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