Sentence examples for phase iii trial data from inspiring English sources
This article provides a systematic overview of the available phase III trial data, discusses biomarkers predictive of response to treatment, addresses safety concerns associated with specific agents, and provides practical, evidence-based recommendations for the later lines of treatment for patients with unresectable aCRC.
Preliminary Phase III trial data for the experimental Alzheimer's disease treatment is expected in the second quarter of 2007.
Definitive phase III trial data are lacking for the VEGF pathway inhibitors in this patient population.
Definitive phase III trial data are lacking for the VEGF pathway inhibitors in patients with poor prognostic features.
Mean duration of OS partitioned into health states TOX, TWiST, and REL was estimated from the phase III trial data (Marcus et al, 2008).
However, phase III trial data found it to be inferior to tamoxifen, bringing an apparent end to its investigation as a breast cancer treatment.
For phase III trials, data from phase II trials generally exist [ 24].
The addition of cetuximab to oxaliplatin-based regimens has not been previously reported in a phase III trial, but data from the large OPUS phase II study show no significant uplift in toxicity when combining cetuximab with FOLFOX-4 (a regimen with a lower infused 5FU dose compared with that used in the COIN trial) (Bokemeyer et al, 2007).
The increased scrutiny also led the FDA to issue guidance recommendations in December 2008, requiring that all investigational antidiabetic agents demonstrate that treatment will not result in an unacceptable increase in CV risk, via meta-analysis of phase II and III trial data and/or large, long-term CV safety studies [ 10].
Considering that in phase III trials comparable data for both treatment and control groups are available, it is important to compare frequency and pattern of liver injury between the groups.
A second Phase III trial intended to provide supporting data for registration has been completed.
