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NCT04186845 · ADVERSE EVENTS

Adverse events

Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence · Source last updated 2025-09-22

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
AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
Other-event reporting threshold
0%

AEs (treatment emergent) were coded with MedDRA and data listed by patient: 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 listed by patient

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

Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron emission tomography scan: Imaging scan with radioligand

2 / 39128 / 3912 / 391

Group identifiers: EG000: Single Arm

Serious 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
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Sudden death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Pulmonary embolism

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
    Vascular disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      391
      num Events
      7
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Flushing
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      391
      num Events
      2
    term
    Injection site reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Injection site discomfort
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Sinus congestion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Anxiety
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      391
      num Events
      2
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Paraesthesia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Dizziness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Vision blurred
Complete source fields
description
AEs (treatment emergent) were coded with MedDRA and data listed by patient: 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 listed by patient
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    391
    description
    Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron emission tomography scan: Imaging scan with radioligand
    id
    EG000
    other Num Affected
    28
    other Num At Risk
    391
    serious Num Affected
    2
    serious Num At Risk
    391
    title
    Single Arm
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      391
      num Events
      7
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Flushing
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      391
      num Events
      2
    term
    Injection site reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Injection site discomfort
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Sinus congestion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Anxiety
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      391
      num Events
      2
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Paraesthesia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Dizziness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Vision blurred
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Sudden death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      391
      num Events
      1
    term
    Pulmonary embolism
time Frame
AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.

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Preserved source evidence · Not medical advice