Placebo-fingolimod 0.5 mg (n = 27) | Placebo-fingolimod 1.25 mg (n = 23) | Fingolimod 0.5 mg (n = 47) | Fingolimod 1.25 mg (n = 46) | Total (n = 143) | |
---|---|---|---|---|---|
Any AE | 27 (100) | 23 (100) | 45 (95.7) | 44 (95.7) | 139 (97.2) |
AEs leading to study drug discontinuationa | 8 (29.6) | 5 (21.7) | 7 (14.9) | 2 (4.3) | 22 (15.4) |
SAEs | 1 (3.7) | 5 (21.7) | 8 (17.0) | 5 (10.9) | 19 (13.3) |
SAEs leading to study drug discontinuationb | 1 (3.7) | 1 (4.3) | 3 (6.4) | 0 (0.0) | 5 (3.5) |
Frequent or special-interest adverse events | |||||
Infections and infestations | 22 (81.5) | 17 (73.9) | 37 (78.7) | 38 (82.6) | 114 (79.7) |
Total upper respiratory tract infections | 17 (63.0) | 12 (52.2) | 31 (66.0) | 29 (63.0) | 89 (62.2) |
Nasopharyngitis | 15 (55.6) | 12 (52.2) | 29 (61.7) | 28 (60.9) | 84 (58.7) |
Pharyngitis | 1 (3.7) | 2 (8.7) | 5 (10.6) | 4 (8.7) | 12 (8.4) |
Upper respiratory tract infection | 1 (3.7) | 0 (0.0) | 2 (4.3) | 1 (2.2) | 4 (2.8) |
Influenza viral infections | 2 (7.4) | 3 (13.0) | 3 (6.4) | 6 (13.0) | 14 (9.8) |
Lower respiratory tract and lung infections | 1 (3.7) | 0 (0.0) | 1 (2.1) | 2 (4.3) | 4 (2.8) |
Bronchitis | 1 (3.7) | 0 (0.0) | 1 (2.1) | 2 (4.3) | 4 (2.8) |
Herpes viral infections | 2 (7.4) | 4 (17.4) | 1 (2.1) | 3 (6.5) | 10 (7.0) |
Herpes zoster | 1 (3.7) | 2 (8.7) | 1 (2.1) | 1 (2.2) | 5 (3.5) |
Oral herpes | 0 (0.0) | 2 (8.7) | 0 (0.0) | 0 (0.0) | 2 (1.4) |
Urinary tract infections | 2 (7.4) | 1 (4.3) | 4 (8.5) | 9 (19.6) | 16 (11.2) |
Cystitis | 2 (7.4) | 1 (4.3) | 3 (6.4) | 7 (15.2) | 13 (9.1) |
Vascular disorders | 1 (3.7) | 1 (4.3) | 4 (8.5) | 2 (4.3) | 8 (5.6) |
Hypertension | 0 (0.0) | 1 (4.3) | 3 (6.4) | 1 (2.2) | 5 (3.5) |
Eye disorders | 5 (18.5) | 3 (13.0) | 14 (29.8) | 9 (19.6) | 31 (21.7) |
Macular edema | 0 (0.0) | 0 (0.0) | 1 (2.1) c | 0 (0.0) | 1 (0.7) |
Nervous system disorders | 4 (14.8) | 6 (26.1) | 14 (29.8) | 9 (19.6) | 33 (23.1) |
Headache | 1 (3.7) | 3 (13.0) | 8 (17.0) | 3 (6.5) | 15 (10.5) |
Investigations | 13 (48.1) | 14 (60.9) | 15 (31.9) | 17 (37.0) | 59 (41.3) |
Abnormal liver function test | 7 (25.9) | 9 (39.1) | 6 (12.8) | 8 (17.4) | 30 (21.0) |
Alanine aminotransferase increased | 2 (7.4) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 3 (2.1) |
Gamma-glutamyl transferase increased | 1 (3.7) | 2 (8.7) | 1 (2.1) | 0 (0.0) | 4 (2.8) |
Aspartate amino-transferase increased | 1 (3.7) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 2 (1.4) |
Hepatic enzyme increased | 1 (3.7) | 1 (4.3) | 1 (2.1) | 0 (0.0) | 3 (2.1) |
Lymphocyte count decreased | 3 (11.1) | 2 (8.7) | 3 (6.4) | 2 (4.3) | 10 (7.0) |
Gastrointestinal disorders | 11 (40.7) | 6 (26.1) | 22 (46.8) | 23 (50.0) | 62 (43.4) |
Stomatitis | 4 (14.8) | 1 (4.3) | 4 (8.5) | 6 (13.0) | 15 (10.5) |
Diarrhea | 1 (3.7) | 2 (8.7) | 3 (6.4) | 6 (13.0) | 12 (8.4) |
Constipation | 1 (3.7) | 0 (0.0) | 5 (10.6) | 2 (4.3) | 8 (5.6) |
Skin and subcutaneous tissue disorders | 8 (29.6) | 9 (39.1) | 14 (29.8) | 16 (34.8) | 47 (32.9) |
Rash | 3 (11.1) | 4 (17.4) | 1 (2.1) | 0 (0.0) | 8 (5.6) |
Blood and lymphatic system disorders | 7 (25.9) | 5 (21.7) | 10 (21.3) | 13 (28.3) | 35 (24.5) |
Lymphopenia | 2 (7.4) | 3 (13.0) | 6 (12.8) | 8 (17.4) | 19 (13.3) |
Leukopenia | 4 (14.8) | 1 (4.3) | 2 (4.3) | 5 (10.9) | 12 (8.4) |
Respiratory, thoracic and mediastinal disorders | 1 (3.7) | 4 (17.4) | 6 (12.8) | 9 (19.6) | 20 (14.0) |
Metabolism and nutrition disorders | 4 (14.8) | 1 (4.3) | 4 (8.5) | 7 (15.2) | 16 (11.2) |
Hyperlipidemia | 2 (7.4) | 0 (0.0) | 2 (4.3) | 5 (10.9) | 9 (6.3) |
Psychiatric disorders | 2 (7.4) | 2 (8.7) | 8 (17.0) | 4 (8.7) | 16 (11.2) |
Neoplasms benign, malignant and unspecified (including cysts and polyps) | 0 (0.0) | 1 (4.3) | 9 (19.1) | 1 (2.2) | 11 (7.7) |
Skin papilloma | 0 (0.0) | 0 (0.0) | 6 (12.8) | 0 (0.0) | 6 (4.2) |
First-dose monitoring eventsd | |||||
Cardiac disorders | 4 (14.8) | 7 (30.4) | 0 (0.0) | 0 (0.0) | 11 (7.7) |
Atrioventricular block second degree | 0 (0.0) | 3 (13.0) | 0 (0.0) | 0 (0.0) | 3 (2.1) |
Bradycardia | 0 (0.0) | 3 (13.0) | 0 (0.0) | 0 (0.0) | 3 (2.1) |
Serious adverse eventse | |||||
Infections and infestations | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.3) | 2 (1.4) |
Appendicitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 1 (0.7) |
Urinary tract infection | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 1 (0.7) |
Cardiac disorders | 0 (0.0) | 2 (8.7) | 0 (0.0) | 0 (0.0) | 2 (1.4) |
Bradycardia | 0 (0.0) | 2 (8.7) | 0 (0.0) | 0 (0.0) | 2 (1.4) |
Neoplasms benign, malignant and unspecified (including cysts and polyps) | 0 (0.0) | 0 (0.0) | 2 (4.3) | 0 (0.0) | 2 (1.4) |
Breast cancer | 0 (0.0) | 0 (0.0) | 1 (2.1) | 0 (0.0) | 1 (0.7) |
CNS lymphoma | 0 (0.0) | 0 (0.0) | 1 (2.1) | 0 (0.0) | 1 (0.7) |
Nervous system disorders | 1 (3.7) | 2 (8.7) | 3 (6.4) | 1 (2.2) | 7 (4.9) |
Status epilepticus | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 1 (0.7) |
Convulsion | 0 (0.0) | 0 (0.0) | 1 (2.1) | 0 (0.0) | 1 (0.7) |
Leukoencephalopathy | 0 (0.0) | 1 (4.3) | 0 (0.0) | 0 (0.0) | 1 (0.7) |
Multiple sclerosis relapse | 0 (0.0) | 0 (0.0) | 1 (2.1) | 0 (0.0) | 1 (0.7) |
Myoclonus | 0 (0.0) | 0 (0.0) | 1 (2.1) | 0 (0.0) | 1 (0.7) |
Neuromyelitis optica | 1 (3.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.7) |
Radiculitis | 0 (0.0) | 1 (4.3) | 0 (0.0) | 0 (0.0) | 1 (0.7) |