reported

Week 9, n=4

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	85.5	Not reported	66	107	Not reported

Antiviral Baseline, n=48

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	131.5	Not reported	76	274	Not reported

End of Treatment/Withdrawal, n=22

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	76.5	Not reported	13	257	Not reported

Last on Treatment, n=39

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	87.0	Not reported	13	267	Not reported

Week 4 Follow-Up, n=20

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	42.0	Not reported	11	156	Not reported

Week 12 Follow-Up, n=15

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	43.0	Not reported	8	91	Not reported

Week 24 Follow-Up, n=14

Values in Gi/L · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Eltrombopag: OL Phase	41.0	Not reported	13	87	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
12
upper Limit
95
value
59.0
title
Baseline, n=797
categories
measurements
group Id
OG000
lower Limit
5
upper Limit
117
value
58.0
title
Day 1, n=714
categories
measurements
group Id
OG000
lower Limit
5
upper Limit
223
value
77.0
title
Week 1, n=791
categories
measurements
group Id
OG000
lower Limit
9
upper Limit
489
value
93.0
title
Week 2, n=530
categories
measurements
group Id
OG000
lower Limit
10
upper Limit
504
value
89.0
title
Week 3, n=288
categories
measurements
group Id
OG000
lower Limit
10
upper Limit
280
value
90.0
title
Week 4, n=161
categories
measurements
group Id
OG000
lower Limit
9
upper Limit
252
value
92.0
title
Week 5, n=98
categories
measurements
group Id
OG000
lower Limit
14
upper Limit
138
value
86.0
title
Week 6, n=55
categories
measurements
group Id
OG000
lower Limit
11
upper Limit
136
value
78.0
title
Week 7, n=35
categories
measurements
group Id
OG000
lower Limit
15
upper Limit
146
value
87.5
title
Week 8, n=24
categories
measurements
group Id
OG000
lower Limit
66
upper Limit
107
value
85.5
title
Week 9, n=4
categories
measurements
group Id
OG000
lower Limit
76
upper Limit
274
value
131.5
title
Antiviral Baseline, n=48

denoms

counts
group Id
OG000
value
797
units
Participants

description

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 \<100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<100 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 \>=100 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 \>=100 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

type

SECONDARY

unit Of Measure

Gi/L

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Preserved source evidence · Not medical advice