Table 3

Cox proportional hazards regression analysis assessing the time dependence of risk factors for clinical events*

Years on agalsidase β
Model 1: 0–0.5 yearModel 2: >0.5–5 yearsModel 3: >0–5 years
HR95% CIp ValueHR95% CIp ValueHR95% CIp Value
Pre-ERT event: yes (vs no)1.10.6 to 2.00.811.81.2 to 2.7< to 2.10.02
Age ≥40 years at first ERT (vs age <40 years)4.42.2 to 8.7< to 3.8< to 4.2<0.01
Male (vs female)1.91.1 to to to 2.2<0.01
  • *Three models were run to assess if the incidence of events according to the above factors was time-dependent: Model 1 examined risk factors within the first 6 months; Model 2 examined risk factors within 6 months to 5 years; and Model 3 examined risk factors for the entire analysis period of up to 5 years.

  • ERT, enzyme replacement therapy.