While the safety and tolerability of abatacept has been described in the individual randomized trials [ 12], it is prudent to evaluate the overall risk of infections requiring hospitalization (hospitalized infections), of hospitalized pneumonia, and of tuberculosis (TB) and other opportunistic infections in the cumulative trial experience.
RESULTS: A total of 8,988 patients were enrolled in the MERIT-HF (Metoprolol Controlled-Release Randomized Intervention Trial in Heart Failure), COPERNICUS (Carvedilol Prospective Randomized Cumulative Survival trial), and BEST (β-Blocker Evaluation of Survival Trial) combined; 4,198 (46.7%) were from the United States.
Incidence rates and number of actual events reported in the cumulative abatacept trial population fall within the range of those expected based on infection rates in external RA cohorts.
11 In the 21-day cumulative irritation trial, 200 mL of each study product – tazarotene foam 0.1%, sodium lauryl sulfate 0.5% (positive control), distilled water (negative control), and vehicle foam – was applied to participants' backs once daily for 24±1 hours, and the application site was evaluated for signs of irritation.
Although the cumulative clinical trial evidence suggests that biologics do not confer susceptibility to CMC, it is important to bear in mind that with their increased use, biologics may be found to increase susceptibility to CMC in patients with otherwise subclinical mucosal Candida colonization.
A limitation of this study is that our figures on the cumulative percent of trials accounted for (Table 4) assume that all trials published in that journal were indexed in the database.
The same analyses were extended to the cumulative data from Trials 1 4 for the two pretesting conditions, although for these trials all rats were tested in the light and so increasingly experienced the same interference conditions.
First solution times were calculated using a cumulative score across trials.
We searched Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED) and five Korean databases up to February 2013.
We will search African Index Medicus, AFRO Library, the Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health, Dissertation Abstracts International, EMBASE, Education Resources Information Center, Western Pacific Region Index Medicus, Literatura Latinoamericana y del Caribe en Ciencias de la Salud, MEDLINE and PsycINFO for relevant studies.
