Table 6 Incidence of most frequent treatment-related adverse events (≥5% per treatment, by participant)
Adverse Event (AE) | PF-03654764 + fexofenadine (N = 48) | PF-03654764 (N = 15) | Pseudoephedrine + fexofenadine (N = 61) | Placebo (N = 15) |
|---|---|---|---|---|
Insomnia | 10 (20.8) | 5 (33.3) | 3 (4.9) | 0 |
Headache | 9 (18.8) | 3 (20.0) | 1 (1.6) | 0 |
Nausea | 9 (18.8) | 4 (26.7) | 1 (1.6) | 0 |
Dysgeusia | 5 (10.4) | 0 | 1 (1.6) | 0 |
Hot flush | 4 (8.3) | 1 (6.7) | 1 (1.6) | 0 |
Nightmare | 4 (8.3) | 0 | 0 | 0 |
Abnormal Dreams | 3 (6.3) | 0 | 0 | 0 |
Dizziness | 3 (6.3) | 1 (6.7) | 2 (3.3) | 0 |
Malaise | 3 (6.3) | 0 | 0 | 0 |
Night Sweats | 3 (6.3) | 3 (20.0) | 0 | 0 |
Tachycardia | 3 (6.3) | 0 | 0 | 0 |
Diarrhea | 2 (4.2) | 1 (6.7) | 0 | 0 |
Palpitations | 2 (4.2) | 1 (6.7) | 1 (1.6) | 0 |
Fatigue | 1 (2.1) | 1 (6.7) | 0 | 0 |
Hallucination | 1 (2.1) | 2 (13.3) | 0 | 0 |
Upper abdominal pain | 0 | 1 (6.7) | 0 | 0 |
Feeling Jittery | 0 | 1 (6.7) | 0 | 0 |
Feeling of body temperature change | 0 | 1 (6.7) | 0 | 0 |
Cognitive disorder | 0 | 1 (6.7) | 0 | 0 |
Migraine | 0 | 1 (6.7) | 0 | 0 |
Parosmia | 0 | 1 (6.7) | 0 | 0 |
Anxiety | 0 | 1 (6.7) | 0 | 0 |
Hyperhidrosis | 0 | 1 (6.7) | 0 | 0 |