TABLE 3.
Most common adverse events (≥2%) reported by etiology and length of bimatoprost 0.03% exposure in the six pooled studies
| ADVERSE EVENT | ETIOLOGY | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | |
| Overall | 228 (40.6) | 116 (30.6) | 322 (47.4) | 130 (34.3) | 173 (38.6) | 94 (28.7) | 223 (41.8) | 102 (31.1) | 55 (48.2) | 22 (43.1) | 99 (67.8) | 28 (54.9) |
| Conjunctival hyperemia | 31 (5.5) | 5 (1.3) | 43 (6.3) | 5 (1.3) | 19 (4.2) | 4 (1.2) | 24 (4.5) | 4 (1.2) | 12 (10.5) | 1 (2.0) | 19 (13.0) | 1 (2.0) |
| Eyelids pruritus | 18 (3.2) | 8 (2.1) | 23 (3.4) | 8 (2.1) | 15 (3.3) | 7 (2.1) | 20 (3.7) | 7 (2.1) | 3 (2.6) | 1 (2.0) | 3 (2.1) | 1 (2.0) |
| Nasopharyngitis | 13 (2.3) | 10 (2.6) | 23 (3.4) | 10 (2.6) | 13 (2.9) | 6 (1.8) | 18 (3.4) | 6 (1.8) | 0 | 4 (7.8) | 5 (3.4) | 4 (7.8) |
| Blepharal pigmentation | 16 (2.8) | 1 (0.3) | 23 (3.4) | 2 (0.5) | 12 (2.7) | 0 | 16 (3.0) | 1 (0.3) | 4 (3.5) | 1 (2.0) | 7 (4.8) | 1 (2.0) |
| Erythema of eyelid | 11 (2.0) | 2 (0.5) | 22 (3.2) | 3 (0.8) | 9 (2.0) | 2 (0.6) | 17 (3.2) | 3 (0.9) | 2 (1.8) | 0 | 5 (3.4) | 0 |
| Punctate keratitis | 13 (2.3) | 3 (0.8) | 22 (3.2) | 6 (1.6) | 9 (2.0) | 3 (0.9) | 10 (1.9) | 4 (1.2) | 4 (3.5) | 0 | 12 (8.2) | 2 (3.9) |
| URT infection | 4 (0.7) | 6 (1.6) | 16 (2.4) | 6 (1.6) | 3 (0.7) | 5 (1.5) | 8 (1.5) | 5 (1.5) | 1 (0.9) | 1 (2.0) | 8 (5.5) | 1 (2.0) |
| Eye pruritus | 13 (2.3) | 3 (0.8) | 15 (2.2) | 3 (0.8) | 7 (1.6) | 2 (0.6) | 7 (1.3) | 2 (0.6) | 6 (5.3) | 1 (2.0) | 8 (5.5) | 1 (2.0) |
| Dry eye | 12 (2.1) | 3 (0.8) | 14 (2.1) | 3 (0.8) | 10 (2.2) | 1 (0.3) | 12 (2.2) | 1 (0.3) | 2 (1.8) | 2 (3.9) | 2 (1.4) | 2 (3.9) |
| Sinusitis | 4 (0.7) | 4 (1.1) | 9 (1.3) | 5 (1.3) | 3 (0.7) | 4 (1.2) | 4 (0.7) | 5 (1.5) | 1 (0.9) | 0 | 5 (3.4) | 0 |
| Radiation skin injury | 8 (1.4) | 2 (0.5) | 8 (1.2) | 2 (0.5) | 0 | 0 | 0 | 0 | 8 (7.0) | 2 (3.9) | 8 (5.5) | 2 (3.9) |
| Blepharitis | 4 (0.7) | 1 (0.3) | 8 (1.2) | 1 (0.3) | 3 (0.7) | 1 (0.3) | 4 (0.7) | 1 (0.3) | 1 (0.9) | 0 | 4 (2.7) | 0 |
| Nausea | 4 (0.7) | 2 (0.5) | 7 (1.0) | 2 (0.5) | 2 (0.4) | 2 (0.6) | 3 (0.6) | 2 (0.6) | 2 (1.8) | 0 | 4 (2.7) | 0 |
| Headache | 3 (0.5) | 4 (1.1) | 7 (1.0) | 4 (1.1) | 1 (0.2) | 4 (1.2) | 3 (0.6) | 4 (1.2) | 2 (1.8) | 0 | 4 (2.7) | 0 |
| Bronchitis | 4 (0.7) | 5 (1.3) | 6 (0.9) | 5 (1.3) | 2 (0.4) | 5 (1.5) | 2 (0.4) | 5 (1.5) | 2 (1.8) | 0 | 4 (2.7) | 0 |
| Procedural pain | 3 (0.5) | 3 (0.8) | 4 (0.6) | 3 (0.8) | 1 (0.2) | 2 (0.6) | 1 (0.2) | 2 (0.6) | 2 (1.8) | 1 (2.0) | 3 (2.1) | 1 (2.0) |
| Hypothyroidism | 1 (0.2) | 1 (0.3) | 4 (0.6) | 1 (0.3) | 0 | 1 (0.3) | 1 (0.2) | 1 (0.3) | 1 (0.9) | 0 | 3 (2.1) | 0 |
| Pyrexia | 2 (0.4) | 4 (1.1) | 3 (0.4) | 4 (1.1) | 0 | 2 (0.6) | 1 (0.2) | 2 (0.6) | 2 (1.8) | 2 (3.9) | 2 (1.4) | 2 (3.9) |
| Ligament sprain | 2 (0.4) | 2 (0.5) | 3 (0.4) | 2 (0.5) | 0 | 2 (0.6) | 0 | 2 (0.6) | 2 (1.8) | 0 | 3 (2.1) | 0 |
| Cough | 3 (0.5) | 3 (0.8) | 3 (0.4) | 3 (0.8) | 0 | 2 (0.6) | 0 | 2 (0.6) | 3 (2.6) | 1 (2.0) | 3 (2.1) | 1 (2.0) |
| Ovarian cyst‡ | 1 (0.2) | 0 | 3 (0.5) | 0 | 0 | 0 | 0 | 0 | 1 (0.9) | 0 | 3 (2.1) | 0 |
| Insomnia | 2 (0.4) | 2 (0.5) | 2 (0.3) | 2 (0.5) | 0 | 0 | 0 | 0 | 2 (1.8) | 2 (3.9) | 2 (1.4) | 2 (3.9) |
*
Subjects in Study 5 are not included in the analysis up to four months.
†
Up to six months for vehicle group.
‡
Percentage was calculated based on the number of females in each group.
BIM=bimatoprost; URT=upper respiratory tract; VEH=vehicle