TABLE 1.
Overall safety and exposure in all sotatercept-treated participants
| Placebo to sotatercept 0.3 mg·kg−1 (n=15) | Placebo to sotatercept 0.7 mg·kg−1 (n=15) | Continuing sotatercept 0.3 mg·kg−1 (n=32) | Continuing sotatercept 0.7 mg·kg−1 (n=42) | Combined sotatercept 0.3 mg·kg−1 (n=47) | Combined sotatercept 0.7 mg·kg−1 (n=57) | Total (n=104) | |
| TEAEs | 13 (86.7) | 15 (100.0) | 32 (100.0) | 42 (100.0) | 45 (95.7) | 57 (100.0) | 102 (98.1) |
| TEAEs related to treatment | 10 (66.7) | 13 (86.7) | 20 (62.5) | 29 (69.0) | 30 (63.8) | 42 (73.7) | 72 (69.2) |
| AESI # | 5 (33.3) | 1 (6.7) | 5 (15.6) | 7 (16.7) | 10 (21.3) | 8 (14.0) | 18 (17.3) |
| Serious TEAEs | 5 (33.3) | 3 (20.0) | 8 (25.0) | 16 (38.1) | 13 (27.7) | 19 (33.3) | 32 (30.8) |
| Serious TEAEs related to treatment | 2 (13.3) | 0 (0.0) | 1 (3.1) | 2 (4.8) | 3 (6.4) | 2 (3.5) | 5 (4.8) |
| TEAEs leading to treatment discontinuation | 1 (6.7) | 0 (0.0) | 2 (6.3) | 7 (16.7) | 3 (6.4) | 7 (12.3) | 10 (9.6) |
| TEAEs leading to study discontinuation | 1 (6.7) | 0 (0.0) | 2 (6.3) | 7 (16.7) | 3 (6.4) | 7 (12.3) | 10 (9.6) |
| TEAEs leading to death | 1 (6.7) | 0 (0.0) | 0 (0.0) | 2 (4.8) | 1 (2.1) | 2 (3.5) | 3 (2.9) |
| Median exposure, days | 623 | 627 | 788 | 771 | 756 | 737 | 742 |
Safety population (includes all randomised participants who received at least one dose of study treatment). Data are presented as n (%), unless otherwise stated. A treatment-emergent adverse event (TEAE) has start date on or after the first dose of treatment and up to 8 weeks after the last dose of treatment. #: treatment-emergent adverse event of special interest (AESI) is defined as any TEAE of leukopenia, neutropenia or thrombocytopenia.