Table 4.
Solicited local reactions and systemic adverse events by study groups, intention-to-treat population.
| DSJI (n = 170) |
N-S (n = 170) |
p-Valueα | |||||
|---|---|---|---|---|---|---|---|
| No. subjects | No. events | % subjects (95% CI) | No. subjects | No. events | % subjects (95% CI) | ||
| Local adverse events | |||||||
| Pain | 76 | 81 | 44.7 (37.1, 52.5) | 60 | 61 | 35.3 (28.1, 43.0) | .096 |
| Redness | 40 | 42 | 23.5 (17.4, 30.6) | 22 | 22 | 12.9 (8.3, 18.9) | .016 |
| Swelling | 47 | 48 | 27.6 (21.1, 35.0) | 27 | 27 | 15.9 (10.7, 22.3) | .012 |
| Bruising | 2 | 2 | 1.2 (0.1, 4.2) | 2 | 2 | 1.2 (0.1, 4.2) | 1.00 |
| At least one local reaction | 97* | 173 (Mild: 155; Moderate: 16; Severe: 1) Severity for one local reaction i.e. redness is missing | 57.1 (49.3, 64.6) | 75* | 112 (Mild: 99; Moderate: 13; Severe: Nil) | 44.1 (36.5, 51.9) | .02 |
| Systemic adverse events | |||||||
| Loss of appetite | 34 | 44 | 20.0 (14.3, 26.8) | 29 | 35 | 17.1 (11.7, 23.6) | .58 |
| Fever | 19 | 19 | 11.2 (6.9, 16.9) | 20 | 20 | 11.8 (7.3, 17.6) | 1.00 |
| Rash | 13 | 15 | 7.6 (4.1, 12.7) | 12 | 13 | 7.1 (3.7, 12.0) | 1.00 |
| Lymphaden-opathy | 4 | 5 | 2.4 (0.6, 56.0) | 2 | 2 | 1.2 (0.1, 4.2) | 0.25 |
| Parotitis | 3 | 3 | 1.8 (0.4, 5.1) | 0 | 0 | 0 (0.0, 2.2) | 0.68 |
| At least one event | 51* | 86 (Mild: 68; Moderate: 14; Sever: 4) | 30.0 (23.2, 37.5) | 46* | 70 (Mild: 56; Moderate: 11; Severe: 3) | (20.5, 34.4) | 0.63 |
α
p-Value for number of subjects calculated using Fisher’s exact test.
*
Total number of subjects with at least one local reaction or systemic adverse event is less than the sum of the numbers for that column because some subjects experienced more than one event.