TriangleNCT03158220 · OUTCOME
Percentage of Participants That Experienced at Least 1 Adverse Event (AE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 1 month post vaccination 3 (up to 7 months)
What was measured
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.
Analysis population: All participants that received at least 1 vaccination and had available data for endpoint.
Groups in this outcome
Women 16-26 Years of Age
Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
Women 27-45 Years of Age
Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
| Group | Source count |
|---|---|
| Women 16-26 Years of Age | 570 |
| Women 27-45 Years of Age | 640 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Women 16-26 Years of Age | 92.8 | Not reported | Not reported | Not reported | Not reported |
| Women 27-45 Years of Age | 92.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 92.8
- group Id
- OG001
- value
- 92.5
- denoms
- counts
- group Id
- OG000
- value
- 570
- group Id
- OG001
- value
- 640
- units
- Participants
- description
- An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.
- groups
- description
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- id
- OG000
- title
- Women 16-26 Years of Age
- description
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- id
- OG001
- title
- Women 27-45 Years of Age
- param Type
- NUMBER
- population Description
- All participants that received at least 1 vaccination and had available data for endpoint.
- reporting Status
- POSTED
- time Frame
- Up to 1 month post vaccination 3 (up to 7 months)
- title
- Percentage of Participants That Experienced at Least 1 Adverse Event (AE)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice