Treatment-emergent adverse events occurring in 10% or more of patients treated with eculizumab in SHEPHERD and in placebo-treated patients from TRIUMPH
| Adverse event . | Patients, no. (%) . | |||
|---|---|---|---|---|
| SHEPHERD eculizumab . | TRIUMPH* placebo . | |||
| 52 wk, n = 97 . | 1st 26 wk, n = 97 . | 2nd 26 wk, n = 96 . | 26 wk, n = 44 . | |
| Headache | 51 (52.6) | 47 (48.5) | 14 (14.6) | (27.3) |
| Nasopharyngitis | 31 (32.0) | 22 (22.7) | 15 (15.6) | (18.2) |
| Upper respiratory tract infection | 29 (29.9) | 14 (14.4) | 18 (18.8) | (22.7) |
| Nausea | 20 (20.6) | 16 (16.5) | 7 (7.3) | (11.4) |
| Pyrexia | 19 (19.6) | 11 (11.3) | 10 (10.4) | (4.5) |
| Back pain | 15 (15.5) | 7 (7.2) | 9 (9.4) | (9.1) |
| Dizziness | 14 (14.4) | 10 (10.3) | 6 (6.3) | (11.4) |
| Urinary tract infection | 13 (13.4) | 7 (7.2) | 7 (7.3) | (9.1) |
| Arthralgia | 12 (12.4) | 10 (10.3) | 2 (2.1) | (11.4) |
| Diarrhea | 12 (12.4) | 8 (8.2) | 6 (6.3) | (11.4) |
| Abdominal pain | 11 (11.3) | 9 (9.3) | 2 (2.1) | (11.4) |
| Myalgia | 10 (10.3) | 9 (9.3) | 3 (3.1) | (2.3) |
| Vomiting | 10 (10.3) | 8 (8.2) | 4 (4.2) | (11.4) |
| Adverse event . | Patients, no. (%) . | |||
|---|---|---|---|---|
| SHEPHERD eculizumab . | TRIUMPH* placebo . | |||
| 52 wk, n = 97 . | 1st 26 wk, n = 97 . | 2nd 26 wk, n = 96 . | 26 wk, n = 44 . | |
| Headache | 51 (52.6) | 47 (48.5) | 14 (14.6) | (27.3) |
| Nasopharyngitis | 31 (32.0) | 22 (22.7) | 15 (15.6) | (18.2) |
| Upper respiratory tract infection | 29 (29.9) | 14 (14.4) | 18 (18.8) | (22.7) |
| Nausea | 20 (20.6) | 16 (16.5) | 7 (7.3) | (11.4) |
| Pyrexia | 19 (19.6) | 11 (11.3) | 10 (10.4) | (4.5) |
| Back pain | 15 (15.5) | 7 (7.2) | 9 (9.4) | (9.1) |
| Dizziness | 14 (14.4) | 10 (10.3) | 6 (6.3) | (11.4) |
| Urinary tract infection | 13 (13.4) | 7 (7.2) | 7 (7.3) | (9.1) |
| Arthralgia | 12 (12.4) | 10 (10.3) | 2 (2.1) | (11.4) |
| Diarrhea | 12 (12.4) | 8 (8.2) | 6 (6.3) | (11.4) |
| Abdominal pain | 11 (11.3) | 9 (9.3) | 2 (2.1) | (11.4) |
| Myalgia | 10 (10.3) | 9 (9.3) | 3 (3.1) | (2.3) |
| Vomiting | 10 (10.3) | 8 (8.2) | 4 (4.2) | (11.4) |
TRIUMPH was a phase 3, double-blind, placebo-controlled, international study of eculizumab treatment in patients with PNH.7 The inclusion criteria for TRIUMPH were different from that of SHEPHERD.