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NCT03739684 · OUTCOME

Collection of Concomitant Medications (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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.

What was measured

Medications will be coded using the WHO drug dictionary. The medications are summarized by ATC level 4 category and presented as number and percentage of participants. Results are presented where the percentage of participants within an ATC level 4 category is \>5.0.

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

GroupSource count
18F-DCFPyL Injection208

Reported measurements

HMG COA REDUCTASE INHIBITORS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection103Not reportedNot reportedNot reportedNot reported
PLATELET AGGREGATION INHIBITORS (EXCLUDING HEPARIN)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection63Not reportedNot reportedNot reportedNot reported
ACE INHIBITORS, PLAIN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection36Not reportedNot reportedNot reportedNot reported
VITAMIN D AND ANALOGUES
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection32Not reportedNot reportedNot reportedNot reported
ANGIOTENSIN II ANTAGONISTS, PLAIN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection31Not reportedNot reportedNot reportedNot reported
BETA BLOCKING AGENTS, SELECTIVE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection31Not reportedNot reportedNot reportedNot reported
DIHYDROPYRIDINE DERIVATIVES
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection31Not reportedNot reportedNot reportedNot reported
PROTEIN PUMP INHIBITORS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection29Not reportedNot reportedNot reportedNot reported
DRUGS USED IN ERECTILE DYSFUNCTION
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection23Not reportedNot reportedNot reportedNot reported
MULTIVITAMINS, PLAIN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection18Not reportedNot reportedNot reportedNot reported
BIGUANIDES
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection17Not reportedNot reportedNot reportedNot reported
THIAZIDES, PLAIN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection16Not reportedNot reportedNot reportedNot reported
OTHER ANTIDEPRESSANTS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection15Not reportedNot reportedNot reportedNot reported
ALPHA-ADRENORECEPTOR ANTAGONISTS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection12Not reportedNot reportedNot reportedNot reported
PROPIONIC ACID DERIVATIVES
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection12Not reportedNot reportedNot reportedNot reported
THYROID HORMONES
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection11Not reportedNot reportedNot reportedNot reported
UNSPECIFIED HERBAL AND TRADITIONAL MEDICINE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        103
    title
    HMG COA REDUCTASE INHIBITORS
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        63
    title
    PLATELET AGGREGATION INHIBITORS (EXCLUDING HEPARIN)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        36
    title
    ACE INHIBITORS, PLAIN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        32
    title
    VITAMIN D AND ANALOGUES
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    title
    ANGIOTENSIN II ANTAGONISTS, PLAIN
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    title
    BETA BLOCKING AGENTS, SELECTIVE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    title
    DIHYDROPYRIDINE DERIVATIVES
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    PROTEIN PUMP INHIBITORS
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    DRUGS USED IN ERECTILE DYSFUNCTION
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    MULTIVITAMINS, PLAIN
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    BIGUANIDES
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    THIAZIDES, PLAIN
denoms
  1. counts
    1. group Id
      OG000
      value
      208
    units
    Participants
description
Medications will be coded using the WHO drug dictionary. The medications are summarized by ATC level 4 category and presented as number and percentage of participants. Results are presented where the percentage of participants within an ATC level 4 category is \>5.0.
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
COUNT_OF_PARTICIPANTS
population Description
The Safety Set includes all participants who received any amount of 18F-DCFPyL.
reporting Status
POSTED
time Frame
From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
title
Collection of Concomitant Medications (Safety Outcome Measure)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice