Table 3. Overview of Adverse Events in Safety Analysis Set.
| Characteristics | Patients, No. (%) | |
|---|---|---|
| Ponesimod, 20 mg (n = 565) | Teriflunomide, 14 mg (n = 566) | |
| TEAEs | 502 (88.8) | 499 (88.2) |
| ≥1 TEAEs in either group leading to treatment discontinuation, by system organ class termsa | 49 (8.7) | 34 (6.0) |
| Investigations | 12 (2.1) | 10 (1.8) |
| Respiratory, thoracic, and mediastinal disorders | 7 (1.2) | NA |
| Eye disorders | 5 (0.9) | NA |
| Gastrointestinal disorders | 4 (0.7) | 4 (0.7) |
| Blood and lymphatic system disorders | 3 (0.5) | 2 (0.4) |
| General disorders and administration site conditions | 3 (0.5) | 2 (0.4) |
| Hepatobiliary disorders | 3 (0.5) | 2 (0.4) |
| Pregnancy, puerperium, and perinatal conditions | 3 (0.5) | 3 (0.5) |
| Vascular disorders | 3 (0.5) | NA |
| Nervous system disorders | 2 (0.4) | 4 (0.7) |
| Social circumstances | 2 (0.4) | 1 (0.2) |
| Cardiac disorders | 1 (0.2) | 2 (0.4) |
| Skin and subcutaneous tissue disorders | 1 (0.2) | 2 (0.4) |
| Adverse event of special interestb | ||
| Hepatobiliary disorders or liver test result abnormality | ||
| End of treatment plus 1 d | 128 (22.7) | 69 (12.2) |
| End of treatment plus 15 d | 145 (25.7) | 82 (14.5) |
| ≥1 Serious adverse event | 2 (0.4) | 4 (0.7) |
| Hypertension | 57 (10.1) | 51 (9.0) |
| Pulmonary events | 45 (8.0) | 15 (2.7) |
| Effect on heart rate and rhythm plus hypotension on day 1 | 12 (2.1) | 2 (0.4) |
| Herpetic infection | 27 (4.8) | 27 (4.8) |
| Infectionc | 9 (1.6) | 5 (0.9) |
| Seizure | 8 (1.4) | 1 (0.2) |
| Macular edema | 6 (1.1) | 1 (0.2)d |
| Skin malignant condition | 5 (0.9)e | 1 (0.2)f |
| Nonskin malignant condition | 1 (0.2) | 1 (0.2) |
| Fatal TEAEs | NA | 2 (0.4)g |
| Serious adverse events (n ≥1 in either group by system organ class terms | 49 (8.7) | 46 (8.1) |
| Nervous system disorders | 9 (1.6) | 6 (1.1) |
| Infections and infestations | 7 (1.2) | 4 (0.7) |
| Gastrointestinal disorders | 6 (1.1) | 4 (0.7) |
| Neoplasms, benign, malignant, and unspecified, including cysts and polyps | 6 (1.1) | 3 (0.5) |
| Surgical and medical procedures | 5 (0.9) | 1 (0.2) |
| Injury, poisoning, and procedural complications | 4 (0.7) | 7 (1.2) |
| Kidney and urinary disorders | 4 (0.7) | 1 (0.2) |
| Musculoskeletal and connective tissue disorders | 3 (0.5) | 4 (0.7) |
| Reproductive system and breast disorders | 3 (0.5) | 6 (1.1) |
| Hepatobiliary disorders | 2 (0.4) | 7 (1.2) |
| Investigations | 2 (0.4) | 3 (0.5) |
| Respiratory, thoracic, and mediastinal disorders | 2 (0.4) | 1 (0.2) |
| Vascular disorders | 2 (0.4) | 2 (0.4) |
| Blood and lymphatic system disorders | 1 (0.2) | 1 (0.2) |
| Psychiatric disorders | 1 (0.2) | 2 (0.4) |
| Cardiac disorders | 0 | 2 (0.4) |
| Metabolism and nutrition disorders | 0 | 1 (0.2) |
Abbreviations: NA, not applicable; TEAE, treatment-emergent adverse events.
a
Only system organ classes with at least 2 events in at least 1 treatment arm are displayed.
b
Up to end of treatment plus 15 days, unless otherwise specified.
c
Infection adverse event of special interests were identified by the adverse events from the infections and infestations system organ class, only if reported as serious or severe.
d
Adverse event macular hole was not confirmed as macular edema.
e
Two with basal cell carcinoma, 2 with excision of preexisting benign lesions (nevus), and 1 with malignant melanoma.
f
One with basal cell carcinoma.
g
One because of coronary artery insufficiency and 1 because of multiple sclerosis.