Table 3.
AEs reported across black, Hispanic, and Asian patients, and ITT population (integrated analysis of DEFINE and CONFIRM)
| AE, n (%) | Black patients | Hispanic patients | Asian patients | ITT population | ||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 19) | DMFa (n = 10) | Placebo (n = 23) | DMFa (n = 31) | Placebo (n = 70) | DMFa (n = 66) | Placebo (n = 771) | DMFa (n = 769) | |
| Any AE | 17 (89) | 8 (80) | 22 (96) | 30 (97) | 64 (91) | 60 (91) | 720 (93) | 733 (95) |
| Most common AEsb,c | ||||||||
| MS relapse | 7 (37) | 1 (10) | 7 (30) | 6 (19) | 28 (40) | 19 (29) | 344 (45) | 221 (29) |
| Flushing | 0 | 2 (20) | 1 (4) | 6 (19) | 1 (1) | 1 (2) | 33 (4) | 264 (34) |
| Nasopharyngitis | 3 (16) | 2 (20) | 3 (13) | 6 (19) | 6 (9) | 4 (6) | 159 (21) | 170 (22) |
| Headache | 3 (16) | 3 (30) | 4 (17) | 7 (23) | 9 (13) | 8 (12) | 129 (17) | 133 (17) |
| Diarrhea | 1 (5) | 0 | 4 (17) | 8 (26) | 3 (4) | 4 (6) | 83 (11) | 107 (14) |
| Back pain | 3 (16) | 1 (10) | 4 (17) | 4 (13) | 6 (9) | 8 (12) | 90 (12) | 94 (12) |
| Fatigue | 3 (16) | 1 (10) | 3 (13) | 6 (19) | 3 (4) | 3 (5) | 87 (11) | 94 (12) |
| Nausea | 1 (5) | 1 (10) | 3 (13) | 4 (13) | 4 (6) | 4 (6) | 67 (9) | 93 (12) |
| Proteinuria | 1 (5) | 3 (30) | 1 (4) | 3 (10) | 3 (4) | 11 (17) | 59 (8) | 67 (9) |
| Pain in extremity | 1 (5) | 1 (10) | 4 (17) | 3 (10) | 4 (6) | 7 (11) | 58 (8) | 58 (8) |
| Paraesthesia | 4 (21) | 3 (30) | 3 (13) | 2 (6) | 4 (6) | 4 (6) | 69 (9) | 56 (7) |
| Albumin present in urine | 1 (5) | 3 (30) | 0 | 0 | 2 (3) | 12 (18) | 27 (4) | 46 (6) |
| Hematuria | 1 (5) | 2 (20) | 0 | 1 (3) | 5 (7) | 5 (8) | 34 (4) | 33 (4) |
| Hypoesthesia | 3 (16) | 4 (40) | 2 (9) | 2 (6) | 5 (7) | 1 (2) | 48 (6) | 31 (4) |
| Pyrexia | 1 (5) | 1 (10) | 1 (4) | 1 (3) | 17 (24) | 12 (18) | 40 (5) | 27 (4) |
| Alopecia | 3 (16) | 2 (20) | 1 (4) | 0 | 2 (3) | 1 (2) | 19 (2) | 17 (2) |
| No. of patients with any serious AEc | 3 (16) | 0 | 5 (22) | 3 (10) | 26 (37) | 21 (32) | 165 (21) | 135 (18) |
| No. of patients with any AE leading to treatment discontinuation | 2 (11) | 2 (20) | 1 (4) | 2 (7) | 8 (11) | 3 (5) | 93 (12) | 109 (14) |
AE adverse event, BID twice daily, MS multiple sclerosis
aDMF denotes delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF)
bWith the exception of multiple sclerosis relapse, these events are those reported by more than 10% of patients treated with DMF BID in any race subgroup analyzed, with an incidence that was at least 3% higher than in the placebo group, and occurring in at least 3 patients in any race subgroup. The events are listed by decreasing incidence among DMF-treated patients in the ITT population except for multiple sclerosis relapse
cNo deaths occurred during the study or within 30 days of withdrawal in black, Hispanic, and Asian patients; there were two deaths reported in the ITT population: one in the DMF BID group (DEFINE) due to a bicycle accident 3 weeks after withdrawing from the study, and one in the placebo group (CONFIRM) due to stroke