A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®
Observational Model: Cohort, Time Perspective: Prospective
Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
Alexandra Mangili, MD, MPH
EMD Serono, Inc.
United States: Food and Drug Administration
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