Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (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 clinical chemistry 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 calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the 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: all randomized participants who had received study drug in the DB Phase
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
Calcium (hypocalcemia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
173
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
343
Not reported
Not reported
Not reported
Not reported
Calcium (hypocalcemia), Increase to G1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
127
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
211
Not reported
Not reported
Not reported
Not reported
Calcium (hypocalcemia), Increase to G2
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
126
Not reported
Not reported
Not reported
Not reported
Calcium (hypocalcemia), Increase to G3
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
4
Not reported
Not reported
Not reported
Not reported
Calcium (hypocalcemia), Increase to G4
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
2
Not reported
Not reported
Not reported
Not reported
Calcium (hypercalcemia), Any Grade Increase
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
5
Not reported
Not reported
Not reported
Not reported
Calcium (hypercalcemia), Increase to G1
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
4
Not reported
Not reported
Not reported
Not reported
Calcium (hypercalcemia), Increase to G2
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
1
Not reported
Not reported
Not reported
Not reported
Calcium (hypercalcemia), Increase to G3
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
0
Not reported
Not reported
Not reported
Not reported
Calcium (hypercalcemia), Increase to G4
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
0
Not reported
Not reported
Not reported
Not reported
Glu. (hypoglycemia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
23
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
58
Not reported
Not reported
Not reported
Not reported
Glu. (hypoglycemia), Increase to G1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
14
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
30
Not reported
Not reported
Not reported
Not reported
Glu. (hypoglycemia), Increase to G2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
6
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
22
Not reported
Not reported
Not reported
Not reported
Glu. (hypoglycemia), Increase to G3
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
4
Not reported
Not reported
Not reported
Not reported
Glu. (hypoglycemia), Increase to G4
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
2
Not reported
Not reported
Not reported
Not reported
Glu. (hyperglycemia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
111
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
239
Not reported
Not reported
Not reported
Not reported
Glu. (hyperglycemia), Increase to G1
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
61
Not reported
Not reported
Not reported
Not reported
Glu. (hyperglycemia), Increase to G2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
62
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
148
Not reported
Not reported
Not reported
Not reported
Glu. (hyperglycemia), Increase to G3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
19
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
29
Not reported
Not reported
Not reported
Not reported
Glu. (hyperglycemia), Increase to G4
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
1
Not reported
Not reported
Not reported
Not reported
Pot. (hyperkalemia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
6
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
10
Not reported
Not reported
Not reported
Not reported
Pot. (hyperkalemia), Increase to G1
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
6
Not reported
Not reported
Not reported
Not reported
Pot. (hyperkalemia), Increase to G2
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
2
Not reported
Not reported
Not reported
Not reported
Pot. (hyperkalemia), Increase to G3
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
1
Not reported
Not reported
Not reported
Not reported
Pot. (hyperkalemia), Increase to G4
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
1
Not reported
Not reported
Not reported
Not reported
Pot. (hypokalemia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
33
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
58
Not reported
Not reported
Not reported
Not reported
Pot. (hypokalemia), Increase to G1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
29
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
53
Not reported
Not reported
Not reported
Not reported
Pot. (hypokalemia), Increase to G2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
4
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
5
Not reported
Not reported
Not reported
Not reported
Pot. (hypokalemia), Increase to G3
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
0
Not reported
Not reported
Not reported
Not reported
Pot. (hypokalemia), Increase to G4
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
0
Not reported
Not reported
Not reported
Not reported
Sod. (hypernatremia), Any Grade Increase
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
12
Not reported
Not reported
Not reported
Not reported
Sod. (hypernatremia), Increase to G1
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
11
Not reported
Not reported
Not reported
Not reported
Sod. (hypernatremia), Increase to G2
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
0
Not reported
Not reported
Not reported
Not reported
Sod. (hypernatremia), Increase to G3
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
0
Not reported
Not reported
Not reported
Not reported
Sod. (hypernatremia), Increase to G4
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
Sod. (hyponatremia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
65
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
151
Not reported
Not reported
Not reported
Not reported
Sod. (hyponatremia), Increase to G1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo+Antiviral Therapy: DB Phase
62
Not reported
Not reported
Not reported
Not reported
Eltrombopag+Antiviral Therapy: DB Phase
134
Not reported
Not reported
Not reported
Not reported
Sod. (hyponatremia), Increase to G2
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
11
Not reported
Not reported
Not reported
Not reported
Sod. (hyponatremia), Increase to G3
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
3
Not reported
Not reported
Not reported
Not reported
Sod. (hyponatremia), Increase to G4
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
3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
173
group Id
OG001
value
343
title
Calcium (hypocalcemia), Any Grade Increase
categories
measurements
group Id
OG000
value
127
group Id
OG001
value
211
title
Calcium (hypocalcemia), Increase to G1
categories
measurements
group Id
OG000
value
45
group Id
OG001
value
126
title
Calcium (hypocalcemia), Increase to G2
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
title
Calcium (hypocalcemia), Increase to G3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Calcium (hypocalcemia), Increase to G4
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
5
title
Calcium (hypercalcemia), Any Grade Increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
4
title
Calcium (hypercalcemia), Increase to G1
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Calcium (hypercalcemia), Increase to G2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Calcium (hypercalcemia), Increase to G3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Calcium (hypercalcemia), Increase to G4
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
58
title
Glu. (hypoglycemia), Any Grade Increase
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
30
title
Glu. (hypoglycemia), Increase to G1
denoms
counts
group Id
OG000
value
232
group Id
OG001
value
449
units
Participants
description
Blood samples for the assessment of clinical chemistry 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 calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
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: all randomized participants who had received study drug in the DB Phase
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 Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase
Triangle