TABLE 3.
Adverse Events
| Preferred Term AE | CaboNivo (n = 64) | CaboNivoIpi (n = 56) | ||
|---|---|---|---|---|
| G1/G2, No. (%) | G3/G4, No. (%) | G1/G2, No. (%) | G3/G4, No. (%) | |
| Fatigue | 41 (64) | 8 (13) | 30 (54) | 9 (16) |
| Diarrhea | 36 (56) | 2 (3) | 27 (48) | 4 (7) |
| Anorexia | 26 (41) | 0 | 24 (43) | 1 (2) |
| Skin toxicity | 35 (55) | 1 (2) | 27 (48) | 0 |
| Dysphonia | 19 (30) | 0 | 11 (20) | 0 |
| Nausea | 34 (53) | 2 (3) | 22 (40) | 2 (3) |
| Myalgia | 17 (27) | 0 | 8 (14) | 0 |
| Mucositis | 38 (59) | 0 | 19 (34) | 1 (2) |
| Dysgeusia | 25 (39) | 0 | 13 (23) | 0 |
| Weight loss | 19 (3) | 1 (2) | 21 (38) | 0 |
| Vomiting | 16 (25) | 2 (3) | 10 (18) | 0 |
| PPE | 32 (50) | 0 | 12 (21) | 0 |
| Abdominal pain | 18 (28) | 1 (2) | 9 (16) | 1 (2) |
| Hypertension | 15 (23) | 8 (13) | 6 (11) | 6 (11) |
| Headache | 13 (20) | 0 | 3 (5) | 1 (2) |
| Cough | 9 (14) | 0 | 12 (21) | 0 |
| Muscle weakness | 1 (2) | 1 (2) | 6 (11) | 0 |
| Dehydration | 6 (9) | 4 (6) | 9 (16) | 3 (5) |
| Infection | 7 (11) | 1 (2) | 5 (9) | 0 |
| Thromboembolic event | 5 (8) | 4 (6) | 1 (2) | 3 (5) |
| Fever | 3 (5) | 0 | 5 (9) | 1 (2) |
| Dyspnea | 9 (14) | 1 (2) | 7 (13) | 0 |
| Vaginal or rectal fistula | 1 (2) | 2 (3) | 0 | 0 |
| Chronic kidney disease | 0 | 1 (2) | 3 (5) | 1 (2) |
| Dry mouth | 12 (19) | 0 | 11 (20) | 0 |
| Dizziness | 7 (11) | 0 | 6 (11) | 0 |
| Rhinitis | 5 (8) | 0 | 6 (11) | 0 |
| Arthralgia | 6 (9) | 0 | 7 (13) | 0 |
| Hematology | ||||
| White blood cell count decrease | 20 (31) | 3 (5) | 11 (20) | 0 |
| Neutrophil count decrease | 13 (20) | 7 (11) | 3 (5) | 1 (2) |
| Lymphocyte count decrease | 22 (34) | 2 (3) | 7 (13) | 5 (9) |
| Anemia | 16 (25) | 4 (6) | 20 (36) | 3 (5) |
| Platelet count decrease | 20 (31) | 2 (3) | 12 (21) | 1 (2) |
| Electrolytes | ||||
| Hypocalcemia | 17 (27) | 0 | 10 (18) | 2 (4) |
| Hyponatremia | 17 (27) | 3 (5) | 10 (18) | 4 (7) |
| Hypophosphatemia | 26 (41) | 7 (11) | 17 (30) | 8 (14) |
| Hypomagnesemia | 16 (25) | 1 (1.5) | 10 (18) | 0 |
| Hypokalemia | 12 (19) | 0 | 9 (16) | 0 |
| Renal | ||||
| Proteinuria | 12 (19) | 2 (3) | 10 (18) | 0 |
| Hepatic | ||||
| ALT elevation | 31 (48) | 3 (5) | 17 (30) | 3 (5) |
| AST elevation | 28 (44) | 4 (6) | 17 (30) | 2 (4) |
| Alkaline phosphatase elevation | 8 (13) | 2 (3) | 9 (16) | 1 (2) |
| Hypoalbuminemia | 16 (25) | 0 | 10 (18) | 0 |
| PTT prolongation | 2 (3) | 1 (2) | 3 (5) | 0 |
| Pancreatic | ||||
| Amylase elevation | 12 (19) | 4 (6) | 12 (21) | 2 (4) |
| Lipase elevation | 15 (23) | 9 (14) | 11 (20) | 11 (20) |
| Endocrine | ||||
| Hyperthyroidism | 4 (6) | 1 (2) | 9 (16) | 0 |
| Hypothyroidism | 21 (33) | 2 (3) | 13 (23) | 0 |
Abbreviations: AE, adverse event; PPE, palmar-plantar erythrodyselthesia; PTT, partial thromboplastin time.