Table 4.
Treatment-emergent adverse events of special interest from the TEMSO trial.
| Placebo (n = 360) | Teriflunomide 7 mg (n = 368) | Teriflunomide 14 mg (n = 358) | |
|---|---|---|---|
| Hepatic | 43 (11.9) | 71 (19.3) | 69 (19.3) |
| SAE | 9 (2.5) | 7 (1.9) | 9 (2.5) |
| Discontinuation | 15 (4.2) | 16 (4.3) | 13 (3.6) |
| Bone marrow disorders | 8 (2.2) | 36 (9.8) | 27 (7.5) |
| SAE | 0 | 0 | 2 (0.6) |
| Discontinuation | 0 | 1 (0.3) | 0 |
| Infections | 209 (58.1) | 220 (59.8) | 222 (62.0) |
| SAE | 8 (2.2) | 6 (1.6) | 9 (2.5) |
| Discontinuation | 4 (1.1) | 1 (0.3) | 3 (0.8) |
| Malignancy* | 5 (1.4) | 1 (0.3) | 2 (0.6) |
| SAE | 4 (1.1) | 0 | 1 (0.3) |
| Discontinuation | 3 (0.8) | 0 | 1 (0.3) |
| Blood pressure | 11 (3.1) | 20 (5.4) | 18 (5.0) |
| SAE | 0 | 0 | 0 |
| Discontinuation | 0 | 0 | 0 |
| Peripheral neuropathy | 11 (3.1) | 9 (2.4) | 17 (4.7) |
| SAE | 0 | 0 | 0 |
| Discontinuation | 0 | 1 (0.3) | 1 (0.3) |
| Hair thinning/decreased hair density$ | 12 (3.3) | 38 (10.3) | 48 (13.4) |
| SAE | 0 | 0 | 0 |
| Discontinuation | 0 | 2 (0.5) | 5 (1.4) |
Safety population. Events identified and retrieved for the analyses using MedDRA.
*
Malignant neoplasms were reported in three placebo patients (breast cancer, thyroid cancer, and cervical carcinoma), and one patient in the teriflunomide 14 mg group (cervical carcinoma with recovery following surgery).
$
MedDRA-preferred term for hair thinning/decreased hair density: alopecia. The term ‘alopecia’ is used to describe any type of hair loss. Most cases of alopecia were reported as hair thinning, decreased hair density, or hair loss.
MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event.