Table 2.

Treatment-related adverse events of any grade observed in ≥1 patient

Pembrolizumab every 2 weeksPembrolizumab every 3 weeks
Adverse event, n (%)1 mg/kg, n = 43 mg/kg, n = 310 mg/kg, n = 102 mg/kg, n = 710 mg/kg, n = 6Total, N = 30
Any3 (75)3 (100)4 (40)7 (100)4 (67)21 (70)
Fatigue01 (33)4 (40)3 (43)2 (33)10 (33)
Nausea02 (67)1 (10)2 (29)2 (33)7 (23)
Pruritus2 (50)1 (33)1 (10)1 (14)05 (17)
Decreased appetite002 (20)02 (33)4 (13)
Diarrhea01 (33)1 (10)002 (7)
Hypothyroidism0001 (14)1 (17)2 (7)
Asthenia00001 (17)1 (3)
Blurred vision0001 (14)01 (3)
Breast pain01 (33)0001 (3)
Dizziness0001 (14)01 (3)
Dysgeusia1 (25)00001 (3)
Erythema0001 (14)01 (3)
Exertional dyspnea0001 (14)01 (3)
Gait disturbance0001 (14)01 (3)
Gastritisa001 (10)001 (3)
Hypomagnesemia001 (10)001 (3)
Hypotension001 (10)001 (3)
Impaired healing0001 (14)01 (3)
Insomnia00001 (17)1 (3)
Muscular weakness0001 (14)01 (3)
Night sweats0001 (14)01 (3)
Nipple pain0001 (14)01 (3)
Pain0001 (14)01 (3)
Pain in extremity00001 (17)1 (3)
Pleuritic pain00001 (17)1 (3)
Pneumonitis01 (33)0001 (3)
Skin hypopigmentation001 (10)001 (3)
Tumor pain0001 (14)01 (3)
Vomiting00001 (17)1 (3)
Weight decreased001 (10)001 (3)

NOTE: All treatment-related adverse events were of grade 1 or 2 severity. Individual patients could have experienced ≥1 event.

  • aOne patient died of disseminated cryptococcal infection in the lungs and central nervous system 92 days after discontinuing pembrolizumab 10 mg/kg once every 2 weeks. The death was considered possibly related to study treatment based on the prolonged use of corticosteroids for grade 2 gastritis, which was considered treatment related.