Trial · NCT00982488
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT00982488, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2016-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia. Trials, record NCT00982488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00982488
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- NCT number
- NCT00982488
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 238 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia
- Interventions
- Dasatinib, Imatinib
- First posted
- 2009-09-23
- Last updated
- 2016-01-22
- Results first posted
- 2016-01-22
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Day 1 of treatment through a maximum of 82 months + 30 days | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Day 1 of treatment through a maximum of 82 months + 30 days | All participants who received at least 1 dose of study drug | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase | All deaths | 22 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Imatinib, 400 mg BID, Chronic Phase | All deaths | 0 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | All deaths | 4 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP | All deaths | 0 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL | All deaths | 0 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase | Deaths within 30 days of last dose | 9 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Imatinib, 400 mg BID, Chronic Phase | Deaths within 30 days of last dose | 0 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | Deaths within 30 days of last dose | 2 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP | Deaths within 30 days of last dose | 0 | Participants | |
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL | Deaths within 30 days of last dose | 0 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib 50 mg QD to 120 mg BID, Chronic Phase | 185 | |
| Overall Study | STARTED | Imatinib, 400 mg BID, Chronic Phase | 14 | |
| Overall Study | STARTED | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | 34 | |
| Overall Study | STARTED | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB | 3 | |
| Overall Study | STARTED | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL | 1 | |
| Overall Study | COMPLETED | Dasatinib 50 mg QD to 120 mg BID, Chronic Phase | 0 | |
| Overall Study | COMPLETED | Imatinib, 400 mg BID, Chronic Phase | 0 | |
| Overall Study | COMPLETED | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | 0 | |
| Overall Study | COMPLETED | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB | 0 | |
| Overall Study | COMPLETED | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events700
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diastolic dysfunction | Cardiac disorders | Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase | 0 | 185 | |
| other | Diastolic dysfunction | Cardiac disorders | Imatinib, 400 mg BID, Chronic Phase | 0 | 14 | |
| other | Diastolic dysfunction | Cardiac disorders | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | 0 | 34 | |
| other | Diastolic dysfunction | Cardiac disorders | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP | 1 | 3 | |
| other | Diastolic dysfunction | Cardiac disorders | Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL | 0 | 1 | |
| other | Dizziness | Nervous system disorders | Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase | 13 | 185 | |
| other | Dizziness | Nervous system disorders | Imatinib, 400 mg BID, Chronic Phase | 0 | 14 | |
| other | Dizziness | Nervous system disorders | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | 2 | 34 | |
| other | Dizziness | Nervous system disorders | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP | 0 | 3 | |
| other | Dizziness | Nervous system disorders | Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL | 0 | 1 |
1 to 10 of 700Source ClinicalTrials.gov
See all 700 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase | ||
| Total, all-cause mortality | Imatinib, 400 mg BID, Chronic Phase | ||
| Total, all-cause mortality | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | ||
| Total, all-cause mortality | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP | ||
| Total, all-cause mortality | Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL | ||
| Total, other adverse events | Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase | 138 | 185 |
| Total, other adverse events | Imatinib, 400 mg BID, Chronic Phase | 10 | 14 |
| Total, other adverse events | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP | 24 | 34 |
| Total, other adverse events | Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP | 2 | 3 |
| Total, other adverse events | Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL | 0 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00982488
GET https://conductscience.org/api/trials/v1/NCT00982488/results?page=2