TriangleNCT03248492 · OUTCOME
Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
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
- at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
What was measured
The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.
Analysis population: Progression-free survival was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Groups in this outcome
Part 1: DS-8201a Medium Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
Part 1: DS-8201a High Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
Part 1 + Part 2a: DS-8201a Low Dose
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
| Group | Source count |
|---|---|
| Part 1: DS-8201a Medium Dose | 48 |
| Part 1: DS-8201a High Dose | 21 |
| Part 1 + Part 2a: DS-8201a Low Dose | 180 |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 184 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: DS-8201a Medium Dose | NA | Not reported | NA | NA | Lack of a median value is due to less than 50% of the participants experiencing the event. |
| Part 1: DS-8201a High Dose | 9.5 | Not reported | 7.4 | 13.2 | Not reported |
| Part 1 + Part 2a: DS-8201a Low Dose | NA | Not reported | 10.6 | NA | There were not enough events to estimate a standard error for the median survival time. |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | NA | Not reported | 10.6 | NA | There were not enough events to estimate a standard error for the median survival time. |
Complete source fields
- classes
- categories
- measurements
- comment
- Lack of a median value is due to less than 50% of the participants experiencing the event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 7.4
- upper Limit
- 13.2
- value
- 9.5
- comment
- There were not enough events to estimate a standard error for the median survival time.
- group Id
- OG002
- lower Limit
- 10.6
- upper Limit
- NA
- value
- NA
- comment
- There were not enough events to estimate a standard error for the median survival time.
- group Id
- OG003
- lower Limit
- 10.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 180
- group Id
- OG003
- value
- 184
- units
- Participants
- description
- The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
- id
- OG000
- title
- Part 1: DS-8201a Medium Dose
- description
- T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
- id
- OG001
- title
- Part 1: DS-8201a High Dose
- description
- All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
- id
- OG002
- title
- Part 1 + Part 2a: DS-8201a Low Dose
- description
- All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
- id
- OG003
- title
- Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
- param Type
- MEDIAN
- population Description
- Progression-free survival was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
- reporting Status
- POSTED
- time Frame
- at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
- title
- Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice