Table 3.
Subject incidence of adverse events
| Adverse events | Placebo (month 0–12) N = 50 |
First-course romosozumab 210 mg QM (month 0–12) N = 51 |
First-course romosozumaba 210 mg QM (month 36–48) N = 27 |
Second-course romosozumabb 210 mg QM (month 36–48) (prior romosozumab 210 mg QM) (month 0–24) N = 35 |
Second-course romosozumabc 210 mg QM (month 36–48) (any prior romosozumab dose) (month 0–24) N = 140 |
|---|---|---|---|---|---|
| All | 45 (90.0) | 43 (84.3) | 24 (88.9) | 28 (80.0) | 118 (84.3) |
| Seriousd | 7 (14.0) | 6 (11.8) | 1 (3.7) | 2 (5.7) | 7 (5.0) |
| Leading to study discontinuation | 0 (0) | 0 (0) | 1 (3.7) | 0 (0) | 4 (2.9) |
| Death | 1 (2.0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Adverse events of interest | |||||
| Potentially associated with hypersensitivity | 4 (8.0) | 4 (7.8) | 2 (7.4) | 0 (0) | 11 (7.9) |
| Injection-site reactions | 2 (4.0) | 3 (5.9) | 2 (7.4) | 2 (5.7) | 10 (7.1) |
| Malignancies | 2 (4.0) | 1 (2.0) | 1 (3.7) | 1 (2.9) | 5 (3.6) |
| Osteoarthritis | 5 (10.0) | 0 (0) | 3 (11.1) | 1 (2.9) | 3 (2.1) |
| Atypical femoral fracturee | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Hypocalcemia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Hyperostosis | 2 (4.0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Osteonecrosis of the jawe | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Data are n (%)
N, number of participants in each treatment group; n, number of participants reporting at least one event; QM, every month; Q6M, every 6 months
aPlacebo from month 0 to month 24; placebo or denosumab 60 mg Q6M from month 24 to month 36; romosozumab 210 mg QM from months 36 to month 48
bRomosozumab 210 mg QM from month 0 to month 24; placebo or denosumab 60 mg Q6M from month 24 to month 36; romosozumab 210 mg QM from month 36 to month 48
cAny prior romosozumab doses from month 0 to month 24; placebo or denosumab 60 mg Q6M from month 24 to month 36; romosozumab 210 mg QM from month 36 to month 48
dSerious adverse events reported in the group receiving a second course of romosozumab were breast cancer in 2 participants, lung cancer in 2 participants, myocardial infarction in 1 participant, inguinal hernia in 1 participant, and osteoarthritis in 1 participant; 1 participant in the group receiving their first course of romosozumab in the second-course period reported thyroid cancer
eAll potential events of osteonecrosis of the jaw and atypical femur fracture from the start of the study were retrospectively assessed for adjudication