Table 4.
Number of patients with injection site reactions by maximal intensity
| Daily rhGH 0.37 mg/kg/week (n = 16) | LB03002 0.5 mg/kg/week (n = 14) | LB03002 0.7 mg/kg/week (n = 16) | |
|---|---|---|---|
| Maximum intensity | |||
| Warmth | |||
| None | 12 | 5 | 5 |
| Mild | 4 | 8 | 9 |
| Moderate | 0 | 1 | 2 |
| Erythema | |||
| None | 12 | 2 | 1 |
| Mild (<5 mm) | 3 | 5 | 4 |
| Moderate (≥5 mm, <20 mm) | 0 | 5 | 7 |
| Severe (≥20 mm) | 1 | 2 | 4 |
| Swelling | |||
| None | 9 | 1 | 0 |
| Mild (<3 mm) | 6 | 2 | 4 |
| Moderate (≥3 mm, <20 mm) | 1 | 6 | 5 |
| Severe (≥20 mm) | 0 | 5 | 7 |
|
Duration (after 1st dosing) Warmth | |||
| 0~3 day | 2 | 4 | 4 |
| 4~6 day | 1 | 1 | 1 |
| Over 7 day | 0 | 0 | 0 |
| Erythema | |||
| 0~3 day | 1 | 5 | 6 |
| 4~6 day | 1 | 3 | 5 |
| Over 7 day | 1 | 0 | 0 |
| Swelling | |||
| 0~3 day | 1 | 5 | 10 |
| 4~6 day | 1 | 6 | 3 |
| Over 7 day | 0 | 0 | 0 |
The intensity of each reaction is based on the maximum intensity experienced by each patient anytime during the whole study period. The information about reaction duration is based on the diary records collected during the first week of dosing.