Table 2:
Adverse events in the safety population.
| Maintenance (n=50)1, 2 | Withdrawal (n=52)1, 2 | |||
|---|---|---|---|---|
|
|
||||
| n (%) | Events, n | n (%) | Events, n | |
| Serious Adverse Events | 7 (14·0) | 12 | 5 (9·6) | 6 |
| Total Adverse Events | 45 (90·0) | 189 | 46 (88·5) | 205 |
| Related to SLE* | 25 (50·0) | 63 | 32 (61·5) | 79 |
| Adverse Events by Severity | ||||
| Grade 1 | 0 | 0 | 1 (1·9) | 1 |
| Grade 2 | 45 (90·0) | 169 | 45 (86·5) | 189 |
| Grade 3 | 10 (20·0) | 18 | 11 (21·2) | 15 |
| Grade 4 | 2 (4·0) | 2 | 0 | 0 |
| Total Infections | 32 (64·0) | 63 | 24 (46·2) | 49 |
| Infections by Severity | ||||
| Grade 2 | 30 (60·0) | 57 | 24 (46·2) | 48 |
| Grade 3 | 4 (8·0) | 6 | 1 (1·9) | 1 |
| Grade 4 | 0 | 0 | 0 | 0 |
*
Related includes definitely, probably, or possibly related.
1
Percentages for the number of subjects with AEs/SAEs are based on the number of subjects in the safety population (N).
2
Subjects who experienced one or more adverse events in a category are counted only once.