TriangleNCT04186819 · OUTCOME
PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
What was measured
This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology.
Groups in this outcome
Efficacy Analysis Population (EAP)
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
| Group | Source count |
|---|---|
| Efficacy Analysis Population (EAP) | 296 |
Reported measurements
Central Reader 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Analysis Population (EAP) | 48.6 | Not reported | 31.9 | 65.6 | Not reported |
Central Reader 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Analysis Population (EAP) | 54.5 | Not reported | 36.4 | 71.9 | Not reported |
Central Reader 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Analysis Population (EAP) | 65.2 | Not reported | 42.7 | 83.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.9
- upper Limit
- 65.6
- value
- 48.6
- title
- Central Reader 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.4
- upper Limit
- 71.9
- value
- 54.5
- title
- Central Reader 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 42.7
- upper Limit
- 83.6
- value
- 65.2
- title
- Central Reader 3
- denoms
- counts
- group Id
- OG000
- value
- 296
- units
- Participants
- description
- This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
- id
- OG000
- title
- Efficacy Analysis Population (EAP)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
- title
- PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)
- type
- SECONDARY
- unit Of Measure
- percentage
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice