TriangleNCT02807454 · 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose to 90 days after last dose (up to approximately 58 months)
What was measured
Number of participants who experienced at least one adverse event. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition should be considered an AE.
Analysis population: All participants who received at least 1 dose of the study medications.
Groups in this outcome
Simon Stage 1: D2 Arm
Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.
PD3 Arm
Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
| Group | Source count |
|---|---|
| Simon Stage 1: D2 Arm | 32 |
| PD3 Arm | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Simon Stage 1: D2 Arm | 31 | Not reported | Not reported | Not reported | Not reported |
| PD3 Arm | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Number of participants who experienced at least one adverse event. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition should be considered an AE.
- groups
- description
- Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.
- id
- OG000
- title
- Simon Stage 1: D2 Arm
- description
- Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
- id
- OG001
- title
- PD3 Arm
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least 1 dose of the study medications.
- reporting Status
- POSTED
- time Frame
- From first dose to 90 days after last dose (up to approximately 58 months)
- title
- Number of Participants With Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice