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NCT00372619 · ADVERSE EVENTS

Adverse events

Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia · Source last updated 2017-06-05

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
Not reported
Other-event reporting threshold
0%

There are n=42 pts enrolled to group Clofarabine 52 mg/m² to Assess Efficacy in AML Patients, 2 pts ineligible \& 1 inevaluable for response. For toxicity, ineligible pts are excluded, but the inevaluable pt is included for analysis of toxicity resulting in n=40. OM #2 reports the number of pts having at least 1, gr 3 or higher AE during therapy. Pts with SAEs are not determined by this definition, but by whether a pt had at least 1 reportable AE requiring an AdEERs report during therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.

Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis

5 / 88 / 8Not reported / Not reported
Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.

Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis

2 / 22 / 2Not reported / Not reported
Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.

Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis

2 / 33 / 3Not reported / Not reported
Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.

Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis

7 / 1010 / 10Not reported / Not reported
Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.

Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis

3 / 77 / 7Not reported / Not reported
Clofarabine 52 mg/m² to Assess Efficacy in AML Patients

Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis

14 / 4038 / 40Not reported / Not reported
Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt

Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis

2 / 22 / 2Not reported / Not reported

Group identifiers: EG000: Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients. · EG001: Clofarabine 40 mg/m² to Assess Feasibility in AML Patients. · EG002: Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients. · EG003: Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients. · EG004: Clofarabine 52 mg/m² to Assess Feasibility in AML Patients. · EG005: Clofarabine 52 mg/m² to Assess Efficacy in AML Patients · EG006: Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Abdominal pain
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Alanine aminotransferase increased
  3. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Alopecia
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Anorexia
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Aspartate aminotransferase increased
  6. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Back pain
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Bladder infection
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Blood bilirubin increased
  9. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Bone pain
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Capillary leak syndrome
  11. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Chest wall pain
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Chills

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Abdominal distension
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Abdominal pain
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Acidosis
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Acute kidney injury
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    term
    Alanine aminotransferase increased
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Alkaline phosphatase increased
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Allergic reaction
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Allergic rhinitis
  9. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Alopecia
  10. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Anaphylaxis
  11. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Anemia
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      2
    term
    Anorexia
Complete source fields
description
There are n=42 pts enrolled to group Clofarabine 52 mg/m² to Assess Efficacy in AML Patients, 2 pts ineligible \& 1 inevaluable for response. For toxicity, ineligible pts are excluded, but the inevaluable pt is included for analysis of toxicity resulting in n=40. OM #2 reports the number of pts having at least 1, gr 3 or higher AE during therapy. Pts with SAEs are not determined by this definition, but by whether a pt had at least 1 reportable AE requiring an AdEERs report during therapy.
event Groups
  1. description
    Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    5
    serious Num At Risk
    8
    title
    Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.
  2. description
    Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.
  3. description
    Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.
  4. description
    Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis
    id
    EG003
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    7
    serious Num At Risk
    10
    title
    Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.
  5. description
    Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis
    id
    EG004
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.
  6. description
    Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis
    id
    EG005
    other Num Affected
    38
    other Num At Risk
    40
    serious Num Affected
    14
    serious Num At Risk
    40
    title
    Clofarabine 52 mg/m² to Assess Efficacy in AML Patients
  7. description
    Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. clofarabine: Given IV for 5 days cytarabine: Given IV methotrexate: Given intrathecally or IT age based dosage laboratory biomarker analysis
    id
    EG006
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Abdominal distension
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Abdominal pain
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Acidosis
  4. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Acute kidney injury
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    term
    Alanine aminotransferase increased
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Alkaline phosphatase increased
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Allergic reaction
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Allergic rhinitis
  9. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Alopecia
  10. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Anaphylaxis
  11. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Anemia
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      2
    term
    Anorexia
serious Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Abdominal pain
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Alanine aminotransferase increased
  3. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Alopecia
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Anorexia
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Aspartate aminotransferase increased
  6. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Back pain
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Bladder infection
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Blood bilirubin increased
  9. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Bone pain
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Capillary leak syndrome
  11. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Chest wall pain
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      40
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    term
    Chills

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Preserved source evidence · Not medical advice