TriangleNCT00306202 · OUTCOME
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0
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
- Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
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
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2, as long as clinical benefit was maintained.
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
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). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 11 |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 6 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 8 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 9 |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 6 |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 6 |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 6 |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 6 |
Reported measurements
Low Calcium GR1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Low Calcium GR2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
Low Calcium GR3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Low Calcium GR4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Low magnesium GR1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 5 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 4 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
Low Magnesium GR2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Low Magnesium GR3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Low Magnesium GR4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Low Phosphate GR1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
Low Phosphate GR2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
Low Phosphate GR3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
Low Phosphate GR4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- title
- Low Calcium GR1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- title
- Low Calcium GR2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- title
- Low Calcium GR3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Low Calcium GR4
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- title
- Low magnesium GR1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Low Magnesium GR2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Low Magnesium GR3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Low Magnesium GR4
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- title
- Low Phosphate GR1
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- title
- Low Phosphate GR2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- title
- Low Phosphate GR3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Low Phosphate GR4
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- 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). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG000
- title
- Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
- description
- Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2, as long as clinical benefit was maintained.
- id
- OG001
- title
- Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
- 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). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG002
- title
- Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
- 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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG003
- title
- Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG004
- title
- Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG005
- title
- Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG006
- title
- Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG007
- title
- Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
- param Type
- NUMBER
- population Description
- All treated participants: Participants who received at least one dose of study therapy.
- reporting Status
- POSTED
- time Frame
- Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
- title
- Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice