Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups.
Safety was evaluated through incidence of adverse events, changes in laboratory parameters and subject's rating for tolerability of treatment.
Analysis of the results of the global tolerability assessments by the investigators and patients/parents revealed that the treatment was well-tolerated (tolerability rating of "good") or very well-tolerated (tolerability rating of "very good") in the vast majority of cases for both the FAS and PPS (see Table 5).
In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.
Interestingly outpatients seemed more difficult to manage, as they had much higher medication switch rates with lack of tolerability being three-fold increased compared to inpatients, and lack of compliance being substantially increased.
At month 8 of course 1, 75.0% of physicians and 71.5% of patients considered the efficacy of RTX to be good or very good, while 98.6% of physicians and 92.7% of patients rated the tolerability of RTX to be good or very good.
Safety assessments included incidence of AEs, neurological and physical examinations, vital signs and patient and investigator global assessment of tolerability, rated on a four-point scale (1=very good; 2=good; 3=moderate; 4=insufficient).
Similarly 91.8 % of the physicians rated the tolerability of the treatment with incobotulinumtoxinA as ‚very good', but only 13.3%% of the CON group.
The aim of our phase II ECKINOXE study is to evaluate the efficacy (response rate) and tolerability of two regimens of neoadjuvant chemotherapy among patients with locally advanced CC.
On the basis of these considerations, we conducted a single-arm phase II study to evaluate the objective response rate and tolerability of the combination of gemcitabine and carboplatin in Chinese patients with advanced transitional cell carcinoma of the urothelium.
