Overall summary of treatment-emergent adverse events [TEAEs]: safety analysis set.
| . | Placebo [N = 38] . | Amiselimod 0.4 mg [N = 39] . | Overall [N = 77] . |
|---|---|---|---|
| . | n [%] . | n [%] . | n [%] . |
| Participants with at least one TEAE | 21 [55.3] | 26 [66.7] | 47 [61.0] |
| Participants with at least one SAE | 1 [2.6] | 6 [15.4] | 7 [9.1] |
| Participants with at least one adverse drug reaction | 9 [23.7] | 12 [30.8] | 21 [27.3] |
| Participants with at least one serious adverse drug reaction | 1 [2.6] | 4 [10.3] | 5 [6.5] |
| Participants with TEAEs leading to discontinuation of study medication | 4 [10.5] | 7 [17.9] | 11 [14.3] |
| Participants with SAEs leading to discontinuation of study medication | 1 [2.6] | 4 [10.3] | 5 [6.5] |
| Participants with adverse drug reaction leading to discontinuation of study medication | 4 [10.5] | 5 [12.8] | 9 [11.7] |
| Participants with SAR leading to discontinuation of study medication | 1 [2.6] | 3 [7.7] | 4 [5.2] |
| . | Placebo [N = 38] . | Amiselimod 0.4 mg [N = 39] . | Overall [N = 77] . |
|---|---|---|---|
| . | n [%] . | n [%] . | n [%] . |
| Participants with at least one TEAE | 21 [55.3] | 26 [66.7] | 47 [61.0] |
| Participants with at least one SAE | 1 [2.6] | 6 [15.4] | 7 [9.1] |
| Participants with at least one adverse drug reaction | 9 [23.7] | 12 [30.8] | 21 [27.3] |
| Participants with at least one serious adverse drug reaction | 1 [2.6] | 4 [10.3] | 5 [6.5] |
| Participants with TEAEs leading to discontinuation of study medication | 4 [10.5] | 7 [17.9] | 11 [14.3] |
| Participants with SAEs leading to discontinuation of study medication | 1 [2.6] | 4 [10.3] | 5 [6.5] |
| Participants with adverse drug reaction leading to discontinuation of study medication | 4 [10.5] | 5 [12.8] | 9 [11.7] |
| Participants with SAR leading to discontinuation of study medication | 1 [2.6] | 3 [7.7] | 4 [5.2] |
SAE, serious adverse event; SAR, serious adverse reaction; TEAE, treatment-emergent adverse event.
Overall summary of treatment-emergent adverse events [TEAEs]: safety analysis set.
| . | Placebo [N = 38] . | Amiselimod 0.4 mg [N = 39] . | Overall [N = 77] . |
|---|---|---|---|
| . | n [%] . | n [%] . | n [%] . |
| Participants with at least one TEAE | 21 [55.3] | 26 [66.7] | 47 [61.0] |
| Participants with at least one SAE | 1 [2.6] | 6 [15.4] | 7 [9.1] |
| Participants with at least one adverse drug reaction | 9 [23.7] | 12 [30.8] | 21 [27.3] |
| Participants with at least one serious adverse drug reaction | 1 [2.6] | 4 [10.3] | 5 [6.5] |
| Participants with TEAEs leading to discontinuation of study medication | 4 [10.5] | 7 [17.9] | 11 [14.3] |
| Participants with SAEs leading to discontinuation of study medication | 1 [2.6] | 4 [10.3] | 5 [6.5] |
| Participants with adverse drug reaction leading to discontinuation of study medication | 4 [10.5] | 5 [12.8] | 9 [11.7] |
| Participants with SAR leading to discontinuation of study medication | 1 [2.6] | 3 [7.7] | 4 [5.2] |
| . | Placebo [N = 38] . | Amiselimod 0.4 mg [N = 39] . | Overall [N = 77] . |
|---|---|---|---|
| . | n [%] . | n [%] . | n [%] . |
| Participants with at least one TEAE | 21 [55.3] | 26 [66.7] | 47 [61.0] |
| Participants with at least one SAE | 1 [2.6] | 6 [15.4] | 7 [9.1] |
| Participants with at least one adverse drug reaction | 9 [23.7] | 12 [30.8] | 21 [27.3] |
| Participants with at least one serious adverse drug reaction | 1 [2.6] | 4 [10.3] | 5 [6.5] |
| Participants with TEAEs leading to discontinuation of study medication | 4 [10.5] | 7 [17.9] | 11 [14.3] |
| Participants with SAEs leading to discontinuation of study medication | 1 [2.6] | 4 [10.3] | 5 [6.5] |
| Participants with adverse drug reaction leading to discontinuation of study medication | 4 [10.5] | 5 [12.8] | 9 [11.7] |
| Participants with SAR leading to discontinuation of study medication | 1 [2.6] | 3 [7.7] | 4 [5.2] |
SAE, serious adverse event; SAR, serious adverse reaction; TEAE, treatment-emergent adverse event.
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