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NCT03771157 · ADVERSE EVENTS

Adverse events

Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors · Source last updated 2024-03-15

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
Adverse events were collected from day one to four weeks after the second vaccine administration, up to approximately 3 months.
Other-event reporting threshold
0%

Only adverse events grade 3 and greater will be collected. Adverse events were obtained through medical chart review and self-reporting by participants.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Shingrix Vaccine

On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose. Antibody and cellular response to vaccination will be assessed at 4 weeks and 24 months after the second dose.

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Group identifiers: EG000: Shingrix Vaccine

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Atrial fibrillation

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
    Only adverse events grade 3 and greater will be collected. Adverse events were obtained through medical chart review and self-reporting by participants.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      32
      description
      On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose. Antibody and cellular response to vaccination will be assessed at 4 weeks and 24 months after the second dose.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      32
      serious Num Affected
      1
      serious Num At Risk
      32
      title
      Shingrix Vaccine
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      term
      Atrial fibrillation
    time Frame
    Adverse events were collected from day one to four weeks after the second vaccine administration, up to approximately 3 months.

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

    Preserved source evidence · Not medical advice