Table 4 Frequency of patients with treatment-emergent adverse events by preferred term (safety population), incidence >5% in any treatment group
Preferred term (MedDRA 9.1) | Placebo (N= 112) | 25 mg/d Neramexane (N= 108) | 50 mg/d Neramexane (N= 107) | 75 mg/d Neramexane (N= 102) | ||||
|---|---|---|---|---|---|---|---|---|
n | % | n | % | n | % | n | % | |
Any adverse event | 79 | 70.5 | 64 | 59.3 | 79 | 73.8 | 80 | 78.4 |
Dizziness | 9 | 8.0 | 11 | 10.2 | 21 | 19.6 | 38 | 37.3 |
Headache | 15 | 13.4 | 11 | 10.2 | 14 | 13.1 | 11 | 10.8 |
Vertigo | 1 | 0.9 | 3 | 2.8 | 10 | 9.3 | 11 | 10.8 |
Fatigue | 3 | 2.7 | 4 | 3.7 | 9 | 8.4 | 8 | 7.8 |
Hypertension | 3 | 2.7 | 1 | 0.9 | 3 | 2.8 | 6 | 5.9 |
Nasopharyngitis | 9 | 8.0 | 7 | 6.5 | 6 | 5.6 | 6 | 5.9 |
Nausea | 5 | 4.5 | 7 | 6.5 | 5 | 4.7 | 5 | 4.9 |