TriangleNCT00560391 · OUTCOME
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
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 (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.
Analysis population: All treated participants, participants who received at least 1 dose of dasatinib.
Groups in this outcome
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
| Group | Source count |
|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 6 |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 6 |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 17 |
Reported measurements
All deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
Deaths within 30 days of last dose
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 2 | Not reported | Not reported | Not reported | Not reported |
All SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 9 | Not reported | Not reported | Not reported | Not reported |
Drug-related SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 4 | Not reported | Not reported | Not reported | Not reported |
AEs leading to discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 8 | Not reported | Not reported | Not reported | Not reported |
Drug-related AEs leading to discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 7 | Not reported | Not reported | Not reported | Not reported |
All AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 17 | Not reported | Not reported | Not reported | Not reported |
Drug-related AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 17 | 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
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- title
- All deaths
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- title
- Deaths within 30 days of last dose
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 9
- title
- All SAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- title
- Drug-related SAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 8
- title
- AEs leading to discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 7
- title
- Drug-related AEs leading to discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 17
- title
- All AEs
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 17
- title
- Drug-related AEs
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 17
- 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 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.
- groups
- description
- Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
- id
- OG000
- title
- Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
- description
- Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
- id
- OG001
- title
- Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
- description
- Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
- id
- OG002
- title
- Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
- description
- Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
- id
- OG003
- title
- Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
- description
- Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
- id
- OG004
- title
- Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
- param Type
- NUMBER
- population Description
- All treated participants, participants who received at least 1 dose of dasatinib.
- reporting Status
- POSTED
- time Frame
- Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
- title
- Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice