Table 1.
Summary of All Reported Adverse Events in ≥2 Subjects and All Drug‐Related Adverse Events—Study 2, Single Dosing
| GSK1940029 | |||||||
|---|---|---|---|---|---|---|---|
| Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | |||
| 0.3% | 1% | 1% | 0.3% | 1% | |||
| 400 cm2 | 400 cm2 | 1600 cm2 | 1600 cm2 | 1600 cm2 | Vehicle | Total | |
| Preferred Term | (N = 6) | (N = 6) | (N = 6) | (N = 6) | (N = 5) | (N = 10) | (N = 39) |
| Subjects with ≥1 AE | 3 (50.0) | 2 (33.3) | 4 (66.7) | 4 (66.7) | 5 (100.0) | 8 (80.0) | 26 (66.7) |
| Subjects with ≥1 drug‐related AE | 1 (16.7) | 1 (16.7) | 3 (50.0) | 0 | 2 (40.0) | 3 (30.0) | 10 (25.6) |
| All AEs reported by ≥2 subjects | |||||||
| Headache | 1 (16.7) | 1 (16.7) | 1 (16.7) | 1 (20.0) | 1 (10.0) | 5 (12.8) | |
| Injection‐site bruising | 2 (33.3) | 1 (20.0) | 1 (10.0) | 4 (10.3) | |||
| Nausea | 3 (30.0) | 3 (7.7) | |||||
| Erythema | 1 (16.7) | 1 (20.0) | 1 (10.0) | 3 (7.7) | |||
| Application‐site erythema | 2 (33.3) | 1 (16.7) | 3 (7.7) | ||||
| Ocular discomfort | 2 (40.0) | 2 (5.1) | |||||
| Contusion | 2 (33.3) | 2 (5.1) | |||||
| Dermatitis contact | 2 (33.3) | 2 (5.1) | |||||
| Rash erythematous | 1 (16.7) | 1 (16.7) | 2 (5.1) | ||||
| Drug‐related AEs reported by ≥1 subject | |||||||
| Headache | 1 (16.7) | 1 (16.7) | 1 (20.0) | 1 (10.0) | 4 (10.3) | ||
| Nausea | 2 (20.0) | 2 (5.1) | |||||
| Ocular discomfort | 2 (40.0) | 2 (5.1) | |||||
| Rash erythematous | 1 (16.7) | 1 (16.7) | 2 (5.1) | ||||
| Photophobia | 1 (10.0) | 1 (2.6) | |||||
| Abdominal discomfort | 1 (20.0) | 1 (2.6) | |||||
| Diarrhea | 1 (20.0) | 1 (2.6) | |||||
| Acne | 1 (16.7) | 1 (2.6) | |||||
| Application‐site erythema | 1 (16.7) | 1 (2.6) | |||||
| Application‐site pruritus | 1 (16.7) | 1 (2.6) | |||||
| Tear breakup time decreased | 1 (16.7) | 1 (2.6) | |||||