Table 1 Summary of adverse events occurred during the study grouped by study treatment; (a) frequency of occurrence and (b) overall severity, outcome and relation with study drugs (all adverse events together).
Treatment | ||||
|---|---|---|---|---|
Symptom | Placebo (n = 10) | Acetaminophen (n = 10) | NCX701 (1 g) (n = 10) | NCX701 (2 g) (n = 10) |
a) | ||||
Back pain (n; %) | 0 | 2 (20) | 0 | 0 |
Bone pain (n; %) | 0 | 1 (10) | 0 | 0 |
Circulatory insufficiency (n; %) | 2 (20) | 0 | 0 | 0 |
Coldness (n; %) | 4 (40) | 4 (40) | 4 (40) | 1 (10) |
Cough (n; %) | 0 | 0 | 1 (10) | 0 |
Headache (n; %) | 10 (100) | 6 (60)* | 5 (50) ** | 5 (50) ** |
Herpes labialis (n; %) | 1 (10) | 1 (10) | 0 | 0 |
Joint pain (n; %) | 1 (10) | 0 | 0 | 0 |
Limb pain (n; %) | 0 | 1 (10) | 0 | 1 (10) |
Nausea (n; %) | 0 | 1 (10) | 0 | 0 |
Perspire (n; %) | 0 | 0 | 1 (10) | 0 |
Rhinitis (n; %) | 0 | 1 (10) | 0 | 0 |
Shivers (n; %) | 2 (20) | 1 (10) | 1 (10) | 0 |
Vertigo (n; %) | 1 (10) | 0 | 0 | 0 |
Weakness (n; %) | 0 | 1 (10) | 0 | 0 |
Total adverse events | 23 | 19 | 12 | 7 |
b) | ||||
Relation with study drug | ||||
- unlikely (n = 10/%) | 0 | 7 (35) | 1 (8.3) | 0 |
- not related (n = 10/%) | 13 (56.5) | 6 (30) | 6 (50) | 2 (28.6) |
- possible (n = 10/%) | 10 (43.5) | 7 (35) | 5 (41.7) | 5 (71.4) |
Outcome | ||||
- recovered (n = 10/%) | 23 (100) | 18 (90) | 11 (91.7) | 7 (100) |
- ongoing (n = 10/%) | 0 | 2 (10) | 1 (8.3) | 0 |
Severity | ||||
- mild (n = 10/%) | 17 (73.9) | 20 (100) | 9 (75) | 7 (100) |
- moderate (n = 10/%) | 5 (21.7) | 0 | 3 (25) | 0 |
- severe (n = 10/%) | 1 (4.3) | 0 | 0 | 0 |
