Serious adverse events in trials evaluating biologics in psoriasis

Postoperative serious adverse events in a teaching hospital.

OBJECTIVE To assess the incidence and nature of postoperative serious adverse events (SAEs) among inpatients having surgery in a tertiary hospital, and to determine which subgroups of patients might be at greatest risk. DESIGN Prospective observational study from 1 December 1998 - 31 March 1999. SETTING Tertiary teaching hospital in Melbourne, Victoria. SUBJECTS 1,125 subjects having inpa...

Serious adverse events in academic critical care research.

Biologics in the management of psoriasis

Psoriasis is a chronic inflammatory systemic disease for which there exist topical, ultraviolet, systemic, and biologic treatments. Biologic agents selectively interfere with the immune mechanisms responsible for psoriasis. Etanercept, infliximab, and adalimumab target tumor necrosis factor-alpha and have demonstrated efficacy in the treatment of psoriasis and psoriatic arthritis. Alefacept and...

Classifying Adverse Events from Clinical Trials

Statistical Analysis of Adverse Events in Randomized Clinical Trials

Adverse events are generally tabulated and listed in statistical reports in randomized clinical trials. This paper introduces how to apply statistical methods to assess adverse events using SAS. In addition to the crude percentage (rate), adverse events are also adjusted by exposure time or multiple repeat. The paper also introduces the commonly used chi-square test and Fisher‟s exact test, and...