NCT00123487 · OUTCOME
Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology 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 National Cancer Institute Common Terminology Criteria (NCI CTC) version 3.0. CTC Grade 3 and 4 criteria are defined as follows: White blood cells (WBC): Grade (Gr) 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. Absolute neutrophil count (ANC): Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Baseline was laboratory value 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. Those 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
WBC
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 129 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 114 | Not reported | Not reported | Not reported | Not reported |
|---|
WBC 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelets
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 64 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 79 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelets 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
ANC
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 127 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 143 | Not reported | Not reported | Not reported | Not reported |
|---|
ANC not reported at baseline
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib 140 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib 70 mg BID | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 114
- title
- WBC
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- WBC not reported at baseline
- categories
- measurements
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 79
- title
- Platelets
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- Platelets not reported at baseline
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 13
- title
- Hemoglobin
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- Hemoglobin not reported at baseline
- categories
- measurements
- group Id
- OG000
- value
- 127
- group Id
- OG001
- value
- 143
- title
- ANC
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 8
- title
- ANC 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 National Cancer Institute Common Terminology Criteria (NCI CTC) version 3.0. CTC Grade 3 and 4 criteria are defined as follows: White blood cells (WBC): Grade (Gr) 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. Absolute neutrophil count (ANC): Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Baseline was laboratory value 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. Those 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 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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