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NCT05152927 · ADVERSE EVENTS

Adverse events

Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy · Source last updated 2025-12-15

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 6 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Parathyroid Eye (PTeye)

For participants assigned to the study arm, the surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.

2 / 380 / 380 / 38
Usual Standard of Care

The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

5 / 410 / 410 / 41

Group identifiers: EG000: Parathyroid Eye (PTeye) · EG001: Usual Standard of Care

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pleural effusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Ovarian cancer
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Syncope
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Myoma
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps), Other - specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Benign hemangioma and benign angiolipoma
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

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
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      38
      description
      For participants assigned to the study arm, the surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      38
      serious Num Affected
      2
      serious Num At Risk
      38
      title
      Parathyroid Eye (PTeye)
    2. deaths Num Affected
      0
      deaths Num At Risk
      41
      description
      The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      41
      serious Num Affected
      5
      serious Num At Risk
      41
      title
      Usual Standard of Care
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        38
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        41
        num Events
        0
      term
      Pleural effusion
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Ovarian cancer
      organ System
      Neoplasms benign, malignant and unspecified (incl cysts and polyps)
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        38
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        41
        num Events
        0
      term
      Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        38
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        41
        num Events
        1
      term
      Fracture
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        38
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        41
        num Events
        1
      term
      Pericardial effusion
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        38
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        41
        num Events
        1
      term
      Syncope
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Myoma
      organ System
      Neoplasms benign, malignant and unspecified (incl cysts and polyps)
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        38
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        41
        num Events
        1
      term
      Neoplasms benign, malignant and unspecified (incl cysts and polyps), Other - specify
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Benign hemangioma and benign angiolipoma
      organ System
      Neoplasms benign, malignant and unspecified (incl cysts and polyps)
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        38
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        41
        num Events
        1
      term
      Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
    time Frame
    Up to 6 months

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

    Preserved source evidence · Not medical advice