NCT00516321 · OUTCOME

Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB 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: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

What was measured

Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.

Analysis population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

Groups in this outcome

Placebo+Antiviral Therapy: DB Phase

Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).

Eltrombopag+Antiviral Therapy: DB Phase

Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).

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
Placebo+Antiviral Therapy: DB Phase	198
Eltrombopag+Antiviral Therapy: DB Phase	383

Reported measurements

End of Treatment, CS change from BL, n=198, 383

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	2	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	5	Not reported	Not reported	Not reported	Not reported

End of Treatment, NCS change from BL, n=198, 383

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	196	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	377	Not reported	Not reported	Not reported	Not reported

End of Treatment, Not applicable, n=198, 383

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	0	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	1	Not reported	Not reported	Not reported	Not reported

24-week FU, CS change from BL, n=186, 369

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	1	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	8	Not reported	Not reported	Not reported	Not reported

24-week FU, NCS change from BL, n=186, 369

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	185	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	361	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
5
title
End of Treatment, CS change from BL, n=198, 383
categories
measurements
group Id
OG000
value
196
group Id
OG001
value
377
title
End of Treatment, NCS change from BL, n=198, 383
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
End of Treatment, Not applicable, n=198, 383
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
8
title
24-week FU, CS change from BL, n=186, 369
categories
measurements
group Id
OG000
value
185
group Id
OG001
value
361
title
24-week FU, NCS change from BL, n=186, 369

denoms

counts
group Id
OG000
value
198
group Id
OG001
value
383
units
Participants

description

groups

description
Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
id
OG000
title
Placebo+Antiviral Therapy: DB Phase
description
Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
id
OG001
title
Eltrombopag+Antiviral Therapy: DB Phase

param Type

NUMBER

population Description

Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

reporting Status

POSTED

time Frame

End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

title

Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase

type

SECONDARY

unit Of Measure

participants

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Preserved source evidence · Not medical advice