NCT00123487 · OUTCOME
Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML · Source last updated 2014-11-03
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
- Baseline to Year 2
What was measured
Laboratory abnormalities were graded according to the NCI CTC version 3.0. Grade 3 and 4 criteria were defined as follows: Upper limit of normal (ULN). Alanine transaminase (ALT) Grade (Gr) 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Aspartate aminotransferase (AST) Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Total bilirubin Gr 3: \>3.0 to 10..0\*ULN; Gr 4: \>10.0.0\*ULN. Serum creatinine (H) Gr 3: \>3.0 to 6.0\*ULN; Gr 4: \>6.0\*ULN. Calcium (L) Gr3: 6.0-7.0; Gr 4: \<6.0 mg/dL; Phosphorus (L): Gr 3: \<2.0 - 1.0 mg/dL , Gr 4: \<1.0 mg/dL. Non-hematologic laboratory results were not collected beyond Year 2. Baseline values were obtained within 2 weeks prior to randomization.
Analysis population: All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Participants who did not have a parameter reported at baseline are indicated.
Groups in this outcome
Dasatinib 140 mg QD
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
Dasatinib 70 mg BID
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
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 140 mg QD | 304 |
|---|
| Dasatinib 70 mg BID | 305 |
|---|
Reported measurements
Hypophosphatemia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
Phosphorus not reported at baseline
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
Hypocalcemia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Calcium not reported at baseline
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Elevated ALT
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
ALT not reported at baseline
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Elevated AST
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
AST not reported at baseline
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Elevated Bilirubin
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Bilirubin not reported at baseline
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Elevated Serum Creatinine
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Serum Creatinine not reported at baseline
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 26
- title
- Hypophosphatemia
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 20
- title
- Phosphorus not reported at baseline
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 9
- title
- Hypocalcemia
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 13
- title
- Calcium not reported at baseline
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 4
- title
- Elevated ALT
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- title
- ALT not reported at baseline
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Elevated AST
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- title
- AST not reported at baseline
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- title
- Elevated Bilirubin
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- title
- Bilirubin not reported at baseline
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- title
- Elevated Serum Creatinine
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- title
- Serum Creatinine not reported at baseline
- denoms
- counts
- group Id
- OG000
- value
- 304
- group Id
- OG001
- value
- 305
- units
- Participants
- description
- Laboratory abnormalities were graded according to the NCI CTC version 3.0. Grade 3 and 4 criteria were defined as follows: Upper limit of normal (ULN). Alanine transaminase (ALT) Grade (Gr) 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Aspartate aminotransferase (AST) Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Total bilirubin Gr 3: \>3.0 to 10..0\*ULN; Gr 4: \>10.0.0\*ULN. Serum creatinine (H) Gr 3: \>3.0 to 6.0\*ULN; Gr 4: \>6.0\*ULN. Calcium (L) Gr3: 6.0-7.0; Gr 4: \<6.0 mg/dL; Phosphorus (L): Gr 3: \<2.0 - 1.0 mg/dL , Gr 4: \<1.0 mg/dL. Non-hematologic laboratory results were not collected beyond Year 2. Baseline values were obtained within 2 weeks prior to randomization.
- groups
- description
- Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
- id
- OG000
- title
- Dasatinib 140 mg QD
- description
- Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
- id
- OG001
- title
- Dasatinib 70 mg BID
- param Type
- NUMBER
- population Description
- All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Participants who did not have a parameter reported at baseline are indicated.
- reporting Status
- POSTED
- time Frame
- Baseline to Year 2
- title
- Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants
- type
- SECONDARY
- unit Of Measure
- participants
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