Table 3.
Overall summary of treatment emergent adverse events (TEAEs) in the TOFU study.
| Arm 1 | Arm 2 | Arm 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| (N = 28) | (N = 29) | (N = 29) | |||||||
| n | % | E | n | % | E | n | % | E | |
| Subjects with at least one TEAE | 21 | 75 | 67 | 21 | 72.4 | 47 | 15 | 51.7 | 38 |
| Subjects with at least one Ocular TEAE | 16 | 57.1 | 41 | 19 | 65.5 | 38 | 10 | 34.5 | 19 |
| - Study Eye | 15 | 53.6 | 36 | 17 | 58.6 | 34 | 8 | 27.6 | 14 |
| - Non-study Eye | 8 | 28.6 | 13 | 5 | 17.2 | 7 | 6 | 20.7 | 8 |
| Subjects with at least one Non-ocular TEAE | 13 | 46.4 | 26 | 6 | 20.7 | 9 | 9 | 31 | 19 |
| Subjects with at least one TEAE Related to Study Drug | 3 | 10.7 | 9 | 2 | 6.9 | 8 | 0 | 0 | |
| Subjects with at least one Procedure TEAE Related to Injection | 9 | 32.1 | 15 | 10 | 34.5 | 14 | 6 | 20.7 | 9 |
| Subjects with at least one serious TEAE | 3 | 10.7 | 6 | 2 | 6.9 | 4 | 3 | 10.3 | 3 |
| Subjects with at least one serious TEAE related to Study Drug | 2 | 7.1 | 5 | 1 | 3.4 | 3 | 0 | 0 | |
| Subjects with at least one serious TEAE related to Injection Procedure | 0 | 0 | 1 | 3.4 | 1 | 0 | 0 | ||
One subject in the Sham + umedaptanib pegol group (Arm 1) received umedaptanib pegol+aflibercept at baseline visit by rescue treatment. This subject was included in the umedaptanib pegol+flibercept group (Arm 2) for all safety analysis.
Note. A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following the first administration of the study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once in the subject count(n) column. Occurrences are counted each time in the occurrence/event(E) column. Adverse events were coded using MedDRA Ver 23.0.