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NCT02566265 · ADVERSE EVENTS

Adverse events

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients · Source last updated 2019-01-30

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
Adverse event data were collected up to 12 months after initial vaccination
Other-event reporting threshold
5%

The definition does not differ.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Fluzone High Dose Vaccine Then Fluzone High Dose Booster

Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine. Fluzone High Dose Vaccine

8 / 810 / 815 / 81
Standard of Care

Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine. Standard of care/Placebo

1 / 410 / 412 / 41

Group identifiers: EG000: Fluzone High Dose Vaccine Then Fluzone High Dose Booster · EG001: 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
    Vascular disorders
    source Vocabulary
    CTEP-AERS
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      81
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Intracranial hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTEP-AERS
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      81
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Small intestinal obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTEP-AERS
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      81
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTEP-AERS
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      81
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTEP-AERS
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      81
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Thromboembolic event
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTEP-AERS
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      81
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pneumonitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTEP-AERS
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      81
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Seizure

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
    description
    The definition does not differ.
    event Groups
    1. deaths Num Affected
      5
      deaths Num At Risk
      81
      description
      Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine. Fluzone High Dose Vaccine
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      81
      serious Num Affected
      8
      serious Num At Risk
      81
      title
      Fluzone High Dose Vaccine Then Fluzone High Dose Booster
    2. deaths Num Affected
      2
      deaths Num At Risk
      41
      description
      Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine. Standard of care/Placebo
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      41
      serious Num Affected
      1
      serious Num At Risk
      41
      title
      Standard of Care
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      CTEP-AERS
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        81
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        41
        num Events
        0
      term
      Intracranial hemorrhage
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTEP-AERS
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        81
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        41
        num Events
        0
      term
      Small intestinal obstruction
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTEP-AERS
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        81
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        41
        num Events
        0
      term
      Febrile neutropenia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTEP-AERS
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        81
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        41
        num Events
        1
      term
      Sepsis
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      CTEP-AERS
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        81
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        41
        num Events
        0
      term
      Thromboembolic event
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTEP-AERS
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        81
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        41
        num Events
        0
      term
      Pneumonitis
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTEP-AERS
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        81
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        41
        num Events
        0
      term
      Seizure
    time Frame
    Adverse event data were collected up to 12 months after initial vaccination

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

    Preserved source evidence · Not medical advice