Table 2.
Treatment-emergent adverse events (safety population, N=43)
| TEAE | During Double-Blind Treatment | During Double-Blind or Open-Label Treatment | |
|---|---|---|---|
| Lademirsen (n=29) | Placebo (n=14) | Lademirsen (n=38) | |
| TEAEs, n (%), occurring in any participant | |||
| Any TEAE | 29 (100) | 14 (100) | 37 (97) |
| Any serious TEAE | 2 (7) | 0 | 5 (13) |
| Any severe TEAE | 9 (31) | 1 (7) | 8 (21) |
| TEAE leading to discontinuation | 3 (10) | 0 | 4 (11) |
| TEAESI | 6 (21) | 1 (7) | 11 (29) |
| TEAEs, n (%), occurring in ≥10% of participantsa | |||
| General disorders and admin-site conditions | 24 (83) | 9 (64) | 32 (84) |
| ISRs | 21 (72) | 6 (43) | 26 (68) |
| Injection-site pain | 5 (17) | 0 | 7 (18) |
| Pyrexia | 5 (17) | 0 | 5 (13) |
| Asthenia | 3 (10) | 0 | 3 (8) |
| Fatigue | 2 (7) | 2 (14) | 4 (11) |
| Chills | 3 (10) | 0 | 4 (11) |
| Injection-site erythema | 2 (7) | 1 (7) | 4 (11) |
| Infections and infestations | 18 (62) | 7 (50) | 23 (61) |
| Upper respiratory tract infection | 6 (21) | 1 (7) | 9 (24) |
| COVID-19 | 5 (17) | 5 (36) | 8 (21) |
| Nasopharyngitis | 4 (14) | 1 (7) | 4 (11) |
| Blood and lymphatic system disorders | 8 (28) | 4 (29) | 10 (26) |
| Anemia | 3 (10) | 2 (14) | 5 (13) |
| Iron deficiency anemia | 0 | 2 (14) | 1 (3) |
| Thrombocytopenia | 3 (10) | 0 | 3 (78) |
| Metabolism and nutrition disorders | 16 (55) | 5 (36) | 19 (50) |
| Hyperkalemia | 5 (17) | 1 (7) | 7 (18) |
| Metabolic acidosis | 5 (17) | 1 (7) | 8 (21) |
| Hypertriglyceridemia | 2 (7) | 1 (7) | 4 (11) |
| Gout | 2 (7) | 2 (14) | 2 (5) |
| Vitamin D deficiency | 1 (3) | 2 (14) | 1 (3) |
| Nervous system disorders | 11 (38) | 4 (29) | 13 (34) |
| Headache | 6 (21) | 3 (21) | 6 (16) |
| Dizziness | 4 (14) | 1 (7) | 5 (13) |
| Migraine | 3 (10) | 0 | 3 (8) |
| GI disorders | 14 (48) | 4 (29) | 20 (53) |
| Nausea | 5 (17) | 0 | 6 (16) |
| Diarrhea | 4 (14) | 2 (14) | 6 (16) |
| Vomiting | 3 (10) | 1 (7) | 6 (16) |
| Skin and subcutaneous tissue disorders | 9 (31) | 4 (29) | 9 (24) |
| Skin discoloration | 3 (10) | 0 | 3 (8) |
| Pruritus | 0 | 2 (14) | 1 (3) |
| Musculoskeletal disorders | 6 (21) | 4 (29) | 9 (24) |
| Back pain | 1 (3) | 2 (14) | 4 (11) |
| Investigations | 22 (76) | 13 (93) | 28 (74) |
| eGFR decreased | 20 (69) | 10 (71) | 26 (68) |
| Blood bicarbonate decreased | 0 | 2 (14) | 0 |
| BP increased | 0 | 2 (14) | 0 |
COVID-19, coronavirus disease 2019; GI, gastrointestinal; ISR, injection-site reaction; SC, subcutaneous; TEAE, treatment-emergent adverse event; TEAESI, treatment-emergent adverse event of special interest.
a
Of the treatment groups shown.