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NCT00566696 · ADVERSE EVENTS

Adverse events

Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies · Source last updated 2020-04-14

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 events were collected from the date of participant enrollment through December 23, 2015.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
High-Risk Hematologic Malignancies

Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.

20 / 3130 / 3116 / 31

Group identifiers: EG000: High-Risk Hematologic Malignancies

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Allergic reaction, micafungin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Graft failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Coagulopathy
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Post-transplant lymphoproliferative disease
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      31
      num Events
      11
    term
    Fever without neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Headache
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Rash
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Colitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Vomiting (disorder)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Hemorrhage, diffuse alveolar
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Failure, hepatic
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Veno-occlusive disease, hepatic

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
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      31
      num Events
      8
    term
    Hypertension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Hypotension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Mucositis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Nausea (finding)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Vomiting (disorder)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Epistaxis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Hemorrhagic cystitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Elevated ALT (SGPT)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Elevated GGT
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Hyperglycemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      7
    term
    Hypokalemia (disorder)
Complete source fields
event Groups
  1. deaths Num Affected
    16
    deaths Num At Risk
    31
    description
    Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    31
    serious Num Affected
    20
    serious Num At Risk
    31
    title
    High-Risk Hematologic Malignancies
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      31
      num Events
      8
    term
    Hypertension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Hypotension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Mucositis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Nausea (finding)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Vomiting (disorder)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Epistaxis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Hemorrhagic cystitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Elevated ALT (SGPT)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Elevated GGT
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Hyperglycemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      7
    term
    Hypokalemia (disorder)
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Allergic reaction, micafungin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Graft failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Coagulopathy
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Post-transplant lymphoproliferative disease
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      31
      num Events
      11
    term
    Fever without neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Headache
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Rash
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Colitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Vomiting (disorder)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Hemorrhage, diffuse alveolar
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Failure, hepatic
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    NCI CTC v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Veno-occlusive disease, hepatic
time Frame
Adverse events were collected from the date of participant enrollment through December 23, 2015.

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