TriangleNCT00128102 · OUTCOME
Percentage of Participants With ≥10% Change From Baseline in FVC 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
Pulmonary function test was conducted using a spirometer for assessment of FVC. FVC is the volume of air forcibly exhaled from the lungs after taking the deepest breath possible. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥10% change (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100) in FVC 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 FVC.
Analysis population: All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for FVC 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 | 210 |
| Placebo | 208 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat | 24.76 | Not reported | 19.08 | 31.17 | Not reported |
| Placebo | 21.63 | Not reported | 16.24 | 27.86 | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.97
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.17
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.488
- param Type
- Difference in Percentage
- param Value
- 3.1
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Lower Limit
- -4.97
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.17
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.488
- param Type
- Difference in Percentage
- param Value
- 3.1
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.08
- upper Limit
- 31.17
- value
- 24.76
- group Id
- OG001
- lower Limit
- 16.24
- upper Limit
- 27.86
- value
- 21.63
- denoms
- counts
- group Id
- OG000
- value
- 210
- group Id
- OG001
- value
- 208
- units
- Participants
- description
- Pulmonary function test was conducted using a spirometer for assessment of FVC. FVC is the volume of air forcibly exhaled from the lungs after taking the deepest breath possible. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥10% change (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100) in FVC 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 FVC.
- 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 FVC available.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 12
- title
- Percentage of Participants With ≥10% Change From Baseline in FVC 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