Table 2.
Summary of adverse events reported over the study period (mITT population)
| Number (%) patients with | Placebo (n = 5) |
Atacicept 25 mg (n = 6) |
Atacicept 75 mg (n = 5) |
Total (N = 16) |
|---|---|---|---|---|
| Any TEAEs | 5 (100) | 6 (100) | 3 (60) | 14 (88) |
| TEAEs during the treatment period | 5 (100) | 6 (100) | 3 (60) | 14 (88) |
| TEAEs in the post-treatment period | 0 | 3 (50) | 0 | 3 (19) |
| Mild TEAEs | 5 (100) | 6 (100) | 3 (60) | 14 (88) |
| Moderate TEAEs | 2 (40) | 5 (83) | 1 (20) | 8 (50) |
| Severe TEAEs | 0 | 1 (17) | 0 | 1 (6) |
| Treatment-related TEAEs | 1 (20) | 5 (83) | 3 (60) | 9 (56) |
| Serious TEAEs | 1 (20) | 3 (50) | 0 | 4 (25) |
| Serious TEAEs in the treatment period | 1 (20) | 2 (33) | 0 | 3 (19) |
| Serious TEAEs in the post-treatment period | 0 | 1 (17) | 0 | 1 (6) |
| TEAEs leading to treatment discontinuation | 0 | 1 (17) | 0 | 1 (6) |
| TEAEs with fatal outcome | 0 | 0 | 0 | 0 |
mITT, modified intent-to-treat; TEAE, treatment-emergent adverse event.
TEAEs are defined as events occurring between the date of first dose and the end of the 24-week safety follow-up period. The treatment period is defined as the period between the date of first and last dose plus 7 days. Percentages are a proportion of the total number of patients in each column.