Sentence examples for endpoints of safety from inspiring English sources

Phase 1 trials use standard endpoints of safety, pharmacokinetics and limited pharmacodynamics.

This phase I IDE study (STAPLE-1) evaluated the primary endpoints of safety (major device-related adverse events at 30 days) and feasibility (successful deployment of all endograft components) of the Aptus Endovascular abdominal aortic aneurysm (AAA) Repair System (Aptus Endosystems, Inc, Sunnyvale, Calif) to treat AAAs.

In this multicentre, nonrandomised study, the investigators looked at primary endpoints of safety and sustained blood pressure reduction from the procedure, with secondary endpoints of procedural effect on renal noradrenaline spillover and effect on renal function [ 30].

This was an open-label, single-institution, single-arm, phase I study with the primary endpoint to evaluate the immunogenicity of ICT-107 and secondary endpoints of safety and efficacy in patients with glioblastoma or brainstem glioma.

The primary endpoint was CBR with secondary endpoints of safety, objective response rate (ORR) and time-to-treatment failure (TTF), which is the duration of treatment (in months) of patients who have failed on treatment including those with adverse events and also including patients still on treatment.

7 9 10 We analysed single (instead of composite) endpoints of safety and have provided new insights suggesting that biodegradable polymer biolimus-ES is associated with similar (not higher) safety compared with the first generation sirolimus-ES and with a significantly higher rate of myocardial infarction compared with everolimus-ES.

The second primary endpoint of safety for this study showed that there were no serious or unexpected adverse events.

Although some have argued that such studies with a primary endpoint of safety cannot confirm efficacy of the test agent, they have identified the presence of certain safety concerns.

These can be a family of primary safety endpoints, of secondary safety endpoints, of efficacy on subgroups, and so on.

In phase I clinical studies of cytotoxic anticancer agents, the incidence, type, and grade of toxicity are evaluated as primary endpoints for assessment of safety and tolerability.

This study met its primary endpoint of cardiac safety, as the rate of cardiac events was low.