Fig. 1: CONSORT flowchart of TOTEM study.

On the 19 subjects enrolled, 10 completed 26 weeks of taselisib therapy. All treated patients were analyzed for the primary outcome measure (safety), and 13/19 had anatomy that permitted analysis of the efficacy measure with DXA. DXA dual energy X-ray absorptiometry, MRI magnetic resonance imaging, QoL quality of life.