An Independent Data Monitoring Committee (IDMC) was established to evaluate data related to efficacy and safety at predefined time points (see on-line supplement for IDMC statistical monitoring guidelines).
An interim analysis meeting will be held by the data monitoring and safety committee to review data relating to intervention efficacy, participant safety and quality of trial conduct.
Most of the mature data relating to the efficacy of targeted agents in CRC treatment have been derived using irinotecan combinations.
In line with the terms of the DMSC charter, one formal interim analysis meeting will be held to review data relating to treatment efficacy, participant safety and quality of trial conduct.
Overall, it is therefore important that data relating to the efficacy and safety/tolerability of fingolimod in Latin America should be generated by studies drawing from the appropriate ethnic backgrounds.
Despite these limitations, the initial long-term data relating to the efficacy of MR-prednisone are positive, with more than 29% of patients reporting less than 1 hour of morning stiffness after 12 months of treatment with MR-prednisone in the single-arm, open-label study.
Owing to the duration of the studies, the large number of patients planned for enrolment in multiple centres, and the clinical practice setting of NEXT and VENICE, these studies will produce a significant amount of comprehensive, high-quality, evaluable data relating to the safety, efficacy and clinical use of Nivestim™.
Excellent safety and efficacy data relating to AAV-mediated retinal gene augmentation therapy have been collected in early- and late-phase clinical trials in children and adults with a rare, early onset blindness called Leber's Congenital Amaurosis.
Data relating to EPZ007210.
Whereas the use of AAF in food allergy is well documented, there is a paucity of data related to their efficacy in treating CD due to other causes.
