TABLE 4.
Preferred Term, n (%) | Squamous n = 30 | Nonsquamous n = 33 | Total N = 63 |
---|---|---|---|
Nausea, vomiting, diarrhea | 22 (73.3) | 17 (51.5) | 39 (61.9) |
Asthenia/fatigue | 14 (46.7) | 17 (51.5) | 31 (49.2) |
Hyperglycemia | 13 (43.3) | 12 (36.4) | 25 (39.7) |
Liver toxicity | 11 (36.7) | 9 (27.3) | 20 (31.7) |
Hypersensitivity/rash | 10 (33.3) | 8 (24.2) | 18 (28.6) |
Mood disorders | 3 (10.0) | 5 (15.2) | 8 (12.7) |
Pneumonitis | 3 (10.0) | 0 | 3 (4.8) |
QTc prolongation | 1 (3.3) | 0 | 1 (1.6) |
Adverse events regardless of relationship to study drug treatment were described according to MedDRA v17.0, and are listed by specific safety event category in order of descending frequency in the “Total” column.
MedDRA, Medical Dictionary for Regulatory Activities.