CIDP04 TEAEs*
| TEAE | Treatment period | Observation period | ||
| Placebo/rozanolixizumab (n=11) | Rozanolixizumab/rozanolixizumab (n=10) | Placebo/rozanolixizumab (n=11) | Rozanolixizumab/rozanolixizumab (n=10) | |
| Any TEAE, n (%) | 9 (82) | 10 (100) | 7 (64) | 4 (40) |
| Blood IgG decreased | 4 (36) | 4 (40) | 0 | 1 (10) |
| Fatigue | 2 (18) | 3 (30) | 1 (9) | 0 |
| Headache | 4 (36) | 1 (10) | 0 | 0 |
| Nasopharyngitis | 2 (18) | 1 (10) | 0 | 1 (10) |
| Muscle strain | 1 (9) | 2 (20) | 0 | 0 |
| Joint swelling | 0 | 2 (20) | 1 (9) | 0 |
| Neuralgia | 0 | 2 (20) | 1 (9) | 0 |
| Constipation | 0 | 2 (20) | 0 | 0 |
| Fever | 2 (18) | 0 | 0 | 0 |
| Influenza | 2 (18) | 0 | 0 | 0 |
| Upper respiratory tract infection | 2 (18) | 0 | 0 | 0 |
| Fall | 0 | 2 (20) | 0 | 0 |
| Muscle spasms | 0 | 2 (20) | 0 | 0 |
| Muscular weakness | 1 (9) | 0 | 2 (18) | 0 |
| Sensory loss | 1 (9) | 0 | 2 (18) | 0 |
| Serious TEAE, n (%) | 1 (9) | 0 | 1 (9) | 2 (20) |
| Drug-related TEAE, n (%) | 6 (55) | 5 (50) | 0 | 0 |
| Severe TEAE, n (%) | 3 (27) | 4 (40) | 2 (18) | 4 (40) |
| Discontinuations due to TEAE, n (%)† | 1 (9) | 0 | 1 (9) | 1 (10) |
| Deaths, n (%) | 0 | 0 | 0 | 0 |
*TEAEs occurring in two or more patients during the treatment period.
†TEAEs leading to discontinuation were a serious TEAE of malignant melanoma in the placebo/rozanolixizumab group during the treatment period and a serious TEAE of CIDP relapse in the rozanolixizumab/rozanolixizumab group during the observation period, both of which resolved. These patients are reported in the trial profile as withdrawing due to an adverse event. One patient in the placebo/rozanolixizumab group experienced peripheral swelling (resolved) and muscular weakness (outcome unknown) during the observation period; this patient is reported in the trial profile as having withdrawn consent.
CIDP, chronic inflammatory demyelinating neuropathy; TEAE, treatment-emergent adverse event.