Table 6.
Overall summary of safety (%)
| Safety parameter | 3 years (pivotal)
|
Monthly oral
|
3-monthly intravenous
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=975) | Daily 2.5 mg (n=977) | Intermittent 20 mg (n=977) | Comparator 1 year, 2.5 mg daily PO (n=395) | 1 year, 150 mg (n=396) | 5 year, 150 mg (n=176) | Comparator 1 year, 2.5 mg daily PO (n=469) | 1 Year, 3 mg (n=465) | 5 year, 3 mg (n=264) | |
| AE | 88.9 | 90.9 | 91.9 | 69.1 | 69.9 | 90.3 | 76.1 | 77.4 | 93.9 |
| Drug-related AE | 17.9 | 19.8 | 18.5 | 30.1 | 32.6 | 32.4 | 39.0 | 33.3 | 38.6 |
| SAE | 21.6 | 24.0 | 25.3 | 4.8 | 7.1 | NA | 7.5 | 8.0 | NA |
| Drug-related SAE | 0.3 | 0.3 | 0.7 | 0.5 | 0 | NA | 0.4 | 0.2 | NA |
| AE leading to withdrawal | 18.8 | 18.5 | 18.5 | NA | NA | NA | NA | NA | NA |
| Drug-related AE leading to withdrawal | 8.1 | 7.5 | 7.2 | 7.3 | 5.8 | NA | 6.6 | 4.5 | NA |
| Drug-related SAE leading to withdrawal | NA | NA | NA | 0.3 | 0 | NA | 0 | 0 | NA |
| AE leading to death | 1.0 | 1.1 | 0.8 | NA | NA | NA | 0.4 | 0.2 | NA |
| Upper GI AE | 9.1 | 11.4 | 9.0 | 18.0 | 16.9 | 7.4 | NA | NA | 3.4 |
| Upper GI AE PWH | NA | NA | NA | 38.1 | 19.6 | NA | NA | NA | NA |
| Upper-GI AE NSAID | NA | NA | NA | 18.4 | 18.3 | NA | NA | NA | NA |
| Influenza-like symptoms* | NA | NA | NA | 2.8 | 8.3 | 1.1 | NA | 4.1 | 4.5 |
| Upper abdominal pain | 2.6 | 1.9 | 2.5 | NA | NA | 4.0 | NA | NA | 3.4 |
| Nausea | 6.3 | 4.2 | 6.4 | NA | NA | 3.4 | NA | NA | 1.1 |
| Vomiting | 2.5 | 3.0 | 2.8 | NA | NA | NA | NA | NA | NA |
| ONJ | NA | NA | NA | 0 | 0 | 0 | 0 | 0 | 0 |
Note:
*
Occurring within 72 hours of dosing and lasting for no longer than 7 days.
Abbreviations: AE, adverse events; GI, gastrointestinal; NA, not available; NSAID, in patients receiving concomitant nonsteroidal anti-inflammatory drugs; ONJ, osteonecrosis of the jaw; PO, per oral; PWH, in patients with prior history of upper gastrointestinal disorder; SAE, serious adverse events.