TriangleNCT00123474 · OUTCOME
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up
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 30 days post last dose, up to 24 months
What was measured
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. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants.
Analysis population: All randomized participants who received at least one dose of study drug were summarized.
Groups in this outcome
Dasatinib 100 mg QD
Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
Dasatinib 140 mg QD
Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
Dasatinib 50 mg BID
Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
Dasatinib 70 mg BID
Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
| Group | Source count |
|---|---|
| Dasatinib 100 mg QD | 165 |
| Dasatinib 140 mg QD | 163 |
| Dasatinib 50 mg BID | 167 |
| Dasatinib 70 mg BID | 167 |
Reported measurements
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 58 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg QD | 67 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 50 mg BID | 73 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg BID | 78 | Not reported | Not reported | Not reported | Not reported |
Drug-Related SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 32 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg QD | 40 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 50 mg BID | 47 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg BID | 55 | Not reported | Not reported | Not reported | Not reported |
Drug-Related AEs that led to discontinuationt
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 14 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg QD | 24 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 50 mg BID | 20 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg BID | 25 | Not reported | Not reported | Not reported | Not reported |
Death within 30 days of last dose
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 100 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 50 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 67
- group Id
- OG002
- value
- 73
- group Id
- OG003
- value
- 78
- title
- Any SAE
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 47
- group Id
- OG003
- value
- 55
- title
- Drug-Related SAE
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 25
- title
- Drug-Related AEs that led to discontinuationt
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- title
- Death within 30 days of last dose
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 163
- group Id
- OG002
- value
- 167
- group Id
- OG003
- value
- 167
- units
- Participants
- description
- 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. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants.
- groups
- description
- Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG000
- title
- Dasatinib 100 mg QD
- description
- Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG001
- title
- Dasatinib 140 mg QD
- description
- Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG002
- title
- Dasatinib 50 mg BID
- description
- Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- id
- OG003
- title
- Dasatinib 70 mg BID
- param Type
- NUMBER
- population Description
- All randomized participants who received at least one dose of study drug were summarized.
- reporting Status
- POSTED
- time Frame
- Baseline to 30 days post last dose, up to 24 months
- title
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice