Supportive Care in Cancer

, Volume 6, Issue 5, pp 457–461 | Cite as

Stratification in clinical trials of febrile neutropenia

  • Linda S. Elting


Patients with febrile neutropenia are characterized by well described prognostic factors leading to heterogeneity of risk of serious clinical outcomes. These prognostic factors complicate the design and interpretation of clinical trials of antimicrobial therapy in this population. Stratification is a method by which comparability of groups is ensured. This method can be employed prior to randomization or during the analysis. Factors that should be considered for stratification prior to randomization include the underlying neoplasm (leukemia vs solid tumor vs BMT), use of granulocyte growth factors, comorbid conditions and study site (in multicenter trials). In stratified analyses, trend in neutrophil count, site of infection, organism and susceptibility should be considered.

Key words Stratification Randomization clinical trials 


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Copyright information

© Springer-Verlag Berlin Heidelberg 1998

Authors and Affiliations

  • Linda S. Elting
    • 1
  1. 1.The Ambulatory and Supportive Care Oncology Research Program, The Section of General Internal Medicine, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd. (Box 40), Houston, TX 77030, USA Tel.: +1 713 792–8645US

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