Table 2.
Summary of safety data for Cladribine Tablets 3.5 mg/kg by HDA subgroup (safety population).
| Characteristic | Placebo |
Cladribine Tablets 3.5 mg/kg |
||||
|---|---|---|---|---|---|---|
| Overall N = 433 | HRA N = 131 | HRA + DAT N = 148 | Overall N = 442 | HRA N = 131 | HRA + DAT N = 142 | |
| Any treatment-emergent AE, n (%) | 317 (73.2) | 100 (76.3) | 112 (75.7) | 359 (81.2) | 99 (75.6) | 109 (76.8) |
| 95% CI | 68.8–77.3 | 68.1–83.3 | 67.9–82.3 | 77.3–84.8 | 67.3–82.7 | 68.9–83.4 |
| Any treatment-related AE, n (%) | 167 (38.6) | 53 (40.5) | 61 (41.2) | 251 (56.8) | 68 (51.9) | 74 (52.1) |
| 95% CI | 34.0–43.3 | 32.0–49.4 | 33.2–49.6 | 52.0–61.5 | 43.0–60.7 | 43.6–60.6 |
| Any severe treatment-emergent AE, n (%) | 31 (7.2) | 12 (9.2) | 17 (11.5) | 37 (8.4) | 10 (7.6) | 10 (7.0) |
| 95% CI | 4.9–10.0 | 4.8–5.5 | 6.8–17.8 | 6.0–11.4 | 3.7–13.6 | 3.4–12.6 |
| Any serious treatment-emergent AE, n (%) | 32 (7.4) | 10 (7.6) | 11 (7.4) | 44 (10.0) | 17 (13.0) | 17 (12.0) |
| 95% CI | 5.1–10.3 | 3.7–13.6 | 3.8–12.9 | 7.3–13.1 | 7.7–20.0 | 7.1–18.5 |
AE: adverse event; CI: confidence interval; HRA: high relapse activity; HRA + DAT: high relapse activity plus disease activity on treatment.