TriangleNCT01419197 · OUTCOME
Duration of the Objective Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- 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
Duration of the objective response was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.
Analysis population: Randomized population: All participants who were randomized to the study. Only participants with an objective response 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 | 108 |
| Treatment of Physician's Choice | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Emtansine | 9.7 | Not reported | 6.60 | 10.51 | Not reported |
| Treatment of Physician's Choice | NA | Not reported | 2.40 | NA | The median and the upper confidence interval value could not be estimated due to too few events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.60
- upper Limit
- 10.51
- value
- 9.7
- comment
- The median and the upper confidence interval value could not be estimated due to too few events.
- group Id
- OG001
- lower Limit
- 2.40
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 108
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Duration of the objective response was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.
- 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
- MEDIAN
- population Description
- Randomized population: All participants who were randomized to the study. Only participants with an objective response 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
- Duration of the Objective Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice