Table 3.
Adverse Events. Data are expressed as the number of patients (%) and include all patients who received at least 1 romosozumab injection (N = 230).
| Total (N = 230) |
|
|---|---|
| All adverse events | 64 (27.8) |
| Adverse events leading to discontinuation of trial participation | 10 (4.3) |
| Serious adverse events | 4 (1.7) |
| Anterior mediastinal tumor (recurrence of breast cancer) | |
| Cerebral infarction | 1 (0.4) |
| Osteonecrosis of the jaw | 1 (0.4) |
| Pneumothorax | 1 (0.4) |
| Injection site reactiona | 32 (13.9) |
| Pain | 18 (7.8) |
| Swelling | 13 (5.7) |
| Redness | 1 (0.4) |
| Other events of interest | 17 (7.4) |
| Hypozincemia | 1 (0.4) |
| Arrhythmia | 1 (0.4) |
| Fever | 2 (0.9) |
| Anacatesthesia | 1 (0.4) |
| Osteonecrosis of the leg | 1 (0.4) |
| Numbness in limbs | 1 (0.4) |
| Rash | 1 (0.4) |
| Blood pressure elevation | 2 (0.9) |
| Facial flare | 1 (0.4) |
| Fatigue | 3 (1.3) |
| Dysphoria | 2 (0.9) |
| Headache | 1 (0.4) |
| Bloody discharge | 1 (0.4) |
| Hypocalcemiab | 1 (0.4) |
| New fractures during romosozumab therapy | 7 (3.0) |
| Thoracic or/and lumbar spine | 3 (1.3) |
| Left proximal tibial fracture | 1 (0.4) |
| Left distal radius fracture | 1 (0.4) |
| Left distal fibular fracture | 1 (0.4) |
| Right proximal humeral fracture | 1 (0.4) |
a
The most frequent adverse event was injection site reaction associated with pain, swelling, and redness lasting 2 days or longer.
b
Hypocalcemia was judged as Grade 2 or higher on the CTCAE v5.0 grading scale.