TriangleNCT00304070 · OUTCOME
Five Year Event-free Survival (EFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Estimated probability five year EFS
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to five years after enrollment
What was measured
The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.
Groups in this outcome
Stratum 1
Stage I Disease (surgery, observation)
Stratum 2
Stage II Disease (surgery, observation)
Stratum 3
Stage III OR IV Disease (chemotherapy)
| Group | Source count |
|---|---|
| Stratum 1 | 24 |
| Stratum 2 | 15 |
| Stratum 3 | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 | 0.86 | Not reported | 0.62 | 0.95 | Not reported |
| Stratum 2 | 0.53 | Not reported | 0.26 | 0.74 | Not reported |
| Stratum 3 | 0.51 | Not reported | 0.33 | 0.66 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.44
- param Type
- 2 Year EFS
- param Value
- 0.89
- statistical Method
- 2-year KM estimate
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.
- group Ids
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.40
- param Type
- 2 Year EFS
- param Value
- 0.53
- statistical Method
- 2-year KM estimate
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.
- group Ids
- OG002
- non Inferiority Type
- OTHER
- p Value
- 0.00000853
- param Type
- 2 Year EFS
- param Value
- 0.55
- statistical Method
- 2-year KM estimate
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.44
- param Type
- 2 Year EFS
- param Value
- 0.89
- statistical Method
- 2-year KM estimate
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.
- group Ids
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.40
- param Type
- 2 Year EFS
- param Value
- 0.53
- statistical Method
- 2-year KM estimate
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.
- group Ids
- OG002
- non Inferiority Type
- OTHER
- p Value
- 0.00000853
- param Type
- 2 Year EFS
- param Value
- 0.55
- statistical Method
- 2-year KM estimate
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.62
- upper Limit
- 0.95
- value
- 0.86
- group Id
- OG001
- lower Limit
- 0.26
- upper Limit
- 0.74
- value
- 0.53
- group Id
- OG002
- lower Limit
- 0.33
- upper Limit
- 0.66
- value
- 0.51
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 39
- units
- Participants
- description
- The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Stage I Disease (surgery, observation)
- id
- OG000
- title
- Stratum 1
- description
- Stage II Disease (surgery, observation)
- id
- OG001
- title
- Stratum 2
- description
- Stage III OR IV Disease (chemotherapy)
- id
- OG002
- title
- Stratum 3
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to five years after enrollment
- title
- Five Year Event-free Survival (EFS)
- type
- PRIMARY
- unit Of Measure
- Estimated probability five year EFS
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Preserved source evidence · Not medical advice