NCT00516321 · OUTCOME
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy 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
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-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 | 450 |
|---|
Reported measurements
<25 Gi/L
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 | 12 | 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 | 135 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 125 | 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 | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 245 | 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 | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 58 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 6 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 1 | 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 | 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
- 63
- group Id
- OG001
- value
- 12
- title
- <25 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 125
- title
- >=25 to <50 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 245
- title
- >=50 to <90 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 58
- title
- >=90 to <150 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- title
- >=150 to <200 Gi/L
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- 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
- 0
- group Id
- OG001
- value
- 3
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 450
- 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-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
- 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 During the DB Phase
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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