TriangleNCT03158220 · OUTCOME
Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.
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 adverse event 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 adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status 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 | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Women 27-45 Years of Age | 0.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.2
- denoms
- counts
- group Id
- OG000
- value
- 570
- group Id
- OG001
- value
- 640
- units
- Participants
- description
- An adverse event 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 adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status 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 Who Had Study Vaccine Discontinued Due to Adverse Event.
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice