TriangleNCT02579863 · OUTCOME
Number of Participants Who Experienced One or More Adverse Events (AEs)
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 55 months
What was measured
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The database cutoff date was August 3, 2020.
Analysis population: The analysis population consisted of all randomized participants who received at least one dose of study treatment.
Groups in this outcome
Pembrolizumab + Lenalidomide + Dexamethasone
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Lenolidomide + Dexamethasone
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
| Group | Source count |
|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | 154 |
| Lenolidomide + Dexamethasone | 148 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | 152 | Not reported | Not reported | Not reported | Not reported |
| Lenolidomide + Dexamethasone | 141 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 141
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 148
- units
- Participants
- description
- An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The database cutoff date was August 3, 2020.
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
- id
- OG000
- title
- Pembrolizumab + Lenalidomide + Dexamethasone
- description
- Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
- id
- OG001
- title
- Lenolidomide + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis population consisted of all randomized participants who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 55 months
- title
- Number of Participants Who Experienced One or More Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice