Table 2.
Treatment emergent adverse events occurring at >10% for any grade or >2% for grade 3 or 4
| Eribulin (n = 932) |
Comparator (n = 689) |
|||||
|---|---|---|---|---|---|---|
| Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | |
| Subjects with any TEAE | 901 (96.7) | 361 (38.7) | 258 (27.7) | 629 (91.3) | 248 (36.0) | 76 (11.0) |
| Subjects with any serious TEAE | 199 (21.4) | 83 (8.9) | 49 (5.3) | 155 (22.5) | 60 (8.7) | 38 (5.5) |
| Subjects with TEAEs leading to discontinuation | 105 (11.3) | 49 (5.3) | 10 (1.1) | 94 (13.6) | 43 (6.2) | 17 (2.5) |
| Neutropenia | 500 (53.6) | 218 (23.4) | 208 (22.3) | 142 (20.6) | 53 (7.7) | 20 (2.9) |
| Alopecia | 361 (38.7) | 0 | 0 | 42 (6.1) | 0 | 0 |
| Nausea | 268 (28.8) | 7 (0.8) | 0 | 176 (25.5) | 13 (1.9) | 0 |
| Peripheral neuropathya | 266 (28.5) | 64 (6.9) | 4 (0.4) | 87 (12.6) | 10 (1.5) | 0 |
| Leukopenia | 255 (27.4) | 113 (12.1) | 18 (1.9) | 74 (10.7) | 21 (3.0) | 3 (0.4) |
| Fatigue | 221 (23.7) | 24 (2.6) | 3 (0.3) | 116 (16.8) | 23 (3.3) | 1 (0.1) |
| Asthenia | 203 (21.8) | 45 (4.8) | 0 | 122 (17.7) | 27 (3.9) | 0 |
| Anemia | 177 (19.0) | 17 (1.8) | 1 (0.1) | 133 (19.3) | 11 (1.6) | 2 (0.3) |
| Pyrexia | 161 (17.3) | 3 (0.3) | 0 | 56 (8.1) | 4 (0.6) | 0 |
| Diarrhea | 158 (17.0) | 4 (0.4) | 1 (0.1) | 174 (25.3) | 27 (3.9) | 1 (0.1) |
| Constipation | 154 (16.5) | 3 (0.3) | 0 | 89 (12.9) | 3 (0.4) | 0 |
| Headache | 148 (15.9) | 5 (0.5) | 0 | 73 (10.6) | 0 | 2 (0.3) |
| Vomiting | 146 (15.7) | 5 (0.5) | 2 (0.2) | 119 (17.3) | 11 (1.6) | 0 |
| Dyspnea | 129 (13.8) | 29 (3.1) | 4 (0.4) | 79 (11.5) | 19 (2.8) | 7 (1.0) |
| Back pain | 124 (13.3) | 9 (1.0) | 2 (0.2) | 49 (7.1) | 5 (0.7) | 1 (0.1) |
| Weight decreased | 124 (13.3) | 3 (0.3) | 0 | 53 (7.7) | 1 (0.1) | 0 |
| Cough | 113 (12.1) | 4 (0.4) | 0 | 57 (8.3) | 1 (0.1) | 0 |
| Arthralgia | 106 (11.4) | 5 (0.5) | 1 (0.1) | 34 (4.9) | 3 (0.4) | 0 |
| Anorexia | 101 (10.8) | 2 (0.2) | 0 | 32 (4.6) | 3 (0.4) | 0 |
| Bone pain | 97 (10.4) | 15 (1.6) | 0 | 57 (8.3) | 6 (0.9) | 0 |
| Pain in extremity | 94 (10.1) | 8 (0.9) | 0 | 47 (6.8) | 5 (0.7) | 0 |
| Decreased appetite | 73 (7.8) | 2 (0.2) | 0 | 70 (10.2) | 7 (1.0) | 0 |
| Alanine aminotransferase increased | 60 (6.4) | 23 (2.5) | 0 | 20 (2.9) | 2 (0.3) | 0 |
| Febrile neutropenia | 32 (3.4) | 22 (2.4) | 9 (1.0) | 9 (1.3) | 4 (0.6) | 5 (0.7) |
| Palmar-plantar erythrodysesthesia syndrome | 8 (0.9) | 2 (0.2) | 0 | 240 (34.8) | 72 (10.4) | 0 |
aPeripheral neuropathy combines the following preferred terms: peripheral neuropathy, neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy, demyelinating polyneuropathy, and paraesthesia.