TriangleNCT01286077 · OUTCOME
Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Months
- Interval / dispersion
- Standard Error
- Time frame
- Baseline up to end of study (approximately 4 years 7 months)
What was measured
The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Analysis population: Full Analysis Set (FAS) included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data.
Groups in this outcome
Bortezomib
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
Non-treated Control
no treatment, observation only
| Group | Source count |
|---|---|
| Bortezomib | 46 |
| Non-treated Control | 47 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 39.56 | 2.02 | Not reported | Not reported | Not reported |
| Non-treated Control | 31.66 | 1.81 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.02
- value
- 39.56
- group Id
- OG001
- spread
- 1.81
- value
- 31.66
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 47
- units
- Participants
- description
- The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
- dispersion Type
- Standard Error
- groups
- description
- bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
- id
- OG000
- title
- Bortezomib
- description
- no treatment, observation only
- id
- OG001
- title
- Non-treated Control
- param Type
- MEAN
- population Description
- Full Analysis Set (FAS) included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of study (approximately 4 years 7 months)
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice