Table 4.
Physical adverse event frequency
| Sham-controlled phase | Open-label phase | |||||||
|---|---|---|---|---|---|---|---|---|
| Sham (646 sessions) | Active (650 sessions) | Pearson Chi-square | Active (1161 sessions) | |||||
| n | % | n | % | χ2 | P-value | n | % | |
| Erythema | 129 | 20.0 | 454 | 69.8 | 323.67 | <.001 | 781 | 67.3 |
| Tingling | 126 | 19.5 | 332 | 51.1 | 139.96 | <.001 | 623 | 53.7 |
| Burning | 15 | 2.3 | 251 | 38.6 | 214.14 | <.001 | 370 | 31.9 |
| Itching | 40 | 6.2 | 97 | 14.9 | 25.21 | <.001 | 170 | 14.6 |
| Fatigue | 33 | 5.1 | 60 | 9.2 | 7.66 | .006 | 75 | 6.5 |
| Headache | 43 | 6.7 | 30 | 4.6 | 2.17 | .141 | 31 | 2.7 |
| Dizziness/light-headedness | 10 | 1.5 | 31 | 4.8 | 9.95 | .002 | 48 | 4.1 |
| Nausea | 7 | 1.1 | 15 | 2.3 | 2.22 | .136 | 36 | 3.1 |
| Scalp Discomfort | 7 | 1.1 | 9 | 1.4 | 0.06 | .811 | 10 | 0.9 |
| Other | 14 | 2.2 | 26 | 4.0 | 3.05 | .081 | 58 | 5.0 |
Adverse events are sorted according to overall likelihood of occurrence, with events most likely to occur listed first. Differences in frequency of adverse event occurrence during the sham-controlled phase was tested using Pearson chi-square tests with Yates’ continuity correction. Statistically significant P values (< .05) are highlighted in bold.