Author Contributions: Dr Bennett had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Bennett,
Gleason, Courtney, McKoy, West, Henke.
Acquisition of data: Bennett, Samaras,
Gleason, Barnato, Elverman, Edwards.
Analysis and interpretation of data: Bennett, Silver, Djulbegovic, Blau, Gleason, Barnato, Courtney,
McKoy, Edwards, Tigue, Raisch, Yarnold, Dorr, Kuzel, Tallman, Trifilio,
Drafting of the manuscript: Bennett,
Samaras, Gleason, Barnato, Courtney, Trifilio, West, Henke.
Critical revision of the manuscript for important intellectual content: Bennett, Silver, Djulbegovic, Blau, Gleason,
Elverman, Courtney, McKoy, Edwards, Tigue,
Raisch, Yarnold, Dorr, Kuzel, Tallman, West, Lai, Henke.
Statistical analysis: Bennett, Djulbegovic,
Barnato, Courtney, Yarnold.
Obtained funding: Bennett.
Administrative, technical, or material support: Bennett, Samaras, Gleason, Elverman, McKoy, Tigue, Dorr, West,
Study supervision: Bennett, Edwards,
Kuzel, Tallman, Trifilio, West.
Financial Disclosures: Dr Blau reported that he was named as an inventor on patent applications related to the regulation of blood cell production and is a cofounder of CellNexus LLC, which aims to develop this technology for the treatment of anemia.
Drs Bennett and Djulbegovic reported serving as consultants to AMGEN and Dr Bennett reported that he has received grant support from AMGEN previously. Dr Silver reported that he is a consultant for Bear Stearns,
Maverick Capital, and The Marwood Group. No other authors reported financial disclosures.
Funding/Support: This work (Research on Adverse Drug Events and Reports [RADAR]) was supported by grants 1R01CA 102713-01, 1R-1 CA125077-01A1, and P 30 CA60553 from the National Cancer Institute and grant 5K23HL077404-04 from the National Heart,
Lung, and Blood Institute. The RADAR project does not accept funds from medical schools, hospitals, pharmaceutical organizations, or philanthropic donations. Dr Lai received support from the Young Clinical Scientist Award from the Flight Attendant Medical Research Institute and a National Institutes of Health Mentored Career Development Award (K08 DE018061).
Role of the Sponsor: The sponsors of this study had no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript.
Previous Presentations: This work has been presented in part at the plenary session for the Society of Clinical Trialists; May 23, 2007; Montreal, Canada, and at a poster session for the American Society of Clinical Oncology; June 5, 2007; Chicago,
Additional Contributions: Simone N.
Boyle, BA, Divisions of Hematology/Oncology, Northwestern University Feinberg School of Medicine, provided assistance with searching for studies included in the meta-analysis. Ms Boyle was supported by grant 1R-1 CA125077-01A1 from the National Cancer Institute.