Table 7.
Adverse events reported by all patients and AEs reported by ≥ 2 patients in any treatment group—TS (as treated)
| System organ class Preferred term |
Placebo N (%) |
Capsaicin N (%) |
Diclofenac N (%) |
Diclofenac + capsaicin N (%) |
Total N (%) |
|---|---|---|---|---|---|
| Number of patients | 75 (100.0) | 223 (100.0) | 223 (100.0) | 225 (100.0) | 746 (100.0) |
| Total with any AE | 12 (16.0) | 59 (26.5) | 27 (12.1) | 48 (21.3) | 146 (19.6) |
| Gastrointestinal disorders | 1 (1.3) | 3 (1.3) | 1 (0.4) | 1 (0.4) | 6 (0.8) |
| Vomiting | 1 (1.3) | 2 (0.9) | 1 (0.4) | 0 (0.0) | 4 (0.5) |
| Diarrhea | 0 (0.0) | 2 (0.9) | 1 (0.4) | 0 (0.0) | 3 (0.4) |
| General disorders and administration site conditions | 0 (0.0) | 31 (13.9) | 3 (1.3) | 20 (8.9) | 54 (7.2) |
| Burning sensation | 0 (0.0) | 16 (7.2) | 1 (0.4) | 12 (5.3) | 29 (3.9) |
| Application site pain | 0 (0.0) | 10 (4.5) | 0 (0.0) | 7 (3.1) | 17 (2.3) |
| Application site warmth | 0 (0.0) | 3 (1.3) | 0 (0.0) | 0 (0.0) | 3 (0.4) |
| Infections and infestations | 5 (6.7) | 12 (5.4) | 5 (2.2) | 3 (1.3) | 25 (3.4) |
| Nasopharyngitis | 4 (5.3) | 9 (4.0) | 4 (1.8) | 3 (1.3) | 20 (2.7) |
| Nervous system disorders | 4 (5.3) | 5 (2.2) | 8 (3.6) | 7 (3.1) | 24 (3.2) |
| Headache | 3 (4.0) | 5 (2.2) | 6 (2.7) | 6 (2.7) | 20 (2.7) |
| Paresthesia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (0.9) | 2 (0.3) |
| Skin and subcutaneous tissue disorders | 1 (1.3) | 13 (5.8) | 3 (1.3) | 19 (8.4) | 36 (4.8) |
| Skin burning sensation | 0 (0.0) | 7 (3.1) | 2 (0.9) | 12 (5.3) | 21 (2.8) |
| Pruritus | 1 (1.3) | 5 (2.2) | 0 (0.0) | 5 (2.2) | 11 (1.5) |
AE adverse event, TS treated set