TriangleNCT02576977 · OUTCOME
Participants Experiencing 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 54 months
What was measured
An adverse event (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. Database cutoff was August 3, 2020.
Analysis population: The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.
Groups in this outcome
Pembrolizumab+Pomalidomide+Dexamethasone
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Standard of Care (SOC) Pomalidomide+Dexamethasone
Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
| Group | Source count |
|---|---|
| Pembrolizumab+Pomalidomide+Dexamethasone | 122 |
| Standard of Care (SOC) Pomalidomide+Dexamethasone | 123 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab+Pomalidomide+Dexamethasone | 122 | Not reported | Not reported | Not reported | Not reported |
| Standard of Care (SOC) Pomalidomide+Dexamethasone | 119 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 119
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 123
- units
- Participants
- description
- An adverse event (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. Database cutoff was August 3, 2020.
- groups
- description
- Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
- id
- OG000
- title
- Pembrolizumab+Pomalidomide+Dexamethasone
- description
- Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
- id
- OG001
- title
- Standard of Care (SOC) Pomalidomide+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. Participants were included in the treatment group corresponding to the study treatment they actually received.
- reporting Status
- POSTED
- time Frame
- Up to approximately 54 months
- title
- Participants Experiencing 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