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NCT02918357 · OUTCOME

Safety Assessment - Heart Rate

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence · Source last updated 2019-12-02

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

Measure
MEAN
Unit
beats per minute
Interval / dispersion
Standard Deviation
Time frame
1 day

What was measured

Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.

Groups in this outcome

Pre-Infusion Heart Rate

All patients were assessed for safety measures that included Heart Rate before infusion

Post-Infusion Heart Rate

All patients were assessed for safety measures that included Heart Rate after infusion

Absolute Change in Heart Rate

All subjects had the absolute mean in heart rate calculated to assess for safety

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

Analysis denominator · Participants

GroupSource count
Pre-Infusion Heart Rate385
Post-Infusion Heart Rate385
Absolute Change in Heart Rate385

Reported measurements

Source class 1
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pre-Infusion Heart Rate67.813.3Not reportedNot reportedNot reported
Post-Infusion Heart Rate66.913.6Not reportedNot reportedNot reported
Absolute Change in Heart Rate0.911.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.3
        value
        67.8
      2. group Id
        OG001
        spread
        13.6
        value
        66.9
      3. group Id
        OG002
        spread
        11.2
        value
        0.9
denoms
  1. counts
    1. group Id
      OG000
      value
      385
    2. group Id
      OG001
      value
      385
    3. group Id
      OG002
      value
      385
    units
    Participants
description
Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
dispersion Type
Standard Deviation
groups
  1. description
    All patients were assessed for safety measures that included Heart Rate before infusion
    id
    OG000
    title
    Pre-Infusion Heart Rate
  2. description
    All patients were assessed for safety measures that included Heart Rate after infusion
    id
    OG001
    title
    Post-Infusion Heart Rate
  3. description
    All subjects had the absolute mean in heart rate calculated to assess for safety
    id
    OG002
    title
    Absolute Change in Heart Rate
param Type
MEAN
reporting Status
POSTED
time Frame
1 day
title
Safety Assessment - Heart Rate
type
SECONDARY
unit Of Measure
beats per minute

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

Preserved source evidence · Not medical advice