Table 4 Number (%) of subjects (≥5% in any treatment group) with adverse events: safety population (n = 140)

Adverse event preferred termAVP-923, n = 70DM, n = 33Q, n = 37
* Number reported significantly different between groups.
DM = dextromethorphan hydrobromide; Q = quinidine sulfate; NEC = not elsewhere classified; NOS = not otherwise specified.
Anorexia4 (5.7)1 (3.0)0 (0.0)
Anxiety NEC3 (4.3)0 (0.0)3 (8.1)
Arthralgia2 (2.9)3 (9.1)2 (5.4)
Constipation5 (7.1)2 (6.1)0 (0.0)
Confusion1 (1.4)2 (6.1)0 (0.0)
Diarrhea NOS11 (15.7)7 (21.2)4 (10.8)
Dizziness (excluding vertigo)*14 (20.0)5 (15.2)1 (2.7)
Dyspnea NOS2 (2.9)0 (0.0)3 (8.1)
Edema lower limb0 (0.0)1 (3.0)2 (5.4)
Fall6 (8.6)2 (6.1)0 (0.0)
Fatigue13 (18.6)3 (9.1)4 (10.8)
Flatulence1 (1.4)2 (6.1)0 (0.0)
Headache NOS11 (15.7)4 (12.1)4 (10.8)
Hypertonia5 (7.1)0 (0.0)1 (2.7)
Joint stiffness7 (10.0)0 (0.0)1 (2.7)
Localized infection0 (0.0)0 (0.0)2 (5.4)
Loose stools*0 (0.0)3 (9.1)0 (0.0)
Muscle cramps5 (7.1)2 (6.1)1 (2.7)
Muscle spasms2 (2.9)2 (6.1)0 (0.0)
Nasopharyngitis1 (1.4)3 (9.1)1 (2.7)
Nausea*23 (32.9)2 (6.1)3 (8.1)
Pruritus NOS0 (0.0)0 (0.0)2 (5.4)
Sinus congestion2 (2.9)2 (6.1)1 (2.7)
Sleep disorder NOS0 (0.0)0 (0.0)2 (5.4)
Somnolence*9 (12.9)1 (3.0)0 (0.0)
Sweating increased4 (5.7)0 (0.0)1 (2.7)
Upper respiratory tract infection NOS3 (4.3)1 (3.0)2 (5.4)
Vomiting NOS4 (5.7)0 (0.0)0 (0.0)
Weakness4 (5.7)1 (3.0)4 (10.8)