TriangleNCT00128102 · OUTCOME
Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, Week 12
What was measured
LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥50% change (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100) and \>10 mm absolute change in LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
Analysis population: All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
Groups in this outcome
Vorinostat
Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
Placebo
Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Vorinostat | 299 |
| Placebo | 299 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat | 15.05 | Not reported | 11.19 | 19.62 | Not reported |
| Placebo | 16.39 | Not reported | 12.38 | 21.08 | Not reported |
Source statistical analyses
- ci Lower Limit
- -7.20
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.53
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.736
- param Type
- Difference in Percentage
- param Value
- -1.3
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Lower Limit
- -7.20
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.53
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.736
- param Type
- Difference in Percentage
- param Value
- -1.3
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.19
- upper Limit
- 19.62
- value
- 15.05
- group Id
- OG001
- lower Limit
- 12.38
- upper Limit
- 21.08
- value
- 16.39
- denoms
- counts
- group Id
- OG000
- value
- 299
- group Id
- OG001
- value
- 299
- units
- Participants
- description
- LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥50% change (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100) and \>10 mm absolute change in LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Vorinostat
- description
- Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 12
- title
- Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice