TriangleNCT00099437 · OUTCOME
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
What was measured
Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.
Groups in this outcome
Fulvestrant 250 mg
Fulvestrant 250 mg Intramuscular Injection every 28 days
Fulvestrant 500 mg
Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
| Group | Source count |
|---|---|
| Fulvestrant 250 mg | 35 |
| Fulvestrant 500 mg | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fulvestrant 250 mg | -5.9 | 9.89 | Not reported | Not reported | Not reported |
| Fulvestrant 500 mg | -7.5 | 13.72 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.89
- value
- -5.9
- group Id
- OG001
- spread
- 13.72
- value
- -7.5
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 34
- units
- Participants
- description
- Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.
- dispersion Type
- Standard Deviation
- groups
- description
- Fulvestrant 250 mg Intramuscular Injection every 28 days
- id
- OG000
- title
- Fulvestrant 250 mg
- description
- Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
- id
- OG001
- title
- Fulvestrant 500 mg
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)
- title
- Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice