Study of the long term safety of serlopitant for the treatment of pruritus in adults.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
558
Serlopitant Tablets
Number of Subjects With Treatment-emergent Adverse Events
Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.
Time frame: From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early.
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Study Site 504
Birmingham, Alabama, United States
Study Site 204
Fremont, California, United States
Study Site 383
North Hollywood, California, United States
Study Site 356
San Diego, California, United States
Study Site 514
Santa Ana, California, United States
Study Site 501
Aventura, Florida, United States
Study Site 210
Coral Gables, Florida, United States
Study Site 534
Fort Lauderdale, Florida, United States
Study Site 531
Miami, Florida, United States
Study Site 222
North Miami Beach, Florida, United States
...and 75 more locations