NCT00351468 · OUTCOME
Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline
EXTEND (Eltrombopag Extended Dosing Study) · Source last updated 2017-04-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Points on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
What was measured
The SF-36v2 assessment tool was used to obtain information about subjects' general health status and health-related quality of life. Until a formal assessment of minimal clinically important differences (MCID) is performed, changes from baseline of more than 0.5 standard deviations are suggested as clinically meaningful. Scores were transformed to a 0-100 point scale, with higher scores representing more positive answers. Scores were normalized to have a mean of 50 and SD of 10 to allow for comparison with outcomes from other chronic diseases. Recall period is the past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group
Groups in this outcome
Eltrombopag
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
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 |
|---|
| Eltrombopag | 290 |
|---|
Reported measurements
SF-36v2 Physical function (n=273
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 12.0 | Not reported | 9.6 | 14.5 | Not reported |
|---|
SF-36v2 Physical role (n=273)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 14.2 | Not reported | 11.5 | 16.9 | Not reported |
|---|
SF-36v2 Bodily pain (n=273)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 14.5 | Not reported | 11.6 | 17.4 | Not reported |
|---|
SF-36v2 General health (n=273)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 11.1 | Not reported | 9.0 | 13.1 | Not reported |
|---|
SF-36v2 Vitality (n=290)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 13.9 | Not reported | 11.6 | 16.3 | Not reported |
|---|
SF-36v2 Social function (n=290)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 12.6 | Not reported | 10.2 | 15.1 | Not reported |
|---|
SF-36v2 Emotional role (n=290)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 11.4 | Not reported | 8.7 | 14.0 | Not reported |
|---|
SF-36v2 Mental health (n=290)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 11.3 | Not reported | 9.4 | 13.3 | Not reported |
|---|
SF-36v2 Physical component summary (n=273)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 5.3 | Not reported | 4.5 | 6.2 | Not reported |
|---|
SF-36v2 Mental component summary (n=290)
Values in Points on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 5.8 | Not reported | 4.6 | 6.9 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.6
- upper Limit
- 14.5
- value
- 12.0
- title
- SF-36v2 Physical function (n=273
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.5
- upper Limit
- 16.9
- value
- 14.2
- title
- SF-36v2 Physical role (n=273)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.6
- upper Limit
- 17.4
- value
- 14.5
- title
- SF-36v2 Bodily pain (n=273)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.0
- upper Limit
- 13.1
- value
- 11.1
- title
- SF-36v2 General health (n=273)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.6
- upper Limit
- 16.3
- value
- 13.9
- title
- SF-36v2 Vitality (n=290)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.2
- upper Limit
- 15.1
- value
- 12.6
- title
- SF-36v2 Social function (n=290)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.7
- upper Limit
- 14.0
- value
- 11.4
- title
- SF-36v2 Emotional role (n=290)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.4
- upper Limit
- 13.3
- value
- 11.3
- title
- SF-36v2 Mental health (n=290)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 6.2
- value
- 5.3
- title
- SF-36v2 Physical component summary (n=273)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.6
- upper Limit
- 6.9
- value
- 5.8
- title
- SF-36v2 Mental component summary (n=290)
- description
- The SF-36v2 assessment tool was used to obtain information about subjects' general health status and health-related quality of life. Until a formal assessment of minimal clinically important differences (MCID) is performed, changes from baseline of more than 0.5 standard deviations are suggested as clinically meaningful. Scores were transformed to a 0-100 point scale, with higher scores representing more positive answers. Scores were normalized to have a mean of 50 and SD of 10 to allow for comparison with outcomes from other chronic diseases. Recall period is the past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
- id
- OG000
- title
- Eltrombopag
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
- title
- Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline
- type
- SECONDARY
- unit Of Measure
- Points on a scale
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