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NCT02700841 · ADVERSE EVENTS

Adverse events

Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation · Source last updated 2024-03-12

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
Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Vaccine, CD34 Transplant, DLI)

ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant. Melphalan: Given IV Peripheral Blood Stem Cell Transplantation--CD34 HSCT: Undergo autologous CD34 HSCT Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo autologous CD34 HSCT Tetanus Toxoid Vaccine: Given IM

0 / 44 / 40 / 4
Arm II (Vaccine, Stem Cell Transplant)

Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0. Melphalan: Given IV Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT Tetanus Toxoid Vaccine: Given IM

0 / 44 / 40 / 4

Group identifiers: EG000: Arm I (Vaccine, CD34 Transplant, DLI) · EG001: Arm II (Vaccine, Stem Cell Transplant)

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
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        4
        num Events
        12
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        4
        num Events
        12
      term
      white blood cell decreased
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        4
        num Events
        6
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
        num Events
        8
      term
      Lymphocyte Count Decreased
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
        num Events
        2
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
        num Events
        5
      term
      Neutrophil Count Decreased
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        4
        num Events
        11
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        4
        num Events
        5
      term
      Platelet Count Decreased
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      term
      Typhlitis
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      term
      Diarrhea
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      term
      Anemia
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      4
      description
      ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant. Melphalan: Given IV Peripheral Blood Stem Cell Transplantation--CD34 HSCT: Undergo autologous CD34 HSCT Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo autologous CD34 HSCT Tetanus Toxoid Vaccine: Given IM
      id
      EG000
      other Num Affected
      4
      other Num At Risk
      4
      serious Num Affected
      0
      serious Num At Risk
      4
      title
      Arm I (Vaccine, CD34 Transplant, DLI)
    2. deaths Num Affected
      0
      deaths Num At Risk
      4
      description
      Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0. Melphalan: Given IV Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT Tetanus Toxoid Vaccine: Given IM
      id
      EG001
      other Num Affected
      4
      other Num At Risk
      4
      serious Num Affected
      0
      serious Num At Risk
      4
      title
      Arm II (Vaccine, Stem Cell Transplant)
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        4
        num Events
        12
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        4
        num Events
        12
      term
      white blood cell decreased
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        4
        num Events
        6
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
        num Events
        8
      term
      Lymphocyte Count Decreased
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
        num Events
        2
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
        num Events
        5
      term
      Neutrophil Count Decreased
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        4
        num Events
        11
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        4
        num Events
        5
      term
      Platelet Count Decreased
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      term
      Typhlitis
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      term
      Diarrhea
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      term
      Anemia
    time Frame
    Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.

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

    Preserved source evidence · Not medical advice