TriangleNCT00829166 · OUTCOME
Percentage of Participants Who Were Alive at Year 1
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
- Year 1
What was measured
1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.
Analysis population: ITT population included all randomized participants on the basis of the treatment assigned at randomization.
Groups in this outcome
Trastuzumab Emtansine
Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
Lapatinib + Capecitabine
Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
| Group | Source count |
|---|---|
| Trastuzumab Emtansine | 495 |
| Lapatinib + Capecitabine | 496 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Emtansine | 85.3 | Not reported | 82.15 | 88.54 | Not reported |
| Lapatinib + Capecitabine | 78.9 | Not reported | 75.19 | 82.65 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.15
- upper Limit
- 88.54
- value
- 85.3
- group Id
- OG001
- lower Limit
- 75.19
- upper Limit
- 82.65
- value
- 78.9
- denoms
- counts
- group Id
- OG000
- value
- 495
- group Id
- OG001
- value
- 496
- units
- Participants
- description
- 1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
- id
- OG000
- title
- Trastuzumab Emtansine
- description
- Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
- id
- OG001
- title
- Lapatinib + Capecitabine
- param Type
- NUMBER
- population Description
- ITT population included all randomized participants on the basis of the treatment assigned at randomization.
- reporting Status
- POSTED
- time Frame
- Year 1
- title
- Percentage of Participants Who Were Alive at Year 1
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice