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NCT02919111 · OUTCOME

Number of Participants With Grade 3 Treatment-related Adverse Events

Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients · Source last updated 2020-12-10

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
Up to 3 days

What was measured

All grade 3 and above adverse events were recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The Investigator assigns grade, attribution of the possible association of the event with use of the investigational drug. The safety parameters include spontaneous reports of adverse events reported to the investigator by patients

Groups in this outcome

Ga-68 Labeled PSMA-11 PET

PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

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

Analysis denominator · Participants

GroupSource count
Ga-68 Labeled PSMA-11 PET299

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ga-68 Labeled PSMA-11 PET0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      299
    units
    Participants
description
All grade 3 and above adverse events were recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The Investigator assigns grade, attribution of the possible association of the event with use of the investigational drug. The safety parameters include spontaneous reports of adverse events reported to the investigator by patients
groups
  1. description
    PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
    id
    OG000
    title
    Ga-68 Labeled PSMA-11 PET
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 3 days
title
Number of Participants With Grade 3 Treatment-related Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice