Four other patients were excluded from the PP population,

Four other patients were excluded from the PP population, selleck chemicals llc one due to a major protocol violation and three due to insufficient exposure time. In regard to analysis of the primary efficacy outcome, 39 40 patients had sufficient post baseline data available for analysis in the ITT LOCF group. The PP OC efficacy analysis group had sufficient data available for analysis of 27 36 patients. Secondary effi cacy outcomes were likewise analysed according to the number of patients possessing sufficient data for evaluation at 12 weeks. Subgroup analysis of the ITT population with respect to previ ous DMARD treatment failure revealed that 20 40 patients were unresponsive to anti TNF. In addition, 33 40 patients were unresponsive to MTX. Among them, 18 patients were unresponsive to both anti TNFand MTX.

Analyses Inhibitors,Modulators,Libraries of the participant baseline characteristics with respect to previ ous treatment failure suggest that, although the entire Inhibitors,Modulators,Libraries population was classified as having very active RA, those patients previously treated with anti TNFwere suffer ing from RA of even greater severity than that of the other patients. Safety and tolerability of masitinib Assessment of safety was performed on all patients who had received at least one dose of masitinib over the study duration, including Inhibitors,Modulators,Libraries the treatment extension period with a cutoff date of 31 August 2008. Overall patient exposure to masitinib was 288 378 days on average, with a median exposure of 91 days and a range of 8 to 1,274 days. The incidence of com mon treatment related AEs according to intensity is presented in Table 2 for the initial and extension phases.

Inhibitors,Modulators,Libraries A total of 40 43 patients reported at least one masitinib related AE during the initial phase. In general, AEs were transient in nature and of mild to moderate intensity, nevertheless, occurrence of AEs was the main reason Inhibitors,Modulators,Libraries that 13 43 patients discontinued treatment. In 9 43 patients, the AEs were severe, including oedema and rash in 3 43 and 2 43 patients, respectively.One patient presented with angioedema of moderate intensity. This event resolved upon masitinib interruption and without specific med ications, ruling out any anaphylactic or anaphylactic like reac tion. No changes considered to be of clinical relevance were observed in regard to physical, haematological or urinalysis parameters during the initial phase, however, 1 43 patient presented with hepatic disorder of increased liver enzymes at a dose of 6 mg kg per day.

This episode, reported as a severe transaminase increase AE, occurred after 14 selleck Regorafenib days of treatment and resolved within 4 weeks of drug with drawal, with no reoccurrence following the reintroduction of treatment. Analysis of AEs with respect to the dose of their occurrence showed that no clear dose toxic ity relationships exist, with the exception of oedema. The number of patients experiencing at least one oedema was 11 43, with 6 36 for doses of not more than 6. 0 mg kg per day and 5 15 for doses of greater than 6.

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