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NCT03739684 · OUTCOME

The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)

Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer · Source last updated 2021-06-14

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

Measure
MEAN
Unit
mmHg
Interval / dispersion
Standard Deviation
Time frame
Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.

What was measured

The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.

Analysis population: The Safety Set includes all participants who received any amount of 18F-DECPyL.

Groups in this outcome

18F-DCFPyL Injection

Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.

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

Analysis denominator · Participants

GroupSource count
18F-DCFPyL Injection208

Reported measurements

Systolic Blood Pressure: Baseline (actual)

Analysis denominator · Participants

GroupSource count
18F-DCFPyL Injection207
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection138.918.61Not reportedNot reportedNot reported
Systolic Blood Pressure: Post-dosing (actual)

Analysis denominator · Participants

GroupSource count
18F-DCFPyL Injection202
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection136.717.15Not reportedNot reportedNot reported
Systolic Blood Pressure: Change from Baseline

Analysis denominator · Participants

GroupSource count
18F-DCFPyL Injection202
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection-2.213.24Not reportedNot reportedNot reported
Diastolic Blood Pressure: Baseline (actual)

Analysis denominator · Participants

GroupSource count
18F-DCFPyL Injection207
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection78.510.18Not reportedNot reportedNot reported
Diastolic Blood Pressure: Post-dosing (actual)

Analysis denominator · Participants

GroupSource count
18F-DCFPyL Injection202
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection77.39.57Not reportedNot reportedNot reported
Diastolic Blood Pressure: Change from Baseline

Analysis denominator · Participants

GroupSource count
18F-DCFPyL Injection202
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection-1.28.20Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.61
        value
        138.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        207
      units
      Participants
    title
    Systolic Blood Pressure: Baseline (actual)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.15
        value
        136.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      units
      Participants
    title
    Systolic Blood Pressure: Post-dosing (actual)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.24
        value
        -2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      units
      Participants
    title
    Systolic Blood Pressure: Change from Baseline
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.18
        value
        78.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        207
      units
      Participants
    title
    Diastolic Blood Pressure: Baseline (actual)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.57
        value
        77.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      units
      Participants
    title
    Diastolic Blood Pressure: Post-dosing (actual)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.20
        value
        -1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      units
      Participants
    title
    Diastolic Blood Pressure: Change from Baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      208
    units
    Participants
description
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
    id
    OG000
    title
    18F-DCFPyL Injection
param Type
MEAN
population Description
The Safety Set includes all participants who received any amount of 18F-DECPyL.
reporting Status
POSTED
time Frame
Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.
title
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
type
SECONDARY
unit Of Measure
mmHg

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Preserved source evidence · Not medical advice