Adverse Cardiovascular Events in Cancer Trials

Trials of testosterone replacement reporting cardiovascular adverse events

The numbers of testosterone prescriptions written have increased several-fold worldwide, but the incidence of pathological hypogonadism due to hypothalamic, pituitary, and testicular disease has remained unchanged. Most of these prescriptions are being dispensed to middle-aged and older men who have experienced age-related decline in serum testosterone levels; a subset of the population in whic...

Classifying Adverse Events from Clinical Trials

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

BACKGROUND Varenicline is an efficacious smoking-cessation drug. However, previous meta-analyses provide conflicting results regarding its cardiovascular safety. The publication of several new randomized controlled trials (RCTs) provides an opportunity to reassess this potential adverse drug reaction. METHODS AND RESULTS We searched MEDLINE, EMBASE, and the Cochrane Library for RCTs that comp...

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...

Patient-reported tolerability of adverse events in phase 1 trials

BACKGROUND Phase I experts recommend revisiting dose-limiting toxicity (DLT) definition to include chronic and cumulative toxicities induced by new molecularly targeted therapies. Patient's assessment of late toxicities' tolerability is, however, unknown. MATERIALS AND METHODS A prospective survey on adverse events (AEs) tolerability on 23 National Cancer InstituteCommon Terminology Criteria ...