TABLE 3.
Overview of AEs
| AEa | Subcutaneous Group (n = 206), No. (%) | Intravenous Group (n = 210), No. (%) | ||
|---|---|---|---|---|
| Any event | 204 (99) | 209 (99) | ||
| Grade ≥3 | 107 (52) | 118 (56) | ||
| Any serious event | 59 (29) | 64 (30) | ||
| Any event resulting in death | 7 (3) | 10 (5) | ||
| Any event leading to: | ||||
| Interruption of any study agentb | 127 (62) | 127 (60) | ||
| Reduction of any study agent | 63 (31) | 52 (25) | ||
| Discontinuation of any study agent | 26 (13) | 29 (14) | ||
| AEs reported in ≥15% of patients in either groupc | All | Grade ≥3 | All | Grade ≥3 |
| Paronychia | 111 (54) | 8 (4) | 108 (51) | 3 (1) |
| Hypoalbuminemia | 96 (47) | 9 (4) | 77 (37) | 8 (4) |
| Rash | 95 (46) | 8 (4) | 91 (43) | 8 (4) |
| Dermatitis acneiform | 64 (31) | 18 (9) | 69 (33) | 12 (6) |
| Nausea | 60 (29) | 1 (0.5) | 52 (25) | 3 (1) |
| Stomatitis | 57 (28) | 1 (0.5) | 69 (33) | 5 (2) |
| Peripheral edema | 52 (25) | 6 (3) | 58 (28) | 1 (0.5) |
| Increased alanine aminotransferase | 46 (22) | 6 (3) | 56 (27) | 8 (4) |
| Decreased appetite | 45 (22) | 1 (0.5) | 52 (25) | 3 (1) |
| Fatigue | 44 (21) | 3 (1) | 43 (20) | 5 (2) |
| Vomiting | 44 (21) | 2 (1) | 41 (20) | 1 (0.5) |
| Diarrhea | 43 (21) | 3 (1) | 39 (19) | 2 (1) |
| Constipation | 42 (20) | 0 | 42 (20) | 1 (0.5) |
| Headache | 42 (20) | 1 (0.5) | 36 (17) | 1 (0.5) |
| Increased aspartate aminotransferase | 42 (20) | 2 (1) | 45 (21) | 3 (1) |
| Anemia | 39 (19) | 4 (2) | 40 (19) | 5 (2) |
| Pruritus | 33 (16) | 0 | 25 (12) | 0 |
| Hypocalcemia | 33 (16) | 0 | 27 (13) | 0 |
| Myalgia | 32 (16) | 0 | 13 (6) | 0 |
| Asthenia | 31 (15) | 4 (2) | 23 (11) | 2 (1) |
| Thrombocytopenia | 29 (14) | 4 (2) | 33 (16) | 2 (1) |
| IRR | 27 (13) | 1 (0.5) | 138 (66) | 8 (4) |
Abbreviations: AE, adverse event; IRR, infusion-related reaction.
a
The safety population included all patients who had undergone random assignment and received at least one dose of any trial treatment.
b
Excluding infusion-/administration-related reactions.
c
Events in this category are listed according to decreasing incidence in the subcutaneous group.