Table 3.

Drug‐related adverse events in the lung subgroup of of patients with advanced, progressive, well‐differentiated, non‐functional neuroendocrine tumors (NET) treated with everolimus or placebo (≥10% incidence in either arm)

Preferred term, n (%)	Patients with lung NET (n = 90)
	Everolimus n = 62a		Placebo n = 27
	All grades	Grade 3 or 4	All grades	Grade 3 or 4
Stomatitisb
Totalc , d	38 (61.3)	7 (11.3)	7 (25.9)	0 (0.0)
Stomatitis	33 (53.2)	7 (11.3)	5 (18.5)	0 (0.0)
Mouth ulceration	4 (6.5)	0 (0.0)	0 (0.0)	0 (0.0)
Aphthous stomatitis	2 (3.2)	0 (0.0)	2 (7.4)	0 (0.0)
Glossitis	2 (3.2)	0 (0.0)	0 (0.0)	0 (0.0)
Rash	22 (35.5)	0 (0.0)	1 (3.7)	0 (0.0)
Fatigue	20 (32.3)	2 (3.2)	6 (22.2)	0 (0.0)
Peripheral edema	17 (27.4)	2 (3.2)	0 (0.0)	0 (0.0)
Diarrhea	16 (25.8)	3 (4.8)	2 (7.4)	0 (0.0)
Infectionse	14 (22.6)	5 (7.1)	1 (3.7)	0 (0.0)
Asthenia	14 (22.6)	1 (1.6)	0 (0.0)	0 (0.0)
Anemia	13 (21.0)	2 (3.2)	1 (3.7)	0 (0.0)
Decreased appetite	13 (21.0)	0 (0.0)	2 (7.4)	0 (0.0)
Nausea	12 (19.4)	2 (3.2)	3 (11.1)	0 (0.0)
Pyrexia	12 (19.4)	2 (3.2)	1 (3.7)	0 (0.0)
Hyperglycemia	11 (17.7)	6 (9.8)	2 (7.4)	0 (0.0)
Dyspnea	9 (14.5)	1 (1.6)	3 (11.1)	1 (3.7)
Non‐infectious pneumonitis	8 (12.9)	1 (1.6)	1 (3.7)	0 (0.0)
Dysgeusia	8 (12.9)	0 (0.0)	1 (3.7)	0 (0.0)
Cough	8 (12.9)	0 (0.0)	1 (3.7)	0 (0.0)
Pruritus	7 (11.3)	1 (1.6)	0 (0.0)	0 (0.0)
Dry mouth	7 (11.3)	0 (0.0)	0 (0.0)	0 (0.0)
Weight decreased	5 (8.1)	1 (1.6)	3 (11.1)	0 (0.0)

^aIn the everolimus arm, one patient withdrew consent.

^bIncludes stomatitis, aphthous stomatitis, mouth ulceration, and glossitis.

^cRepresents the total number of patients with stomatitis that includes mouth and stoma‐derived adverse events.

^dA patient with multiple adverse events within a category is counted only once in the “Total” row.

^eIncludes all infections.