NCT01642004 · OUTCOME
Overall Survival (OS) Rate in All Randomized Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent probability of OS
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Randomization to 18 months post-randomization, up to June 2015
What was measured
The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
| Group | Source count |
|---|---|
| Nivolumab | 135 |
| Docetaxel | 137 |
Reported measurements
6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 63.7 | Not reported | 55.0 | 71.2 | Not reported |
| Docetaxel | 50.7 | Not reported | 42.1 | 58.8 | Not reported |
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 42.2 | Not reported | 33.8 | 50.4 | Not reported |
| Docetaxel | 24.3 | Not reported | 17.4 | 31.7 | Not reported |
18 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 28.1 | Not reported | 20.8 | 35.8 | Not reported |
| Docetaxel | 12.5 | Not reported | 7.6 | 18.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 55.0
- upper Limit
- 71.2
- value
- 63.7
- group Id
- OG001
- lower Limit
- 42.1
- upper Limit
- 58.8
- value
- 50.7
- title
- 6 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.8
- upper Limit
- 50.4
- value
- 42.2
- group Id
- OG001
- lower Limit
- 17.4
- upper Limit
- 31.7
- value
- 24.3
- title
- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.8
- upper Limit
- 35.8
- value
- 28.1
- group Id
- OG001
- lower Limit
- 7.6
- upper Limit
- 18.7
- value
- 12.5
- title
- 18 months
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 137
- units
- Participants
- description
- The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
- id
- OG001
- title
- Docetaxel
- param Type
- NUMBER
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- Randomization to 18 months post-randomization, up to June 2015
- title
- Overall Survival (OS) Rate in All Randomized Participants
- type
- PRIMARY
- unit Of Measure
- Percent probability of OS
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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