TriangleNCT00529568 · OUTCOME
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points 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
- End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
What was measured
Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.
Analysis population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
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 | 218 |
| Eltrombopag+Antiviral Therapy: DB Phase | 428 |
Reported measurements
End of Treatment, CS change from BL, n=218, 428
| 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 | 7 | Not reported | Not reported | Not reported | Not reported |
End of Treatment, NCS change from BL, n=218, 428
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 218 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 420 | Not reported | Not reported | Not reported | Not reported |
End of Treatment, Not applicable, n=218, 428
| 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 |
24-week FU, CS change from BL, n=194, 383
| 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 | 4 | Not reported | Not reported | Not reported | Not reported |
24-week FU, NCS change from BL, n=194, 383
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | 193 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 379 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- title
- End of Treatment, CS change from BL, n=218, 428
- categories
- measurements
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 420
- title
- End of Treatment, NCS change from BL, n=218, 428
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- End of Treatment, Not applicable, n=218, 428
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- title
- 24-week FU, CS change from BL, n=194, 383
- categories
- measurements
- group Id
- OG000
- value
- 193
- group Id
- OG001
- value
- 379
- title
- 24-week FU, NCS change from BL, n=194, 383
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 428
- units
- Participants
- description
- Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.
- 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
- Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
- reporting Status
- POSTED
- time Frame
- End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
- title
- Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice