e., randomized subjects who took any study medication), whether or not they provided any efficacy data. The specific terms used to describe the adverse events in each of the articles were retained during the data extraction. These were then EX 527 cost grouped into relevant categories. Dyspepsia, nausea/vomiting, and abdominal pain were considered separately and also

in aggregate as ‘minor gastrointestinal events’. Dyspepsia was taken to include terms covered by the Medical Dictionary for Regulatory Activities (MedDRA) preferred term ‘dyspepsia’, nonspecific (functional) gastrointestinal disorders, eructation, abdominal/epigastric discomfort, and abdominal tenderness but not abdominal pain. Gastrointestinal bleeding was defined as including all bleeding in the gastrointestinal tract, ranging from a positive stool test to melena. Clinically active gastrointestinal ulcers LCZ696 mouse and perforations were also tabulated, but purely endoscopic findings were not. The term ‘gastrointestinal events’ was

reserved for descriptions of low specificity reported as a sole safety outcome, as well as an overall summary of other events considered in the same publication. Gastrointestinal events that did not match one of these outcome categories were not considered in the analysis (e.g. diarrhea, flatulence, constipation, dry mouth). Data entry was repeated on the 5 % of clinical trial and observational reports that provided the largest number of endpoints. Articles with discrepancies were re-reviewed to reconcile the differences. The risk of experiencing gastrointestinal adverse events after short-term treatment with aspirin was assessed using meta-analytical

methods. We did not include observational studies, as they rarely provided ASK1 detailed data regarding dose and duration of treatment, and they did not directly compare different agents with each other. We OSI-027 solubility dmso included parallel-design, randomized clinical studies with at least one aspirin arm at a dose between 325 and 4,000 mg/day and a treatment duration of at most 10 days. We included only articles that studied aspirin as monotherapy, i.e., not in combination with other active agents (e.g., ephedrine). Vitamin C and caffeine were not considered active components. No exclusions were made with regard to blinding, subject compliance, single vs. multiple dosing, total dosages, or formulations. Crossover trials were excluded because of concerns regarding unknown carryover effects, patient dropout between treatment phases, and within-patient correlations. To avoid including previously reported data, publications describing Bayer-sponsored studies that were included in a previous report [7] were also not included in the current analysis. After these exclusions, a total of 152 studies from 150 publications were considered. In some reports, the number of subjects allocated to each study treatment was stated only as a percentage of an overall total.