NCT01196390 · OUTCOME
Overall Survival
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 randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
What was measured
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.
Analysis population: Eligible randomized participants
Groups in this outcome
Chemoradiation and Trastuzumab
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
Chemoradiation
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
| Group | Source count |
|---|---|
| Chemoradiation and Trastuzumab | 98 |
| Chemoradiation | 96 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiation and Trastuzumab | 38.5 | Not reported | 26.2 | 70.4 | Not reported |
| Chemoradiation | 38.9 | Not reported | 29.0 | 64.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.69
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.47
- estimate Comment
- Reference level = Chemoradiation arm
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.95
- param Type
- Hazard Ratio (HR)
- param Value
- 1.01
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.69
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.47
- estimate Comment
- Reference level = Chemoradiation arm
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.95
- param Type
- Hazard Ratio (HR)
- param Value
- 1.01
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.2
- upper Limit
- 70.4
- value
- 38.5
- group Id
- OG001
- lower Limit
- 29.0
- upper Limit
- 64.5
- value
- 38.9
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- id
- OG000
- title
- Chemoradiation and Trastuzumab
- description
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- id
- OG001
- title
- Chemoradiation
- param Type
- MEDIAN
- population Description
- Eligible randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle