We identified 11 blinded, randomized studies which reported use of quality-of-life measures (Table 13). Studies which compared different treatment regimens, other than hemoglobin targets, were excluded. Two studies (8701 and 8904) submitted for the initial erythropoietin NDA submission and resubmitted for the 2007 FDA advisory committee meeting on ESAs and quality-of life-measures have never been published and were not available for review despite requests to the FDA and the sponsor (Amgen). (See FDA section.)
