Table 3.
Treatment-related AEs of interest and those that occurred in ≥10% of the intent-to-treat population (N=348)
| Adverse event | n (%)
|
||
|---|---|---|---|
| Grade 1/2 | Grade 3/4 | Totala | |
| Nonhematologic AEs | |||
| Mucosal inflammation | 167 (48) | 22 (6) | 189 (54) |
| Diarrhea | 159 (46) | 27 (8) | 186 (53) |
| Asthenia | 99 (28) | 42 (12) | 141 (41) |
| Decreased appetite | 105 (30) | 9 (3) | 115 (33)b |
| Nausea | 106 (31) | 7 (2) | 113 (33) |
| Fatigue | 74 (21) | 31 (9) | 105 (30) |
| Vomiting | 90 (26) | 15 (4) | 105 (30) |
| Hypertension | 70 (20) | 21 (6) | 91 (26) |
| Hand–foot syndrome | 63 (18) | 23 (7) | 87 (25)b |
| Yellow skin | 83 (24) | 1 (<1) | 84 (24) |
| Skin discoloration | 72 (21) | 0 | 72 (21) |
| Headache | 62 (18) | 5 (1) | 67 (19) |
| Stomatitis | 61 (18) | 5 (1) | 66 (19) |
| Dysguesia | 63 (18) | 2 (<1) | 65 (19) |
| Dyspepsia | 57 (16) | 1 (<1) | 58 (17) |
| Abdominal pain, upper | 48 (14) | 1 (<1) | 49 (14) |
| Hypothyroidism | 45 (13) | 2 (<1) | 47 (14) |
| Epistaxis | 40 (12) | 5 (1) | 45 (13) |
| Abdominal pain | 36 (10) | 5 (1) | 41 (12) |
| Rash | 41 (12) | 0 | 41 (12) |
| Peripheral edema | 37 (11) | 2 (<1) | 39 (11) |
| Pain in extremity | 37 (11) | 2 (<1) | 39 (11) |
| Constipation | 36 (10) | 1 (<1) | 37 (11) |
| Skin exfoliation | 35 (10) | 1 (<1) | 36 (10) |
| Hair color changes | 35 (10) | 0 | 35 (10) |
| Cardiac failure | 0 | 1 (<1) | 1 (<1) |
| Congestive cardiac failure | 0 | 2 (<1) | 2 (<1) |
| Hematologic AEs | |||
| Neutropenia | 62 (18) | 36 (10) | 98 (28) |
| Thrombocytopenia | 58 (17) | 32 (9)c | 91 (26) |
| Anemia | 57 (16) | 26 (8) | 83 (24) |
| Leukopenia | 44 (13) | 10 (3) | 54 (16) |
Notes:
a
In total, twelve patients had grade 5 treatment-related AEs (two patients each with hemorrhagic gastritis and multiple organ failure, and one patient each with thrombocytopenia, adrenal insufficiency, gastrointestinal hemorrhage, death, pneumonia, necrotizing fasciitis, septic shock, perinephric abscess, cerebrovascular accident, ischemic stroke, pulmonary hemorrhage, and hemorrhage).
b
Grade missing for one additional patient.
c
Grade 5 thrombocytopenia occurred in one additional patient.
Abbreviation: AE, adverse event.