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NCT04186819 · ADVERSE EVENTS

Adverse events

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer. · Source last updated 2025-02-26

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
All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
Other-event reporting threshold
0%

AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Full Safety Population (FSP)

All patients who received the rhPSMA-7.3 (18F) injection. The FSP was used for all safety summaries.

0 / 35628 / 3560 / 356

Group identifiers: EG000: Full Safety Population (FSP)

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
      SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Tracheal deviation
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Aortic aneurysm
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        356
        num Events
        2
      term
      Hypertension
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Thrombophlebitis
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Atrial fibrillation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Dysgeusia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        356
        num Events
        5
      term
      Headache
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Chills
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        356
        num Events
        3
      term
      Injection site pain
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Peripheral swelling
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Diarrhea
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Proctalgia
    Complete source fields
    description
    AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      356
      description
      All patients who received the rhPSMA-7.3 (18F) injection. The FSP was used for all safety summaries.
      id
      EG000
      other Num Affected
      28
      other Num At Risk
      356
      serious Num Affected
      0
      serious Num At Risk
      356
      title
      Full Safety Population (FSP)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Tracheal deviation
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Aortic aneurysm
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        356
        num Events
        2
      term
      Hypertension
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Thrombophlebitis
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Atrial fibrillation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Dysgeusia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        356
        num Events
        5
      term
      Headache
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Chills
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        356
        num Events
        3
      term
      Injection site pain
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Peripheral swelling
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Diarrhea
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA 23
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        356
        num Events
        1
      term
      Proctalgia
    time Frame
    All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.

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

    Preserved source evidence · Not medical advice