NCT00516321 · OUTCOME

Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS 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: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

What was measured

Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase 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.

Analysis population: Safety DB Population

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	232
Eltrombopag+Antiviral Therapy: DB Phase	449

Reported measurements

Hemoglobin (anemia), Any Grade Increase

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	148	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	324	Not reported	Not reported	Not reported	Not reported

Hemoglobin (anemia), Increase to G1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	45	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	91	Not reported	Not reported	Not reported	Not reported

Hemoglobin (anemia), Increase to G2

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	63	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	128	Not reported	Not reported	Not reported	Not reported

Hemoglobin (anemia), Increase to G3

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	37	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	98	Not reported	Not reported	Not reported	Not reported

Hemoglobin (anemia), Increase to G4

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	3	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	7	Not reported	Not reported	Not reported	Not reported

Lym. (lymphocytopenia), Any Grade Increase

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	123	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	300	Not reported	Not reported	Not reported	Not reported

Lym. (lymphocytopenia), Increase to G1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	16	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	26	Not reported	Not reported	Not reported	Not reported

Lym. (lymphocytopenia), Increase to G2

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	28	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	50	Not reported	Not reported	Not reported	Not reported

Lym. (lymphocytopenia), Increase to G3

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	43	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	96	Not reported	Not reported	Not reported	Not reported

Lym. (lymphocytopenia), Increase to G4

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	36	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	128	Not reported	Not reported	Not reported	Not reported

Tot Neu. (neutropenia), Any Grade Increase

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	394	Not reported	Not reported	Not reported	Not reported

Tot Neu. (neutropenia), Increase to G1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	32	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	90	Not reported	Not reported	Not reported	Not reported

Tot Neu. (neutropenia), Increase to G2

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	39	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	104	Not reported	Not reported	Not reported	Not reported

Tot Neu. (neutropenia), Increase to G3

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	80	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	129	Not reported	Not reported	Not reported	Not reported

Tot Neu. (neutropenia), Increase to G4

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	45	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	71	Not reported	Not reported	Not reported	Not reported

WBC (leukocytopenia), Any Grade Increase

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	187	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	376	Not reported	Not reported	Not reported	Not reported

WBC (leukocytopenia), Increase to G1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	51	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	94	Not reported	Not reported	Not reported	Not reported

WBC (leukocytopenia), Increase to G2

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	59	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	142	Not reported	Not reported	Not reported	Not reported

WBC (leukocytopenia), Increase to G3

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	68	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	117	Not reported	Not reported	Not reported	Not reported

WBC (leukocytopenia), Increase to G4

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	9	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	23	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
148
group Id
OG001
value
324
title
Hemoglobin (anemia), Any Grade Increase
categories
measurements
group Id
OG000
value
45
group Id
OG001
value
91
title
Hemoglobin (anemia), Increase to G1
categories
measurements
group Id
OG000
value
63
group Id
OG001
value
128
title
Hemoglobin (anemia), Increase to G2
categories
measurements
group Id
OG000
value
37
group Id
OG001
value
98
title
Hemoglobin (anemia), Increase to G3
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
7
title
Hemoglobin (anemia), Increase to G4
categories
measurements
group Id
OG000
value
123
group Id
OG001
value
300
title
Lym. (lymphocytopenia), Any Grade Increase
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
26
title
Lym. (lymphocytopenia), Increase to G1
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
50
title
Lym. (lymphocytopenia), Increase to G2
categories
measurements
group Id
OG000
value
43
group Id
OG001
value
96
title
Lym. (lymphocytopenia), Increase to G3
categories
measurements
group Id
OG000
value
36
group Id
OG001
value
128
title
Lym. (lymphocytopenia), Increase to G4
categories
measurements
group Id
OG000
value
196
group Id
OG001
value
394
title
Tot Neu. (neutropenia), Any Grade Increase
categories
measurements
group Id
OG000
value
32
group Id
OG001
value
90
title
Tot Neu. (neutropenia), Increase to G1

denoms

counts
group Id
OG000
value
232
group Id
OG001
value
449
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

reporting Status

POSTED

time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

title

Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase

type

SECONDARY

unit Of Measure

participants

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Preserved source evidence · Not medical advice