TriangleNCT04639219 · OUTCOME
Duration of Response (DoR) 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
- Inter-Quartile Range
- 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, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months)
What was measured
DoR was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression (date of progression-free survival \[PFS\] event or censoring - date of first response + 1). The DoR was calculated using Kaplan-Meier technique.
Analysis population: The FAS consisted of all participants who received at least 1 dose of study treatment. Participants with response were evaluated.
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
DoR by ICR
| Group | Source count |
|---|---|
| T-DXd | 30 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | NA | Not reported | 6.8 | NA | NA indicates that median and upper limit of confidence interval (CI) were not estimable due to insufficient number of participants with events at study closure. |
DoR by Investigator assessment
| Group | Source count |
|---|---|
| T-DXd | 33 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 11.0 | Not reported | 6.9 | 18.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA indicates that median and upper limit of confidence interval (CI) were not estimable due to insufficient number of participants with events at study closure.
- group Id
- OG000
- lower Limit
- 6.8
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- title
- DoR by ICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.9
- upper Limit
- 18.1
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 33
- units
- Participants
- title
- DoR by Investigator assessment
- denoms
- counts
- group Id
- OG000
- value
- 102
- units
- Participants
- description
- DoR was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression (date of progression-free survival \[PFS\] event or censoring - date of first response + 1). The DoR was calculated using Kaplan-Meier technique.
- dispersion Type
- Inter-Quartile Range
- 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. Participants with response were evaluated.
- 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, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months)
- title
- Duration of Response (DoR) 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