TriangleNCT00128102 · OUTCOME
Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percent Change
- 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 percent change in FVC from baseline to Week 12 post treatment initiation (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100)\] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for FVC available.
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 | -6.0 | Not reported | -9.82 | -2.09 | Not reported |
| Placebo | -5.6 | Not reported | -9.2 | -2.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.49
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.979
- param Type
- Difference in Percent Change
- param Value
- -0.06
- statistical Method
- Longitudinal Model
Complete source fields
- analyses
- ci Lower Limit
- -4.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.49
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.979
- param Type
- Difference in Percent Change
- param Value
- -0.06
- statistical Method
- Longitudinal Model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -9.82
- upper Limit
- -2.09
- value
- -6.0
- group Id
- OG001
- lower Limit
- -9.2
- upper Limit
- -2.0
- value
- -5.6
- 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 percent change in FVC from baseline to Week 12 post treatment initiation (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100)\] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for FVC 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
- MEAN
- 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
- Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 12
- type
- SECONDARY
- unit Of Measure
- Percent Change
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice