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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment - Supplemental page

- 8/6/15 - 5 forms, 22 itemgroups, 81 items, 1 language
Itemgroups: EXCEPTION, PREVIOUS AND CURRENT MEDICATIONS, PRE-TREATMENT EVENTS, BONE MARROW BIOPSY/ ASPIRATE, ELECTROCARDIOGRAM, CHEST X-RAY, TRANSFUSIONS, FLUORESCENT IN SITU HYBRIDIZATION, EXTERNAL DATA TRACKING, LABORATORY TEST RESULTS, DRUG DISPENSATION, BMS-354825 DOSING, CONCOMITANT MEDICATIONS, NON-SERIOUS ADVERSE EVENTS, DEATH DATA, ENROLLMENT IN PREVIOUS BMS CA180 PROTOCOL, DOSE ADMINISTRATION FOR UNSCHEDULED CSF, CSF PHARMACOKINETICS, BLOOD PHARMACOKINETICS, DOSE ADMINISTRATION, PLEURAL OR OTHER BODY FLUID PHARMACOKINETICS, DIAGNOSTIC PROCEDURES
Study documentation part: End of treatment. This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment

10 itemgroups 46 items

Serious Adverse Event (SAE)- Form

3 itemgroups 36 items

Pharmacokinetics

4 itemgroups 22 items

Follow- Up

3 itemgroups 11 items

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 11/18/21 - 9 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: Subject details
Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 itemgroups 84 items

On-Treatment 2

13 itemgroups 62 items

On-Treatment 4

12 itemgroups 62 items

On-Treatment 6

12 itemgroups 62 items

On-Treatment 7

13 itemgroups 67 items

On-Treatment 8

13 itemgroups 67 items

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Pre-Treatment - General Medical History

- 9/20/21 - 8 forms, 5 itemgroups, 37 items, 1 language
Itemgroups: System, INITIAL LEUKEMIA DIAGNOSIS, CURRENT DISEASE STATUS, EXTRAMEDULLARY INVOLVEMENT, CHEST X-RAY
Study documentation part: Pre-Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3.

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