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NCT00703820 · ADVERSE EVENTS

Adverse events

Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2021-08-10

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
Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cytarabine+Daunorubicin+Etoposide

Participants received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.

127 / 1339 / 13343 / 133
Clofarabine+Cytarabine

Participants received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.

122 / 1299 / 12932 / 129
Stem Cell Donors

This group enrolled in the study to provide donor cells to participants. Donors did not receive therapy.

0 / 290 / 290 / 29

Group identifiers: EG000: Cytarabine+Daunorubicin+Etoposide · EG001: Clofarabine+Cytarabine · EG002: Stem Cell Donors

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      133
      num Events
      47
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      129
      num Events
      62
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      133
      num Events
      78
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      129
      num Events
      90
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Potassium, serum-low (hypokalemia)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      133
      num Events
      26
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      129
      num Events
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    AST, SGOT (serum glutamic oxaloacetic transaminase)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      133
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      129
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Acidosis (metabolic or respiratory)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      133
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      129
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Allbumin, serum-low (hypoalbuminemia)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      133
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      129
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Alkalosis (metabolic or respiratory)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      133
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      129
      num Events
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Bilirubin (hyperbilirubinemia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      133
      num Events
      19
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      129
      num Events
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Glucose, serum-high (hyperglycemia)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      133
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      129
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Sodium, serum-high (hypernatremia)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      133
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      129
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Sodium, serum-low (hyponatremia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      133
      num Events
      20
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      129
      num Events
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Calcium, serum-low (hypocalcemia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      129
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Lipase

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
    Immune system disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      133
      num Events
      11
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      129
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
Complete source fields
event Groups
  1. deaths Num Affected
    43
    deaths Num At Risk
    133
    description
    Participants received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
    id
    EG000
    other Num Affected
    9
    other Num At Risk
    133
    serious Num Affected
    127
    serious Num At Risk
    133
    title
    Cytarabine+Daunorubicin+Etoposide
  2. deaths Num Affected
    32
    deaths Num At Risk
    129
    description
    Participants received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
    id
    EG001
    other Num Affected
    9
    other Num At Risk
    129
    serious Num Affected
    122
    serious Num At Risk
    129
    title
    Clofarabine+Cytarabine
  3. deaths Num Affected
    0
    deaths Num At Risk
    29
    description
    This group enrolled in the study to provide donor cells to participants. Donors did not receive therapy.
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    29
    serious Num Affected
    0
    serious Num At Risk
    29
    title
    Stem Cell Donors
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      133
      num Events
      11
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      129
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      133
      num Events
      47
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      129
      num Events
      62
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      133
      num Events
      78
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      129
      num Events
      90
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Potassium, serum-low (hypokalemia)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      133
      num Events
      26
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      129
      num Events
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    AST, SGOT (serum glutamic oxaloacetic transaminase)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      133
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      129
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Acidosis (metabolic or respiratory)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      133
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      129
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Allbumin, serum-low (hypoalbuminemia)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      133
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      129
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Alkalosis (metabolic or respiratory)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      133
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      129
      num Events
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Bilirubin (hyperbilirubinemia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      133
      num Events
      19
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      129
      num Events
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Glucose, serum-high (hyperglycemia)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      133
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      129
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Sodium, serum-high (hypernatremia)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      133
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      129
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Sodium, serum-low (hyponatremia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      133
      num Events
      20
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      129
      num Events
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Calcium, serum-low (hypocalcemia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      133
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      129
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
      num Events
      0
    term
    Lipase
time Frame
Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed. Participants who received NK cell infusions were followed until any identified toxicities resolved to less than grade 2. Donors were followed for adverse events from the day of apheresis through seven days following apheresis.

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