Table 4.
| A | |||
|---|---|---|---|
|
| |||
| Study Arm | |||
|
|
|||
| Sirolimus (N=27) |
Sham (N=25) |
Total (N=52) |
|
| Number of Events/Participants | |||
| Number of Adverse Events | 111 | 42 | 153 |
| Participants with at least one AE, N (%) | 22 (81) | 16 (64) | 38 (73) |
| Number of SAEs | 12 | 9 | 21 |
| Participants with at least one SAE, N (%) | 7 (26) | 6 (24) | 13 (25) |
| Specific Ocular Events (at least one) Per Participant, N (%) | |||
| Drug depot/floater in vitreous related to injection1 | 12 (44) | 0 (0) | 12 (23) |
| Eye Pain related to injection | 5 (19) | 3 (12) | 8 (15) |
| Anterior Uveitis or Sterile Endophthalmitis2 | 4 (15) | 0 (0) | 4 (10) |
| At least one Reasonable Possibility Study Injection Caused Event, Per Participant, N (%) | |||
| Yes1 | 17 (63) | 5 (20) | 22 (42) |
| Reasonable Possibility Study Injection Caused Event among All AEs, N (%) | |||
| Yes1 | 46 (41) | 5 (20) | 51 (33) |
| Reasonable Possibility Study Injection Caused Event among All SAEs, N (%) | |||
| Yes | 4 (33) | 0 (0) | 4 (19) |
| Deaths | 1 (4) | 1 (4) | 2 (4) |
| B | |||
|---|---|---|---|
|
| |||
| Study Arm | |||
|
|
|||
| Sirolimus (N=27) |
Sham (N=25) |
Total (N=52) |
|
| Number of Events/Participants | |||
| Number of Adverse Events | 111 | 42 | 153 |
| Participants with at least one AE, N (%) | 22 (81) | 16 (64) | 38 (73) |
| Number of SAEs | 12 | 9 | 21 |
| Participants with at least one SAE, N (%) | 7 (26) | 6 (24) | 13 (25) |
| Type of Event among All AEs, N (%) | |||
| Non-ocular1 | 55 (50) | 31 (74) | 86 (56) |
| Non-study eye | 2 (2) | 1 (1) | 3 (2) |
| Study eye1 | 52 (47) | 7 (17) | 59 (39) |
| Both eyes | 2 (2) | 3 (7) | 5 (3) |
| Severity among All AEs, N (%) | |||
| Mild | 76 (68) | 22 (52) | 98 (64) |
| Moderate | 31 (28) | 12 (29) | 43 (28) |
| Severe1 | 4 (4) | 8 (19) | 12 (8) |
| Highest Severity Per Participant, N (%) | |||
| Mild | 10 (37) | 6 (24) | 16 (31) |
| Moderate | 9 (33) | 5 (20) | 14 (27) |
| Severe | 3 (11) | 5 (20) | 8 (15) |
1
Fisher exact test p<0.05 (Drug depot/floater: p=0.0001; Study injection, pts: p=0.0023; Study injection, all AEs: p=0.0005)
2
Does not include one case of sterile endophthalmitis event that occurred in a non-study eye that received antivascular endothelial growth factor therapy for neovascular AMD.
1
Fisher exact test p<0.05 (Non-ocular AEs: p=0.0101; Study eye AEs: p=0.0007; Severe AEs: p=0.0037)