System Organ Class Preferred Term, n (%) | NGX-4010 (n = 102) | Control (n = 53) |
---|---|---|
Number of Patients Reporting 1 or More Adverse Events | 76 (75%) | 28 (53%) |
Gastrointestinal Disorders | 10 (10%) | 4 (8%) |
   Nausea | 5 (5%) | 1 (2%) |
General Disorders and Administration Site Conditions | 38 (37%) | 12 (23%) |
   Application Site Burning | 3 (3%) | 0 |
   Application Site Discoloration | 0 | 3 (6%) |
   Application Site Dryness | 10 (10%) | 2 (4%) |
   Application Site Erythema | 4 (4%) | 0 |
   Application Site Pain | 4 (4%) | 2 (4%) |
   Application Site Papules | 4 (4%) | 2 (4%) |
   Application Site Pruritus | 17 (17%) | 6 (11%) |
   Application Site Swelling | 10 (10%) | 1 (2%) |
   Application Site Urticaria | 3 (3%) | 0 |
   Application Site Vesicles | 5 (5%) | 1 (2%) |
   Pain Exacerbated | 3 (3%) | 0 |
Infections and Infestations | 16 (16%) | 8 (15%) |
   Bronchitis | 3 (3%) | 0 |
   Herpes Zoster | 3 (3%) | 2 (4%) |
   Upper Respiratory Tract Infection | 1 (1%) | 2 (4%) |
Injury, Poisoning and Procedural Complications | 4 (4%) | 6 (11%) |
   Injury | 1 (1%) | 2 (4%) |
Musculoskeletal and Connective Tissue Disorders | 10 (10%) | 2 (4%) |
   Back Pain | 3 (3%) | 1 (2%) |
Nervous Systems Disorders | 5 (5%) | 5 (9%) |
   Dizziness | 1 (1%) | 3 (6%) |
Respiratory, Thoracic and Mediastinal Disorders | 12 (12%) | 4 (8%) |
   Cough | 3 (3%) | 0 |
   Nasal Congestion | 1 (1%) | 2 (4%) |
   Nasopharyngitis | 3 (3%) | 2 (4%) |
Vascular Disorders | 5 (5%) | 1 (2%) |
   Hypertension | 3 (3%) | 0 |