Sentence examples for ole studies of from inspiring English sources

The phase III and OLE studies of pegloticase employed a standardized method (CAPER) for assessing tophus size.

Overall, the frequency of TEAEs (range, 63% to 79%) and the frequency of SAEs (range, 7% to 13%) were consistent with other OLE studies of RA treatments such as belimumab, tocilizumab and abatacept [ 9, 11, 12].

Similarly, the IR of serious infections reported in this study (4.1/100 PYs) is consistent with IRs reported from OLE studies of other anti-TNFs (ranging from 2.8/100 PYs to 6.4/100 PYs) [ 19, 22– 24] and also with a recent pooled safety analysis of clinical CZP trials in RA (3.65/100 PYs) [ 25].

During the OLE study, pharmacokinetic concentrations of tabalumab closely aligned with RCT1 and RCT2 model predictions (data not shown).

The proportion of patients with an overall response of CR and the proportion of tophi with TT-CR increased with treatment duration in the OLE study, reaching (39 (70%) of 56 patients and 132 (55%) of (238) of target tophi after one year of treatment in patients receiving pegloticase during both studies.

After 1 year of pegloticase treatment in the OLE study, 61% (185/302) of all target tophi had completely resolved.

Gout flares occurred in 71% of patients (106/149) during the OLE study; the mean number of flares per patient per 3-month period was 0.5 over the duration of the trial.

In the present OLE study, exposure-adjusted rates of TEAEs were lower than rates reported for other biologics used to treat RA, although data in the previous studies were summarized from a greater number of PYs [ 13, 14].

For example, in the cohort of patients sustaining goal urate-lowering on the biweekly pegloticase OLE dose schedule, flares diminished substantially (occurring in 26% (9/35) during months 1 3 of the OLE study, 9% (3/32) during months 10 12 and 3% (1/29) during months 22 24).

For all patients in the OLE study, overall tophus CR was achieved in 60% of patients (56 of 94) and the TT-CR was 53% (207 of 390 target tophi) at the final visit.

At that level, PrEP has been shown to reduce the risk of transmission by an estimated 96percentthoughugh a majority of participants in the iPrEx OLE study, from which that figure is derived, did not achieve that level of adherence).