TriangleNCT03043313 · OUTCOME
Overall Survival (OS) in Pooled Cohorts A+B
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
- Up to 71.8 months
What was measured
OS was defined as the time from start of study treatment (Cohort A) or randomization (Cohort B) to date of death due to any cause.
Analysis population: The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had HER2+ tumors as defined by one or more protocol required local tests. Data for cohort A and B was combined as prespecified in SAP.
Groups in this outcome
Tucatinib+Trastuzumab (Cohorts A+B)
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
| Group | Source count |
|---|---|
| Tucatinib+Trastuzumab (Cohorts A+B) | 84 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib+Trastuzumab (Cohorts A+B) | 23.9 | Not reported | 18.7 | 28.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.7
- upper Limit
- 28.3
- value
- 23.9
- denoms
- counts
- group Id
- OG000
- value
- 84
- units
- Participants
- description
- OS was defined as the time from start of study treatment (Cohort A) or randomization (Cohort B) to date of death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
- id
- OG000
- title
- Tucatinib+Trastuzumab (Cohorts A+B)
- param Type
- MEDIAN
- population Description
- The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had HER2+ tumors as defined by one or more protocol required local tests. Data for cohort A and B was combined as prespecified in SAP.
- reporting Status
- POSTED
- time Frame
- Up to 71.8 months
- title
- Overall Survival (OS) in Pooled Cohorts A+B
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice