Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study

Table 6 Summary of serious infections, serious cutaneous AEs, serious hepatic AEs, and hepatic laboratory abnormalities

n (%)	Daclizumab 150 mg SC
Any serious infection^a (n = 410)	13 (3)
Pneumonia	3 (<1)
Urinary tract infection	3 (<1)
Bronchitis	2 (<1)
Clostridium difficile colitis	1 (<1)
Diverticulitis	1 (<1)
Gastrointestinal infection	1 (<1)
Hepatitis C	1 (<1)
Infectious mononucleosis	1 (<1)
Upper respiratory tract infection	1 (<1)
Any serious cutaneous AE^b (n = 410)	8 (2)
Urticaria	2 (<1)
Allergic dermatitis	1 (<1)
Erythrodermic psoriasis	1 (<1)
Photodermatitis	1 (<1)
Psoriasis	1 (<1)
Stevens-Johnson syndrome^c	1 (<1)
Toxic skin eruption	1 (<1)
Any serious hepatic AE^d (n = 410)	5 (1)
Hepatic enzyme increased	3 (<1)
Autoimmune hepatitis	1 (<1)
Gamma-glutamyltransferase increased	1 (<1)
Hepatic laboratory abnormalities (n = 409)
ALT or AST
≥3 × ULN	37 (9)
>5 × ULN	18 (4)
>10 × ULN	11 (3)
Elevation in ALT or AST ≥3 × ULN with concurrent total bilirubin >2 × ULN	2 (<1)^e

AE Adverse event, ALT Alanine aminotransferase, AST aspartate aminotransferase, SC Subcutaneous, ULN Upper limit of normal
Patients counted once at each level of summarization
^aSerious infections defined as SAEs in the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) Infections and Infestations
^bSerious cutaneous AEs defined as SAEs in the MedDRA SOC Skin and Subcutaneous Tissues Disorders
^cOne case was reported as Stevens-Johnson syndrome but the diagnosis was not supported by the case details per the central independent dermatologist and the local site dermatologist (see text for details)
^dSerious hepatic AEs defined as SAEs under the Standarized MedDRA Query (SMQ) of drug-related hepatic disorders
^eNo patients had concurrent elevations of ALT or AST ≥3 × ULN and total bilirubin >2 × ULN in the clinical database at the time of the interim analysis; however, two patients experienced such abnormalities either while hospitalized or after the data cutoff. In both cases, other factors as reported in the text that could have contributed to the events were noted

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