NCT03739684 · OUTCOME

The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (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: bpm
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-DCFPyL.

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

Group	Source count
18F-DCFPyL Injection	208

Reported measurements

Heart Rate: Baseline (actual)

Analysis denominator · Participants

Group	Source count
18F-DCFPyL Injection	207

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
18F-DCFPyL Injection	69.3	12.75	Not reported	Not reported	Not reported

Heart Rate: Post-dosing (actual)

Analysis denominator · Participants

Group	Source count
18F-DCFPyL Injection	202

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
18F-DCFPyL Injection	65.1	12.09	Not reported	Not reported	Not reported

Heart Rate: Change from Baseline

Analysis denominator · Participants

Group	Source count
18F-DCFPyL Injection	202

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
18F-DCFPyL Injection	-4.3	7.93	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
12.75
value
69.3
denoms
counts
group Id
OG000
value
207
units
Participants
title
Heart Rate: Baseline (actual)
categories
measurements
group Id
OG000
spread
12.09
value
65.1
denoms
counts
group Id
OG000
value
202
units
Participants
title
Heart Rate: Post-dosing (actual)
categories
measurements
group Id
OG000
spread
7.93
value
-4.3
denoms
counts
group Id
OG000
value
202
units
Participants
title
Heart Rate: Change from Baseline

denoms

counts
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

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-DCFPyL.

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 Heart Rate (Safety Outcome Measure)

type

SECONDARY

unit Of Measure

bpm

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

Preserved source evidence · Not medical advice