TriangleNCT00529568 · OUTCOME
Number of Participants With the Indicated Levels of Peginterferon 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
The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.
Analysis population: ITT Population. One participant could have had more than one dose reduction.
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 | Source count |
|---|---|
| Placebo+Antiviral Therapy: DB Phase | 253 |
| Eltrombopag+Antiviral Therapy: DB Phase | 506 |
Reported measurements
<=25%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 44 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 89 | Not reported | Not reported | Not reported | Not reported |
>25% to <=34%
| 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 | 35 | Not reported | Not reported | Not reported | Not reported |
>34% to <=50%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 115 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 112 | Not reported | Not reported | Not reported | Not reported |
>50%
| 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 | 30 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 89
- title
- <=25%
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 35
- title
- >25% to <=34%
- categories
- measurements
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 112
- title
- >34% to <=50%
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 30
- title
- >50%
- denoms
- counts
- group Id
- OG000
- value
- 253
- group Id
- OG001
- value
- 506
- units
- Participants
- description
- The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.
- 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. One participant could have had more than one dose reduction.
- 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 With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice