Table 3.

Infections in the open-label period

AE, count	Brazikumab/ Brazikumab (n = 52)	Placebo/ Brazikumab (n = 52)	Total (N = 104)
Total infectionsa	42	58	100
Urinary tract infection	4	5	9
Vulvovaginal mycotic infection	1	6	7
Sinusitis	1	6	7
Bronchitis	2	4	6
Upper respiratory tract infection	2	4	6
Tonsilitis	2	3	5
Tooth infection	3	2	5
Subcutaneous abscess	4	0	4
Clostridium difficile colitis	3	0	3
Pharyngitis streptococcal	1	2	3
Anal abscess	2	0	2
Anal candidiasis	0	2	2
Ear infection	0	2	2
Groin abscess	1	1	2
Influenza	1	1	2
Nasopharyngitis	1	1	2
Pharyngitis	2	0	2
Pyelonephritis	1	1	2
Tooth abscess	0	2	2

Infections occurring in 1 patient each for the brazikumab/brazikumab group included abdominal abscess, Campylobacter infection, cholecystitis, external ear inflammation, gingivitis, mastoiditis, esophageal candidiasis, pilonidal cyst, postprocedural infection, rhinitis, and viral infection

Infections occurring in 1 patient each for the placebo/brazikumab group included amoebiasis, Cryptosporidiosis infection, diarrhea, folliculitis, gastroenteritis, herpes zoster, infected dermal cyst, pelvic abscess, peritonitis, pneumonia, pyrexia, respiratory tract infection, respiratory tract infection (viral), sialadenitis, tracheobronchitis, and vomiting

^aInfections were defined as any events involving a suspected viral, bacterial, fungal, or other infectious agent, including viral reactivation events and opportunistic infections, meeting ≥ 1 of the following criteria: events that are serious, grade 3 or higher, involve treatment with oral or parenteral antibiotics/antivirals/antifungals, or involve study discontinuation

AE, adverse event