Table 2. Adverse Events Reported by 5% or More Patients in Any Treatment Group.
| Adverse event | No. (%) | |||||
|---|---|---|---|---|---|---|
| Cycle 1 | Hypericin | Total | ||||
| Hypericin | Placebo | Cycle 2 | Cycle 3 | Overall | ||
| Total participants, No. | 116 | 50 | 155 | 110 | 161 | 166 |
| Patients with ≥1 TEAEa | 56 (48.3) | 27 (54.0) | 66 (42.6) | 49 (44.5) | 108 (67.1) | 116 (69.9) |
| All skin/subcutaneous tissue-related disordersb | 19 (16.4) | 5 (10.0) | 21 (13.5) | 19 (17.3) | 48 (29.8) | 53 (31.9) |
| Pruritusb | 6 (5.2) | 2 (4.0) | 2 (1.3) | 5 (4.5) | 12 (7.5) | 14 (8.4) |
| URI | 8 (6.9) | 4 (8.0) | 2 (1.3) | 2 (1.8) | 12 (7.5) | 16 (9.6) |
| Viral URI | 4 (3.4) | 0 | 4 (2.6) | 4 (3.6) | 11 (6.8) | 11 (6.6) |
| Application-site painb | 8 (6.9) | 2 (4.0) | 5 (3.2) | 6 (5.5) | 16 (9.9) | 17 (10.2) |
| Application-site pruritusb | 5 (4.3) | 1 (2.0) | 5 (3.2) | 0 | 9 (5.6) | 9 (5.4) |
| Fatigue | 3 (2.6) | 1 (2.0) | 3 (1.9) | 2 (1.8) | 8 (5.0) | 9 (5.4) |
| Headache | 5 (4.3) | 3 (6.0) | 5 (3.2) | 2 (1.8) | 10 (6.2) | 13 (7.8) |
Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event; URI, upper respiratory tract infection.
a
TEAE was defined as an AE that was new or worsened in severity after the first dose of study drug and within 1 month following the last evaluation visit. Patients were counted only once for each AE they experienced. All adverse events were coded using the Medical Dictionary for Regulatory Activities, version 20. Most of the AEs were mild, required no intervention or treatment, and did not interfere with continued therapy use and study participation. AE-related discontinuation rate was 1.2% during the study.
b
TEAE of special interest.