TABLE 5.
Common treatment-related adverse events (≥2% and >1 subject in either group in a subpopulation), reported by etiology and length of bimatoprost 0.03% exposure in the six pooled studies
| ANY TREATMENT-RELATED AE | Overall, n (%) | Idiopathic, n (%) | Postchemotherapy, n (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ≤4 Months* | ≤12 Months† | ≤4 Months* | ≤12 Months† | ≤4 Months* | ≤12 Months† | |||||||
| BIM (n=562) | VEH (n=379) | BIM (n=680) | VEH (n=379) | BIM (n=448) | VEH (n=328) | BIM (n=534) | VEH (n=328) | BIM (n=114) | VEH (n=51) | BIM (n=146) | VEH (n=51) | |
| 111 (19.8) | 25 (6.6) | 143 (21.0) | 30 (7.9) | 86 (19.2) | 21 (6.4) | 106 (19.9) | 25 (7.6) | 25 (21.9) | 4 (7.8) | 37 (25.3) | 5 (9.8) | |
| EYE DISORDERS | ||||||||||||
| Overall | 94 (16.7) | 22 (5.8) | 126 (18.5) | 27 (7.1) | 71 (15.8) | 19 (5.8) | 90 (16.9) | 23 (7.0) | 23 (20.2) | 3 (5.9) | 36 (24.7) | 4 (7.8) |
| Conjunctival hyperemia | 28 (5.0) | 2 (0.5) | 36 (5.3) | 2 (0.5) | 17 (3.8) | 2 (0.6) | 22 (4.1) | 2 (0.6) | 11 (9.6) | 0 | 14 (9.6) | 0 |
| Blepharal pigmentation | 15 (2.7) | 1 (0.3) | 22 (3.2) | 2 (0.5) | 11 (2.5) | 0 | 15 (2.8) | 1 (0.3) | 4 (3.5) | 1 (2.0) | 7 (4.8) | 1 (2.0) |
| Eyelids pruritus | 16 (2.8) | 7 (1.8) | 21 (3.1) | 7 (1.8) | 13 (2.9) | 6 (1.8) | 18 (3.4) | 6 (1.8) | 3 (2.6) | 1 (2.0) | 3 (2.1) | 1 (2.0) |
| Erythema of eyelid | 10 (1.8) | 2 (0.5) | 20 (2.9) | 3 (0.8) | 8 (1.8) | 2 (0.6) | 16 (3.0) | 3 (0.9) | 2 (1.8) | 0 | 4 (2.7) | 0 |
| Punctate keratitis | 11 (2.0) | 1 (0.3) | 16 (2.4) | 3 (0.8) | 8 (1.8) | 1 (0.3) | 8 (1.5) | 2 (0.6) | 3 (2.6) | 0 | 8 (5.5) | 1 (2.0) |
| Eye pruritus | 9 (1.6) | 2 (0.5) | 10 (1.5) | 2 (0.5) | 6 (1.3) | 1 (0.3) | 6 (1.1) | 1 (0.3) | 3 (2.6) | 1 (2.0) | 4 (2.7) | 1 (2.0) |
*
Subjects in Study 5 are not included in the analysis up to four months.
†
Up to six months for vehicle group.
BIM=bimatoprost; VEH=vehicle