Table 3 Frequency and distribution of the systemic events occurred at each dose level
Systemic Events | Group I (14 mg) | Group II (70 mg) | Group III (245 mg) | Group IV (490 mg) | |
|---|---|---|---|---|---|
Itching | 8 (14.6%) | 18 (25.0%) | 29 (25.9%) | 29 (32.3%) | 84 |
Hot flashes | 12 (21.8%) | 14 (11.7%) | 8 (7.1%) | 8 (8.9%) | 42 |
Localized rash | 3 (5.4%) | 21 (17.5%) | 6 (5.4%) | 8 (8.9%) | 38 |
Localized facial edema | 9 (16.4%) | 6 (5.0%) | 8 (7.1%) | 13 (14.4%) | 36 |
Bumps | 0 | 12 (10.0%) | 17 (15.2%) | 6 (6.7%) | 35 |
Extensive rash | 2 (3.6%) | 0 | 21 (18.8%) | 5 (5.6%) | 28 |
Cramps | 3 (5.4%) | 2 (1.7%) | 11 (9.0%) | 6 (6.7%) | 22 |
Headache | 3 (5.4%) | 2 (1.7%) | 4 (3.6%) | 2 (2.2%) | 11 |
Metallic flavor | 4 (7.3%) | 6 (5.0%) | 1 (0.9%) | 0 | 11 |
Tickling or tingling | 5 (9.1%) | 6 (5.0%) | 0 | 0 | 11 |
Tachycardia | 0 | 7 (5.8%) | 3 (2.7%) | 0 | 10 |
Tinnitus | 0 | 7 (5.8%) | 0 | 0 | 7 |
Nausea | 0 | 3 (2.5%) | 1 (0.9%) | 3 (3.3%) | 7 |
Facial erythema | 0 | 7 (5.8%) | 0 | 0 | 7 |
Palpitations | 0 | 2 (1.7%) | 1 (0.9%) | 2 (2.2%) | 5 |
Hypertension | 3 (5.4%) | 1 (0.8%) | 0 | 1 (1.1%) | 5 |
Vasovagal syndrome | 0 | g2: 2 (1.7%) | g3: 2 (2.2%) | 4 | |
Dizziness | 1 (1.8%) | 2 (1.7%) | 0 | 0 | 3 |
Tremors | 0 | 0 | 0 | 3 (3.3%) | 3 |
Vomiting | 0 | 2 (1.7%) | 0 | 0 | 2 |
Fast breathing | 1 (1.8%) | 0 | 0 | 0 | 1 |
Abdominal pain | 1 (1.8%) | 0 | 0 | 0 | 1 |
Arrhythmia | 0 | 0 | 0 | 1 (1.1%) | 1 |
Hypotension | 0 | 0 | 1 (0.9%) | 0 | 1 |
Posture-related tremor in lower limbs | 0 | 0 | 0 | 1 (1.1%) | 1 |
Red eyes | 0 | 0 | 1 (0.9%) | 0 | 1 |
Total | 55 | 120 | 112 | 90 |