Table 3.
Shifts in Tanner staging from baseline to endpoint (safety analysis population, N = 314)
| Male individuals (overall; n = 250) | LOTA | ||||||
|---|---|---|---|---|---|---|---|
| Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 | Total | ||
| Hair development | |||||||
| Baseline | Stage 1, n (%) | 35 (14.3) | 31 (12.7) | 15 (6.1) | 2 (0.8) | 0 | 83 (33.9) |
| Stage 2, n (%) | 2 (0.8) | 19 (7.8) | 14 (5.7) | 8 (3.3) | 2 (0.8) | 45 (18.4) | |
| Stage 3, n (%) | 1 (0.4) | 4 (1.6) | 14 (5.7) | 22 (9.0) | 3 (1.2) | 44 (18.0) | |
| Stage 4, n (%) | 0 | 0 | 1 (0.4) | 35 (14.3) | 23 (9.4) | 59 (24.1) | |
| Stage 5, n (%) | 0 | 0 | 0 | 3 (1.2) | 11 (4.5) | 14 (5.7) | |
| Total (LOTA) | 38 (15.5) | 54 (22.0) | 44 (18.0) | 70 (28.6) | 39 (15.9) | 245 (100) | |
| Genitalia development | |||||||
| Baseline | Stage 1, n (%) | 25 (10.2) | 30 (12.3) | 13 (5.3) | 2 (0.8) | 0 | 70 (28.7) |
| Stage 2, n (%) | 4 (1.6) | 29 (11.9) | 11 (4.5) | 10 (4.1) | 1 (0.4) | 55 (22.5) | |
| Stage 3, n (%) | 2 (0.8) | 1 (0.4) | 19 (7.8) | 23 (9.4) | 2 (0.8) | 47 (19.3) | |
| Stage 4, n (%) | 0 | 1 (0.4) | 1 (0.4) | 29 (11.9) | 22 (9.0) | 53 (21.7) | |
| Stage 5, n (%) | 0 | 0 | 0 | 4 (1.6) | 15 (6.1) | 19 (7.8) | |
| Total (LOTA) | 31 (12.7) | 61 (25.0) | 44 (18.0) | 68 (27.9) | 40 (16.4) | 244 (100) | |
| Female individuals (overall; n = 64) | LOTA | ||||||
|---|---|---|---|---|---|---|---|
| Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 | Total | ||
| Hair development | |||||||
| Baseline | Stage 1, n (%) | 9 (14.3) | 4 (6.3) | 4 (6.3) | 2 (3.2) | 0 | 19 (30.2) |
| Stage 2, n (%) | 0 | 2 (3.2) | 3 (4.8) | 4 (6.3) | 1 (1.6) | 10 (15.9) | |
| Stage 3, n (%) | 0 | 0 | 3 (4.8) | 6 (9.5) | 0 | 9 (14.3) | |
| Stage 4, n (%) | 0 | 0 | 2 (3.2) | 9 (14.3) | 4 (6.3) | 15 (23.8) | |
| Stage 5, n (%) | 0 | 0 | 0 | 3 (4.8) | 7 (11.1) | 10 (15.9) | |
| Total (LOTA) | 9 (14.3) | 6 (9.5) | 12 (19.0) | 24 (38.1) | 12 (19.0) | 63 (100) | |
| Breast development | |||||||
| Baseline | Stage 1, n (%) | 10 (15.9) | 4 (6.3) | 3 (4.8) | 1 (1.6) | 0 | 18 (28.6) |
| Stage 2, n (%) | 0 | 2 (3.2) | 5 (7.9) | 4 (6.3) | 0 | 11 (17.5) | |
| Stage 3, n (%) | 0 | 0 | 6 (9.5) | 3 (4.8) | 0 | 9 (14.3) | |
| Stage 4, n (%) | 0 | 0 | 0 | 12 (19.0) | 5 (7.9) | 17 (27.0) | |
| Stage 5, n (%) | 0 | 0 | 0 | 1 (1.6) | 7 (11.1) | 8 (12.7) | |
| Total (LOTA) | 10 (15.9) | 6 (9.5) | 14 (22.2) | 21 (33.3) | 12 (19.0) | 63 (100) | |
Italics indicate participants with the same Tanner score at baseline and LOTA; bold indicate participants with an increase from baseline in Tanner score at LOTA; bold italics indicate participants with a decrease from baseline in Tanner score at LOTA
LOTA last on-treatment assessment