TABLE A8.
Treatment-Related AEs
| Event | Subcutaneous Group (n = 206), No. (%) | Intravenous Group (n = 210), No. (%) | ||
|---|---|---|---|---|
| Any event | 196 (95) | 206 (98) | ||
| Grade ≥3 | 79 (38) | 82 (39) | ||
| Any serious event | 33 (16) | 34 (16) | ||
| Any event resulting in death | 3 (1) | 4 (2) | ||
| AEs reported in ≥15% of patients in either groupa | All | Grade ≥3 | All | Grade ≥3 |
| Paronychia | 110 (53) | 8 (4) | 108 (51) | 3 (1) |
| Rash | 90 (44) | 8 (4) | 91 (43) | 8 (4) |
| Hypoalbuminemia | 79 (38) | 5 (2) | 66 (31) | 7 (3) |
| Dermatitis acneiform | 64 (31) | 18 (9) | 69 (33) | 12 (6) |
| Stomatitis | 54 (26) | 1 (0.5) | 67 (32) | 5 (2) |
| Peripheral edema | 46 (22) | 4 (2) | 43 (20) | 1 (0.5) |
| Nausea | 43 (21) | 1 (0.5) | 40 (19) | 3 (1) |
| Increased alanine aminotransferase | 40 (19) | 6 (3) | 49 (23) | 6 (3) |
| Decreased appetite | 37 (18) | 1 (0.5) | 44 (21) | 2 (1) |
| Diarrhea | 36 (17) | 3 (1) | 31 (15) | 2 (1) |
| Increased aspartate aminotransferase | 35 (17) | 2 (1) | 37 (18) | 2 (1) |
| Vomiting | 33 (16) | 2 (1) | 29 (14) | 1 (0.5) |
| Fatigue | 30 (15) | 2 (1) | 30 (14) | 4 (2) |
| Infusion-related reaction | 27 (13) | 1 (0.5) | 136 (65) | 8 (4) |
NOTE. The safety population included all patients who were randomly assigned and received at least one dose of any trial treatment.
Abbreviation: AE, adverse event.
a
Events in this category are listed according to decreasing incidence in the subcutaneous group.