Woman and Man
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Extract
The objectives of this open-label extension−safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety Monitoring; SM) • Progressive multifocal leukoencephalopathy (PML) safety monitoring in patients who have stopped study treatment Safety Objectives The other safety objectives for this study are as follows: Part 1 (OLE) • To evaluate the incidence, rate per subject-year, and severity of infection-related adverse events • To evaluate the incidence and rate per subject-year of malignancies • To evaluate the incidence and severity of hypersensitivity reactions • To evaluate the incidence and the clinical significance of anti-therapeutic antibodies (ATAs)
Inclusion criteria
- Crohn’s Disease