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NCT03734601 · ADVERSE EVENTS

Adverse events

Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation · Source last updated 2023-12-12

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
60 days, except collection of mortality information was open-ended.
Other-event reporting threshold
5%

Per protocol, adverse event collection was limited, as follows. * Non-serious adverse event collection was limited to Grade 1 to 3 events that resulted in participant termination or withdrawal from the study * Serious adverse events, and details of, were only collected for 60 days after the transplant. * Mortality collection was open-ended.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
TBI+TLI

TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days

2 / 220 / 226 / 22

Group identifiers: EG000: TBI+TLI

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Chronic graft vs host disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Sepsis

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
    Per protocol, adverse event collection was limited, as follows. * Non-serious adverse event collection was limited to Grade 1 to 3 events that resulted in participant termination or withdrawal from the study * Serious adverse events, and details of, were only collected for 60 days after the transplant. * Mortality collection was open-ended.
    event Groups
    1. deaths Num Affected
      6
      deaths Num At Risk
      22
      description
      TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      22
      serious Num Affected
      2
      serious Num At Risk
      22
      title
      TBI+TLI
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        22
        num Events
        1
      term
      Febrile neutropenia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        22
        num Events
        1
      term
      Chronic graft vs host disease
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        22
        num Events
        1
      term
      Sepsis
    time Frame
    60 days, except collection of mortality information was open-ended.

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

    Preserved source evidence · Not medical advice