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NCT00536601 · ADVERSE EVENTS

Adverse events

High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors · Source last updated 2021-04-22

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
SAE= 100 days after transplantation All cause mortality = 12 years
Other-event reporting threshold
0%

SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Acute Leukemia

Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia

1 / 60 / 64 / 6
Hodgkin Lymphoma

Patients diagnosed with and treated for Hodgkin Lymphoma

9 / 210 / 218 / 21
Non-Hodgkin Lymphoma

Patients diagnosed with and treated for Non-Hodgkin Lymphoma

19 / 710 / 7141 / 71
MM/Amyloid

Patients diagnosed with or treated for multiple myeloma or amyloidosis

31 / 650 / 6545 / 65
Solid Tumors

Patients diagnosed with and treated for a solid tumor

3 / 110 / 116 / 11

Group identifiers: EG000: Acute Leukemia · EG001: Hodgkin Lymphoma · EG002: Non-Hodgkin Lymphoma · EG003: MM/Amyloid · EG004: Solid Tumors

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
    notes
    Any organ system (cardiac, renal, pulmonary, lower GI, CNS, hepatic, stomatitis, bladder)
    organ System
    General disorders
    source Vocabulary
    Bearman Criteria
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      21
      num Events
      9
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      71
      num Events
      19
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      65
      num Events
      31
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      11
      num Events
      3
    term
    Regimen Related Toxicity

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
    SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
    event Groups
    1. deaths Num Affected
      4
      deaths Num At Risk
      6
      description
      Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      6
      serious Num Affected
      1
      serious Num At Risk
      6
      title
      Acute Leukemia
    2. deaths Num Affected
      8
      deaths Num At Risk
      21
      description
      Patients diagnosed with and treated for Hodgkin Lymphoma
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      21
      serious Num Affected
      9
      serious Num At Risk
      21
      title
      Hodgkin Lymphoma
    3. deaths Num Affected
      41
      deaths Num At Risk
      71
      description
      Patients diagnosed with and treated for Non-Hodgkin Lymphoma
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      71
      serious Num Affected
      19
      serious Num At Risk
      71
      title
      Non-Hodgkin Lymphoma
    4. deaths Num Affected
      45
      deaths Num At Risk
      65
      description
      Patients diagnosed with or treated for multiple myeloma or amyloidosis
      id
      EG003
      other Num Affected
      0
      other Num At Risk
      65
      serious Num Affected
      31
      serious Num At Risk
      65
      title
      MM/Amyloid
    5. deaths Num Affected
      6
      deaths Num At Risk
      11
      description
      Patients diagnosed with and treated for a solid tumor
      id
      EG004
      other Num Affected
      0
      other Num At Risk
      11
      serious Num Affected
      3
      serious Num At Risk
      11
      title
      Solid Tumors
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Any organ system (cardiac, renal, pulmonary, lower GI, CNS, hepatic, stomatitis, bladder)
      organ System
      General disorders
      source Vocabulary
      Bearman Criteria
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        9
        num At Risk
        21
        num Events
        9
      3. group Id
        EG002
        num Affected
        19
        num At Risk
        71
        num Events
        19
      4. group Id
        EG003
        num Affected
        31
        num At Risk
        65
        num Events
        31
      5. group Id
        EG004
        num Affected
        3
        num At Risk
        11
        num Events
        3
      term
      Regimen Related Toxicity
    time Frame
    SAE= 100 days after transplantation All cause mortality = 12 years

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

    Preserved source evidence · Not medical advice