Infection-related adverse events observed during treatment with eculizumab in SHEPHERD and in placebo-treated patients from TRIUMPH
| . | Patients, no. (%) . | |||
|---|---|---|---|---|
| SHEPHERD eculizumab . | TRIUMPH* placebo (n = 44) . | |||
| 52 wk, n = 97 . | 1st 26 wk, n = 97 . | 2nd 26 wk, n = 96 . | 26 wk . | |
| Patients experiencing infection | ||||
| 1 or more infections | 89 (91.8) | 73 (75.3) | 68 (70.8) | (77.3) |
| 1 infection | 15 (15.5) | 33 (34.0) | 34 (35.4) | (29.5) |
| 2 infections | 32 (33.0) | 23 (23.7) | 19 (19.8) | (20.5) |
| 3 or more infections | 42 (43.3) | 17 (17.5) | 15 (15.6) | (27.3) |
| 1 or more serious infections | 6 (6.2) | 2 (2.1) | 5 (5.2) | (11.4) |
| Total no. of infections | 277 | 151 | 126 | 82 |
| Infections by severity | ||||
| Mild | 207 (74.7) | 113 (74.8) | 94 (74.6) | (74.4) |
| Moderate | 67 (24.2) | 37 (24.5) | 30 (23.8) | (22.0) |
| Severe | 3 (1.1) | 1 (0.7) | 2 (1.6) | (3.7) |
| Infections by relatedness | ||||
| Unrelated | 253 (91.3) | 141 (93.4) | 112 (88.9) | (97.6) |
| Possibly | 23 (8.3) | 10 (6.6) | 13 (10.3) | (2.4) |
| Probably | 1 (0.4) | 0 | 1 (0.8) | (0.0) |
| Definitely | 0 | 0 | 0 | (0.0) |
| . | Patients, no. (%) . | |||
|---|---|---|---|---|
| SHEPHERD eculizumab . | TRIUMPH* placebo (n = 44) . | |||
| 52 wk, n = 97 . | 1st 26 wk, n = 97 . | 2nd 26 wk, n = 96 . | 26 wk . | |
| Patients experiencing infection | ||||
| 1 or more infections | 89 (91.8) | 73 (75.3) | 68 (70.8) | (77.3) |
| 1 infection | 15 (15.5) | 33 (34.0) | 34 (35.4) | (29.5) |
| 2 infections | 32 (33.0) | 23 (23.7) | 19 (19.8) | (20.5) |
| 3 or more infections | 42 (43.3) | 17 (17.5) | 15 (15.6) | (27.3) |
| 1 or more serious infections | 6 (6.2) | 2 (2.1) | 5 (5.2) | (11.4) |
| Total no. of infections | 277 | 151 | 126 | 82 |
| Infections by severity | ||||
| Mild | 207 (74.7) | 113 (74.8) | 94 (74.6) | (74.4) |
| Moderate | 67 (24.2) | 37 (24.5) | 30 (23.8) | (22.0) |
| Severe | 3 (1.1) | 1 (0.7) | 2 (1.6) | (3.7) |
| Infections by relatedness | ||||
| Unrelated | 253 (91.3) | 141 (93.4) | 112 (88.9) | (97.6) |
| Possibly | 23 (8.3) | 10 (6.6) | 13 (10.3) | (2.4) |
| Probably | 1 (0.4) | 0 | 1 (0.8) | (0.0) |
| Definitely | 0 | 0 | 0 | (0.0) |
TRIUMPH was a phase 3, double-blind, international, placebo-controlled study of eculizumab treatment in patients with PNH.7 The inclusion criteria for TRIUMPH were different from that of SHEPHERD. Only the most severe infection per patient is counted for each time period.