TriangleNCT00306202 · OUTCOME
Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.
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 the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
What was measured
AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3 = Severe; Grade 4 = Life-threatening or disabling.
Analysis population: All treated participants: Participants who received at least 1 dose of study therapy.
Groups in this outcome
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 11 |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 6 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 8 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 9 |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 6 |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 6 |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 6 |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 6 |
Reported measurements
Drug-Related Deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Drug-Related SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
Drug-Related AEs Leading to Discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 3/4 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 5 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 4 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | 4 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | 3 | Not reported | Not reported | Not reported | Not reported |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Drug-Related Deaths
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- title
- Drug-Related SAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- title
- Drug-Related AEs Leading to Discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- title
- Grade 3/4 AEs
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- units
- Participants
- description
- AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3 = Severe; Grade 4 = Life-threatening or disabling.
- groups
- description
- Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG000
- title
- Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
- description
- Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG001
- title
- Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
- description
- Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG002
- title
- Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
- description
- Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG003
- title
- Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG004
- title
- Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG005
- title
- Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG006
- title
- Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG007
- title
- Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
- param Type
- NUMBER
- population Description
- All treated participants: Participants who received at least 1 dose of study therapy.
- reporting Status
- POSTED
- time Frame
- From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
- title
- Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice