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NCT04186819 · OUTCOME

Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer. · Source last updated 2025-02-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage
Interval / dispersion
Not reported
Time frame
PET/CT scans on Day 1

What was measured

Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements)

Analysis population: All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan

Groups in this outcome

Extended Efficacy Population (EEP)

All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Extended Efficacy Population (EEP)352

Reported measurements

Agreement between reader 1 and reader 2
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)97.7Not reportedNot reportedNot reportedNot reported
Agreement between Reader 1 and Reader 3
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)95.2Not reportedNot reportedNot reportedNot reported
Agreement between Reader 2 and Reader 3
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)96.9Not reportedNot reportedNot reportedNot reported
Agreement between initial read and re-read in Reader 1
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)100Not reportedNot reportedNot reportedNot reported
Agreement between initial read and re-read in Reader 2
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)100Not reportedNot reportedNot reportedNot reported
Agreement between initial read and re-read in Reader 3
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)95.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        97.7
    title
    Agreement between reader 1 and reader 2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        95.2
    title
    Agreement between Reader 1 and Reader 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        96.9
    title
    Agreement between Reader 2 and Reader 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    title
    Agreement between initial read and re-read in Reader 1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    title
    Agreement between initial read and re-read in Reader 2
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        95.7
    title
    Agreement between initial read and re-read in Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      352
    units
    Participants
description
Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements)
groups
  1. description
    All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan
    id
    OG000
    title
    Extended Efficacy Population (EEP)
param Type
NUMBER
population Description
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan
reporting Status
POSTED
time Frame
PET/CT scans on Day 1
title
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
type
SECONDARY
unit Of Measure
percentage

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice