Table 3

AEs observed in ≥3% of patients in any treatment group and all serious AEs (all treated set)

EventPlacebo
(n=121)
Ponesimod
10 mg (n=108)
Ponesimod
20 mg (n=114)
Ponesimod
40 mg (n=119)
AEs
 Patients with ≥1 AE90 (74.4)83 (76.9)88 (77.2)88 (73.9)
 Total number of AEs310275304325
 Anxiety5 (4.6)3 (2.6)4 (3.4)
 Arthralgia7 (5.8)2 (1.9)1 (0.9)1 (0.8)
 Back pain6 (5.0)2 (1.9)5 (4.4)6 (5.0)
 Bronchitis2 (1.7)4 (3.7)4 (3.5)5 (4.2)
 Chest discomfort3 (2.5)5 (4.4)4 (3.4)
 Cough2 (1.7)1 (0.9)3 (2.6)8 (6.7)
 Diarrhoea8 (6.6)3 (2.8)3 (2.6)2 (1.7)
 Dizziness3 (2.5)8 (7.4)7 (6.1)11 (9.2)
 Dyspnoea4 (3.3)5 (4.6)7 (6.1)17 (14.3)
 Fatigue7 (5.8)7 (6.5)9 (7.9)6 (5.0)
 Gastroenteritis4 (3.3)5 (4.6)3 (2.6)1 (0.8)
 Headache18 (14.9)15 (13.9)15 (13.2)15 (12.6)
 Increased alanine aminotransferase1 (0.8)5 (4.6)7 (6.1)7 (5.9)
 Influenza2 (1.7)3 (2.8)3 (2.6)5 (4.2)
 Insomnia1 (0.8)4 (3.7)4 (3.5)2 (1.7)
 Nasopharyngitis17 (14.0)16 (14.8)11 (9.6)13 (10.9)
 Nausea6 (5.0)2 (1.9)3 (2.6)4 (3.4)
 Oropharyngeal pain4 (3.3)4 (3.7)2 (1.8)5 (4.2)
 Peripheral oedema2 (1.7)2 (1.9)3 (2.6)13 (10.9)
 Sinusitis5 (4.1)4 (3.7)5 (4.4)6 (5.0)
 Upper respiratory tract infection11 (9.1)4 (3.7)9 (7.9)11 (9.2)
 Urinary tract infection6 (5.0)2 (1.9)1 (0.9)3 (2.5)
SAEs
 Patients with ≥1 SAE5 (4.1)7 (6.5)7 (6.1)3 (2.5)
 Total number of SAEs51084
 Alanine aminotransferase increased1 (0.9)
 Anaphylactic reaction1 (0.8)
 Appendectomy1 (0.9)
 Appendicitis1 (0.9)1 (0.8)
 Aspartate aminotransferase increased1 (0.9)
 Atrioventricular block second degree2 (1.9)1 (0.9)
 Breast cancer1 (0.9)
 Cellulitis1 (0.8)
 Cervix carcinoma1 (0.8)
 Coronary artery disease1 (0.9)
 Dyspnoea1 (0.8)
 ECG QT prolongation1 (0.9)
 Macular oedema2 (1.8)
 Measles1 (0.8)
 Nuclear MRI abnormal1 (0.9)
 Papilloedema1 (0.9)
 Pleural effusion1 (0.8)
 Postmenopausal haemorrhage1 (0.8)
 Pyrexia1 (0.9)
 Somnolence1 (0.9)
 Upper abdominal pain1 (0.9)
 Urinary tract infection bacterial1 (0.8)
 Vertigo1 (0.9)
  • Unless otherwise indicated, values are number of patients (%).

  • AE, adverse event; SAE, serious adverse event.