Sentence examples for a registration trial from inspiring English sources

A registration trial with onabotulinumtoxinA treatment of glabellar lines in Japanese subjects was also conducted.

This study is also performed as a registration trial for regulatory approval.

The European Medicines Agency EMAA) denied that a comparator arm would be pivotal in a registration trial pointing at the a.m. biochemical surrogate and an internationally accepted (and harmonized) threshold for castration.

To this end, a single-dose study will not be sufficient in a registration trial, and at least two administrations of the study drug will be required because otherwise an acute-on-chronic phenomenon cannot be excluded.

Even though all CV events were prospectively adjudicated, the study was a registration trial neither designed nor powered to assess CV outcomes, and the overall number of CV events was low (n = 38).

(7, 10, 31) Paclitaxel at a dose of 210 mg/m, repeated every 3 weeks, was initially evaluated in Japan and yielded an objective PR rate of 28% in a registration trial of untreated or minimally treated gastric cancer patients.

To clear up the confusion, Scios is initiating a European registration trial: Evaluating Treatment with Nesiritide in Acute Decompensated Heart Failure (ETNA).

A phase II registration trial of an ipilimumab regimen consisting of 10 mg/kg doses every 3 weeks for 4 doses followed by maintenance infusions every 12 weeks was tested in 150 patients and yielded an overall response rate of 5.8% with stabiliation of disease in an additional 21.3%.

A phase II registration trial is underway for unmet need in refractory CLL patients using this PK-directed schedule.

In a phase 3 registration trial, 808 patients with HER2-positive metastatic breast cancer were randomized to receive placebo plus trastuzumab plus docetaxel (control group) or pertuzumab plus trastuzumab plus docetaxel (pertuzumab group) as first-line treatment.

Monitoring these outcomes has been built in to a number of registration trial programs, and further data collection over coming years will be important to build on the studies analyzed here.