Table 4.
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