Table 1.
Summary of AEs and KRs in the ITT population (n=547) and SAR at year 5 (n=161)
| Patients, n (%) | ITT | SAR | ||||||||
| Placebo | Sprifermin | Placebo | Sprifermin | |||||||
| n=107 | 30 µg q12mo n=109 |
30 µg q6mo n=111 | 100 µg q12mo n=111 |
100 µg q6mo n=109 |
n=34 | 30 µg q12mo n=36 | 30 µg q6mo n=27 | 100 µg q12mo n=31 | 100 µg q6mo n=33 | |
| All AEs | 105 (98.1) | 107 (98.2) | 109 (98.2) | 107 (96.4) | 107 (98.2) | 34 (100.0) | 35 (97.2) | 27 (100.0) | 31 (100.0) | 33 (100.0) |
| Local AEs | 52 (48.6) | 54 (49.5) | 57 (51.4) | 54 (48.6) | 53 (48.6) | 18 (52.9) | 17 (47.2) | 13 (48.1) | 18 (58.1) | 12 (36.4) |
| Systemic AEs | 103 (96.3) | 104 (95.4) | 105 (94.6) | 105 (94.6) | 106 (97.2) | 34 (100.0) | 35 (97.2) | 27 (100.0) | 31 (100.0) | 33 (100.0) |
| All SAEs | 39 (36.4) | 35 (32.1) | 34 (30.6) | 32 (28.8) | 41 (37.6) | 18 (52.9) | 11 (30.6) | 10 (37.0) | 11 (35.5) | 12 (36.4) |
| Local SAEs | 5 (4.7) | 4 (3.7) | 6 (5.4) | 3 (2.7) | 1 (0.9) | 4 (11.8) | 1 (2.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| SAEs leading to death | 1 (0.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| KRs* | 4 (4.6) | 4 (4.0) | 5 (5.4) | 2 (2.0) | 0 (0.0) | 3 (8.8) | 1 (2.8) | 1 (3.7) | 0 (0.0) | 0 (0.0) |
*The incidence of partial or total replacement of the treated knee at year 5, presented as a percentage of patients who completed year 2 per group (placebo, N=87; 30 µg q12mo, N=99; 30 µg q6mo, N=92; 100 µg q12mo, N=98; 100 µg q6mo, N=96).
AEs, adverse events; ITT, intention to treat; KRs, knee replacements; q6mo, every 6 months; q12mo, every 12 months; SAEs, serious adverse events; SAR, subgroup at risk.