NCT00516321 · OUTCOME
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase
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 12
What was measured
RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.
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 | Source count |
|---|---|
| Placebo+Antiviral Therapy: DB Phase | 232 |
| Eltrombopag+Antiviral Therapy: DB Phase | 450 |
Reported measurements
RVR
| 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 | 73 | Not reported | Not reported | Not reported | Not reported |
eRVR
| 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 | 68 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 73
- title
- RVR
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 68
- title
- eRVR
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 450
- units
- Participants
- description
- RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.
- 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 12
- title
- Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) 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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