cover image: Common Drug Review Clinical Review Report

Premium

20.500.12592/htn04t

Common Drug Review Clinical Review Report

3 Apr 2017

This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. [...] The clinical expert on this review also noted that the cosmetic issues can be particularly problematic for patients who work with the public, and this includes not only the lesions on the face but lesions that occur on the back of the hands. [...] The target areas were the face/forehead (A) and bald scalp (B), and the overall treatment area contained at least four and no more than 10 distinct AK lesions, with a distance of at least one centimetre between lesions, and a maximum lesion diameter of 1.5 cm.2 The primary outcome of the study was the proportion of patients with complete histological clearance of their pre-defined AK target lesion [...] The most common site of involvement was the face/forehead (48% of patients), and a small proportion of patients had involvement of both the face/forehead and bald scalp. [...] April 2017 CDR CLINICAL REVIEW REPORT FOR ACTICKERALL The sample size estimation for the test on superiority to placebo was based on the following assumptions: The rate of responders with respect to histological clearance of the target lesion was estimated to be: o 30% at a maximum for treatment with placebo o approximately 55% for treatment with 5-FU/SA the significance level was set to a = 0
health biology cancer medicine pharmacology therapy clinical trial biopsy medline clinical medicine license health sciences medical specialties adverse effect sd cancers randomized actinic keratosis phase ii fluorouracil 5-fu actinic keratoses hyperkeratotic actinic keratosis
Pages
42
Published in
Ottawa, ON, CA

Related Topics

All