TriangleNCT04639219 · OUTCOME
PFS as Per RECIST v1.1 Using ICR and Investigator Assessment
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
- Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months)
What was measured
PFS was defined as the time from first dose of study treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from assigned therapy or received another anti-cancer therapy prior to progression (i.e. date of PFS event or censoring - date of first dose + 1). PFS was calculated using the Kaplan-Meier technique. CI for median PFS derived based on the Brookmeyer-Crowley method.
Analysis population: The FAS consisted of all participants who received at least 1 dose of study treatment.
Groups in this outcome
T-DXd
Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
| Group | Source count |
|---|---|
| T-DXd | 102 |
Reported measurements
PFS by ICR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 5.4 | Not reported | 2.7 | 7.1 | Not reported |
PFS by Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 4.4 | Not reported | 2.8 | 5.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.7
- upper Limit
- 7.1
- value
- 5.4
- title
- PFS by ICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 5.6
- value
- 4.4
- title
- PFS by Investigator assessment
- denoms
- counts
- group Id
- OG000
- value
- 102
- units
- Participants
- description
- PFS was defined as the time from first dose of study treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from assigned therapy or received another anti-cancer therapy prior to progression (i.e. date of PFS event or censoring - date of first dose + 1). PFS was calculated using the Kaplan-Meier technique. CI for median PFS derived based on the Brookmeyer-Crowley method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
- id
- OG000
- title
- T-DXd
- param Type
- MEDIAN
- population Description
- The FAS consisted of all participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months)
- title
- PFS as Per RECIST v1.1 Using ICR and Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice