Secondary endpoint data showed that SPID at 24 hours and 72 hours also was significantly greater in the sufentanil-treated patients...Previously, Ceregene reported the primary endpoint was not met for the overall study population, although a key secondary endpoint of diary-hours off demonstrated statistical significance and no safety issues were identified
AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies
The primary endpoint is overall survival, with secondary endpoints evaluating safety, tolerability, tumor response rates and the effect of therapy on Hsp27 levels and circulating tumor cells
Pfizer Inc., of New York, said that top-line data for a Phase IV trial of Celebrex (celecoxib) capsules or naproxen in juvenile idiopathic arthritis patients demonstrated no difference in changes to systolic blood pressure, the primary endpoint, and diastolic blood pressure, the secondary endpoint
The open-label, pivotal trial will enroll 400 subjects at about 80 sites in Australia, Canada, China, Europe, Latin America and the U.S. The primary endpoint is progression-free survival, and secondary endpoints include overall survival and safety
However, one of the secondary endpoints (Diary-off score), as defined and prespecified in the statistical analysis plan, did produce statistically significant benefit
The 26-week, double-blind, randomized, parallel group, placebo-controlled trial will evaluate change in percent atheroma volume after 26 weeks of treatment, with safety and tolerability as secondary endpoints, as well as changes in ApoA-I, HDL-, HDL-subclasses and non-HDL lipid parameters
Fifty percent of patients completing the study also met certain secondary endpoints, including a partial Mayo score reduction and mucosal healing as evaluated by endoscopy subscore measurements
The primary endpoints are safety and tolerability, with secondary endpoints including the pharmacokinetic profile of the drug and an efficacy evaluation as assessed by various parameters, such as response rate as measured by bone marrow biopsy
The drug also met secondary endpoints of reducing the proportion of patients who relapsed at one year, and reducing MS brain lesion activity...Secondary endpoints included biomarker assessment of patients enrolled in the study
Secondary endpoints will include assessing the change in fibroid volume and hemoglobin, while bone mineral density will be assessed via DXA scan at baseline, the conclusion of dosing and six months postdosing
placebo (p = 0.0007), and also hit statistical significance in secondary endpoints...The primary endpoint is safety, while the secondary endpoint is gluteal muscle function at six months, with the ability to perform biopsies of the involved muscle
The primary endpoint is rate of progression-free survival at 16 weeks, with secondary endpoints of objective response rate, duration of response and evaluation of pharmacodynamic tumor markers
Secondary endpoint data showed that 24 hours and 72 hours after first dose, SPID was significantly greater in the Sufentanil NanoTab arm (p < 0.001 and p = 0.004, respectively
The primary endpoint of the trial is progression-free survival, while secondary endpoints include response rate, overall survival and RAR beta expression, a potential biomarker for responders
The primary endpoint is objective response to the combination treatment compared to the chemotherapy alone, with overall survival as the main secondary endpoint
Secondary endpoints include measurements of changes in VA and central macular thickness, safety and tolerability...Secondary endpoints include absolute improvement in FEV1, change in body mass index or weight gain, number of pulmonary exacerbations and improvements in patient-reported outcomes as measured by the CF Questionnaire Revised
Secondary endpoint data showed that SPID at 24 hours and 72 hours also was significantly greater in the sufentanil-treated patients...Previously, Ceregene reported the primary endpoint was not met for the overall study population, although a key secondary endpoint of diary-hours off demonstrated statistical significance and no safety issues were identified