Table 2.
System organ class preferred term | L.M.X.4 (n = 39) | Topicaine (n = 38) | Betacaine (n = 40) |
---|---|---|---|
Patients reporting one or more treatment-emergent AEs, n (%) | 23 (59) | 19 (50) | 23 (58) |
Cardiac disorders, n (%) | 2 (5) | 2 (5) | 0 |
Cardiac failure congestive | 2 (5) | 0 | 0 |
Gastrointestinal disorders, n (%) | 6 (15) | 4 (11) | 2 (5) |
Nausea | 2 (5) | 4 (11) | 0 |
Toothache | 2 (5) | 0 | 1 (3) |
General disorders and administration-site conditions, n (%) | 13 (33) | 14 (37) | 12 (30) |
Application-site burning | 7 (18) | 8 (21) | 3 (8) |
Application-site dryness | 2 (5) | 0 | 2 (5) |
Application-site edema | 0 | 2 (5) | 0 |
Application-site pain | 3 (8) | 5 (13) | 3 (8) |
Application-site pruritus | 1 (3) | 1 (3) | 2 (5) |
Application-site swelling | 1 (3) | 5 (13) | 2 (5) |
Infections and infestations, n (%) | 15 (38) | 7 (18) | 8 (20) |
Nasopharyngitis | 0 | 4 (11) | 1 (3) |
Urinary tract infection | 2 (5) | 1 (3) | 1 (3) |
Musculoskeletal and connective tissue disorders, n (%) | 10 (26) | 4 (11) | 6 (15) |
Muscle spasm | 2 (5) | 0 | 0 |
Pain in extremity | 1 (3) | 2 (5) | 1 (3) |
Abbreviation: AE, adverse event.