NCT00529568 · OUTCOME
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C 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
- DB Phase: Antiviral BL (up to Week 10); 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 an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. 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.
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 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 | 252 |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 505 |
|---|
Reported measurements
Antiviral BL, Normal, n=232, 478
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 147 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 332 | Not reported | Not reported | Not reported | Not reported |
|---|
Antiviral BL, Abnormal - NCS, n=232, 478
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 63 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 103 | Not reported | Not reported | Not reported | Not reported |
|---|
Antiviral BL, Abnormal - CS, n=232, 478
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
End of Treatment, Normal, n=218, 428
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 134 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 291 | Not reported | Not reported | Not reported | Not reported |
|---|
End of Treatment, Abnormal - NCS, n=218, 428
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 62 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 103 | Not reported | Not reported | Not reported | Not reported |
|---|
End of Treatment, Abnormal - CS, n=218, 428
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
24-week FU, Normal, n=194, 383
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 123 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 238 | Not reported | Not reported | Not reported | Not reported |
|---|
24-week FU, Abnormal - NCS, n=194, 383
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 107 | Not reported | Not reported | Not reported | Not reported |
|---|
24-week FU, Abnormal - CS, n=194, 383
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst ECG post-BL, Normal, n=252, 505
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 113 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 233 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst ECG post-BL, Abnormal - NCS, n=252, 505
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 91 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 171 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst ECG post-BL, Abnormal - CS, n=252, 505
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo+Antiviral Therapy: DB Phase | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
| Eltrombopag+Antiviral Therapy: DB Phase | 101 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 332
- title
- Antiviral BL, Normal, n=232, 478
- categories
- measurements
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 103
- title
- Antiviral BL, Abnormal - NCS, n=232, 478
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 43
- title
- Antiviral BL, Abnormal - CS, n=232, 478
- categories
- measurements
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 291
- title
- End of Treatment, Normal, n=218, 428
- categories
- measurements
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 103
- title
- End of Treatment, Abnormal - NCS, n=218, 428
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 34
- title
- End of Treatment, Abnormal - CS, n=218, 428
- categories
- measurements
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 238
- title
- 24-week FU, Normal, n=194, 383
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 107
- title
- 24-week FU, Abnormal - NCS, n=194, 383
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 38
- title
- 24-week FU, Abnormal - CS, n=194, 383
- categories
- measurements
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 233
- title
- Worst ECG post-BL, Normal, n=252, 505
- categories
- measurements
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 171
- title
- Worst ECG post-BL, Abnormal - NCS, n=252, 505
- categories
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 101
- title
- Worst ECG post-BL, Abnormal - CS, n=252, 505
- denoms
- counts
- group Id
- OG000
- value
- 252
- group Id
- OG001
- value
- 505
- 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 an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. 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.
- 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
- DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
- title
- Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase
- type
- SECONDARY
- unit Of Measure
- participants
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