TriangleNCT03511664 · OUTCOME
Time to Worsening in BPI-SF Worst Pain Intensity Scale (Time to Disease Related Pain)
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 date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
What was measured
Time to worsening in BPI-SF worst pain intensity scale (time to disease related pain) was defined as the time from randomization to the first occurring of worsening exceeding the threshold threshold (\>=30% of baseline or \>=2 point increase) at any time up through EOT visit compared to baseline, clinical disease progression, or death.
Analysis population: PFS-Full analysis set. Only participants with evaluable events were 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) | 332 |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 169 |
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) | 5.0 | Not reported | 4.2 | 5.9 | Not reported |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 2.0 | Not reported | 1.7 | 2.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 5.9
- value
- 5.0
- group Id
- OG001
- lower Limit
- 1.7
- upper Limit
- 2.2
- value
- 2.0
- denoms
- counts
- group Id
- OG000
- value
- 332
- group Id
- OG001
- value
- 169
- units
- Participants
- description
- Time to worsening in BPI-SF worst pain intensity scale (time to disease related pain) was defined as the time from randomization to the first occurring of worsening exceeding the threshold threshold (\>=30% of baseline or \>=2 point increase) at any time up through EOT visit compared to baseline, clinical disease progression, or death.
- 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. Only participants with evaluable events were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- title
- Time to Worsening in BPI-SF Worst Pain Intensity Scale (Time to Disease Related Pain)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice