AE profile for the safety set
| AEs . | Rozanolixizumab . | |||||
|---|---|---|---|---|---|---|
| Single-dose cohorts . | Multiple-dose cohorts . | All patients . | ||||
| 20 mg/kg (n = 12) . | 15 mg/kg (n = 12) . | 2 × 10 mg/kg (n = 12) . | 3 × 7 mg/kg (n = 15) . | 5 × 4 mg/kg (n = 15) . | (N = 66) . | |
| Any AE | 12 (100) | 11 (91.7) | 7 (58.3) | 9 (60.0) | 12 (80.0) | 51 (77.3) |
| Serious AEs | 0 | 2 (16.7) | 1 (8.3) | 0 | 1 (6.7) | 4 (6.1) |
| AEs related to rozanolixizumab | 9 (75.0) | 7 (58.3) | 1 (8.3) | 1 (6.7) | 1 (6.7) | 19 (28.8) |
| Severe AEs | 0 | 1 (8.3) | 1 (8.3) | 0 | 1 (6.7) | 3 (4.5) |
| Discontinuations as a result of AEs | 0 | 0 | 0 | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
| Most common AEs* | ||||||
| Headache | 9 (75.0) | 5 (41.7) | 3 (25.0) | 6 (40.0) | 3 (20.0) | 26 (39.4) |
| Diarrhea | 2 (16.7) | 2 (16.7) | 1 (8.3) | 2 (13.3) | 1 (6.7) | 8 (12.1) |
| Vomiting | 4 (33.3) | 2 (16.7) | 0 | 0 | 0 | 6 (9.1) |
| Pyrexia | 3 (25.0) | 1 (8.3) | 1 (8.3) | 0 | 0 | 5 (7.6) |
| Upper respiratory tract infection | 0 | 1 (8.3) | 1 (8.3) | 1 (6.7) | 1 (6.7) | 4 (6.1) |
| Most common AEs related to rozanolixizumab*† | ||||||
| Headache | 8 (66.7) | 5 (41.7) | 1 (8.3) | 1 (6.7) | 0 | 15 (22.7) |
| Vomiting | 3 (25.0) | 2 (16.7) | 0 | 0 | 0 | 5 (7.6) |
| Diarrhea | 2 (16.7) | 2 (16.7) | 0 | 0 | 0 | 4 (6.1) |
| AEs . | Rozanolixizumab . | |||||
|---|---|---|---|---|---|---|
| Single-dose cohorts . | Multiple-dose cohorts . | All patients . | ||||
| 20 mg/kg (n = 12) . | 15 mg/kg (n = 12) . | 2 × 10 mg/kg (n = 12) . | 3 × 7 mg/kg (n = 15) . | 5 × 4 mg/kg (n = 15) . | (N = 66) . | |
| Any AE | 12 (100) | 11 (91.7) | 7 (58.3) | 9 (60.0) | 12 (80.0) | 51 (77.3) |
| Serious AEs | 0 | 2 (16.7) | 1 (8.3) | 0 | 1 (6.7) | 4 (6.1) |
| AEs related to rozanolixizumab | 9 (75.0) | 7 (58.3) | 1 (8.3) | 1 (6.7) | 1 (6.7) | 19 (28.8) |
| Severe AEs | 0 | 1 (8.3) | 1 (8.3) | 0 | 1 (6.7) | 3 (4.5) |
| Discontinuations as a result of AEs | 0 | 0 | 0 | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
| Most common AEs* | ||||||
| Headache | 9 (75.0) | 5 (41.7) | 3 (25.0) | 6 (40.0) | 3 (20.0) | 26 (39.4) |
| Diarrhea | 2 (16.7) | 2 (16.7) | 1 (8.3) | 2 (13.3) | 1 (6.7) | 8 (12.1) |
| Vomiting | 4 (33.3) | 2 (16.7) | 0 | 0 | 0 | 6 (9.1) |
| Pyrexia | 3 (25.0) | 1 (8.3) | 1 (8.3) | 0 | 0 | 5 (7.6) |
| Upper respiratory tract infection | 0 | 1 (8.3) | 1 (8.3) | 1 (6.7) | 1 (6.7) | 4 (6.1) |
| Most common AEs related to rozanolixizumab*† | ||||||
| Headache | 8 (66.7) | 5 (41.7) | 1 (8.3) | 1 (6.7) | 0 | 15 (22.7) |
| Vomiting | 3 (25.0) | 2 (16.7) | 0 | 0 | 0 | 5 (7.6) |
| Diarrhea | 2 (16.7) | 2 (16.7) | 0 | 0 | 0 | 4 (6.1) |
All data are n (%). All AEs were treatment-emergent occurring during the study after ≥1 rozanolixizumab infusions. All AEs were coded by using the Medical Dictionary for Regulatory Activities (MedDRA; version 21.1) and categorized by severity according to Common Terminology Criteria for Adverse Events (CTCAE; version 4.03) grading or, in the absence of CTCAE, according to intensity (mild, moderate, severe).
Based on a cutoff of 5% in the All patients column.
AEs that were considered related to treatment by the investigator.