OBJECTIVE To quantify the frequency and seriousness of adverse events in non-oncology phase I studies with healthy participants. DESIGN Meta-analysis of individual, healthy volunteer level data. SETTING Phase I studies with healthy volunteers conducted between September 2004 and March 2011 at Pfizer's three dedicated phase I testing sites in Belgium, Singapore, and the United States. These ...

background: imatinib is known as the drug of choice for treatment of chronic myeloid leukemia (cml). for adults the recommended daily dosage of 400 mg requires simultaneous intake of up to four capsules or tablets each 100 mg. a new 400 mg film coated tablet developed due to the need to swallow multiple capsules or tablets per dose and that was a negative impact on treatment adherence. subjects...

: The sheer amount of information about potential adverse drug events published in medical case reports pose major challenges for drug safety experts to perform timely monitoring. Efficient strategies for identification and extraction of information about potential adverse drug events from free-text resources are needed to support pharmacovigilance research and pharmaceutical decision making. T...