Table 2.

Serious treatment emergent adverse events by system organ class

Serious Adverse Events, n (%)	Part Aa		Part B
	Clazakizumab (n=10)	Placebo (n=10)	Clazakizumab (n=19)b
Infections and infestations	0	0	5 (26.3)
Pneumonia	0	0	2 (10.5)
Pyelonephritis	0	0	1 (5.3)
Ovarian abscess	0	0	1 (5.3)
Aseptic meningitis	0	0	1 (5.3)
Gastrointestinal disorders	1 (10)	0	1 (5.3)
Diverticulitis	1 (10)c	0	1 (5.3)d
General disease and administration site conditions	0	1 (10)	0
Pyrexia	0	1 (10)	0
Respiratory, thoracic, and mediastinal disorders	1 (10)	0	1 (5.3)
Pleural effusion	1 (10)	0	1 (5.3)
Surgical and medical procedures	0	0	1 (5.3)
Pleurodesis	0	0	1 (5.3)
Permanent thorax cavity drainage	0	0	1 (5.3)
Renal and urinary disorders	1 (10)	0	0
Acute renal injury	1 (10)	0	0

Bold text indicates the number (%) of adverse events for individual system organ classes.

^aDifferences between groups in part A were NS.

^bOne patient was withdrawn from the trial in part A and was not included in the safety analysis of part B.

^cDiverticulitis resolved after percutaneous abscess drainage and antibiotic therapy.

^dDiverticulitis was complicated by colon perforation requiring open surgery (Hartmann’s procedure).