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NCT00051311 · ADVERSE EVENTS

Adverse events

Modified Stem Cell Transplant Procedure to Treat Patients With Blood and Immune System Cancers · Source last updated 2021-09-09

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
Date treatment consent signed to date off study, approximately 58 months and 13 days.
Other-event reporting threshold
0%

Adverse events data were only collected for the recipients.

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

Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells. Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD). Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD).

0 / 3131 / 3111 / 31

Group identifiers: EG000: Recipient

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
      Gastrointestinal disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        31
        num Events
        10
      term
      Abdominal pain or cramping
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        31
        num Events
        2
      term
      Acute vascular leak syndrome
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        2
      term
      Alkaline phosphatase
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        31
        num Events
        3
      term
      Allergic reaction/hypersensitivity (including drug fever)
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
        num Events
        4
      term
      Allergy-Other
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Amylase
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        31
        num Events
        9
      term
      Anorexia
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Arrhythmia - other
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Arthralgia (joint pain)
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        31
        num Events
        2
      term
      Ascites (non-malignant)
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Ataxia (incoordination)
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Autoimmune reaction
    Complete source fields
    description
    Adverse events data were only collected for the recipients.
    event Groups
    1. deaths Num Affected
      11
      deaths Num At Risk
      31
      description
      Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells. Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD). Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD).
      id
      EG000
      other Num Affected
      31
      other Num At Risk
      31
      serious Num Affected
      0
      serious Num At Risk
      31
      title
      Recipient
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        31
        num Events
        10
      term
      Abdominal pain or cramping
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        31
        num Events
        2
      term
      Acute vascular leak syndrome
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        2
      term
      Alkaline phosphatase
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        31
        num Events
        3
      term
      Allergic reaction/hypersensitivity (including drug fever)
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
        num Events
        4
      term
      Allergy-Other
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Amylase
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        31
        num Events
        9
      term
      Anorexia
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Arrhythmia - other
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Arthralgia (joint pain)
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        31
        num Events
        2
      term
      Ascites (non-malignant)
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Ataxia (incoordination)
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTC 2.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
        num Events
        1
      term
      Autoimmune reaction
    time Frame
    Date treatment consent signed to date off study, approximately 58 months and 13 days.

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

    Preserved source evidence · Not medical advice