TABLE 3.

Summary of AEs in all treated patients.

	Pembrolizumab plus chemotherapy	Placebo plus chemotherapy
	n = 61	n = 26
Any AE	61 (100)	26 (100)
Treatment‐related AE
Any grade	61 (100)	26 (100)
Grade 3–5 a	52 (85)	22 (85)
Led to death	0	0
Led to discontinuation	19 (31)	4 (15)
Any AE leading to dose modification
Pembrolizumab or placebo	40 (66)	17 (65)
Nab‐paclitaxel	5 (8)	3 (12)
Paclitaxel	6 (10)	2 (8)
Gemcitabine	46 (75)	17 (65)
Carboplatin	46 (75)	17 (65)

	Any grade	Grade 3/4	Any grade	Grade 3/4
Treatment‐related AEs with incidence ≥20%
Decreased white blood cell count	46 (75)	30 (49)	22 (85)	15 (58)
Decreased neutrophil count	44 (72)	36 (59)	21 (81)	16 (62)
Anemia	40 (66)	16 (26)	16 (62)	6 (23)
Nausea	32 (52)	1 (2)	16 (62)	1 (4)
Alopecia	25 (41)	0	10 (38)	0
Constipation	24 (39)	1 (2)	10 (38)	0
Malaise	22 (36)	2 (3)	12 (46)	0
Dysgeusia	20 (33)	0	1 (4)	0
Decreased platelet count	20 (33)	6 (10)	8 (31)	4 (15)
Decreased appetite	19 (31)	1 (2)	4 (15)	1 (4)
Stomatitis	18 (30)	0	4 (15)	0
Peripheral sensory neuropathy	16 (26)	1 (2)	6 (23)	0
Fatigue	15 (25)	1 (2)	6 (23)	1 (4)
Rash	13 (21)	0	1 (4)	0
Immune‐mediated AEs and infusion reactions a
Any	20 (33)	4 (7)	4 (15)	0
Infusion reactions	10 (16)	1 (2)	2 (8)	0
Hypothyroidism	7 (11)	0	0	0
Adrenal insufficiency	5 (8)	2 (3)	0	0
Hyperthyroidism	3 (5)	0	1 (4)	0
Pneumonitis	1 (2)	0	0	0
Severe skin reactions	1 (2)	1 (2)	0	0
Thyroiditis	1 (2)	0	0	0
Vasculitis	1 (2)	0	1 (4)	0

Note: All values are presented as n (%).

Abbreviation: AE, adverse event.

^a There were no grade 5 treatment‐related AEs, immune‐mediated AEs, or infusion reactions in either treatment group.