Table 3 Treatment-emergent Adverse Events by System Organ Class and Preferred Term
System organ class Preferred term, n (%) | NGX-4010 (n = 24) | Mild | Moderate | Severe |
|---|---|---|---|---|
Number of subjects reporting one or more treatment-emergent AEs | 24 (100.0) | 6 (25.0) | 14 (58.3) | 4 (16.7) |
   General disorders and administration-site conditions | 24 (100.0) | 6 (25.0) | 15 (62.5) | 3 (12.5) |
   Application-site erythema* | 24 (100.0) | 9 (37.5) | 15 (62.5) | 0 (0) |
   Application-site pain* | 22 (91.7) | 4 (16.7) | 15 (62.5) | 3 (12.5) |
   Application-site edema* | 4 (16.7) | 3 (12.5) | 1 (4.2) | 0 (0) |
   Application-site pruritus* | 1 (4.2) | 1 (4.2) | 0 (0) | 0 (0) |
   Pain | 1 (4.2) | 0 (0) | 0 (0) | 1 (4.2) |
Investigations | 1 (4.2) | 1 (4.2) | 0 (0) | 0 (0) |
   Blood pressure increased* | 1 (4.2) | 1 (4.2) | 0 (0) | 0 (0) |
Musculoskeletal and connective tissue disorders | 2 (8.3) | 1 (4.2) | 0 (0) | 1 (4.2) |
   Back pain | 2 (8.3) | 1 (4.2) | 0 (0) | 1 (4.2) |
   Muscular weakness | 1 (4.2) | 1 (4.2) | 0 (0) | 0 (0) |
Reproductive system and breast disorders | 1 (4.2) | 0 (0) | 1 (4.2) | 0 (0) |
   Breast mass | 1 (4.2) | 0 (0) | 1 (4.2) | 0 (0) |
Skin and subcutaneous tissue disorders | 3 (12.5) | 3 (12.5) | 0 (0) | 0 (0) |
   Erythema | 1 (4.2) | 1 (4.2) | 0 (0) | 0 (0) |
   Rash papular | 2 (8.3) | 2 (8.3) | 0 (0) | 0 (0) |