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NCT02918357 · OUTCOME

Safety Assessment - Blood Pressure

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
mmHg
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.

Analysis population: Pressure exerted by a 1 millimeter vertical column of mercury (Hg) at 0 degree Celsius is defined as (mmHg)

Groups in this outcome

Pre-Injection

All patients were assessed for safety measures that included blood pressure before infusion

Post-Injection

All patients were assessed for safety measures that included blood pressure after infusion

Absolute Mean Change

All subjects had the absolute mean in blood pressure 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-Injection385
Post-Injection385
Absolute Mean Change385

Reported measurements

Systolic blood pressure
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pre-Injection137.817.7Not reportedNot reportedNot reported
Post-Injection137.017.4Not reportedNot reportedNot reported
Absolute Mean Change1.018.6Not reportedNot reportedNot reported
Diastolic blood pressure
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pre-Injection80.333.8Not reportedNot reportedNot reported
Post-Injection81.110.6Not reportedNot reportedNot reported
Absolute Mean Change0.634.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.7
        value
        137.8
      2. group Id
        OG001
        spread
        17.4
        value
        137.0
      3. group Id
        OG002
        spread
        18.6
        value
        1.0
    title
    Systolic blood pressure
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.8
        value
        80.3
      2. group Id
        OG001
        spread
        10.6
        value
        81.1
      3. group Id
        OG002
        spread
        34.0
        value
        0.6
    title
    Diastolic blood pressure
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 blood pressure before infusion
    id
    OG000
    title
    Pre-Injection
  2. description
    All patients were assessed for safety measures that included blood pressure after infusion
    id
    OG001
    title
    Post-Injection
  3. description
    All subjects had the absolute mean in blood pressure calculated to assess for safety
    id
    OG002
    title
    Absolute Mean Change
param Type
MEAN
population Description
Pressure exerted by a 1 millimeter vertical column of mercury (Hg) at 0 degree Celsius is defined as (mmHg)
reporting Status
POSTED
time Frame
1 day
title
Safety Assessment - Blood Pressure
type
SECONDARY
unit Of Measure
mmHg

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

Preserved source evidence · Not medical advice