Table 2.
Shifts in weight, height and body mass index (BMI) category from baseline to last on-treatment assessment (LOTA) [safety analysis population, N = 314]
| LOTA | ||||||
|---|---|---|---|---|---|---|
| < 5th percentile n (%) |
≥ 5th to < 95th percentile n (%) |
≥ 95th percentile n (%) |
Missing n (%) |
Total (baseline) n (%) |
||
| Weight category | ||||||
| Baseline | < 5th percentile | 3 (1.0) | 1 (0.3) | 0 | 0 | 4 (1.3) |
| ≥ 5th percentile to < 95th percentile | 13 (4.1) | 255 (81.2) | 4 (1.3) | 1 (0.3) | 273 (86.9) | |
| ≥ 95th percentile | 0 | 19 (6.1) | 18 (5.7) | 0 | 37 (11.8) | |
| Missing | 0 | 0 | 0 | 0 | 0 | |
| Total (LOTA) | 16 (5.1) | 275 (87.6) | 22 (7.0) | 1 (0.3) | 314 (100) | |
| Height category | ||||||
| Baseline | < 5th percentile | 4 (1.3) | 2 (0.6) | 0 | 0 | 6 (1.9) |
| ≥ 5th percentile to < 95th percentile | 3 (1.0) | 230 (73.2) | 8 (2.5) | 11 (3.5) | 252 (80.3) | |
| ≥ 95th percentile | 0 | 25 (8.0) | 29 (9.2) | 2 (0.6) | 56 (17.8) | |
| Missing | 0 | 0 | 0 | 0 | 0 | |
| Total (LOTA) | 7 (2.2) | 257 (81.8) | 37 (11.8) | 13 (4.1) | 314 (100) | |
| BMI category | ||||||
| Baseline | < 5th percentile | 5 (1.6) | 1 (0.3) | 0 | 0 | 6 (1.9) |
| ≥ 5th percentile to < 95th percentile | 26 (8.3) | 267 (85.0) | 4 (1.3) | 1 (0.3) | 298 (94.9) | |
| ≥ 95th percentile | 0 | 7 (2.2) | 3 (1.0) | 0 | 10 (3.2) | |
| Missing | 0 | 0 | 0 | 0 | 0 | |
| Total (LOTA) | 31 (9.9) | 275 (87.6) | 7 (2.2) | 1 (0.3) | 314 (100) | |
Italics indicate participants who remained in the same percentile category; bold indicates participants who shifted to a lower percentile category; bold italics indicate participants who shifted to a higher percentile category. For calculating BMI, if a height measurement was missing, the last observation carried forward value was used