Table 2.

Summary of adverse events

	Any grade	Grade 3–5
	(N = 21)	(N = 21)
Any adverse event	21 (100.0%)	16 (76.2%)
Treatment-related adverse event	20 (95.2%)	13 (61.9%)
iRAE	16 (76.2%)	11 (52.4%)
GI tract
Diarrhea	5 (23.8%)	4 (19.0%)
Colitis	2 (9.5%)	1 (4.8%)
Lungs
Pneumonitis	5 (23.8%)	2 (9.5%)
Lung infection	1 (4.8%)	1 (4.8%)*
COPD exacerbation	1 (4.8%)	1 (4.8%)
Cough	2 (9.5%)	0 (0.0%)
Dyspnea	2 (9.5%)	0 (0.0%)
Wheezing	1 (4.8%)	0 (0.0%)
Skin
Pruritus	2 (9.5%)	0 (0.0%)
Rash	2 (9.5%)	0 (0.0%)
Liver
Blood bilirubin increased	1 (4.8%)	1 (4.8%)
Endocrine system
Thyroiditis	1 (4.8%)	0 (0.0%)
Hyperthyroidism	1 (4.8%)	0 (0.0%)
Hypothyroidism	2 (9.5%)	0 (0.0%)
Neurologic
Peripheral sensory neuropathy	1 (4.8%)	0 (0.0%)
Other
Thrombocytopenia	2 (9.5%)	2 (9.5%)
Arthralgia	2 (9.5%)	0 (0.0%)
Arthritis	1 (4.8%)	0 (0.0%)
Fever	1 (4.8%)	0 (0.0%)

Abbreviations: COPD = chronic obstructive pulmonary disease; GI = gastrointestinal; iRAE = immune-related adverse event.

^*Grade 5 lung infection possibly related to complications from study therapy.