TriangleNCT02036502 · OUTCOME
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 72.7 months
What was measured
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
Analysis population: All participants who received ≥1 dose of study treatment.
Groups in this outcome
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
| Group | Source count |
|---|---|
| Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg | 6 |
| Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg | 3 |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg | 6 |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg | 1 |
| Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg | 1 |
| Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg | 45 |
| Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg | 1 |
| Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 45
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 10
- units
- Participants
- description
- An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
- groups
- description
- Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
- id
- OG000
- title
- Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
- description
- Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG001
- title
- Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG002
- title
- Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG003
- title
- Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG004
- title
- Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
- description
- Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
- id
- OG005
- title
- Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
- description
- Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
- id
- OG006
- title
- Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
- description
- Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
- id
- OG007
- title
- Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received ≥1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 72.7 months
- title
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice