TriangleNCT00516321 · OUTCOME
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in 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 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
Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.
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
0
| 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 | 195 | Not reported | Not reported | Not reported | Not reported |
1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 57 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 93 | Not reported | Not reported | Not reported | Not reported |
2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 55 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 56 | Not reported | Not reported | Not reported | Not reported |
3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 26 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 49 | Not reported | Not reported | Not reported | Not reported |
>3
| 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 | 57 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 195
- title
- 0
- categories
- measurements
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 93
- title
- 1
- categories
- measurements
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 56
- title
- 2
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 49
- title
- 3
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 57
- title
- >3
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 450
- units
- Participants
- description
- Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.
- 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 Antiviral Therapy Dose Reductions in the DB Phase
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice