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Plasma concentration profiles in the Large White pig model produced a Cmax of 3.77 ± 1.375 μg/mL compared to 10.604 ± 2.846 μg/mL for the comparator formulation.
Probable and highly probable malignancies occurred in 0.055 per 100 person-years among JIA children compared to 0.013 per 100 person-years for the comparator group, leading to a significantly increased SIR of 4.4 (95% CI 1.8 to 9.0).
Safety data pooled from five pivotal tocilizumab studies demonstrate rates of serious infection of 3.5 per 100 patient-years for the 4 mg/kg dose and of 4.9 per 100 patient-years for the 8 mg/kg dose compared with 3.4 per 100 patient-years for the comparator groups over a median 3.1 years' treatment duration [ 109].
A design introduced for the comparator by its manufacturer but not originally intended for the comparator was compared with an A-optimality design that can reduce the average variance by 33%.
In the CPG−DDS safety study by Alloueche et al., Day 3 and Day 14 data were sparse, but at Day 7 there was a significantly larger decrease in mean hemoglobin with CPG−DDS than for the comparator sulfadoxine−pyrimethamine (SP): treatment difference −4 g/L (95%CI −6, −2) [7].
The index date for the comparator cohort was the earliest claim record.
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For the comparator-controlled trials, only patients who received ExQW treatment during the initial controlled periods and who continued ExQW into the extension periods to 52 weeks were included in this analysis.
Similar assessments were done for the comparators studies.
The mortality rates for stage 1 for the comparators were not modelled.
Only stage 2 mortality rates of 20%% (woven graft option) and 30%% (branched graft option) were assumed for the comparators.
As no other product had reported data in a similar subpopulation, a conservative approach was taken by not varying the efficacy rates for the comparators in sensitivity analyses.
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