Table 3.
Exposure to Treatment over the Study Period (Safety Population)
| Parameter | Result |
|---|---|
| Treatment duration, d* (N = 79) | |
| Mean (SD) | 104.5 (120.6) |
| Median (range) | 58.0 (1.0–372.0) |
| Number of sessions (N = 79) | |
| Mean (SD) | 1.6 (0.9) |
| Median (range) | 1.0 (1.0–6.0) |
| Total volume of injection, mL | |
| Mean (SD) | 3.6 (1.5) |
| Median (range) | 4.0 (2.0–8.0) |
| Volume of treatment per injection site, mL (N = 78) | |
| Mean (SD) | 0.2 (0.1) |
| Median (range) | 0.2 (0.1–0.5) |
| Interval between treatments, days† (N = 33) | |
| Mean (SD) | 73.4 (39.5) |
| Median (range) | 65.0 (24.0–220.0) |
| Injection instrument used | |
| Needle, n/N (%) | 78/79 (98.7) |
| Cannula, n/N (%) | 1/79 (1.3) |
| Off-label use, n/N (%)‡ | 7/79 (8.9) |
| Total volume injected outside of submentum (mL) | |
| Mean (SD) | 1.6 (1.3) |
| Median (range) | 0.8 (0.4–3.6) |
*
Treatment duration in days was calculated as date of last treatment session – (date of index treatment + 1).
†
Patients who had only one treatment session were excluded. The interval between treatments was calculated as treatment duration in days/(number of treatment sessions during the treatment period – 1).
‡“
Off-label use” refers to the use of ATX-101 outside the approved submental area.