Table 2.
Summary of adverse events (AEs) occurring in ≥10% of patients across all dose levels (i.e. 100–3000 mg for monotherapy and 200–1350 mg for combination with paclitaxel)
| Monotherapya |
Combination with paclitaxela |
|||||||
|---|---|---|---|---|---|---|---|---|
|
N = 99 |
N = 54 |
|||||||
| Irrespective of relationship |
Related |
Irrespective of relationship |
Related |
|||||
| AEs | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| Any AE | 96 (97) | 51 (52) | 76 (77) | 14 (14) | 54 (100) | 37 (69) | 52 (96) | 26 (48) |
| AEs leading to treatment discontinuationb | 8 (8) | 6 (6) | 4 (4) | 2 (2) | 8 (15) | 6 (11) | 5 (9) | 3 (6) |
| Asthenia | 49 (49) | 7 (7) | 27 (27) | 4 (4) | 42 (78) | 5 (9) | 35 (65) | 4 (7) |
| Anemia | 31 (31) | 9 (9) | 9 (9) | 3 (3) | 28 (52) | 10 (19) | 11 (20) | 4 (7) |
| Decreased appetite | 31 (31) | 1 (1) | 11 (11) | – | 18 (33) | 1 (2) | 10 (19) | – |
| Periorbital edema | 29 (29) | – | 29 (29) | – | 29 (54) | – | 28 (52) | – |
| Peripheral edema | 25 (25) | – | 18 (18) | – | 18 (33) | 1 (2) | 15 (28) | 1 (2) |
| Vomiting | 23 (23) | 1 (1) | 3 (3) | – | 19 (35) | – | 10 (19) | – |
| Pyrexia | 22 (22) | – | 7 (7) | – | 22 (41) | – | 6 (11) | – |
| Pruritus | 21 (21) | – | 18 (18) | – | 10 (19) | 1 (2) | 8 (15) | 1 (2) |
| Nausea | 21 (21) | 1 (1) | 7 (7) | 1 (1) | 24 (44) | – | 15 (28) | – |
| Abdominal pain | 20 (20) | 3 (3) | 4 (4) | – | 9 (17) | 1 (2) | 4 (7) | – |
| Diarrhea | 19 (19) | – | 8 (8) | – | 20 (37) | – | 11 (20) | – |
| Constipation | 18 (18) | – | 1 (1) | – | 15 (28) | 1 (2) | 4 (7) | 1 (2) |
| Dyspnea | 17 (17) | 3 (3) | – | – | 23 (43) | 2 (4) | 6 (11) | – |
| Eyelid edema | 16 (16) | – | 14 (14) | – | 6 (11) | – | 6 (11) | – |
| Fatigue | 16 (16) | 3 (3) | 11 (11) | 2 (2) | 6 (11) | 4 (7) | 5 (9) | 4 (7) |
| Face edema | 15 (15) | – | 14 (14) | – | 14 (26) | – | 14 (26) | – |
| Hypertension | 11 (11) | 2 (2) | 1 (1) | 1 (1) | 6 (11) | 1 (2) | 3 (6) | 1 (2) |
| Headache | 10 (10) | – | 5 (5) | – | 13 (24) | – | 2 (4) | – |
| Upper abdominal pain | 9 (9) | – | 3 (3) | – | 9 (17) | 1 (2) | 2 (4) | – |
| Cough | 9 (9) | – | – | – | 7 (13) | – | 1 (2) | – |
| Anxiety | 9 (9) | – | 1 (1) | – | 7 (13) | – | – | – |
| Rash | 9 (9) | – | 9 (9) | – | 6 (11) | 1 (2) | 4 (7) | 1 (2) |
| Insomnia | 7 (7) | – | – | – | 6 (11) | – | – | – |
| Epistaxis | 5 (5) | – | 3 (3) | – | 13 (24) | – | 10 (19) | – |
| Myalgia | 5 (5) | – | 3 (3) | – | 9 (17) | – | 7 (13) | – |
| Infection, device related | 4 (4) | – | – | – | 8 (15) | 1 (2) | – | – |
| Infection, oral fungal | 4 (4) | – | 1 (1) | – | 7 (13) | – | 2 (4) | – |
| Dysgeusia | 4 (4) | – | 3 (3) | – | 7 (13) | – | 5 (9) | – |
| Mucosal inflammation | 4 (4) | – | 4 (4) | – | 6 (11) | – | 5 (9) | – |
| Hypophosphatemia | 3 (3) | – | 3 (3) | 2 (2) | 8 (15) | 8 (15) | 5 (9) | 5 (9) |
| Peripheral neuropathy | 2 (2) | – | 2 (2) | – | 12 (22) | 1 (2) | 7 (13) | 1 (2) |
| Hypocalcemia | 2 (2) | – | 1 (1) | – | 6 (11) | 3 (6) | 3 (6) | 1 (2) |
| Paraesthesia | – | – | – | – | 11 (20) | – | 4 (7) | – |
| Alopecia | – | – | – | – | 7 (13) | – | 6 (11) | – |
Data are presented as N (%).
Percentages were calculated using the number of patients in the safety population as denominator. Multiple occurrences of the same AE in one individual counted only once.
AEs leading to treatment discontinuation in the emactuzumab monotherapy arm were single patients with asthenia (grade 2, related), cerebral ischemia (grade 5, unrelated), increased blood creatine phosphokinase (grade 4, related) and myalgia (grade 1, unrelated) occurring in one patient, depression (grade 3, unrelated), hematoma (grade 4, related), increased intraocular pressure (grade 1, unrelated), laryngeal edema (grade 2, related), and lung infection (grade 4, unrelated).
SAE, serious adverse event.