2016_Head & Neck COURSE BOOK

Treatment-Related AEs in ≥ 10% of Patients

Nivolumab (n = 236)

Investigator’s Choice (n = 111)

Any grade n (%) 139 (58.9) 33 (14.0)

Grade 3–4 n (%) 31 (13.1)

Any grade n (%) 86 (77.5) 19 (17.1) 23 (20.7) 15 (13.5) 18 (16.2) 16 (14.4) 14 (12.6) 14 (12.6)

Grade 3–4 n (%) 39 (35.1)

Event

Any a

Fatigue Nausea Diarrhea Anemia Asthenia

5 (2.1)

3 (2.7) 1 (0.9) 2 (1.8) 5 (4.5) 2 (1.8) 2 (1.8)

20 (8.5) 16 (6.8) 12 (5.1) 10 (4.2)

0 0

3 (1.3) 1 (0.4)

Mucosal inflammation 3 (1.3)

0 0

Alopecia 3 (2.7) a One Grade 5 event (hypercalcemia) in the nivolumab arm and one Grade 5 event (lung infection) in the investigator’s choice arm were reported. A second death occurred in the nivolumab arm subsequent to pneumonitis. 0