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Of the originally planned enrollment of 2,343 individuals, 1,711 (73%) returned the baseline questionnaire with valid answers to the LBP-questions.
This multicenter, randomized, open-label phase III trial (planned enrollment: 700 patients) was conducted to test the hypothesis that single-agent sunitinib improves progression-free survival (PFS) compared with capecitabine as treatment for advanced breast cancer (ABC).
Planned enrollment was up to 70 patients.
Planned enrollment was 90 patients (60 active-gel and 30 placebo-gel group recipients), the number required to provide a power of ⩾0.80 to detect a difference in response rates conditional on target tumour volume, using a two-tailed α level of 0.05 (Muñoz and Rosner, 1984).
Planned enrollment was 120 adults (≥ 18 years) having Karnofsky performance scores > 80% with recently diagnosed, pathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, or related site, planned to receive a conventional course of external beam irradiation (single daily fractions of 2.0‐2.2 Gy) with a cumulative dose of between 50 Gy and 72 Gy.
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Health plan enrollment for a 6-month baseline period prior to the index date was required to assess patient characteristics and diagnostic/treatment history.
Patients were required to have at least 2 years of continuous health plan enrollment prior to the index laboratory date (i.e., first elevated FPG or A1C value) and for 6 months post index date.
In Part B, a maximum of 54 patients was planned for enrollment.
Before study initiation, up to 30 patients were planned for enrollment with a sample size of 3 6 patients per dose cohort for each of 5 dose cohorts.
Medicare Advantage plan enrollment doubled from 2004 to 2010, and accounts for 25 percent of Medicare beneficiaries.
Exchange plan enrollment began on Oct. 1 and runs through March.
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