TriangleNCT03511664 · OUTCOME
Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percentage change
- Interval / dispersion
- Standard Deviation
- Time frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
What was measured
Best percentage change from baseline in alkaline phosphatase (ALP) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled).
Analysis population: PFS Full Analysis Set (PFS-FAS). Only participants with evaluable post-baseline and baseline samples 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) | 372 |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 172 |
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) | -14.4 | 46.3 | Not reported | Not reported | Not reported |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 0.6 | 33.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 46.3
- value
- -14.4
- group Id
- OG001
- spread
- 33.8
- value
- 0.6
- denoms
- counts
- group Id
- OG000
- value
- 372
- group Id
- OG001
- value
- 172
- units
- Participants
- description
- Best percentage change from baseline in alkaline phosphatase (ALP) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled).
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- PFS Full Analysis Set (PFS-FAS). Only participants with evaluable post-baseline and baseline samples were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- title
- Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level
- type
- SECONDARY
- unit Of Measure
- Percentage change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice