Event | Placebo (n=121) | Ponesimod 10 mg (n=108) | Ponesimod 20 mg (n=114) | Ponesimod 40 mg (n=119) |
---|---|---|---|---|
AEs | ||||
Patients with ≥1 AE | 90 (74.4) | 83 (76.9) | 88 (77.2) | 88 (73.9) |
Total number of AEs | 310 | 275 | 304 | 325 |
Anxiety | – | 5 (4.6) | 3 (2.6) | 4 (3.4) |
Arthralgia | 7 (5.8) | 2 (1.9) | 1 (0.9) | 1 (0.8) |
Back pain | 6 (5.0) | 2 (1.9) | 5 (4.4) | 6 (5.0) |
Bronchitis | 2 (1.7) | 4 (3.7) | 4 (3.5) | 5 (4.2) |
Chest discomfort | 3 (2.5) | – | 5 (4.4) | 4 (3.4) |
Cough | 2 (1.7) | 1 (0.9) | 3 (2.6) | 8 (6.7) |
Diarrhoea | 8 (6.6) | 3 (2.8) | 3 (2.6) | 2 (1.7) |
Dizziness | 3 (2.5) | 8 (7.4) | 7 (6.1) | 11 (9.2) |
Dyspnoea | 4 (3.3) | 5 (4.6) | 7 (6.1) | 17 (14.3) |
Fatigue | 7 (5.8) | 7 (6.5) | 9 (7.9) | 6 (5.0) |
Gastroenteritis | 4 (3.3) | 5 (4.6) | 3 (2.6) | 1 (0.8) |
Headache | 18 (14.9) | 15 (13.9) | 15 (13.2) | 15 (12.6) |
Increased alanine aminotransferase | 1 (0.8) | 5 (4.6) | 7 (6.1) | 7 (5.9) |
Influenza | 2 (1.7) | 3 (2.8) | 3 (2.6) | 5 (4.2) |
Insomnia | 1 (0.8) | 4 (3.7) | 4 (3.5) | 2 (1.7) |
Nasopharyngitis | 17 (14.0) | 16 (14.8) | 11 (9.6) | 13 (10.9) |
Nausea | 6 (5.0) | 2 (1.9) | 3 (2.6) | 4 (3.4) |
Oropharyngeal pain | 4 (3.3) | 4 (3.7) | 2 (1.8) | 5 (4.2) |
Peripheral oedema | 2 (1.7) | 2 (1.9) | 3 (2.6) | 13 (10.9) |
Sinusitis | 5 (4.1) | 4 (3.7) | 5 (4.4) | 6 (5.0) |
Upper respiratory tract infection | 11 (9.1) | 4 (3.7) | 9 (7.9) | 11 (9.2) |
Urinary tract infection | 6 (5.0) | 2 (1.9) | 1 (0.9) | 3 (2.5) |
SAEs | ||||
Patients with ≥1 SAE | 5 (4.1) | 7 (6.5) | 7 (6.1) | 3 (2.5) |
Total number of SAEs | 5 | 10 | 8 | 4 |
Alanine aminotransferase increased | – | 1 (0.9) | – | – |
Anaphylactic reaction | 1 (0.8) | – | – | – |
Appendectomy | – | – | 1 (0.9) | – |
Appendicitis | – | – | 1 (0.9) | 1 (0.8) |
Aspartate aminotransferase increased | – | 1 (0.9) | – | – |
Atrioventricular block second degree | – | 2 (1.9) | 1 (0.9) | – |
Breast cancer | – | 1 (0.9) | – | – |
Cellulitis | – | – | – | 1 (0.8) |
Cervix carcinoma | 1 (0.8) | – | – | – |
Coronary artery disease | – | 1 (0.9) | – | – |
Dyspnoea | – | – | – | 1 (0.8) |
ECG QT prolongation | – | 1 (0.9) | – | – |
Macular oedema | – | – | 2 (1.8) | – |
Measles | 1 (0.8) | – | – | – |
Nuclear MRI abnormal | – | – | 1 (0.9) | – |
Papilloedema | – | – | 1 (0.9) | – |
Pleural effusion | – | – | – | 1 (0.8) |
Postmenopausal haemorrhage | 1 (0.8) | – | – | – |
Pyrexia | – | 1 (0.9) | – | – |
Somnolence | – | 1 (0.9) | – | – |
Upper abdominal pain | – | – | 1 (0.9) | – |
Urinary tract infection bacterial | 1 (0.8) | – | – | – |
Vertigo | – | 1 (0.9) | – | – |
Unless otherwise indicated, values are number of patients (%).
AE, adverse event; SAE, serious adverse event.