Sentence examples for safety dataset from inspiring English sources

The safety dataset included participants who received at least one dose of study drug.

The safety dataset included all patients who received ≥1 dose of investigational product.

Withdrawals due to AEs were summarized for each cohort in the safety dataset.

Analyses of PRO-AEs from prespecified and non-prespecified patient populations need different methodologies, including definition of a core safety dataset to permit useful signal detection.

The relatively small train safety datasets the ERA uses are susceptible to the heavy weighting applied to fatal rail accidents; Britain's last passenger train incident fatality was at Grayrigg in 2007.

There were no identified outliers (studentized residuals) and no predose concentrations > 5% of the corresponding Cmax; therefore, the pharmacokinetic, statistical, and safety datasets included all 36 participants from cohort 1.

All available data from all patients who received at least one infusion of the study medication were included in the safety and efficacy datasets.

This paper examines patterns and trends in motor vehicle safety recalls using a dataset based on 23.1 million vehicles registered in the UK between 1992 and 2002.

This substantial increase in the number of targets for safety assessment makes full dataset evaluations an untenable proposition from an animal testing perspective as well as from simple consideration of resources and timeliness.

Hence, although the FDA guidance infers that PRO instruments should aim to measure the adverse consequences of treatment separately from the effectiveness of treatment, more recent methodologies would support efficacy (or effectiveness) data being collected from the same dataset as safety, and may in fact improve the utility of the information [ 33].

Automated arrhythmia detection is commonly used in the clinic and adapted tools may be used to facilitate analysis of large non-clinical datasets in safety pharmacology.