Secondary Efficacy Endpoints Sample Clauses
Secondary Efficacy Endpoints. Secondary Endpoints
1) mRS 0-2 (functional independence) at 90 days
2) Level of disability at 90 days [mRS 6-level (0,1,2,3,4,5/6) ordinal distribution]
3) NIHSS (neurologic deficit) at 24 hours These additional clinical efficacy endpoints were selected as they assess important aspects of health state that are complementary to the primary endpoint. The mRS 0-2 (functional independence) dichotomy assesses patient ability to return to independent living in the community. The ordinal mRS indexes level of disability unmodified by qualitative patient ratings. The NIHSS at 24 (+/-12) hours indicates early therapeutic effects on neurologic deficits in a manner highly predictive of subsequent course. In the EVT Indication Expansion Domain study population, additional secondary clinical endpoints of distinctive clinical interest and informativeness for those populations will be obtained: Patients with Low NIHSS and patients with Medium/Distal Vessel Occlusion at study entry generally have more favorable prognosis under any treatment strategy. Accordingly, it is desirable to assess additionally the effect of study treatment upon health state transitions important in less severely affected acute ischemic stroke patients. The additional secondary clinical efficacy endpoint will be: o mRS 0-1 (freedom from disability) at 90 days
Secondary Efficacy Endpoints. Mean change from Baseline in the MIDAS Test total score at Week 12. • Mean change from Baseline in the HADS at Week 12. • Mean change from Baseline in patient-rated Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) total score in males and in females, analyzed separately, at Week 12.
Secondary Efficacy Endpoints. The change from baseline in eGFR in bardoxolone methyl-treated patients relative to placebo at Week 100. • The change from baseline in eGFR in bardoxolone methyl-treated patients relative to placebo at Week 104 following a 4-week drug treatment withdrawal period.
Secondary Efficacy Endpoints. Secondary efficacy endpoints will include: • Rate of moderate COPD exacerbations (defined as requiring treatment with systemic corticosteroids and/or antibiotics) and severe COPD exacerbations (defined as requiring hospitalisation) • Quality of Life determined using the St. George’s Respiratory Questionnaire (SGRQ) • COPD-related mortality • On treatment mortality • “Treatment Failure” as the composite endpoint of either severe COPD exacerbation, initiation of LTOT, or on treatment mortality • Clinic post-bronchodilator FEV1 (assessed 24-weekly) • Number of withdrawals from treatment • Health status using the EuroQol (EQ-5D) Questionnaire • Healthcare resource utilisation, including primary care contacts and secondary care contacts and use of rescue/concurrent medications • Other exacerbation endpoints (time to first moderate or severe COPD exacerbation, rate of severe COPD exacerbations, time to first severe COPD exacerbation, rate of moderate and severe COPD exacerbations requiring systemic COPD exacerbations, time to first moderate or severe COPD exacerbation requiring systemic corticosteroids) These will include adverse events reported while on study drug and additional information on bone fractures that occurred. This is a multicentre, randomised, double-blind, parallel group study in subjects with COPD treated for a period of 156 weeks (3 years) with a two-week follow-up period. The follow-up period follows either completion of the treatment period or follows withdrawal from the study. Subjects who prematurely discontinue study drug will also be followed up for 156 weeks (3 years) from randomisation for assessment of survival, moderate and severe exacerbations and concomitant medications. The study subjects will be outpatients, all of whom must fulfil the entry criteria (see Protocol Section 3.2). All inhaled corticosteroids and inhaled long-acting bronchodilators will be discontinued at entry to the run-in period. Approximately 6040 subjects will be randomised from approximately 450 sites. The subjects will be randomised in a ratio of 1:1:1:1 to SERETIDE 50/500µg bd, salmeterol 50µg bd, fluticasone propionate 500µg bd or placebo.
Secondary Efficacy Endpoints. Secondary efficacy endpoints will include: • Rate of moderate COPD exacerbations (defined as requiring treatment with systemic corticosteroids and/or antibiotics) and severe COPD exacerbations (defined as requiring hospitalisation). • Quality of Life determined using the St. George’s Respiratory Questionnaire (SGRQ) • COPD-related mortality • On treatment mortality • Severe COPD exacerbation/LTOT/on treatment mortality • Clinic post-bronchodilator FEV1 (assessed 24-weekly) • Number of withdrawals from treatment • Health status using the EuroQol Questionnaire (EQ-5D) • Healthcare resource utilisation, including primary care contacts and secondary care contacts and use of rescue/concurrent medications. • Other exacerbation endpoints (time to first moderate or severe exacerbation, rate of severe exacerbations, time to first severe exacerbation, rate of moderate and severe exacerbations requiring systemic corticosteroids, time to first moderate or severe exacerbations requiring systemic corticosteroids). These will include adverse events reported while on study drug and additional information on bone fractures that occurred.
Secondary Efficacy Endpoints. Time-to-first clinical improvement event consisting of a persistent change for any of the following: • Improvement by at least one WHO functional class • Increase from baseline in 6MWD by at least 10% • Decrease from baseline in creatine kinase (as a surrogate biomarker for muscle injury and inflammation) by at least 10% The persistence of the change in WHO functional class, 6MWD, or creatinine kinase must be confirmed by a successive assessment also meeting the defined criteria. The confirmatory assessment must be at least 14 days after the initial assessment, or at the next scheduled assessment.
Secondary Efficacy Endpoints. Other secondary endpoints will include: • Difference in pain level between baseline and the 9 month follow-up as determined by VAS by sex and by comorbidities (esp. diabetes or renal dysfunction) • Change in tissue oxygenation (TcPO2) from baseline to 6, 9 and 12 months following the first treatment • Change in hemodynamic measures (ABI and TBI) from baseline to Day 28, Day 90, 6 months, 9 months and 12 months following the first treatment • Change in perfusion (MRA) from baseline to 9 months following the first treatment • Wound healing (no ulcer: change of skin condition, one ulcer: change of ulcer size, multiple ulcer: change of ulcer number) from baseline to 9 months following the first treatment • Change in VAS score from baseline to Day 14, Day 28, Day 42, Day 90, at 6 months, 9 months, and 12 months. • Change in QOL score (VascuQol) at 90 Days, 9 months and 12 months; • Major limb amputation rate at six months and twelve months following the first treatment • Mortality at six and twelve months after first treatment
Secondary Efficacy Endpoints. The secondary efficacy endpoints are described in the master protocol.
Secondary Efficacy Endpoints. The secondary endpoints are: • Percent of subjects achieving a reduction ≥ 5%, ≥ 10% and ≥ 15% of baseline BMI at Week 56; • Change from baseline in waist circumference at Week 56; • Change from baseline in fasting insulin and Whole Body Insulin Sensitivity Index (Matsuda) at Week 56; • Change from baseline in triglycerides and HDL-C at Week 56; • Change from baseline in blood pressure at Week 56.