NCT00306202 · OUTCOME
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia · Source last updated 2021-02-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure NUMBER
Unit participants
Interval / dispersion Not reported
Time frame At baseline (within 1 week before initiation of study therapy) What was measured GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=\<LLN-8.0 mg/dL, GR2=\<8.0-7.0 mg/dL, GR3=\<7.0-6.0 mg/dL, GR4=\<6.0 mg/dL; Low magnesium: GR1=\<LLN-1.2 mg/dL, GR2=\<1.2-0.9 mg/dL, GR3=\<0.9-0.7 mg/dL, GR4=\<0.7 mg/dL; Low phosphate: GR1=\<LLN - 2.5 mg/dL, GR2=\<2.5 - 2.0 mg/dL, GR3=\<2.0 - 1.0 mg/dL, GR4=\<1.0 mg/dL.
Analysis population: All treated participants: Participants who received at least one dose of study therapy.
Groups in this outcome Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 17 Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 17 Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 24
Reported measurements Low Calcium GR1 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 1 Not reported Not reported Not reported Not reported
Low Calcium GR2 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Calcium GR3 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Calcium GR4 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Calcium GR Not Reported Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 2 Not reported Not reported Not reported Not reported
Low Magnesium GR1 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 6 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Magnesium GR2 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Magnesium GR3 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Magnesium GR4 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Magnesium GR Not Reported Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 2 Not reported Not reported Not reported Not reported
Low Phosphate GR1 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 1 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Phosphate GR2 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Phosphate GR3 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 1 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Phosphate GR4 Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported
Low Phosphate GR Not Reported Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose 2 Not reported Not reported Not reported Not reported Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose 0 Not reported Not reported Not reported Not reported Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose 2 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
title Low Calcium GR1 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
title Low Calcium GR2 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
title Low Calcium GR3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
title Low Calcium GR4 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 2
title Low Calcium GR Not Reported categories measurements
group Id OG000
value 0
group Id OG001
value 6
group Id OG002
value 0
title Low Magnesium GR1 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
title Low Magnesium GR2 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
title Low Magnesium GR3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
title Low Magnesium GR4 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 2
title Low Magnesium GR Not Reported categories measurements
group Id OG000
value 0
group Id OG001
value 1
group Id OG002
value 0
title Low Phosphate GR1 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
title Low Phosphate GR2 Show more (12 of 15) denoms counts
group Id OG000
value 17
group Id OG001
value 17
group Id OG002
value 24
units Participants
description GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=\<LLN-8.0 mg/dL, GR2=\<8.0-7.0 mg/dL, GR3=\<7.0-6.0 mg/dL, GR4=\<6.0 mg/dL; Low magnesium: GR1=\<LLN-1.2 mg/dL, GR2=\<1.2-0.9 mg/dL, GR3=\<0.9-0.7 mg/dL, GR4=\<0.7 mg/dL; Low phosphate: GR1=\<LLN - 2.5 mg/dL, GR2=\<2.5 - 2.0 mg/dL, GR3=\<2.0 - 1.0 mg/dL, GR4=\<1.0 mg/dL. groups
description Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.
id OG000
title Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
description Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
id OG001
title Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
description Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
id OG002
title Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
param Type NUMBER
population Description All treated participants: Participants who received at least one dose of study therapy.
reporting Status POSTED
time Frame At baseline (within 1 week before initiation of study therapy)
title Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0
type OTHER_PRE_SPECIFIED
unit Of Measure participants Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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