TriangleNCT00516321 · 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 (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg 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-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
180 to 135 mcg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 73 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 121 | Not reported | Not reported | Not reported | Not reported |
180 to 90 mcg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 94 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 82 | Not reported | Not reported | Not reported | Not reported |
180 to 45 mcg
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
135 to 90 mcg
| 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 | 64 | Not reported | Not reported | Not reported | Not reported |
135 to 45 mcg
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
90 to 45 mcg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 18 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 12 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 121
- title
- 180 to 135 mcg
- categories
- measurements
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 82
- title
- 180 to 90 mcg
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- 180 to 45 mcg
- categories
- measurements
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 64
- title
- 135 to 90 mcg
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- 135 to 45 mcg
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 12
- title
- 90 to 45 mcg
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 450
- units
- Participants
- description
- The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg 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-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. 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
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice