Table 4.
TEAEs by cohort (any grade, ≥ 20% or grade ≥ 3, ≥ 10%)a
|
RCC Cohort N = 39 | ||
| TEAE | Any Grade (≥ 20%) | Grade ≥ 3 (≥ 10%) |
| Stomatitis | 25 (64) | 7 (18) |
| Diarrhea | 22 (56) | 5 (13) |
| Epistaxis | 22 (56) | 0 |
| Anemia | 19 (49) | 10 (26) |
| Decreased appetite | 17 (44) | 0 |
| Fatigue | 16 (41) | 1 (3) |
| Nausea | 16 (41) | 2 (5) |
| Asthenia | 11 (28) | 1 (3) |
| Cough | 11 (28) | 0 |
| Thrombocytopenia | 10 (26) | 1 (3) |
| Vomiting | 10 (26) | 2 (5) |
| Edema peripheral | 9 (23) | 0 |
| Dizziness | 9 (23) | 0 |
| Rash maculo-papular | 9 (23) | 2 (5) |
| Blood creatinine increased | 8 (21) | 0 |
| Hyperglycemia | 8 (21) | 6 (15) |
| Pyrexia | 8 (21) | 0 |
| Hypertension | 4 (10) | 4 (10) |
|
GC Cohort N = 46 | ||
| TEAE | Any Grade (≥ 20%) | Grade ≥ 3 (≥ 10%) |
| Anemia | 27 (59) | 16 (35) |
| Diarrhea | 25 (54) | 2 (4) |
| Neutropenia | 20 (43) | 20 (43) |
| Decreased appetite | 19 (41) | 2 (4) |
| Nausea | 17 (37) | 1 (2) |
| Stomatitis | 17 (37) | 1 (2) |
| Fatigue | 16 (35) | 1 (2) |
| Vomiting | 15 (33) | 0 |
| Alopecia | 14 (30) | 0 |
| Asthenia | 14 (30) | 5 (11) |
| Febrile neutropenia | 14 (30) | 14 (30) |
| Abdominal pain | 10 (22) | 3 (7) |
| Constipation | 10 (22) | 0 |
| Neutrophil count decreased | 10 (22) | 9 (20) |
| White blood cell count decreased | 9 (20) | 5 (11) |
| Neutropenic sepsis | 5 (11) | 5 (11) |
| Pneumonia | 6 (13) | 5 (11) |
|
CRC Cohort N = 50 | ||
| TEAE | Any Grade (≥ 20%) | Grade ≥ 3 (≥ 10%) |
| Dermatitis acneiform | 38 (76) | 12 (24) |
| Stomatitis | 26 (52) | 5 (10) |
| Dry skin | 24 (48) | 1 (2) |
| Diarrhea | 23 (46) | 3 (6) |
| Fatigue | 20 (40) | 2 (4) |
| Paronychia | 19 (38) | 1 (2) |
| Pruritus | 16 (32) | 1 (2) |
| Decreased appetite | 14 (28) | 1 (2) |
| Nausea | 13 (26) | 0 |
| Palmar-plantar erythrodysaesthesia syndrome | 13 (26) | 3 (6) |
| Asthenia | 11 (22) | 3 (6) |
| Epistaxis | 10 (20) | 0 |
aAdverse events listed in descending order based on any grade incidence
CRC colorectal carcinoma, GC gastric adenocarcinoma, RCC renal cell carcinoma, TEAE treatment-emergent adverse event