Table 4.
Open in new tab

Treatment-emergent adverse events occurring in at least 5% participants [placebo or amiselimod 0.4-mg treatment group], by preferred term [safety analysis set].

System organ classPlacebo N = 38]Amiselimod 0.4 mg [N = 39]Overall [N = 77]
Preferred termn [%]n [%]n [%]
Participants with at least one TEAE21 [55.3]26 [66.7]47 [61.0]
Headache6 [15.8]4 [10.3]10 [13.0]
Crohn’s disease1 [2.6]6 [15.4]7 [9.1]
Arthralgia3 [7.9]2 [5.1]5 [6.5]
Nasopharyngitis2 [5.3]3 [7.7]5 [6.5]
Abdominal pain1 [2.6]2 [5.1]3 [3.9]
Back pain2 [5.3]02 [2.6]
Blood creatine phosphokinase02 [5.1]2 [2.6]
increased
Chills2 [5.3]02 [2.6]
Dermatitis allergic02 [5.1]2 [2.6]
Diarrhoea2 [5.3]02 [2.6]
Dysmenorrhoea2 [5.3]02 [2.6]
Iron deficiency anaemia2 [5.3]02 [2.6]
Myalgia02 [5.1]2 [2.6]
Oropharyngeal pain02 [5.1]2 [2.6]
Pyrexia2 [5.3]02 [2.6]
System organ classPlacebo N = 38]Amiselimod 0.4 mg [N = 39]Overall [N = 77]
Preferred termn [%]n [%]n [%]
Participants with at least one TEAE21 [55.3]26 [66.7]47 [61.0]
Headache6 [15.8]4 [10.3]10 [13.0]
Crohn’s disease1 [2.6]6 [15.4]7 [9.1]
Arthralgia3 [7.9]2 [5.1]5 [6.5]
Nasopharyngitis2 [5.3]3 [7.7]5 [6.5]
Abdominal pain1 [2.6]2 [5.1]3 [3.9]
Back pain2 [5.3]02 [2.6]
Blood creatine phosphokinase02 [5.1]2 [2.6]
increased
Chills2 [5.3]02 [2.6]
Dermatitis allergic02 [5.1]2 [2.6]
Diarrhoea2 [5.3]02 [2.6]
Dysmenorrhoea2 [5.3]02 [2.6]
Iron deficiency anaemia2 [5.3]02 [2.6]
Myalgia02 [5.1]2 [2.6]
Oropharyngeal pain02 [5.1]2 [2.6]
Pyrexia2 [5.3]02 [2.6]

Note: MedDRA Version 19.0.

MedDRA ,Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event.

Table 4.
Open in new tab

Treatment-emergent adverse events occurring in at least 5% participants [placebo or amiselimod 0.4-mg treatment group], by preferred term [safety analysis set].

System organ classPlacebo N = 38]Amiselimod 0.4 mg [N = 39]Overall [N = 77]
Preferred termn [%]n [%]n [%]
Participants with at least one TEAE21 [55.3]26 [66.7]47 [61.0]
Headache6 [15.8]4 [10.3]10 [13.0]
Crohn’s disease1 [2.6]6 [15.4]7 [9.1]
Arthralgia3 [7.9]2 [5.1]5 [6.5]
Nasopharyngitis2 [5.3]3 [7.7]5 [6.5]
Abdominal pain1 [2.6]2 [5.1]3 [3.9]
Back pain2 [5.3]02 [2.6]
Blood creatine phosphokinase02 [5.1]2 [2.6]
increased
Chills2 [5.3]02 [2.6]
Dermatitis allergic02 [5.1]2 [2.6]
Diarrhoea2 [5.3]02 [2.6]
Dysmenorrhoea2 [5.3]02 [2.6]
Iron deficiency anaemia2 [5.3]02 [2.6]
Myalgia02 [5.1]2 [2.6]
Oropharyngeal pain02 [5.1]2 [2.6]
Pyrexia2 [5.3]02 [2.6]
System organ classPlacebo N = 38]Amiselimod 0.4 mg [N = 39]Overall [N = 77]
Preferred termn [%]n [%]n [%]
Participants with at least one TEAE21 [55.3]26 [66.7]47 [61.0]
Headache6 [15.8]4 [10.3]10 [13.0]
Crohn’s disease1 [2.6]6 [15.4]7 [9.1]
Arthralgia3 [7.9]2 [5.1]5 [6.5]
Nasopharyngitis2 [5.3]3 [7.7]5 [6.5]
Abdominal pain1 [2.6]2 [5.1]3 [3.9]
Back pain2 [5.3]02 [2.6]
Blood creatine phosphokinase02 [5.1]2 [2.6]
increased
Chills2 [5.3]02 [2.6]
Dermatitis allergic02 [5.1]2 [2.6]
Diarrhoea2 [5.3]02 [2.6]
Dysmenorrhoea2 [5.3]02 [2.6]
Iron deficiency anaemia2 [5.3]02 [2.6]
Myalgia02 [5.1]2 [2.6]
Oropharyngeal pain02 [5.1]2 [2.6]
Pyrexia2 [5.3]02 [2.6]

Note: MedDRA Version 19.0.

MedDRA ,Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event.

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