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NCT00423514 · ADVERSE EVENTS

Adverse events

Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease · Source last updated 2022-12-27

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
1 year
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL

This is a single arm phase I/II clinical trial to assess efficacy (the antileukemic potential and relapse rate), and safety (peri-transplant morbidity and mortality) of a novel cytoreduction regimen in preparation for allogeneic hematopoietic stem cell transplantation (HSCT).

8 / 3131 / 3112 / 31
Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL

This is a single arm phase I/II clinical trial to assess efficacy (the antileukemic potential and relapse rate), and safety (peri-transplant morbidity and mortality) of a novel cytoreduction regimen in preparation for allogeneic hematopoietic stem cell transplantation (HSCT).

3 / 77 / 73 / 7

Group identifiers: EG000: Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL · EG001: Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL

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
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    CNS cerebrovascular ischemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Death not assoc w CTCAE term - Disease prog NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Encephalopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Hypertension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Hypoxia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Ileus, GI (func obstruction of bowel)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Infection, other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Liver dysfunction/failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Metabolic/Lab - Other (specify)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Mucositis (Clin exam) - Oral cavity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Pneumonitis/pulm infiltrates

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    term
    ALT, SGPT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    term
    AST, SGOT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Alkaline phosphatase
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Bilirubin (hyperbilirubinemia)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Creatinine
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Fibrinogen
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Glucose, high (hyperglycemia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    term
    Hemoglobin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    term
    Leukocytes (total WBC)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    term
    Lymphopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Magnesium, high (hypermagnesemia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    term
    Neutrophils/granulocytes (ANC/AGC)
Complete source fields
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    31
    description
    This is a single arm phase I/II clinical trial to assess efficacy (the antileukemic potential and relapse rate), and safety (peri-transplant morbidity and mortality) of a novel cytoreduction regimen in preparation for allogeneic hematopoietic stem cell transplantation (HSCT).
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    8
    serious Num At Risk
    31
    title
    Dose Level 1: Clofarabine at 20 mg/m^2/Dose x 5 + THIO-MEL
  2. deaths Num Affected
    3
    deaths Num At Risk
    7
    description
    This is a single arm phase I/II clinical trial to assess efficacy (the antileukemic potential and relapse rate), and safety (peri-transplant morbidity and mortality) of a novel cytoreduction regimen in preparation for allogeneic hematopoietic stem cell transplantation (HSCT).
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Dose Level 2: Clofarabine at 30 mg/m^2/Dose x 5 + THIO-MEL
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    term
    ALT, SGPT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    term
    AST, SGOT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Alkaline phosphatase
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Bilirubin (hyperbilirubinemia)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Creatinine
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Fibrinogen
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Glucose, high (hyperglycemia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    term
    Hemoglobin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    term
    Leukocytes (total WBC)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    term
    Lymphopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Magnesium, high (hypermagnesemia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
    term
    Neutrophils/granulocytes (ANC/AGC)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    CNS cerebrovascular ischemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Death not assoc w CTCAE term - Disease prog NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Encephalopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Hypertension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Hypoxia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Ileus, GI (func obstruction of bowel)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Infection, other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Liver dysfunction/failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Metabolic/Lab - Other (specify)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Mucositis (Clin exam) - Oral cavity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Pneumonitis/pulm infiltrates
time Frame
1 year

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Preserved source evidence · Not medical advice