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NCT01858740 · ADVERSE EVENTS

Adverse events

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children · 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
AEs and SAEs: Conditioning through D100; All cause mortality: Conditioning through 5 year
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (CD45RA+ T Cell Depleted PBSCT)

Single arm study: CD45RA+ T cell depletion PBSC transplant and Methotrexate and tacrolimus for GVHD prophylaxis (Day -1 to Day 50, then tapered from day 50)

0 / 2020 / 204 / 20

Group identifiers: EG000: Treatment (CD45RA+ T Cell Depleted PBSCT)

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
      Blood and lymphatic system disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Hemolytic uremic syndrome
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Pericardial effusion
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        20
        num Events
        2
      term
      Sinus tachycardia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Abdominal pain
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        20
        num Events
        12
      term
      Diarrhea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Ileus
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        19
        num At Risk
        20
        num Events
        19
      term
      Mucositis oral
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        13
        num At Risk
        20
        num Events
        15
      term
      Nausea
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        20
        num Events
        3
      term
      Vomiting
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Multi-organ failure
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        20
        num Events
        4
      term
      SOS/VOD
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Enterocolitis infectious
    Complete source fields
    event Groups
    1. deaths Num Affected
      4
      deaths Num At Risk
      20
      description
      Single arm study: CD45RA+ T cell depletion PBSC transplant and Methotrexate and tacrolimus for GVHD prophylaxis (Day -1 to Day 50, then tapered from day 50)
      id
      EG000
      other Num Affected
      20
      other Num At Risk
      20
      serious Num Affected
      0
      serious Num At Risk
      20
      title
      Treatment (CD45RA+ T Cell Depleted PBSCT)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Hemolytic uremic syndrome
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Pericardial effusion
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        20
        num Events
        2
      term
      Sinus tachycardia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Abdominal pain
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        20
        num Events
        12
      term
      Diarrhea
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Ileus
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        19
        num At Risk
        20
        num Events
        19
      term
      Mucositis oral
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        13
        num At Risk
        20
        num Events
        15
      term
      Nausea
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        20
        num Events
        3
      term
      Vomiting
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Multi-organ failure
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        20
        num Events
        4
      term
      SOS/VOD
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      NIC CTCAE v.4.03
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Enterocolitis infectious
    time Frame
    AEs and SAEs: Conditioning through D100; All cause mortality: Conditioning through 5 year

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

    Preserved source evidence · Not medical advice