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NCT04241315 · OUTCOME

Clinically Significant Events (CSE)

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting · Source last updated 2023-03-23

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
1 day

What was measured

The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.

Analysis population: Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who: • Were evaluated under both normal light/palpation and NIR fluorescent light imaging

Groups in this outcome

Full Analysis Set (FAS)

The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and 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 Set (FAS)100

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Full Analysis Set (FAS).530Not reported.428.631Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .428
        upper Limit
        .631
        value
        .530
denoms
  1. counts
    1. group Id
      OG000
      value
      100
    units
    Participants
description
The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.
dispersion Type
95% Confidence Interval
groups
  1. description
    The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
    id
    OG000
    title
    Full Analysis Set (FAS)
param Type
NUMBER
population Description
Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who: • Were evaluated under both normal light/palpation and NIR fluorescent light imaging
reporting Status
POSTED
time Frame
1 day
title
Clinically Significant Events (CSE)
type
PRIMARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice