secondary outcome measures

(redirected from secondary end points)

secondary outcome measures

The outcome measures in a clinical trial that provide information on therapeutic effects of secondary importance, side effects or tolerability. Data on secondary outcomes are used to evaluate additional effects of the intervention not included in the primary outcome measure.
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The just ended global Phase I/II clinical test of the company's repositioned investigational drug, Galnobax successfully met both primary and secondary end points for efficiency and safety.
Treatment also was associated with significant improvements in a number of secondary end points, including a 32% reduction in pulmonary vascular resistance.
Secondary end points included change on the PTSD Checklist, the DAS (Dyadic Adjustment Scale), the BDI (Beck Depression Inventory), and the State-Trait Anxiety Inventory (JAMA 20122;308:700-9).
Statistically significant differences emerged for three secondary end points.
The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.
The secondary end points analyzed were length of hospital stay, transfer to rehabilitation facilities, and proportions of patients requiring new home oxygen prescription and readmission rates.
The Panel's report concluded that: "In aggregate these deficiencies, and the fact that all relevant secondary end points were statistically significant in favour of AZD3582, do not allow a conclusion of negative trial outcome.
Although not the basis for approval, the 84 mg dose provided highly statistically significant results for the secondary end points of urinary frequency and volume while the 56 mg dose did not reach statistical significance.
Dodick's report on the proportion of patients achieving at least a 75% reduction in headache days per month was just one of several secondary end points in PREEMPT presented at the congress for the first time.
Secondary end points assessing sleep, depression, and hot flash--related interference with daily life also showed marked improvement in the hypnosis group.
Secondary end points included changes in glucose tolerance, physical activity, and dietary behavior.
Secondary end points also include tumor response, time to neurologic progression and neurocognitive function.