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Abstract Background In an international, randomized Phase III trial ipilimumab demonstrated a significant overall survival benefit in previously treated advanced melanoma patients. This report summarizes health-related quality of life (HRQL) outcomes for ipilimumab with/without gp100 vaccine compared to gp100 alone during the clinical trial’s 12 week treatment induction period. Methods The Phase III clinical trial (MDX010-20) was a double-blind, fixed dose study in 676 previously treated advanced unresectable stage III or IV melanoma patients. Patients were randomized 3:1:1 to receive either ipilimumab (3 mg/kg q3w x 4 doses) + gp100 (peptide vaccine; 1 mg q3w x 4 doses; ipilimumab plus gp100, n = 403); gp100 vaccine + placebo (gp100 alone, n = 136); or ipilimumab + placebo (ipilimumab alone, n = 137). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assessed HRQL. Baseline to Week 12 changes in EORTC QLQ-C30 function, global health status, and symptom scores were analyzed for ipilimumab with/without gp100 vaccine compared to gp100 alone. Mean change in scores were categorized “no change” (0–5), “a little” (5–10 points), “moderate” (10–20 points), and “very much” (>20). Results In the ipilimumab plus gp100 and ipilimumab alone groups, mean changes from baseline to Week 12 generally indicated “no change” or “a little” impairment across EORTC QLQ-C30 global health status, function, and symptom subscales. Significant differences in constipation, favoring ipilimumab, were observed (p Conclusions Ipilimumab with/without gp100 vaccine does not have a significant negative HRQL impact during the treatment induction phase relative to gp100 alone in stage III or IV melanoma patients. Trial registration Clinicaltrials.gov identification number NCT00094653

Etodolac was compared with aspirin and placebo for efficacy and safety, and a minimum effective dose was established in 264 patients with adult-onset, active rheumatoid arthritis. In this six-week, 14-center, double-blind, parallel-group investigation, preceded by a washout period of up to two weeks, patients received daily doses of etodolac at 50, 100, or 200 mg/d; aspirin at 3,900 mg/d; or placebo. Both etodolac at the highest dose and aspirin produced statistically significant improvement from baseline in all disease activity assessments measured at four- and six-week end points and were superior to placebo in the majority of assessments. A greater number of patient complaints occurred with aspirin, especially in regard to gastrointestinal-related and otologic side effects. A significant therapeutic dose response was evident among the etodolac groups without an increase in side effects. Although the 100-mg/d dose was effective in many of the efficacy parameters measured, the 200-mg/d dose, which is comparably efficacious to aspirin 3.9 g/d, was suggested as the minimum effective dose for the relief of the signs and symptoms of active rheumatoid arthritis. [ABSTRACT FROM AUTHOR]