TriangleNCT01419197 · OUTCOME
Percentage of Participants With an Objective Response
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
- Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
What was measured
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.
Analysis population: Randomized population: All participants who were randomized to the study. Only participants with measurable disease at Baseline were included in the analysis. Participants were included in the treatment group to which they were randomized.
Groups in this outcome
Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
Treatment of Physician's Choice
Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
| Group | Source count |
|---|---|
| Trastuzumab Emtansine | 345 |
| Treatment of Physician's Choice | 163 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Emtansine | 31.3 | Not reported | 26.5 | 36.5 | Not reported |
| Treatment of Physician's Choice | 8.6 | Not reported | 5.1 | 13.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 16.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 29.2
- group Description
- The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Difference in Response Percentage
- param Value
- 22.7
- statistical Method
- Mantel Haenszel
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 16.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 29.2
- group Description
- The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Difference in Response Percentage
- param Value
- 22.7
- statistical Method
- Mantel Haenszel
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.5
- upper Limit
- 36.5
- value
- 31.3
- group Id
- OG001
- lower Limit
- 5.1
- upper Limit
- 13.8
- value
- 8.6
- denoms
- counts
- group Id
- OG000
- value
- 345
- group Id
- OG001
- value
- 163
- units
- Participants
- description
- An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
- id
- OG000
- title
- Trastuzumab Emtansine
- description
- Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
- id
- OG001
- title
- Treatment of Physician's Choice
- param Type
- NUMBER
- population Description
- Randomized population: All participants who were randomized to the study. Only participants with measurable disease at Baseline were included in the analysis. Participants were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
- title
- Percentage of Participants With an Objective Response
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice