Randomized phase III and extension studies: efficacy and impacts on quality of life of naldemedine in subjects with opioid-induced constipation and cancer.

Significant improvements from baseline to all assessed time points were also observed for scores of every individual domain of PAC-SYM (all P ≤ 0.03; Figure 5 A) and PAC-QOL (all P ≤ 0.0001; Figure 5 B). In COMPOSE-4, subgroup analysis of subjects who had overall PAC-SYM scores ≥ 1 at baseline (naldemedine, n = 52; placebo, n = 57) showed greater, although marginally insignificant, improvements from baseline to day 15 in overall PAC-SYM scores with naldemedine versus placebo (–0.54 versus –0.35; P = 0.0857; supplementary Table S2 , available at Annals of Oncology online).

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