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NCT02919111 · ADVERSE EVENTS

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 3 days
Other-event reporting threshold
5%

All grade 3 and above adverse events were reported

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

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Group identifiers: EG000: Ga-68 Labeled PSMA-11 PET

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      All grade 3 and above adverse events were reported
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        299
        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
        EG000
        other Num Affected
        0
        other Num At Risk
        299
        serious Num Affected
        0
        serious Num At Risk
        299
        title
        Ga-68 Labeled PSMA-11 PET
      frequency Threshold
      5
      time Frame
      Up to 3 days

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

      Preserved source evidence · Not medical advice