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NCT01861717 · ADVERSE EVENTS

Adverse events

A Pilot Study of Pre- and Post-operative Use of Somatuline Depot. · Source last updated 2021-09-30

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
15 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Somatuline Depot SC

Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses

0 / 22 / 20 / 2

Group identifiers: EG000: Somatuline Depot SC

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
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        2
        num Events
        2
      term
      Headache
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      weight loss
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        2
        num Events
        2
      term
      urinary frequency
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      abdominal pain
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Gastrointestinal pain
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      blurred vision
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      nasal congestion
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      ears feel full of water
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Ear and labyrinth disorders - Other, specify
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      pain
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      due to blood loss during surgery
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      anemia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Dysgeusia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      anorexia
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      2
      description
      Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
      id
      EG000
      other Num Affected
      2
      other Num At Risk
      2
      serious Num Affected
      0
      serious Num At Risk
      2
      title
      Somatuline Depot SC
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        2
        num Events
        2
      term
      Headache
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      weight loss
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        2
        num Events
        2
      term
      urinary frequency
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      abdominal pain
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Gastrointestinal pain
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      blurred vision
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      nasal congestion
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      ears feel full of water
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Ear and labyrinth disorders - Other, specify
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      pain
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      due to blood loss during surgery
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      anemia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Dysgeusia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      anorexia
    time Frame
    15 months

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

    Preserved source evidence · Not medical advice