Table 2.
Safety summary (safety population)
| Data are n (%) | Resmetirom 100 mg OL (n = 171) | Resmetirom 100 mg DB (n = 324) | Resmetirom 80 mg DB (n = 327) | Placebo DB (n = 318) |
|---|---|---|---|---|
| ≥1 TEAEs | 148 (86.5) | 279 (86.1) | 289 (88.4) | 260 (81.8) |
| Grade 1 (mild) | 51 (29.8) | 99 (30.6) | 99 (30.3) | 90 (28.3) |
| Grade 2 (moderate) | 85 (49.7) | 151 (46.6) | 165 (50.5) | 141 (44.3) |
| ≥Grade 3 (severe) | 12 (7.0) | 29 (9.0) | 25 (7.6) | 29 (9.1) |
| ≥1 drug-related TEAEs | 63 (36.8) | 119 (36.7) | 114 (34.9) | 77 (24.2) |
| ≥1 serious TEAEs | 7 (4.1) | 24 (7.4) | 19 (5.8) | 20 (6.3) |
| ≥1 drug-related serious TEAEs | 0 | 0 | 0 | 1 (0.3) |
| TEAEs leading to study discontinuation | 2 (1.2) | 10 (3.1) | 8 (2.4) | 4 (1.3) |
| GI-related TEAEs leading to study discontinuation | 0 | 6 (1.9) | 5 (1.5) | 2 (0.6) |
| Liver enzymes ≥3× ULN (ALT or AST) | 1 (0.5) | 1 (0.3) | 2 (0.6) | 6 (1.9) |
| TEAEs occurring in ≥5% | ||||
| Diarrhea | 51 (29.8) | 101 (31.2) | 77 (23.5) | 44 (13.8) |
| Onset ≤12 weeks | 43 (25.1) | 81 (25.0) | 61 (18.7) | 28 (8.8) |
| Duration, days, median (Q1, Q3) | 26 (5, 64) | 15 (3, 69) | 20 (4, 59) | 22 (3, 97) |
| Onset >12 weeks | 8 (4.7) | 20 (6.2) | 16 (4.9) | 16 (5.0) |
| Nausea | 24 (14.0) | 59 (18.2) | 39 (11.9) | 25 (7.9) |
| Onset ≤12 weeks | 12 (7.0) | 47 (14.5) | 27 (8.3) | 15 (4.7) |
| Onset >12 weeks | 12 (7.0) | 12 (3.7) | 12 (3.7) | 10 (3.1) |
| Abdominal pain | 9 (5.3) | 23 (7.1) | 14 (4.3) | 14 (4.4) |
| COVID-19 | 21 (12.3) | 27 (8.3) | 27 (8.3) | 27 (8.5) |
| Urinary tract infection | 9 (5.3) | 20 (6.2) | 21 (6.4) | 23 (7.2) |
| Arthralgia | 16 (9.4) | 27 (8.3) | 24 (7.3) | 21 (6.6) |
| Back pain | 7 (4.1) | 18 (5.6) | 17 (5.2) | 14 (4.4) |
| Pain in extremity | 5 (2.9) | 18 (5.6) | 16 (4.9) | 16 (5.0) |
| Headache | 13 (7.6) | 27 (8.3) | 22 (6.7) | 24 (7.5) |
| Type 2 diabetes | 8 (4.7) | 21 (6.5) | 18 (5.5) | 14 (4.4) |
| Fatigue | 11 (6.4) | 15 (4.6) | 21 (6.4) | 13 (4.1) |
GI, gastrointestinal.