Table 5.

Treatment-emergent AEs

Characteristic	Study 201,* n (%)					Study 103,† n (%)
	Cohort 1:	Cohort 2:	Cohort 3:	Cohort 4:	Overall,	Cohort 1:	Cohort 2:	Overall,
	1000 mg q4w,	1600 mg q6w,	2400 mg q8w,	5400 mg q12w,		900 mg q4w,	1800 mg q4w,
	n = 6	n = 6	n = 7	n = 7	N = 26	n = 6	n = 7	N = 13
Patients with TEAEs	6 (100)	6 (100)	7 (100)	7 (100)	26 (100)	5 (83.3)	7 (100)	12 (92.3)
Patients with related TEAEs‡	2 (33.3)	2 (33.3)	3 (42.9)	2 (28.6)	9 (34.6)	1 (16.7)	2 (28.6)	3 (23.1)
Headache	1 (16.7)	1 (16.7)	1 (14.3)	2 (28.6)	5 (19.2)	0	1 (14.3)	1 (7.7)
Pain	0	0	0	0	0	0	1 (14.3)	1 (7.7)
Nausea	1 (16.7)	0	0	0	1 (3.8)	0	0	0
Abnormal GI sounds	0	0	1 (14.3)	0	1 (3.8)	0	0	0
Asthenia	0	1 (16.7)	0	0	1 (3.8)	0	0	0
Infusion site swelling	0	0	1 (14.3)	0	1 (3.8)	0	0	0
Anemia	0	0	0	0	0	1 (16.7)	0	1 (7.7)
Atrial flutter	0	0	0	0	0	0	1 (14.3)	1 (7.7)
Meningococcal sepsis/infection	0	1 (16.7)§	1 (14.3)‡,§	0	2 (7.7)	0	0	0
Myalgia	0	1 (16.7)	0	0	1 (3.8)	0	0	0
Neutropenia	0	1 (16.7)	0	0	1 (3.8)	0	0	0
Skin lesion	0	0	1 (14.3)	0	1 (3.8)	0	0	0
Thrombophlebitis, superficial	1 (16.7)	0	0	0	1 (3.8)	0	0	0
Patients with serious TEAEs	2 (33.3)	2 (33.3)	3 (42.9)	1 (14.3)	8 (30.8)	0	0	0
Patients with related serious TEAEs	0	0	1 (14.3)	0	1 (3.8)	0	0	0

GI, gastrointestinal; TEAE, treatment-emergent AE.

^*Coded using the Medical Dictionary for Regulatory Activities v20.0.

^†Coded using the Medical Dictionary for Regulatory Activities v18.1.

^‡Judged by the investigator to be possibly, probably, or definitely related to ravulizumab treatment.

^§This was a serious TEAE.