TriangleNCT03948763 · OUTCOME
Number of Participants Who Discontinued Study Treatment Due to an 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 24 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. The number of participants who discontinued study treatment due to an AE is reported.
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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: V941 + Pembrolizumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) | 3 | 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
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- 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. The number of participants who discontinued study treatment due to an AE is reported.
- 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 24 months
- title
- Number of Participants Who Discontinued Study Treatment Due to an AE
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice