Objective: Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events. The aim of this study was to develop optimised methods to evaluate the c
Data from Adverse Event Evaluation Form [CRF 95] Study Description A two-phase study that tested a behavioral intervention to treat depression in HIV-positive adolescents and young adults. Sites were
This open randomized trial investigates, if clinicians complete CTCAE ratings differently when receiving patients’ patient-reported outcome (PRO) data prior to their CTCAE completion. The primary obje
†3×2 cm abscess beginning three days after second immunization; subject withdrawn from further doses of vaccine; abscess resolved spontaneously. ††Subject developed severe pain, swelling and erythema,
This table enables the identification of the number of raters required to obtain a given certainty that a case ‘truly’ represents an adverse event. For example, if an investigator wished to be 95% cer