Fig 1.
CONSORT flow diagram of patient disposition in the double-blind core phase followed by open-label extension phase and noninterventional follow-up phase.
aPatients with angiomyolipoma progression were unblinded at the end of the double-blind phase, and patients who were on placebo were allowed to cross over to open-label everolimus. bPatients were evaluable for noninterventional follow-up phase as they had at least one adequate efficacy assessment (CT/MRI scan).
Table 1.
Patient demographics and disease characteristics.
Table 2.
Median sum of volumes of target angiomyolipoma lesions at baseline, EOT, and week 48 of non-interventional follow-up phase, and percentage change from baseline to EOT/week 48 of non-interventional follow-up phase and from EOT to week 48 of non-interventional follow-up phase.