TriangleNCT02614794 · OUTCOME
Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR
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
- 34.6 months
What was measured
Defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR).
Analysis population: ITT - PFS population, subset of participants with measurable disease by BICR at baseline. The ITT-PFS Population includes the first 480 randomized participants in the ITT analysis population (evaluated by their randomized treatment assignment).
Groups in this outcome
Tuc+Cap+Tra
Tucatinib in combination with capecitabine \& trastuzumab
Pbo+Cap+Tra
Placebo in combination with capecitabine \& trastuzumab
| Group | Source count |
|---|---|
| Tuc+Cap+Tra | 273 |
| Pbo+Cap+Tra | 137 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tuc+Cap+Tra | 40.7 | Not reported | 34.8 | 46.7 | Not reported |
| Pbo+Cap+Tra | 23.4 | Not reported | 16.6 | 31.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.8
- upper Limit
- 46.7
- value
- 40.7
- group Id
- OG001
- lower Limit
- 16.6
- upper Limit
- 31.3
- value
- 23.4
- denoms
- counts
- group Id
- OG000
- value
- 273
- group Id
- OG001
- value
- 137
- units
- Participants
- description
- Defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Tucatinib in combination with capecitabine \& trastuzumab
- id
- OG000
- title
- Tuc+Cap+Tra
- description
- Placebo in combination with capecitabine \& trastuzumab
- id
- OG001
- title
- Pbo+Cap+Tra
- param Type
- NUMBER
- population Description
- ITT - PFS population, subset of participants with measurable disease by BICR at baseline. The ITT-PFS Population includes the first 480 randomized participants in the ITT analysis population (evaluated by their randomized treatment assignment).
- reporting Status
- POSTED
- time Frame
- 34.6 months
- title
- Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice