NCT00516321 · OUTCOME
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication 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
Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.
Analysis population: Safety DB 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 | 449 |
|---|
Reported measurements
Unilateral CP, Genotype 2/3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Unilateral CP, Non-genotype 2/3
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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Unilateral CP, Missing genotype
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Bilateral CP, Genotype 2/3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Bilateral CP, Non-genotype 2/3
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 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Unilateral IP, Genotype 2/3
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Unilateral IP, Non-genotype 2/3
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 |
|---|
Bilateral IP, Genotype 2/3
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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Bilateral IP, Non-genotype 2/3
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 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Unilateral CP, Genotype 2/3
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Unilateral CP, Non-genotype 2/3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Unilateral CP, Missing genotype
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- title
- Bilateral CP, Genotype 2/3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 9
- title
- Bilateral CP, Non-genotype 2/3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Unilateral IP, Genotype 2/3
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- title
- Unilateral IP, Non-genotype 2/3
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- Bilateral IP, Genotype 2/3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- title
- Bilateral IP, Non-genotype 2/3
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 449
- units
- Participants
- description
- Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.
- 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
- Safety DB 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 Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
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