TriangleNCT03511664 · OUTCOME
Duration of Response (DOR)
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
- From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
What was measured
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as per central review assessment.
Analysis population: PFS Full Analysis Set (PFS-FAS). Only participants for whom BOR was CR or PR and evaluable Duration of Response events (Progression or Death) included in the analysis.
Groups in this outcome
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
| Group | Source count |
|---|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 95 |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 9.8 | Not reported | 9.1 | 11.7 | Not reported |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 10.6 | Not reported | NA | NA | NA: not estimable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.1
- upper Limit
- 11.7
- value
- 9.8
- comment
- NA: not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 10.6
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as per central review assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
- id
- OG000
- title
- Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
- description
- Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
- id
- OG001
- title
- Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
- param Type
- MEDIAN
- population Description
- PFS Full Analysis Set (PFS-FAS). Only participants for whom BOR was CR or PR and evaluable Duration of Response events (Progression or Death) included in the analysis.
- reporting Status
- POSTED
- time Frame
- From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice