Table 2.
Summary of safety outcomes in propensity score–matched Q6W and Q4W patients (unique patient sets).
| Outcome, n (%) | Treatment group |
|
|---|---|---|
| Q6W (n = 219) |
Q4W (n = 196) |
|
| Patients with ⩾1 SAE | 19 (8.7) | 22 (11.2) |
| Patients with ⩾1 treatment-related SAEa | 4 (1.8) | 3 (1.5) |
| SAEs occurring in > 1% of either group, n (%)b | ||
| Infections and infestations | 4 (1.8) | 8 (4.1) |
| Nervous system disorders | 4 (1.8) | 5 (2.6) |
| Gastrointestinal disorders | 1 (0.5) | 4 (2.0) |
| Neoplasmsc | 4 (1.8) | 1 (0.5) |
| Pregnancy, puerperium, and perinatal conditions | 4 (1.8) | 1 (0.5) |
| Injury, poisoning, and procedural complications | 2 (0.9) | 3 (1.5) |
| Musculoskeletal and connective tissue disorders | 3 (1.4) | 3 (1.5) |
| Hepatobiliary disorders | 1 (0.5) | 2 (1.0) |
| Infections requiring hospitalization | 2 (0.9) | 3 (1.5) |
| Malignancy | 2 (0.9) | 1 (0.5) |
| PML | 2 (0.9) | 0 |
| Deaths | 1 (0.5) | 0 |
PML, progressive multifocal leukoencephalopathy; Q4W, every 4 weeks; Q6W, every 6 weeks; SAE, serious adverse event.
a
Includes relation to study medication recorded as related, possibly related, or unknown.
b
Listed by System Organ Class.
c
Benign, malignant, and unspecified neoplasms, including cysts and polyps.