Medical records-based postmarketing safety evaluation of rare events with uncertain status.
J Biopharm Stat
; 23(1): 201-12, 2013.
Article
en En
| MEDLINE
| ID: mdl-23331231
ABSTRACT
We develop a simple statistic for comparing rates of rare adverse events between treatment groups in postmarketing safety studies where the events have uncertain status. In this setting, the statistic is asymptotically equivalent to the logrank statistic, but the limiting distribution has Poisson and binomial components instead of being Gaussian. We develop two new procedures for computing critical values, a Gaussian approximation and a parametric bootstrap. Both numerical and asymptotic properties of the procedures are studied. The test procedures are demonstrated on a postmarketing safety study of the RotaTeq vaccine. This vaccine was developed to reduce the incidence of severe diarrhea in infants.
Texto completo:
1
Ejes tematicos:
Pesquisa_clinica
Banco de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
/
Ensayos Clínicos Controlados Aleatorios como Asunto
/
Registros Médicos
/
Vacunas contra Rotavirus
/
Seguridad del Paciente
Tipo de estudio:
Clinical_trials
/
Etiology_studies
Límite:
Humans
/
Infant
Idioma:
En
Año:
2013
Tipo del documento:
Article