Table 2.

Safety results for native and recurrent KT cohort

Adverse event	Run-in phase	Dose-escalation phasea	Iptacopan 200 mg bid	Overall
Native cohortN = 16, n (%)
Patients with ≥1 AE	7 (43.8)	6 (37.5)	8 (50.0)	14 (87.5)
AEs of mild intensity	6 (37.5)	6 (37.5)	8 (50.0)	14 (87.5)
AEs of moderate intensity	2 (12.5)	1 (6.3)	1 (6.3)	3 (18.8)
AEs of severe intensity	1 (6.3)	0	0	1 (6.3)
SAEs	1 (6.3)	0	0	1 (6.3)
Study drug–related AEs	0	0	2 (12.5)b	2 (12.5)
PTc
Abdominal pain upper	0	1 (6.3)	1 (6.3)	2 (12.5)
Anemia	1 (6.3)	1 (6.3)	0	2 (12.5)
Blood creatine phosphokinase increased	1 (6.3)	1 (6.3)	1 (6.3)	2 (12.5)
Nausea	2 (12.5)	0	0	2 (12.5)
Upper respiratory tract infection	2 (12.5)	0	0	2 (12.5)
Recurrent KT CohortN = 11, n (%)
Patients with at least one AE	2 (18.2)	5 (45.5)	6 (54.5)	8 (72.7)
AEs of mild intensity	1 (9.1)	4 (36.4)	6 (54.5)	7 (63.6)
AEs of moderate intensity	2 (18.2)	1 (9.1)	4 (36.4)	6 (54.5)
AEs of severe intensity	1 (9.1)	0	0	1 (9.1)
SAEs	1 (9.1)	0	2 (18.2)	3 (27.3)
Study drug–related AEs	0	1 (9.1)	2 (18.2)	3 (27.3)d
AEs leading to study drug interruption	0	0	1 (9.1)	1 (9.1)
PTc
Headache	0	2 (18.2)	0	2 (18.2)
Hyperkalemia	0	0	2 (18.2)	2 (18.2)

AE, adverse event; bid, twice a day; KT, kidney transplant; N, total number of patients; PT, preferred term; SAE, serious AE.

^aIptacopan 10 mg, 25 mg, and 100 mg bid.

^b1 patient had mild skin discoloration and second had mild normochromic normocytic anemia.

^cPTs with incidence of >2 events in the overall column are reported in this table.

^d1 patient had lipase increased, second had syncope and urinary tract infection, and third had worsening of nausea.