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NCT05968846 · ADVERSE EVENTS

Adverse events

Repeat PET/CT Imaging of Patients With Amyloid 124I-AT-01 to Measure Changes in Organ-specific Amyloid Load · Source last updated 2026-09-02

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
From enrollment to the end of the study is 8 days
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Participants

Experimental: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys.

0 / 191 / 190 / 19

Group identifiers: EG000: All Participants

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.

    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Severity Mild - Only one treatment-emergent adverse event was reported, worsening of arthralgia, and was ascribed to the Musculoskeletal and connective tissue disorders.
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        19
      term
      Arthralgia
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      19
      description
      Experimental: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      19
      serious Num Affected
      0
      serious Num At Risk
      19
      title
      All Participants
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Severity Mild - Only one treatment-emergent adverse event was reported, worsening of arthralgia, and was ascribed to the Musculoskeletal and connective tissue disorders.
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        19
      term
      Arthralgia
    time Frame
    From enrollment to the end of the study is 8 days

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Independent clinical review pending · Not medical advice