Table 3. Treatment-Emergent Adverse Events (Safety Set).
| Characteristic | No. (%) | |||
|---|---|---|---|---|
| Placebo (n = 162) | Atropine, 0.01% (n = 164) | Atropine, 0.02% (n = 247) | Total (n = 573) | |
| Any treatment-emergent adverse event, No. (%) | 116 (71.6) | 98 (59.8) | 163 (66.0) | 377 (65.8) |
| Serious ocular treatment-emergent adverse event, No. (%) | 0 | 0 | 0 | 0 |
| Serious nonocular treatment-emergent adverse event, No. (%) | 4 (2.5) | 1 (0.6) | 8 (3.2) | 13 (2.3) |
| Any treatment-emergent adverse event leading to permanent discontinuation of trial drug, No. (%) | 10 (6.2) | 0 | 5 (2.0) | 15 (2.5) |
| Treatment-emergent adverse events (partial list), No. (%)a | ||||
| Photophobia | 5 (3.1) | 4 (2.4) | 11 (4.5) | 20 (3.5) |
| Allergic conjunctivitis | 5 (3.1) | 3 (1.8) | 11 (4.5) | 19 (3.3) |
| Eye irritation | 6 (3.7) | 1 (0.6) | 2 (0.8) | 9 (1.6) |
| Mydriasis (enlarged pupil) | 0 | 2 (1.2) | 4 (1.6) | 6 (1.0) |
| Blurred vision | 0 | 2 (1.2) | 4 (1.6) | 6 (1.0) |
| Eyelid swelling | 0 | 3 (1.8) | 1 (0.4) | 4 (0.7) |
| Eyelid irritation | 1 (0.6) | 0 | 2 (0.8) | 3 (0.5) |
| Elevated heart rate | 1 (0.6) | 0 | 2 (0.8) | 3 (0.5) |
| Seizure | 1 (0.6) | 0 | 0 | 1 (0.2) |
a
eTable 1 in Supplement 3 contains a complete list.