Statistical Monitoring and Sensitivity Analyses
Cross-source consensus on Statistical Monitoring and Sensitivity Analyses from 1 sources and 5 claims.
1 sources · 5 claims
Evidence quality
Other
Other
Other
Highlighted claims
- Minimum thresholds are 69 chart-confirmed GBS cases, 12 chart-confirmed ADEM cases, and either 63 adjudicated AF cases or 69 confirmed AF cases if AF PPV is below 80%. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- Annual monitoring queries will cumulatively report vaccine uptake, recipient characteristics, and claims-identified potential outcome cases. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- Inferential analyses occur only after predefined minimum case thresholds are met. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- Sample size calculations support the thresholds as sufficient to detect a twofold increased GBS or AF risk or a sevenfold increased ADEM risk with 80% power. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- Sensitivity analyses will vary risk and control window assumptions for GBS, ADEM, and AF. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study