Trial Outcomes & Findings for Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia (NCT NCT00372619)
NCT ID: NCT00372619
Last Updated: 2017-06-05
Results Overview
Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (\< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) \> 750/μL and platelet count \> 75,000/μL). Overall response for AML patients: (CR + CRp), defined as: CR - complete remission (attainment of an M1 bone marrow (\<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) \> 1000/uL and platelet count \> 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (\<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) \> 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week)).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
74 participants
Primary outcome timeframe
2 cycles or up to 84 days
Results posted on
2017-06-05
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
2
|
3
|
10
|
7
|
42
|
2
|
|
Overall Study
COMPLETED
|
8
|
2
|
3
|
10
|
7
|
39
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Ineligible
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Inevaluable
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.
n=8 Participants
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
|
Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.
n=2 Participants
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
|
Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.
n=3 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.
n=10 Participants
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
|
Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.
n=7 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy in AML Patients
n=42 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
n=2 Participants
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
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
62 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
12.75 years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
15.09 years
STANDARD_DEVIATION 6.33 • n=7 Participants
|
13.09 years
STANDARD_DEVIATION 1.54 • n=5 Participants
|
9.16 years
STANDARD_DEVIATION 6.69 • n=4 Participants
|
9.01 years
STANDARD_DEVIATION 5.79 • n=21 Participants
|
12.01 years
STANDARD_DEVIATION 7.12 • n=8 Participants
|
19.65 years
STANDARD_DEVIATION 1.80 • n=8 Participants
|
15.13 years
STANDARD_DEVIATION 5.94 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
59 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
54 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
7 participants
n=21 Participants
|
37 participants
n=8 Participants
|
2 participants
n=8 Participants
|
65 participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
5 participants
n=8 Participants
|
0 participants
n=8 Participants
|
9 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 2 cycles or up to 84 daysOverall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (\< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) \> 750/μL and platelet count \> 75,000/μL). Overall response for AML patients: (CR + CRp), defined as: CR - complete remission (attainment of an M1 bone marrow (\<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) \> 1000/uL and platelet count \> 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (\<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) \> 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week)).
Outcome measures
| Measure |
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.
n=8 Participants
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
|
Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.
n=2 Participants
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
|
Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.
n=3 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.
n=10 Participants
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
|
Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.
n=7 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy in AML Patients
n=39 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
n=2 Participants
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
|
|---|---|---|---|---|---|---|---|
|
Overall Response (CR for ALL Patients), (CR + CRp for AML Patients)
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
19 participants
|
2 participants
|
SECONDARY outcome
Timeframe: End of therapyPopulation: Ineligible (n=2) and inevaluable (n=1) patients are excluded
Number of participants with at least one grade 3 or higher adverse event during therapy.
Outcome measures
| Measure |
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.
n=8 Participants
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
|
Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.
n=2 Participants
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
|
Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.
n=3 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.
n=10 Participants
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
|
Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.
n=7 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy in AML Patients
n=39 Participants
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
|
Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
n=2 Participants
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
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by CTCAE v3.0
|
7 number participants
|
2 number participants
|
3 number participants
|
10 number participants
|
7 number participants
|
35 number participants
|
2 number participants
|
SECONDARY outcome
Timeframe: End of therapyPopulation: The analysis was not completed, because the tissue microarray was unsuccessful.
Correlate the expression of apoptosis specific genes with chemoresistance and determine whether therapy with clofarabine is able to overcome blocks in apoptosis through modulation of gene expression. Gene expression analysis will be performed on specimens obtained during therapy. Apoptosis specific microarray data will be analyzed using GeneTraffic software (Iobion Informatics, La Jolla CA).
Outcome measures
Outcome data not reported
Adverse Events
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Clofarabine 52 mg/m² to Assess Efficacy in AML Patients
Serious events: 14 serious events
Other events: 38 other events
Deaths: 0 deaths
Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.
n=8 participants at risk
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
|
Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.
n=2 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.
n=3 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.
n=10 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.
n=7 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Efficacy in AML Patients
n=40 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
n=2 participants at risk
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
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
20.0%
2/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Bladder infection
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
7.5%
3/40
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.
|
0.00%
0/2
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.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Chills
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Fatigue
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
2/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
15.0%
6/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
GGT increased
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Headache
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
20.0%
2/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Infections and infestations - Other
|
50.0%
4/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
30.0%
3/10
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.
|
28.6%
2/7
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.
|
20.0%
8/40
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.
|
0.00%
0/2
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.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Lipase increased
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
7.5%
3/40
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.
|
50.0%
1/2
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.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Neuralgia
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Serum amylase increased
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
Other adverse events
| Measure |
Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.
n=8 participants at risk
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
|
Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.
n=2 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.
n=3 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.
n=10 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.
n=7 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Efficacy in AML Patients
n=40 participants at risk
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
|
Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt
n=2 participants at risk
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
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
30.0%
3/10
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.
|
14.3%
1/7
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.
|
7.5%
3/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
30.0%
3/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
4/8
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.
|
100.0%
2/2
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.
|
33.3%
1/3
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.
|
40.0%
4/10
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.
|
14.3%
1/7
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.
|
35.0%
14/40
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.
|
50.0%
1/2
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.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
7.5%
3/40
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.
|
0.00%
0/2
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.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
50.0%
5/10
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.
|
42.9%
3/7
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.
|
27.5%
11/40
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.
|
100.0%
2/2
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.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
66.7%
2/3
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.
|
50.0%
5/10
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.
|
14.3%
1/7
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.
|
25.0%
10/40
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.
|
50.0%
1/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
7.5%
3/40
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.
|
0.00%
0/2
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.
|
|
Renal and urinary disorders
Bladder spasm
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Blood bilirubin increased
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
50.0%
5/10
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.
|
0.00%
0/7
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.
|
15.0%
6/40
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.
|
0.00%
0/2
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.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
20.0%
2/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
50.0%
1/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
28.6%
2/7
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.
|
7.5%
3/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Chills
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
50.0%
1/2
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.
|
|
Investigations
Creatinine increased
|
0.00%
0/8
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.
|
50.0%
1/2
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.
|
33.3%
1/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Renal and urinary disorders
Cystitis noninfective
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
20.0%
2/10
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.
|
57.1%
4/7
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.
|
25.0%
10/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Eye disorders
Dry eye
|
0.00%
0/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Edema face
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Edema limbs
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
7.5%
3/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
20.0%
2/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Eye disorders
Eye pain
|
0.00%
0/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Fatigue
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
37.5%
3/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
50.0%
5/10
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.
|
57.1%
4/7
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.
|
30.0%
12/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Fever
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
30.0%
3/10
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.
|
14.3%
1/7
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.
|
12.5%
5/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Investigations
GGT increased
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
17.5%
7/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Gum infection
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Headache
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
30.0%
3/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
50.0%
1/2
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.
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
4/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
50.0%
5/10
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.
|
14.3%
1/7
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.
|
17.5%
7/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
60.0%
6/10
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.
|
42.9%
3/7
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.
|
22.5%
9/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
40.0%
4/10
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.
|
0.00%
0/7
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.
|
12.5%
5/40
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.
|
0.00%
0/2
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.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
30.0%
3/10
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.
|
14.3%
1/7
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.
|
17.5%
7/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
30.0%
3/10
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.
|
42.9%
3/7
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.
|
32.5%
13/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
10.0%
4/40
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.
|
0.00%
0/2
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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
10.0%
4/40
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.
|
50.0%
1/2
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.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
30.0%
3/10
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.
|
28.6%
2/7
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.
|
10.0%
4/40
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.
|
50.0%
1/2
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.
|
|
Vascular disorders
Hypotension
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
12.5%
5/40
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.
|
50.0%
1/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Infections and infestations - Other
|
25.0%
2/8
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.
|
100.0%
2/2
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.
|
33.3%
1/3
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.
|
20.0%
2/10
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.
|
57.1%
4/7
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.
|
42.5%
17/40
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.
|
50.0%
1/2
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.
|
|
Investigations
INR increased
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Eye disorders
Keratitis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Lipase increased
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Lung infection
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
10.0%
4/40
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.
|
0.00%
0/2
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8
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.
|
50.0%
1/2
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.
|
33.3%
1/3
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.
|
40.0%
4/10
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.
|
57.1%
4/7
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.
|
25.0%
10/40
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.
|
100.0%
2/2
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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
20.0%
2/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
General disorders
Pain
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
10.0%
4/40
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.
|
0.00%
0/2
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
10.0%
4/40
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.
|
50.0%
1/2
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.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
12.5%
1/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
50.0%
1/2
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.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Eye disorders
Photophobia
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Platelet count decreased
|
37.5%
3/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
20.0%
2/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8
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.
|
50.0%
1/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
7.5%
3/40
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.
|
50.0%
1/2
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.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
12.5%
5/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Serum amylase increased
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
50.0%
1/2
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.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
5.0%
2/40
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.
|
0.00%
0/2
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.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
12.5%
1/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
33.3%
1/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
66.7%
2/3
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.
|
40.0%
4/10
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.
|
71.4%
5/7
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.
|
22.5%
9/40
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.
|
50.0%
1/2
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.
|
|
Eye disorders
Watering eyes
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
0.00%
0/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
|
Investigations
Weight loss
|
0.00%
0/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
10.0%
1/10
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.
|
14.3%
1/7
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.
|
0.00%
0/40
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.
|
0.00%
0/2
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.
|
|
Investigations
White blood cell decreased
|
25.0%
2/8
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.
|
0.00%
0/2
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.
|
0.00%
0/3
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.
|
20.0%
2/10
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.
|
0.00%
0/7
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.
|
2.5%
1/40
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.
|
0.00%
0/2
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.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 352-273-0567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER