NCT00481247 · OUTCOME
Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia · Source last updated 2017-02-15
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
- From date of last person, first visit to date of last person, last visit (approximately 8 years)
What was measured
ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE. Absolute neutrophil count: Grade 3 \<1000-500/mm\^3; Grade 4 \<500/mm\^3. Hemoglobin: Grade 3 \<8.0-6.5 g/dL; Grade 4 \<6.5 g/dL. Platelets: Grade 3 \<50,000-25,000/mm\^3; Grade 4 \<25,000/mm\^3. ALT/AST: Grade 3 \>5.0-20\*ULN; Grade 4 \>20\*ULN. Total bilirubin: Grade 3 \>3-10\*ULN; Grade 4 \>10\*ULN. Sample normal ranges (may vary by institution): ALT, Female: 7-30 U/L, Male: 10-55 U/L; AST, Female: 9-25 U/L, Male10-40 U/L; Total bilirubin: 0.0-1.0 mg/dL. Creatinine: Grade 3 \>3.0-6.0\*ULN; Grade 4 \>6.0\*ULN. Phosphate: Grade 3 \<2.0-1.0 mg/dL; Grade 4 \<1.0 mg/dL. Calcium: Grade 3 \<7.0-6.0 mg/dL; Grade 4 \<6.0 mg/dL. Potassium: Grade 3 \<3.0-2.5 mmol/L; Grade 4 \<2.5 mmol/L.
Analysis population: Participants with laboratory assessments
Groups in this outcome
Dasatinib
Tablets, oral, dasatinib 100 mg once daily (QD)
Imatinib
Tablets, oral, imatinib 400 mg once daily (QD)
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 |
|---|
| Dasatinib | 256 |
|---|
| Imatinib | 257 |
|---|
Reported measurements
Grade 3/4 Absolute neutrophil count
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 74 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 61 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Hemoglobin
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Platelets
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 56 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Alanine aminotransferase (ALT)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Aspartate aminotransferase (AST)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Total bilirubin
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Creatinine
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Phosphate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 79 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Calcium
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 Potassium
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Imatinib | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 61
- title
- Grade 3/4 Absolute neutrophil count
- categories
- measurements
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 23
- title
- Grade 3/4 Hemoglobin
- categories
- measurements
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 37
- title
- Grade 3/4 Platelets
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- title
- Grade 3/4 Alanine aminotransferase (ALT)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Grade 3/4 Aspartate aminotransferase (AST)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Grade 3/4 Total bilirubin
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Grade 3/4 Creatinine
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 79
- title
- Grade 3/4 Phosphate
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- title
- Grade 3/4 Calcium
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- title
- Grade 3/4 Potassium
- denoms
- counts
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 257
- units
- Participants
- description
- ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE. Absolute neutrophil count: Grade 3 \<1000-500/mm\^3; Grade 4 \<500/mm\^3. Hemoglobin: Grade 3 \<8.0-6.5 g/dL; Grade 4 \<6.5 g/dL. Platelets: Grade 3 \<50,000-25,000/mm\^3; Grade 4 \<25,000/mm\^3. ALT/AST: Grade 3 \>5.0-20\*ULN; Grade 4 \>20\*ULN. Total bilirubin: Grade 3 \>3-10\*ULN; Grade 4 \>10\*ULN. Sample normal ranges (may vary by institution): ALT, Female: 7-30 U/L, Male: 10-55 U/L; AST, Female: 9-25 U/L, Male10-40 U/L; Total bilirubin: 0.0-1.0 mg/dL. Creatinine: Grade 3 \>3.0-6.0\*ULN; Grade 4 \>6.0\*ULN. Phosphate: Grade 3 \<2.0-1.0 mg/dL; Grade 4 \<1.0 mg/dL. Calcium: Grade 3 \<7.0-6.0 mg/dL; Grade 4 \<6.0 mg/dL. Potassium: Grade 3 \<3.0-2.5 mmol/L; Grade 4 \<2.5 mmol/L.
- groups
- description
- Tablets, oral, dasatinib 100 mg once daily (QD)
- id
- OG000
- title
- Dasatinib
- description
- Tablets, oral, imatinib 400 mg once daily (QD)
- id
- OG001
- title
- Imatinib
- param Type
- NUMBER
- population Description
- Participants with laboratory assessments
- reporting Status
- POSTED
- time Frame
- From date of last person, first visit to date of last person, last visit (approximately 8 years)
- title
- Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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