TriangleNCT00603447 · OUTCOME
Number of Participants With Adverse Events (AEs)
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 first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.
What was measured
Treatment-related are those AEs with possible or probable relationship to carfilzomib, lenalidomide or dexamethasone as assessed by the Investigator. The severity of each adverse event was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, per the following: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Serious adverse events were defined as AEs meeting one of the following: death, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in the offspring of an exposed participant, important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above, or pregnancy or suspected pregnancy.
Analysis population: Safety population consisting of all treated participants
Groups in this outcome
1: CFZ 15 mg/m² + LEN 10 mg
Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
2: CFZ 15 mg/m² + LEN 15 mg
Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
3: CFZ 15 mg/m² + LEN 20 mg
Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
4: CFZ 20 mg/m² + LEN 20 mg
Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
5: CFZ 20 mg/m² + LEN 25 mg
Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
6: CFZ 20/27 mg/m² + LEN 25 mg
Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
7: CFZ 20/27 mg/m² + LEN 25 mg
In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
| Group | Source count |
|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 6 |
| 2: CFZ 15 mg/m² + LEN 15 mg | 6 |
| 3: CFZ 15 mg/m² + LEN 20 mg | 8 |
| 4: CFZ 20 mg/m² + LEN 20 mg | 6 |
| 5: CFZ 20 mg/m² + LEN 25 mg | 6 |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 8 |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 44 |
Reported measurements
Any adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 2: CFZ 15 mg/m² + LEN 15 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 3: CFZ 15 mg/m² + LEN 20 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| 4: CFZ 20 mg/m² + LEN 20 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 5: CFZ 20 mg/m² + LEN 25 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 44 | Not reported | Not reported | Not reported | Not reported |
Treatment-related adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| 2: CFZ 15 mg/m² + LEN 15 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| 3: CFZ 15 mg/m² + LEN 20 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| 4: CFZ 20 mg/m² + LEN 20 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| 5: CFZ 20 mg/m² + LEN 25 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 43 | Not reported | Not reported | Not reported | Not reported |
Grade 3 or higher adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| 2: CFZ 15 mg/m² + LEN 15 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 3: CFZ 15 mg/m² + LEN 20 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| 4: CFZ 20 mg/m² + LEN 20 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 5: CFZ 20 mg/m² + LEN 25 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 41 | Not reported | Not reported | Not reported | Not reported |
Treatment-related Grade 3 or higher adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| 2: CFZ 15 mg/m² + LEN 15 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| 3: CFZ 15 mg/m² + LEN 20 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| 4: CFZ 20 mg/m² + LEN 20 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| 5: CFZ 20 mg/m² + LEN 25 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 38 | Not reported | Not reported | Not reported | Not reported |
Serious adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| 2: CFZ 15 mg/m² + LEN 15 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| 3: CFZ 15 mg/m² + LEN 20 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| 4: CFZ 20 mg/m² + LEN 20 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| 5: CFZ 20 mg/m² + LEN 25 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 22 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation of any study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| 2: CFZ 15 mg/m² + LEN 15 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| 3: CFZ 15 mg/m² + LEN 20 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| 4: CFZ 20 mg/m² + LEN 20 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| 5: CFZ 20 mg/m² + LEN 25 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 18 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation of carfilzomib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| 2: CFZ 15 mg/m² + LEN 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| 3: CFZ 15 mg/m² + LEN 20 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| 4: CFZ 20 mg/m² + LEN 20 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| 5: CFZ 20 mg/m² + LEN 25 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 9 | Not reported | Not reported | Not reported | Not reported |
Deaths within 30 days of last dose of study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| 2: CFZ 15 mg/m² + LEN 15 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| 3: CFZ 15 mg/m² + LEN 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| 4: CFZ 20 mg/m² + LEN 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| 5: CFZ 20 mg/m² + LEN 25 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 44
- title
- Any adverse event
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 43
- title
- Treatment-related adverse event
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 41
- title
- Grade 3 or higher adverse event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 38
- title
- Treatment-related Grade 3 or higher adverse event
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 22
- title
- Serious adverse event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 18
- title
- AE leading to discontinuation of any study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 9
- title
- AE leading to discontinuation of carfilzomib
- 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
- 3
- title
- Deaths within 30 days of last dose of study drug
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 44
- units
- Participants
- description
- Treatment-related are those AEs with possible or probable relationship to carfilzomib, lenalidomide or dexamethasone as assessed by the Investigator. The severity of each adverse event was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, per the following: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Serious adverse events were defined as AEs meeting one of the following: death, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in the offspring of an exposed participant, important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above, or pregnancy or suspected pregnancy.
- groups
- description
- Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
- id
- OG000
- title
- 1: CFZ 15 mg/m² + LEN 10 mg
- description
- Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
- id
- OG001
- title
- 2: CFZ 15 mg/m² + LEN 15 mg
- description
- Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
- id
- OG002
- title
- 3: CFZ 15 mg/m² + LEN 20 mg
- description
- Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
- id
- OG003
- title
- 4: CFZ 20 mg/m² + LEN 20 mg
- description
- Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
- id
- OG004
- title
- 5: CFZ 20 mg/m² + LEN 25 mg
- description
- Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
- id
- OG005
- title
- 6: CFZ 20/27 mg/m² + LEN 25 mg
- description
- In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
- id
- OG006
- title
- 7: CFZ 20/27 mg/m² + LEN 25 mg
- param Type
- NUMBER
- population Description
- Safety population consisting of all treated participants
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.
- title
- Number of Participants With Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice