He continued to accrue stage credits, including a turn as a gay teenager in Edward Albee's The Goat; or, Who Is Sylvia?
It is obvious here that roughly 75% of these costs accrued in stage 1.
The protocol was amended and additional patients accrued to stage II.
If more or less patients are accrued in stage 2, this implies modifying this boundary to control for the type I error rate, but it has no impact on estimation.
The BCIRG 006 trial accrued early stage HER2 overexpressing breast cancer patients between April 2001 and March 2004 and compared three arms: AC-T (adriamycin, cyclophosphamide, and paclitaxel), AC-TH (adriamycin, cyclophosphamide, paclitaxel and trastuzumab), and TCH (docetaxel, cyclophosphamide, and trastuzumab).
Assuming p0 (low response rate) 20% and p1 (target response rate of interest for further investigation) 35% and with an α error of 0.05 and a β error of 0.20 a total of 31 evaluable patients had to be accrued during stage 1.
For those undergoing treatment with curative intent, the majority of costs were accrued during staging, primary treatment and the twelve months of follow-up post referral, with annual costs in the following years ranging from £338 to £815 (uninflated £308-£807) and £363 to £1,452 (uninflated £338-£1,437), for those undergoing chemoradiotherapy and radiotherapy alone, respectively.
The statistical design and planned 3-stage patient accrual, including the numbers of patients to be accrued at each stage in both subgroups is described in Table 3.
The study was designed as a single-arm, prospective, non-randomised, non-comparative, open label phase II trial, with all patients being accrued in one stage.
As the T242N mutation has been previously linked with compensatory mutations we analysed our cohort to see if these accrued in late stage disease to explain the rise in viral fitness despite the maintenance of T242N.
