Table 2.

Summary of safety profiles of sunvozertinib

	50 mg	100 mg	200 mg	300 mg	400 mg	All
	(n = 6)	(n = 9)	(n = 16)	(n = 51)	(n = 20)	(n = 102)
AE category	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Patients with any TEAE	6 (100.0)	9 (100.0)	16 (100.0)	51 (100.0)	20 (100.0)	102 (100.0)
Patients with any TEAE with CTCAE grade ≥3	2 (33.3)	2 (22.2)	2 (12.5)	20 (39.2)	14 (70.0)	40 (39.2)
Patients with any drug-related AE	6 (100.0)	8 (88.9)	16 (100.0)	49 (96.1)	20 (100.0)	99 (97.1)
Patients with any drug-related AE with CTCAE grade ≥3	1 (16.7)	1 (11.1)	1 (6.3)	17 (33.3)	14 (70.0)	34 (33.3)
Patients with any treatment-emergent SAE	0 (0.0)	2 (22.2)	3 (18.8)	14 (27.5)	7 (35.0)	26 (25.5)
Patients with any drug-related SAE	0 (0.0)	0 (0.0)	1 (6.3)	9 (17.6)	6 (30.0)	16 (15.7)
Patients with any TEAE leading to death	0 (0.0)	0 (0.0)	0 (0.0)	2 (3.9)	1 (5.0)	3 (2.9)
Patients with any drug-related AE leading to death	0 (0.0)	0 (0.0)	0 (0.0)	1 (2.0)	0 (0.0)	1 (1.0)
Patients with any TEAE leading to treatment discontinuation	0 (0.0)	1 (11.1)	0 (0.0)	4 (7.8)	2 (10.0)	7 (6.9)
Patients with any drug-related AE leading to treatment discontinuation	0 (0.0)	0 (0.0)	0 (0.0)	4 (7.8)	2 (10.0)	6 (5.9)
Patients with any TEAE leading to dose reduction	0 (0.0)	0 (0.0)	0 (0.0)	6 (11.8)	10 (50.0)	16 (15.7)
Patients with any drug-related AE leading to dose reduction	0 (0.0)	0 (0.0)	0 (0.0)	6 (11.8)	10 (50.0)	16 (15.7)
Patients with any TEAE leading to drug interruption	0 (0.0)	2 (22.2)	2 (12.5)	16 (31.4)	8 (40.0)	28 (27.5)
Patients with any drug-related AE leading to drug interruption	0 (0.0)	1 (11.1)	1 (6.3)	14 (27.5)	8 (40.0)	24 (23.5)

NOTE: Pooled analysis of the WU-KONG1 and WU-KONG2 studies. Data cutoff date: April 3, 2021. Causality assessed by investigators.

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events version 5.0; SAE, serious adverse event.