NCT00529568 · OUTCOME
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy
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
- 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
The minimum platelet count with antiviral therapy was categorized as follows: \<25 Gi/L; \>=25 to \<50 Gi/L; \>=50 to \<90 Gi/L; \>=90 to \<150 Gi/L; \>=150 Gi/L to \<200 Gi/L; \>=200 Gi/L to \<400 Gi/L; and \>=400 Gi/L.
Analysis population: ITT 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-2b 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 \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b 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 | 253 |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 506 |
|---|
Reported measurements
<25 Gi/L
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
>=25 to <50 Gi/L
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 159 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 76 | Not reported | Not reported | Not reported | Not reported |
|---|
>=50 to <90 Gi/L
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 263 | Not reported | Not reported | Not reported | Not reported |
|---|
>=90 to <150 Gi/L
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 135 | Not reported | Not reported | Not reported | Not reported |
|---|
>=150 to <200 Gi/L
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 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
>=200 to <400 Gi/L
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 |
|---|
>=400 Gi/L
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 |
|---|
Missing
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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 20
- title
- <25 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 159
- group Id
- OG001
- value
- 76
- title
- >=25 to <50 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 263
- title
- >=50 to <90 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 135
- title
- >=90 to <150 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- title
- >=150 to <200 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- title
- >=200 to <400 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- >=400 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 253
- group Id
- OG001
- value
- 506
- units
- Participants
- description
- The minimum platelet count with antiviral therapy was categorized as follows: \<25 Gi/L; \>=25 to \<50 Gi/L; \>=50 to \<90 Gi/L; \>=90 to \<150 Gi/L; \>=150 Gi/L to \<200 Gi/L; \>=200 Gi/L to \<400 Gi/L; and \>=400 Gi/L.
- groups
- description
- Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b 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 \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b 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
- ITT 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 in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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