Table 3.

Most common any-grade AEs (≥20% of all patients) and grade ≥3 AEs (≥10% of all patients) (safety population)

	Total (N = 64)	Arm 1: pevonedistat + docetaxel (n = 22)	Arm 2a (lead-in cohort): pevonedistat + carboplatin (n = 6)	Arm 2: pevonedistat + carboplatin + paclitaxel (n = 26)	Arm 3: pevonedistat + gemcitabine (n = 10)
Patients with one or more any-grade AE, n (%)	64 (100)	22 (100)	6 (100)	26 (100)	10 (100)
Fatigue	36 (56)	12 (55)	4 (67)	16 (62)	4 (40)
Nausea	32 (50)	8 (36)	5 (83)	14 (54)	5 (50)
Anemia	26 (41)	7 (32)	3 (50)	12 (46)	4 (40)
Constipation	22 (34)	4 (18)	4 (67)	11 (42)	3 (30)
Diarrhea	22 (34)	9 (41)	1 (17)	11 (42)	1 (10)
Increased AST	20 (31)	6 (27)	2 (33)	9 (35)	3 (30)
Vomiting	19 (30)	4 (18)	1 (17)	11 (42)	3 (30)
Increased ALT	18 (28)	7 (32)	1 (17)	6 (23)	4 (40)
Alopecia	17 (27)	5 (23)	1 (17)	10 (38)	1 (10)
Decreased appetite	15 (23)	4 (18)	0 (0)	6 (23)	5 (50)
Decreased neutrophil count	15 (23)	6 (27)	1 (17)	7 (27)	1 (10)
Thrombocytopenia	15 (23)	2 (9)	3 (50)	7 (27)	3 (30)
Dyspnea	14 (22)	6 (27)	2 (33)	3 (12)	3 (30)
Neutropenia	14 (22)	2 (9)	1 (17)	9 (35)	2 (20)
Peripheral sensory neuropathy	14 (22)	3 (14)	1 (17)	9 (35)	1 (10)
Pyrexia	14 (22)	6 (27)	1 (17)	5 (19)	2 (20)
Arthralgia	13 (20)	2 (9)	0 (0)	9 (35)	2 (20)
Myalgia	13 (20)	3 (14)	0 (0)	10 (38)	0
Decreased platelet count	13 (20)	1 (5)	2 (33)	7 (27)	3 (30)
Patients with one or more grade ≥3 AE, n (%)	53 (83)	18 (82)	4 (67)	21 (81)	10 (100)
Decreased neutrophil count	14 (22)	6 (27)	0 (0)	7 (27)	1 (10)
Increased AST	13 (20)	4 (18)	2 (33)	6 (23)	1 (10)
Anemia	12 (19)	3 (14)	2 (33)	6 (23)	1 (10)
Increased ALT	11 (17)	5 (23)	0 (0)	4 (15)	2 (20)
Neutropenia	10 (16)	1 (5)	1 (17)	7 (27)	1 (10)
Thrombocytopenia	7 (11)	0 (0)	2 (33)	4 (15)	1 (10)

Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase