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NCT03300843 · ADVERSE EVENTS

Adverse events

Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer · Source last updated 2019-12-13

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
Date treatment consent signed to date off study, approximately 6 months and 11 days.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Peptide Loaded Dendritic Cell Vaccine

Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.

0 / 11 / 10 / 1

Group identifiers: EG000: Peptide Loaded Dendritic Cell Vaccine

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
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        4
      term
      Nausea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Fatigue
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        6
      term
      Injection site reaction
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        7
      term
      Headache
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Skin induration
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Peptide Loaded Dendritic Cell Vaccine
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        4
      term
      Nausea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Fatigue
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        6
      term
      Injection site reaction
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        7
      term
      Headache
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Skin induration
    time Frame
    Date treatment consent signed to date off study, approximately 6 months and 11 days.

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

    Preserved source evidence · Not medical advice