Table 3 Treatment-emergent, all-causality adverse events and laboratory abnormalities in ≥20% of patients in any treatment arm a
Adverse events, n(%) | Arm I: Axitinib (Continuous) + Pem/Cis | Arm II: Axitinib (Modified) + Pem/Cis | Arm III: Pem/Cis Alone | |||
|---|---|---|---|---|---|---|
| Â | All | Grade | All | Grade | All | Grade |
| Â | Grades | 3/4 | Grades | 3/4 | Grades | 3/4 |
|  | n= 55 | n= 55 | n= 58 | n= 58 | n= 55 | n= 55 |
Nausea | 38 (69) | 10 (18) | 30 (52) | 3 (5) | 33 (60) | 4 (7) |
Hypertension | 37 (67) | 11 (20) | 28 (48) | 10 (17) | 6 (11) | 0 |
Vomiting | 29 (53) | 8 (15) | 19 (33) | 3 (5) | 16 (29) | 2 (4) |
Decreased appetite | 28 (51) | 4 (7) | 28 (48) | 4 (7) | 23 (42) | 2 (4) |
Fatigue | 27 (49) | 6 (11) | 25 (43) | 9 (16) | 25 (45) | 9 (16) |
Diarrhea | 21 (38) | 4 (7) | 20 (34) | 3 (5) | 9 (16) | 0 |
Constipation | 20 (36) | 0 | 15 (26) | 1 (2) | 23 (42) | 1 (2) |
Neutropenia | 17 (31) | 7 (13) | 12 (21) | 6 (10) | 15 (27) | 5 (9) |
Dyspnea | 13 (24) | 3 (5) | 14 (24) | 2 (3) | 10 (18) | 3 (5) |
Insomnia | 13 (24) | 0 | 8 (14) | 1 (2) | 11 (20) | 0 |
Dysphonia | 12 (22) | 0 | 8 (14) | 0 | 0 | 0 |
Cough | 11 (20) | 1 (2) | 7 (12) | 0 | 9 (16) | 2 (4) |
Headache | 11 (20) | 0 | 17 (29) | 1 (2) | 9 (16) | 0 |
Anemia | 7 (13) | 3 (5) | 20 (34) | 8 (14) | 23 (42) | 6 (11) |
Laboratory abnormalities, n / N b (%) | ||||||
Hyperglycemia | 40/53 (75) | 1/53 (2) | 36/55 (65) | 3/55 (5) | 33/52 (63) | 2/52 (4) |
Hypoalbuminemia | 26/50 (52) | 1/50 (2) | 31/54 (57) | 1/54 (2) | 23/50 (46) | 0 |
Hypokalemia | 23/53 (43) | 0 | 17/55 (31) | 1/55 (2) | 10/52 (19) | 0 |
Creatinine | 22/54 (41) | 2/54 (4) | 29/55 (53) | 5/55 (9) | 24/53 (45) | 3/53 (6) |
Hyponatremia | 18/54 (33) | 3/54 (6) | 18/55 (33) | 7/55 (13) | 11/52 (21) | 1/52 (2) |
Alkaline phosphatase | 16/53 (30) | 0 | 23/55 (42) | 0 | 15/53 (28) | 0 |
Hyperkalemia | 16/53 (30) | 2/53 (4) | 26/55 (47) | 2/55 (4) | 19/52 (37) | 2/52 (4) |
ALT | 15/53 (28) | 1/53 (2) | 23/55 (42) | 1/55 (2) | 12/53 (23) | 2/53 (4) |
Bicarbonate | 8/30 (27) | 0 | 17/38 (45) | 1/38 (3) | 13/39 (33) | 0 |
AST | 10/53 (19) | 1/53 (2) | 21/55 (38) | 1/55 (2) | 10/53 (19) | 2/53 (4) |