Harms and adverse events in clinical research

Failure to report harms and adverse events in clinical trials: why does the problem continue?

Good Clinical Practice (GCP) is an internationally adopted standard for clinical trials, and one important component of this document is the requirement that investigators inform trial sponsors of serious adverse events, defined as ‘‘any untoward medical occurrence that results in hospitalization or prolongation of hospitalization, or is life-threatening, or results in death or disability, incl...

Adverse Events from Clinical Studies in Pharmaceutical Research and Development

Clinical Review, Adverse Events

1.1 Background Carbamazepine (CBZ) is an anticonvulsant with FDA-approved indications in epilepsy, bipolar disorder and neuropathic pain. CBZ is associated with Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), closely related serious cutaneous adverse drug reactions that can be permanently disabling or fatal. Other anticonvulsants, including phenytoin, phenobarbital, and lam...

Combined Leucopenia and Thrombocytopenia Are Possibly Adverse Events of Lamotrigine

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Adverse events and preventable adverse events in children.

CONTEXT Patient safety has been recognized as an important problem in health care. However, knowledge about adverse events and preventable adverse events in children is relatively limited. OBJECTIVE To describe the incidence and types of adverse events and preventable adverse events in children. DESIGN Analysis of pediatric hospitalizations in the Colorado and Utah Medical Practice Study, w...