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Most subjects had been treated with risperidone in their previous study and would be expected to have already established tolerability upon entering this open-label study, Somnolence was limited mainly to the start of open-label treatment.
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Additional studies are needed to explore the relative influences of enhanced tolerability versus efficacy upon prescribing practices in BD patients.
Dose adjustment was permitted based upon tolerability and response criteria.
Dose reductions of GMB and irinotecan were allowed based upon treatment tolerability.
To date, in clinical usage and in observational studies, the findings are mixed with regard to ocular tolerability and may depend upon the study design.
Trials with PD‐1 targeted agents are now under way and the relative merits of these, ipilimumab, and interferon will depend upon the tolerability of regimens.
The recommended phase-II dose of 52 68 mg m−2 was based upon clinical tolerability and the assessment of biological activity by means of PET and DCE MRI analysis.
This phase I study evaluated the tolerability and its effects upon DNA methylation and gene reactivation in patients with untreated cervical cancer.
As methemoglobin serves as a toxicity measure, pre-evaluation of methemoglobin reductase activity may be useful to assess tolerability to methemoglobin rise upon nitrite administration.
The aim of this study was to determine tolerability, toxicities, the maximum tolerated dose (MTD) based upon predetermined dose limiting toxicities (DLT) and the recommended phase II dose of OM-174 administered as a 15 minutes intravenous infusion, repeated twice weekly for 5, 10 or 15 administrations.
In summary, based upon its safety, tolerability profile, PK characteristics and potential antineoplastic activity in patients with advanced solid tumours, further evaluation of TAK-285 for the treatment of patients with solid tumours appears warranted.
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