Skip to main content
. 2019 Oct 16;19(4):351–366. doi: 10.1007/s40268-019-00286-z

Table 4.

Most frequent treatment-emergent adverse events by preferred term (frequency > 2.0% in either treatment arm)

MedDRA SOC TEAEs by MedDRA preferred term Vidofludimus (N = 122) Placebo (N = 119) Total (N = 241)
Gastrointestinal disorders Diarrhea 7 (5.7) 7 (5.9) 14 (5.8)
Nausea 4 (3.3) 5 (4.2) 9 (3.7)
Abdominal pain upper 4 (3.3) 1 (0.8) 5 (2.1)
Dyspepsia 3 (2.5) 0 (0.0) 3 (1.2)
Vomiting 0 (0.0) 3 (2.5) 3 (1.2)
General disorders and administration site conditions Pyrexia 3 (2.5) 1 (0.8) 4 (1.7)
Infections and infestations Nasopharyngitis 8 (6.6) 6 (5.0) 14 (5.8)
Urinary tract infection 6 (4.9) 7 (5.9) 13 (5.4)
Upper respiratory tract infection 2 (1.6) 9 (7.6) 11 (4.6)
Pharyngitis 3 (2.5) 4 (3.4) 7 (2.9)
Viral infection 3 (2.5) 2 (1.7) 5 (2.1)
Cystitis 3 (2.5) 1 (0.8) 4 (1.7)
Respiratory tract infection 0 (0.0) 3 (2.5) 3 (1.2)
Sinusitis 0 (0.0) 3 (2.5) 3 (1.2)
Investigations Blood alkaline phosphatase increased 4 (3.3) 1 (0.8) 5 (2.1)
Musculoskeletal and connective tissue disorders Rheumatoid arthritis 8 (6.6) 7 (5.9) 15 (6.2)
Arthralgia 5 (4.1) 4 (3.4) 9 (3.7)
Musculoskeletal stiffness 0 (0.0) 3 (2.5) 3 (1.2)
Nervous system disorders Headache 19 (15.6) 20 (16.8) 39 (16.2)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain 3 (2.5) 0 (0.0) 3 (1.2)
Vascular disorders Hypertension 4 (3.3) 1 (0.8) 5 (2.1)

Data are expressed as n (%)

MedDRA Medical Dictionary for Regulatory Activities, N number of patients, SOC system organ class, TEAEs treatment-emergent adverse events