TriangleNCT03948763 · OUTCOME
Number of Participants Who Experienced 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 27 months
What was measured
An AE is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study.
Analysis population: All participants who received at least 1 dose of study treatment. For AEs which occurred during Part 1 prior to switch-over, the information is in the Part 1: V941 Monotherapy column. For AEs which occurred during Part 1 subsequent to switch-over, the information is in the Part 1: V941 + Pembrolizumab column.
Groups in this outcome
Part 1: V941 Monotherapy
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
Part 1: V941 + Pembrolizumab
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
| Group | Source count |
|---|---|
| Part 1: V941 Monotherapy | 3 |
| Part 1: V941 + Pembrolizumab | 16 |
| Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab) | 20 |
| Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab) | 16 |
| Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: V941 Monotherapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: V941 + Pembrolizumab | 15 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab) | 20 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab) | 16 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 16
- units
- Participants
- description
- An AE is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study.
- groups
- description
- V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
- id
- OG000
- title
- Part 1: V941 Monotherapy
- description
- V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
- id
- OG001
- title
- Part 1: V941 + Pembrolizumab
- description
- V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
- id
- OG002
- title
- Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
- description
- V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
- id
- OG003
- title
- Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
- description
- V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
- id
- OG004
- title
- Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least 1 dose of study treatment. For AEs which occurred during Part 1 prior to switch-over, the information is in the Part 1: V941 Monotherapy column. For AEs which occurred during Part 1 subsequent to switch-over, the information is in the Part 1: V941 + Pembrolizumab column.
- reporting Status
- POSTED
- time Frame
- Up to approximately 27 months
- title
- Number of Participants Who Experienced an Adverse Event (AE)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice