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The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing.
The above findings should, however, be confirmed in larger studies, once mature data from ongoing HypoARC studies become available.
Mature data from five studies revealed improvement in PFS when bevacizumab was added to standard chemotherapy [ 98, 99, 101] (Table 2).
Survival comparisons of docetaxel and paclitaxel plus carboplatin are awaited – in particular, mature data from the SCOTROC trial (Scottish Randomised Trial in Ovarian Cancer).
There are no mature data from the trials, although an interim report presented at a scientific meeting when 470 patients had been included could not see any gain (van de Velde, personal communication).
Mature data from the IES, with a median follow-up of 91 months, demonstrated that switching to exemestane improves both disease-free and overall survival with serious side-effects rare in both the groups (Bliss et al, 2011).
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The impact of adjuvant treatment on OS was extracted directly or estimated indirectly from published data of six trials with mature data (1,997 patients)[ 7, 14, 16, 18- 20].
The remaining, non-protein coding transcripts were analyzed with mature miRNA data from miRBase.
Using mature (2010) data from the phase 3 trial [ 8], this multivariate analysis aimed to identify potential predictors of survival and response in this older population with AML.
Mature phase III data from the lead compounds is awaited.
To compare DNA methylation status between non-germline (H1 and IMR90) and mature sperm cells, the average DNA methylation level of each CGI was calculated using whole-genome DNA methylation data from mature human sperm cells at single base-pair resolution [ 27, 28].
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