TriangleNCT01302834 · OUTCOME
Overall Survival by Ethnicity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
What was measured
NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Analysis population: Eligible participants. Data were stratified by ethnicity.
Groups in this outcome
IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
| Group | Source count |
|---|---|
| IMRT + Cisplatin | 406 |
| IMRT + Cetuximab | 399 |
Reported measurements
Hispanic or Latino
| Group | Source count |
|---|---|
| IMRT + Cisplatin | 11 |
| IMRT + Cetuximab | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMRT + Cisplatin | 100 | Not reported | NA | NA | SAS software does not compute a confidence interval when the estimate is 100%. |
| IMRT + Cetuximab | 70.7 | Not reported | 46.5 | 95.0 | Not reported |
Not Hispanic or Latino
| Group | Source count |
|---|---|
| IMRT + Cisplatin | 383 |
| IMRT + Cetuximab | 369 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMRT + Cisplatin | 84.7 | Not reported | 80.6 | 88.8 | Not reported |
| IMRT + Cetuximab | 77.9 | Not reported | 73.2 | 82.7 | Not reported |
Unknown or Not Reported
| Group | Source count |
|---|---|
| IMRT + Cisplatin | 12 |
| IMRT + Cetuximab | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMRT + Cisplatin | 66.8 | Not reported | 35.1 | 98.6 | Not reported |
| IMRT + Cetuximab | 85.7 | Not reported | 67.4 | 100 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- SAS software does not compute a confidence interval when the estimate is 100%.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 100
- group Id
- OG001
- lower Limit
- 46.5
- upper Limit
- 95.0
- value
- 70.7
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Hispanic or Latino
- categories
- measurements
- group Id
- OG000
- lower Limit
- 80.6
- upper Limit
- 88.8
- value
- 84.7
- group Id
- OG001
- lower Limit
- 73.2
- upper Limit
- 82.7
- value
- 77.9
- denoms
- counts
- group Id
- OG000
- value
- 383
- group Id
- OG001
- value
- 369
- units
- Participants
- title
- Not Hispanic or Latino
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.1
- upper Limit
- 98.6
- value
- 66.8
- group Id
- OG001
- lower Limit
- 67.4
- upper Limit
- 100
- value
- 85.7
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- OG000
- value
- 406
- group Id
- OG001
- value
- 399
- units
- Participants
- description
- NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG000
- title
- IMRT + Cisplatin
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG001
- title
- IMRT + Cetuximab
- param Type
- NUMBER
- population Description
- Eligible participants. Data were stratified by ethnicity.
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
- title
- Overall Survival by Ethnicity
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice