TriangleNCT00417079 · OUTCOME
Time to Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of randomization up to 104 weeks (study cut-off)
What was measured
Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first
Analysis population: Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
Groups in this outcome
Mitoxantrone + Prednisone
mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Cabazitaxel + Prednisone
cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
| Group | Source count |
|---|---|
| Mitoxantrone + Prednisone | 377 |
| Cabazitaxel + Prednisone | 378 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mitoxantrone + Prednisone | 1.4 | Not reported | 1.4 | 1.7 | Not reported |
| Cabazitaxel + Prednisone | 2.8 | Not reported | 2.4 | 3.0 | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 1.7
- value
- 1.4
- group Id
- OG001
- lower Limit
- 2.4
- upper Limit
- 3.0
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 377
- group Id
- OG001
- value
- 378
- units
- Participants
- description
- Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first
- dispersion Type
- 95% Confidence Interval
- groups
- description
- mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
- id
- OG000
- title
- Mitoxantrone + Prednisone
- description
- cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
- id
- OG001
- title
- Cabazitaxel + Prednisone
- param Type
- MEDIAN
- population Description
- Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
- reporting Status
- POSTED
- time Frame
- From the date of randomization up to 104 weeks (study cut-off)
- title
- Time to Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice