TriangleNCT04639219 · OUTCOME
Percentage of Participants Alive and Progression-Free at 6 and 12 Months 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At Months 6 and 12
What was measured
Percentage of participants alive and progression-free at 6 and 12 months are reported. It 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 rate at 6 months by ICR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 41.4 | Not reported | 30.8 | 51.6 | Not reported |
PFS rate at 6 months by Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 37.7 | Not reported | 28.1 | 47.2 | Not reported |
PFS rate at 12 months by ICR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 30.9 | Not reported | 20.6 | 41.8 | Not reported |
PFS rate at 12 months by Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 26.5 | Not reported | 17.2 | 36.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.8
- upper Limit
- 51.6
- value
- 41.4
- title
- PFS rate at 6 months by ICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.1
- upper Limit
- 47.2
- value
- 37.7
- title
- PFS rate at 6 months by Investigator assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.6
- upper Limit
- 41.8
- value
- 30.9
- title
- PFS rate at 12 months by ICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.2
- upper Limit
- 36.7
- value
- 26.5
- title
- PFS rate at 12 months by Investigator assessment
- denoms
- counts
- group Id
- OG000
- value
- 102
- units
- Participants
- description
- Percentage of participants alive and progression-free at 6 and 12 months are reported. It 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
- NUMBER
- population Description
- The FAS consisted of all participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- At Months 6 and 12
- title
- Percentage of Participants Alive and Progression-Free at 6 and 12 Months as Per RECIST v1.1 Using ICR and Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice