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NCT00569309 · ADVERSE EVENTS

Adverse events

Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma · Source last updated 2018-03-12

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Prevnar

The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)

0 / 3030 / 300 / 30

Group identifiers: EG000: Prevnar

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
      notes
      Upper Respiratory Infection
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        23
        num At Risk
        30
        num Events
        23
      term
      Infection with unknown ANC
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Pneumo fever with origin unknown
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        30
        num Events
        3
      term
      Infection with unknown ANC
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        30
        num Events
        3
      term
      Fever with unknown origin
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        30
        num Events
        2
      term
      Colitis
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      30
      description
      The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
      id
      EG000
      other Num Affected
      30
      other Num At Risk
      30
      serious Num Affected
      0
      serious Num At Risk
      30
      title
      Prevnar
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Upper Respiratory Infection
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        23
        num At Risk
        30
        num Events
        23
      term
      Infection with unknown ANC
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Pneumo fever with origin unknown
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        30
        num Events
        3
      term
      Infection with unknown ANC
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        30
        num Events
        3
      term
      Fever with unknown origin
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        30
        num Events
        2
      term
      Colitis

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

    Preserved source evidence · Not medical advice