Table 3. Safety Profile.
| Adverse event | No. (%) | ||
|---|---|---|---|
| Fingolimod groups | GA, 20 mg, group | ||
| 0.5 mg | 0.25 mg | ||
| Total participants, No. | 345 | 366 | 324 |
| Events ≥3% in any group | |||
| Any event | 312 (90.4) | 323 (88.3) | 283 (87.3) |
| Headache | 52 (15.1) | 52 (14.2) | 27 (8.3) |
| Fatigue | 46 (13.3) | 46 (12.6) | 22 (6.8) |
| Urinary tract infection | 44 (12.8) | 43 (11.7) | 37 (11.4) |
| Upper respiratory tract infection | 30 (8.7) | 35 (9.6) | 20 (6.2) |
| Hypertension | 26 (7.5) | 34 (9.3) | 12 (3.7) |
| Nausea | 24 (7.0) | 30 (8.2) | 15 (4.6) |
| Pain in extremity | 24 (7.0) | 24 (6.6) | 17 (5.2) |
| Depression | 23 (6.7) | 19 (5.2) | 18 (5.6) |
| Lymphopenia | 23 (6.7) | 18 (4.9) | 1 (0.3) |
| Nasopharyngitis | 23 (6.7) | 23 (6.3) | 14 (4.3) |
| Diarrhea | 21 (6.1) | 23 (6.3) | 10 (3.1) |
| Increase in alanine aminotransferase level | 20 (5.8) | 15 (4.1) | 4 (1.2) |
| Back pain | 17 (4.9) | 19 (5.2) | 18 (5.6) |
| Dyspnea | 17 (4.9) | 10 (2.7) | 6 (1.9) |
| Decrease in lymphocyte count | 16 (4.6) | 10 (2.7) | 1 (0.3) |
| Sinusitis | 16 (4.6) | 16 (4.4) | 15 (4.6) |
| Arthralgia | 15 (4.3) | 20 (5.5) | 13 (4.0) |
| Cough | 15 (4.3) | 13 (3.6) | 11 (3.4) |
| Increase in γ glutamyltransferase level | 15 (4.3) | 12 (3.3) | 2 (0.6) |
| Muscle spasms | 14 (4.1) | 15 (4.1) | 11 (3.4) |
| Paresthesia | 14 (4.1) | 13 (3.6) | 11 (3.4) |
| Vision blurred | 14 (4.1) | 13 (3.6) | 6 (1.9) |
| Anxiety | 13 (3.8) | 21 (5.7) | 9 (2.8) |
| Increase in hepatic enzymes | 13 (3.8) | 2 (0.5) | 2 (0.6) |
| Influenza | 13 (3.8) | 16 (4.4) | 9 (2.8) |
| Alopecia | 12 (3.5) | 17 (4.6) | 3 (0.9) |
| Bronchitis | 12 (3.5) | 10 (2.7) | 6 (1.9) |
| Dizziness | 12 (3.5) | 27 (7.4) | 14 (4.3) |
| Hypoesthesia | 12 (3.5) | 17 (4.6) | 10 (3.1) |
| Insomnia | 12 (3.5) | 27 (7.4) | 9 (2.8) |
| Oropharyngeal pain | 12 (3.5) | 8 (2.2) | 4 (1.2) |
| Migraine | 11 (3.2) | 17 (4.6) | 8 (2.5) |
| Vomiting | 11 (3.2) | 9 (2.5) | 6 (1.9) |
| Fall | 9 (2.6) | 10 (2.7) | 10 (3.1) |
| Muscular weakness | 9 (2.6) | 13 (3.6) | 5 (1.5) |
| Vertigo | 9 (2.6) | 12 (3.3) | 6 (1.9) |
| Constipation | 7 (2.0) | 17 (4.6) | 5 (1.5) |
| Dry eye | 5 (1.4) | 5 (1.4) | 10 (3.1) |
| Eye pain | 4 (1.2) | 14 (3.8) | 3 (0.9) |
| Injection site | |||
| Erythema | 0 | 0 | 34 (10.5) |
| Mass | 0 | 0 | 12 (3.7) |
| Pain | 0 | 0 | 36 (11.1) |
| Pruritus | 0 | 0 | 26 (8.0) |
| Reaction | 0 | 0 | 21 (6.5) |
| Serious events >0.5% in any group | |||
| Any event | 25 (7.2) | 32 (8.7) | 20 (6.2) |
| Multiple sclerosis relapse | 4 (1.2) | 7 (1.9) | 7 (2.2) |
| Basal cell carcinoma | 3 (0.9) | 4 (1.1) | 0 |
| Headache | 1 (0.3) | 3 (0.8) | 0 |
| Urinary tract infection | 2 (0.6) | 1 (0.3) | 2 (0.6) |
| Seizure | 1 (0.3) | 2 (0.5) | 0 |
| Syncope | 0 | 0 | 2 (0.6) |
| Dyspnea | 2 (0.6) | 0 | 0 |
| Gait disturbance | 0 | 2 (0.5) | 0 |
| Leukocytosis | 0 | 2 (0.5) | 0 |
| Events leading to study drug discontinuation | |||
| Any event | 32 (9.3) | 27 (7.4) | 45 (13.9) |
| Increase in hepatic enzymes | 4 (1.2) | 2 (0.5) | 0 |
| Drug hypersensitivity | 0 | 0 | 6 (1.9) |
| Injection site | |||
| Pain | 0 | 0 | 6 (1.9) |
| Reaction | 0 | 0 | 7 (2.2) |
Abbreviation: GA, glatiramer acetate.