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Secondary objectives included evaluations of safety and tolerability, time to response (TTR), duration of response (DOR), and progression-free survival (PFS).
The secondary end points included safety and tolerability, time to tumour progression (TTP), OS, and the 1- and 2-year survival rates.
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However, this may not always reflect the patient's experience of tolerability over time.
Outcome variables include seizure reduction, tolerability, and time continued on AED.
Up to now, only few studies have focused on the development of the clinical picture and the drug efficacy and tolerability in time.
Sorafenib was generally tolerated by patients with Child-Pugh class B disease, although their daily average dose of sorafenib was higher than that prescribed for patients with Child-Pugh class A. There was no significant difference in sorafenib tolerability or time to progression between the Child-Pugh class A and B groups, although overall survival was longer in the former group.
When a subgroup analysis was conducted by age categories, no differences were observed in children younger than 12 years old for efficacy (OR 0.86, 95%% CI 0.46 1.60) and tolerability measured as time to treatment withdrawal (HR 0.83, 95%% CI 0.34 2.04).
17, 18 Clinical studies with saxagliptin have demonstrated very satisfactory data on the improvement of glycemic parameters together with a good safety profile and good tolerability over a time range up to 24 weeks in clinical studies in a large cohort of patients.
The aims of the present phase II study, was to confirm the efficacy, convenience and tolerability of short-time EXE.
Drug efficacy, safety, tolerability and procedure times were recorded by an unbiased blinded doctor who did not participate in the sedation and procedures.
Secondary endpoints are overall survival (OS) time, safety, tolerability, RFS/OS in MUC-1 positive cancers.
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