CIDP01 TEAEs*
| TEAE | Treatment period | Observation period | ||
| Placebo (n=17) | Rozanolixizumab (n=17) | Placebo (n=17) | Rozanolixizumab (n=17) | |
| Any TEAE, n (%) | 13 (76) | 14 (82) | 4 (24) | 3 (18) |
| Headache | 5 (29) | 6 (35) | 1 (6) | 1 (6) |
| Arthralgia | 1 (6) | 3 (18) | 0 | 0 |
| CIDP worsening | 1 (6) | 3 (18) | 3 (18) | 3 (18) |
| Peripheral swelling | 1 (6) | 3 (18) | 0 | 0 |
| Infusion-site erythema | 0 | 3 (18) | 0 | 0 |
| Bacterial test positive | 0 | 2 (12) | 0 | 0 |
| Diarrhoea | 3 (18) | 2 (12) | 0 | 0 |
| Fatigue | 3 (18) | 1 (6) | 0 | 0 |
| Urinary tract infection | 3 (18) | 1 (6) | 1 (6) | 0 |
| Nausea | 2 (12) | 1 (6) | 0 | 0 |
| Administration-site pain | 2 (12) | 0 | 0 | 0 |
| Fall | 2 (12) | 0 | 0 | 0 |
| Hypothesia | 2 (12) | 0 | 0 | 0 |
| Rash | 2 (12) | 0 | 0 | 0 |
| Serious TEAE, n (%) | 0 | 2 (12) | 0 | 0 |
| Drug-related TEAE, n (%) | 5 (29) | 10 (59) | 1 (6) | 1 (6) |
| Severe TEAE, n (%) | 0 | 1 (6) | 2 (12) | 0 |
| Discontinuations due to TEAE, n (%)† | 2 (12) | 1 (6) | 3 (18) | 2 (12) |
| Deaths, n (%) | 0 | 0 | 0 | 0 |
*TEAEs occurring in two or more patients during the treatment period.
†TEAEs leading to discontinuation were CIDP worsening/relapse, muscle weakness and paraesthesia, all of which resolved. These patients are reported in the trial profile as withdrawing due to lack of efficacy or CIDP relapse (other).
CIDP, chronic inflammatory demyelinating polyradiculoneuropathy; TEAE, treatment-emergent adverse event.