Table 3 Treatment-emergent adverse events: total and those occurring in ≥2% of subjects by incidence, severity, and relationship to study medicationa (N = 167)
Subjects | Mild | Moderate | Severe | Not related | Possibly related | Probably related | Definitely related | |
|---|---|---|---|---|---|---|---|---|
Overall | 120 (71.9) | 61 (36.5) | 50 (29.9) | 9 (5.4) | 32 (19.2) | 9 (5.4) | 19 (11.4) | 60 (35.9) |
Application site pain | 51 (30.5) | 38 (22.8) | 12 (7.2) | 1 (0.6) | 0 | 2 (1.2) | 9 (5.4) | 40 (24.0) |
Dysgeusia | 35 (21.0) | 30 (18.0) | 5 (3.0) | 0 | 0 | 4 (2.4) | 7 (4.2) | 24 (14.4) |
Application site reaction | 9 (5.4) | 7 (4.2) | 2 (1.2) | 0 | 0 | 1 (0.6) | 2 (1.2) | 6 (3.6) |
Application site irritation | 7 (4.2) | 7 (4.2) | 0 | 0 | 0 | 1 (0.6) | 0 | 6 (3.6) |
Throat irritation | 8 (4.8) | 6 (3.6) | 2 (1.2) | 0 | 0 | 1 (0.6) | 2 (1.2) | 5 (3.0) |
Chest discomfort | 4 (2.4) | 4 (2.4) | 0 | 0 | 1 (0.6) | 0 | 0 | 3 (1.8) |
Nausea | 7 (4.2) | 2 (1.2) | 5 (3.0) | 0 | 1 (0.6) | 1 (0.6) | 2 (1.2) | 3 (1.8) |
Dizziness | 6 (3.6) | 4 (2.4) | 2 (1.2) | 0 | 0 | 3 (1.8) | 1 (0.6) | 2 (1.2) |
Paresthesia | 4 (2.4) | 3 (1.8) | 1 (0.6) | 0 | 1 (0.6) | 1 (0.6) | 1 (0.6) | 1 (0.6) |
Vomiting | 4 (2.4) | 2 (1.2) | 2 (1.2) | 0 | 2 (1.2) | 0 | 2 (1.2) | 0 |
Diarrhea | 4 (2.4) | 3 (1.8) | 1 (0.6) | 0 | 3 (1.8) | 0 | 1 (0.6) | 0 |
Gastroenteritis viral | 6 (3.6) | 3 (1.8) | 3 (1.8) | 0 | 6 (3.6) | 0 | 0 | 0 |
Influenza | 4 (2.4) | 1 (0.6) | 3 (1.8) | 0 | 4 (2.4) | 0 | 0 | 0 |
Nasopharyngitis | 12 (7.2) | 10 (6.0) | 2 (1.2) | 0 | 12 (7.2) | 0 | 0 | 0 |
Sinusitis | 11 (6.6) | 4 (2.4) | 6 (3.6) | 1 (0.6) | 10 (6.0) | 1 (0.6) | 0 | 0 |
Upper respiratory tract infection | 18 (10.8) | 15 (9.0) | 3 (1.8) | 0 | 18 (10.8) | 0 | 0 | 0 |
Urinary tract infection | 5 (3.0) | 3 (1.8) | 2 (1.2) | 0 | 5 (3.0) | 0 | 0 | 0 |