NCT00560352 · OUTCOME
Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade
Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma · Source last updated 2017-03-13
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
- Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)
What was measured
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening.
Analysis population: All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone.
Groups in this outcome
Dasatinib, 50 mg BID
Dasatinib, 50 mg administered BID, with 1.0 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
Dasatinib, 100 mg QD
Dasatinib, 100 mg, given QD with 1.3 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
Dasatinib, 140 mg QD
Dasatinib, 140 mg, administered QD with 1.3 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
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, 50 mg BID | 7 |
|---|
| Dasatinib, 100 mg QD | 3 |
|---|
| Dasatinib, 140 mg QD | 4 |
|---|
Reported measurements
Death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug-related SAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug-related AEs leading to discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs, Grades 3 and 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug-related AEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug-related AEs, Grades 3 and 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dasatinib, 50 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 100 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dasatinib, 140 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- title
- Death
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Drug-related SAEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Drug-related AEs leading to discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- title
- AEs leading to discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- title
- AEs, Grades 3 and 4
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- title
- Drug-related AEs
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- title
- Drug-related AEs, Grades 3 and 4
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening.
- groups
- description
- Dasatinib, 50 mg administered BID, with 1.0 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
- id
- OG000
- title
- Dasatinib, 50 mg BID
- description
- Dasatinib, 100 mg, given QD with 1.3 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
- id
- OG001
- title
- Dasatinib, 100 mg QD
- description
- Dasatinib, 140 mg, administered QD with 1.3 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
- id
- OG002
- title
- Dasatinib, 140 mg QD
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone.
- reporting Status
- POSTED
- time Frame
- Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)
- title
- Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle