Table 4 Overall summary of AEs (safety population)
ITT | East Asian subgroup | Japanese subgroup | Eastern European subgroup | |||||
|---|---|---|---|---|---|---|---|---|
AE, n (%) | Placebo n = 113 | DMFa n = 111 | Placebo n = 72 | DMFa n = 70 | Placebo n = 58 | DMFa n = 56 | Placebo n = 41 | DMFa n = 41 |
Any AE | 87 (77) | 96 (86) | 61 (85) | 64 (91) | 49 (84) | 53 (95) | 26 (63) | 32 (78) |
Mild | 50 (44) | 58 (52) | 31 (43) | 38 (54) | 22 (38) | 29 (52) | ||
Moderate | 35 (31) | 32 (29) | 28 (39) | 24 (34) | 26 (45) | 22 (39) | ||
Severe | 2 (2) | 6 (5) | 2 (3) | 2 (3) | 1 (2) | 2 (4) | 0 | 4 (10) |
Most frequently reported AEsb | ||||||||
Nasopharyngitis | 28 (25) | 26 (23) | 23 (32) | 24 (34) | 22 (38) | 21 (38) | 5 (12) | 2 (5) |
MS relapse | 35 (31) | 25 (23) | 30 (42) | 18 (26) | 27 (47) | 16 (29) | 5 (12) | 7 (17) |
Flushing | 9 (8) | 24 (22) | 5 (7) | 10 (14) | 2 (3) | 8 (14) | 4 (10) | 14 (34) |
Diarrhea | 6 (5) | 11 (10) | 5 (7) | 9 (13) | 5 (9) | 8 (14) | 1 (2) | 2 (5) |
Nausea | 6 (5) | 11 (10) | 4 (6) | 8 (11) | 4 (7) | 6 (11) | 2 (5) | 3 (7) |
Abdominal pain | 0 | 8 (7) | 0 | 4 (6) | 0 | 4 (7) | 0 | 4 (10) |
Pruritus | 2 (2) | 8 (7) | 2 (3) | 8 (11) | 2 (3) | 6 (11) | 0 | 0 |
ALT increased | 2 (2) | 7 (6) | 2 (3) | 6 (9) | 2 (3) | 6 (11) | 1 (2) | 2 (5) |
Hot flush | 1 (< 1) | 7 (6) | 1 (1) | 6 (9) | 1 (2) | 6 (11) | 0 | 1 (2) |
Abdominal pain upper | 6 (5) | 5 (5) | 5 (7) | 3 (4) | 4 (7) | 3 (5) | 1 (2) | 2 (5) |
Upper respiratory tract infection | 11 (10) | 5 (5) | < 5% | < 5% | < 5% | < 5% | 8 (20) | 4 (10) |
Tonsillitis | 2 (2) | 1 (< 1) | 0 | 0 | 0 | 0 | 2 (5) | 1 (2) |
Serious AE | 16 (14) | 15 (14) | 14 (19) | 12 (17) | 11 (19) | 10 (18) | 2 (5) | 3 (7) |
AE leading to discontinuation of study treatment | 2 (2) | 1 (< 1) | 2 (3) | 1 (1) | 2 (3) | 1 (2) | 0 | 0 |
AE of special interest | ||||||||
Flushing and related symptoms | 10 (9) | 33 (30) | 6 (8) | 17 (24) | 3 (5) | 14 (25) | 4 (10) | 16 (39) |
GI tolerability AEs | 18 (16) | 37 (33) | 13 (18) | 25 (36) | 11 (19) | 20 (36) | 5 (12) | 12 (29) |
Infections (including potential opportunistic infections) | 47 (42) | 45 (41) | 27 (38) | 32 (46) | 24 (41) | 27 (48) | 20 (49) | 13 (32) |
CV disorders | 1 (< 1) | 4 (4) | 1 (1) | 2 (3) | 0 | 2 (4) | 0 | 2 (5) |
Potential hepatic disorders | 4 (4) | 10 (9) | 4 (6) | 9 (13) | 4 (7) | 9 (16) | 0 | 1 (2) |
Renal disorders | 8 (7) | 6 (5) | 4 (6) | 2 (3) | 3 (5) | 2 (4) | 4 (10) | 4 (10) |
Potential malignancies and malignancies | 1 (< 1) | 0 | 1 (1) | 0 | 1 (2) | 0 | 0 | 0 |