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NCT03180307 · OUTCOME

Efficacy Patient Level

OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer · Source last updated 2022-02-04

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
30 days

What was measured

Percentage of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation (Full Analysis Set)

Groups in this outcome

Full Analysis Set

Patients exposed to OTL38 and who were randomly assigned to undergo NIR fluorescent imaging (OTL38+imaging) and who: * Were evaluated under both normal light and NIR fluorescent light imaging * Had central pathology and histology confirmation for at least one FR+ ovarian cancer lesion detected under normal light or NIR fluorescent light imaging

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

Analysis denominator · Participants

GroupSource count
Full Analysis Set134

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Full Analysis Set26.9Not reported19.635.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.6
        upper Limit
        35.2
        value
        26.9
denoms
  1. counts
    1. group Id
      OG000
      value
      134
    units
    Participants
description
Percentage of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation (Full Analysis Set)
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients exposed to OTL38 and who were randomly assigned to undergo NIR fluorescent imaging (OTL38+imaging) and who: * Were evaluated under both normal light and NIR fluorescent light imaging * Had central pathology and histology confirmation for at least one FR+ ovarian cancer lesion detected under normal light or NIR fluorescent light imaging
    id
    OG000
    title
    Full Analysis Set
param Type
NUMBER
reporting Status
POSTED
time Frame
30 days
title
Efficacy Patient Level
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice