TriangleNCT01808573 · OUTCOME
Centrally Assessed Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.
What was measured
Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.
Analysis population: Randomized ITT Population
Groups in this outcome
Neratinib Plus Capecitabine
neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
Lapatinib Plus Capecitabine
lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
| Group | Source count |
|---|---|
| Neratinib Plus Capecitabine | 307 |
| Lapatinib Plus Capecitabine | 314 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Neratinib Plus Capecitabine | 8.8 | Not reported | 7.8 | 9.8 | Not reported |
| Lapatinib Plus Capecitabine | 6.6 | Not reported | 5.9 | 7.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.626
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.926
- estimate Comment
- Lapatinib Plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0059
- param Type
- Hazard Ratio (HR)
- param Value
- 0.762
- statistical Comment
- Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.626
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.926
- estimate Comment
- Lapatinib Plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0059
- param Type
- Hazard Ratio (HR)
- param Value
- 0.762
- statistical Comment
- Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.8
- upper Limit
- 9.8
- value
- 8.8
- group Id
- OG001
- lower Limit
- 5.9
- upper Limit
- 7.4
- value
- 6.6
- denoms
- counts
- group Id
- OG000
- value
- 307
- group Id
- OG001
- value
- 314
- units
- Participants
- description
- Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
- id
- OG000
- title
- Neratinib Plus Capecitabine
- description
- lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
- id
- OG001
- title
- Lapatinib Plus Capecitabine
- param Type
- MEAN
- population Description
- Randomized ITT Population
- reporting Status
- POSTED
- time Frame
- From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.
- title
- Centrally Assessed Progression Free Survival
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice