Table 5.
Frequently observed adverse events with or without a causal relation with the study drugs (more than 2% incidence in FAS)
| System organ class (preferred term) | No causal relation with the study drug | Possible causal relation with the study drug | ||||
|---|---|---|---|---|---|---|
| 2.5% BPO, no. cases (%) | 5% BPO, no. cases (%) | Placebo, no. cases (%) | 2.5% BPO, no. cases (%) | 5% BPO, no. cases (%) | Placebo, no. cases (%) | |
| No. of subjects analyzed | 204 | 204 | 201 | 204 | 204 | 201 |
| Adverse events | 115 (56.4) | 120 (58.8) | 95 (47.3) | 76 (37.3) | 79 (38.7) | 26 (12.9) |
| General disorders and administration site conditions | – | – | – | – | – | – |
| Application site irritation | 17 (8.3) | 25 (12.3) | 2 (1.0) | 17 (8.3) | 25 (12.3) | 2 (1.0) |
| Application site erythema | 28 (13.7) | 22 (10.8) | 5 (2.5) | 28 (13.7) | 22 (10.8) | 4 (2.0) |
| Application site pruritus | 7 (3.4) | 5 (2.5) | 0 | 7 (3.4) | 5 (2.5) | 0 |
| Infections and infestations | – | – | – | – | – | – |
| Nasopharyngitis | 17 (8.3) | 31 (15.2) | 20 (10.0) | 0 | 0 | 0 |
| Laboratory test | – | – | – | – | – | – |
| White blood cell count increase | 11 (5.4) | 6 (2.9) | 9 (4.5) | 1 (0.5) | 1 (0.5) | 0 |
| Blood cholesterol decrease | 4 (2.0) | 5 (2.5) | 5 (2.5) | 0 | 1 (0.5) | 0 |
| Blood bilirubin increase | 3 (1.5) | 2 (1.0) | 7 (3.5) | 2 (1.0) | 1 (0.5) | 2 (1.0) |
| Aspartate aminotransferase increase | 2 (1.0) | 0 | 6 (3.0) | 0 | 0 | 4 (2.0) |
| Nervous system disorders | – | – | – | – | – | – |
| Headache | 5 (2.5) | 1 (0.5) | 1 (0.5) | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | – | – | – | – | – | – |
| Skin exfoliation | 42 (20.6) | 49 (24.0) | 19 (9.5) | 39 (19.1) | 48 (23.5) | 16 (8.0) |
| Contact dermatitis | 6 (2.9) | 7 (3.4) | 0 | 5 (2.5) | 3 (1.5) | 0 |
| Eczema | 4 (2.0) | 5 (2.5) | 2 (1.0) | 0 | 0 | 0 |
BPO, benzoyl peroxide; FAS, full analysis set.