Table 2.
Adverse events of interest (safety epidermal growth factor receptor > 0 subpopulation)
| Necitumumab plus gemcitabine–cisplatin (n = 456) |
Gemcitabine–cisplatin (n = 468) |
|||
|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Neutropenia | 199 (44%) | 112 (25%) | 206 (44%) | 126 (27%) |
| Febrile neutropenia | 5 (1%) | 4 (<1%) | 8 (2%) | 7 (1%) |
| Anemia | 186 (41%) | 46 (10%) | 212 (45%) | 50 (11%) |
| Thrombocytopenia | 101 (22%) | 48 (11%) | 120 (26%) | 51 (11%) |
| Diarrhea | 72 (16%) | 9 (2%) | 53 (11%) | 7 (1%) |
| Fatigue | 191 (42%) | 36 (8%) | 195 (42%) | 33 (7%) |
| Hypomagnesemia | 145 (32%) | 44 (10%) | 72 (15%) | 4 (<1%) |
| Hypomagnesemia (laboratory data) | 327 (83%) | 81 (21%) | 282 (71%) | 24 (6%) |
| Skin reactions | ||||
| Rash | 351 (77%) | 29 (6%) | 48 (10%) | 2 (<1%) |
| Hypersensitivity/infusion-related reaction | 8 (2%) | 2 (<1%) | 10 (2%) | 0 |
| Conjunctivitis | 37 (8%) | 1 (<1%) | 12 (3%) | 0 |
| Interstitial lung disease | 4 (<1%) | 2 (<1%)a | 4 (<1%) | 3 (<1%) |
| Arterial thromboembolic events | 26 (6%) | 18 (4%)b | 18 (4%) | 9 (2%)b |
| Venous thromboembolic events | 46 (10%) | 25 (5%)c | 25 (5%) | 12 (3%)c |
This table shows adverse events of interest according to either composite categories or preferred terms (febrile neutropenia and diarrhea only). Data are n (%).
aIncludes one fatal event (0.2%).
bFatal arterial thromboembolic events, n (%): Neci + Gem–Cis 3 (0.7%), Gem–Cis 1 (0.2%).
cFatal venous thromboembolic events, n (%): Neci + Gem–Cis 1 (0.2%), Gem–Cis 1 (0.2%).