Table 3.
Additional safety assessmentsa.
| Local reaction to saline injection | Any observations |
Mild (Grade 1) |
Moderate (Grade 2) |
Severe (Grade 3) |
Potentially Life Threatening (Grade 4) |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| Injection Method: | PRIME | PFS | PRIME | PFS | PRIME | PFS | PRIME | PFS | PRIME | PFS |
| Tenderness at 5 minutes, events | 2/75 | 3/50 | 2 | 3 | ||||||
| Tenderness at 10 minutes, events | 1/75 | 0/49 | 1 | 0 | ||||||
| Other Observations at 5 minutes, events | 0/75 | 2/50 | 0 | 2 | ||||||
| Other Observations at 10 minutes, events | 1/75 | 1/49 | 1 | 1 | No observations of any events greater than mild or Grade 1 for either injection method | |||||
| Erythema/Redness at 5 minutes | 23/75 | 1/50 | 0 | 0 | ||||||
| Ave diameter (cm), those with event | 0.72 | 1.0 | 0 | 0 | ||||||
| Erythema/Redness at 10 minutes, events | 21/75 | 0/49 | 0 | 0 | ||||||
| Ave diameter, (cm) those with event | 0.65 | 0 | 0 | 0 | ||||||
| Induration/Swelling at 5 minutes | 49/75 | 1/50 | 0 | 0 | ||||||
| Ave diameter (cm), those with event | 0.54 | 0.30 | 0 | 0 | ||||||
| Induration/Swelling at 10 minutes, events | 35/75 | 2/49 | 1/75b | 1/49c | ||||||
| Ave diameter (cm), those with event | 0.42 | 0.20 | 4.0 | 0.2 | ||||||
aData were available for n = 41 participants, and n = 40 patients for the 10-minute measures.
bInduration/swelling measures for PRIME injections in one subject were reported as 4.0 cm, however the photos of those injection site did not appear to be that large.
cInduration/swelling was reported as Grade 1 for the PFS injection at 10 minutes in one subject, however the measured diameter was only reported as 0.2 cm, which does not meet the criteria for Grade 1.