Thromboembolism events in patients with and without eculizumab
| TE events . | Pilot* . | TRIUMPH . | SHEPHERD . | Extension† (all studies) . | |
|---|---|---|---|---|---|
| Placebo group . | Eculizumab group . | ||||
| Before treatment | |||||
| Patients, no. | 11 | 44 | 43 | 97 | 195 |
| TE events, no. | 5 | 11 | 16 | 91 | 124 |
| Patient-years, no. | 161.7 | 470.4 | 309.0 | 718.3 | 1683.4 |
| TE event rate, no. per 100 patient-years | 3.09 | 2.34 | 5.18 | 12.67 | 7.37 |
| Eculizumab treatment‡ | |||||
| Patients, no. | 11 | 44 | 43 | 97 | 195 |
| TE events, no. | 0 | 1 | 0 | 2 | 3§ |
| Patient-years, no. | 34.2 | 22.9 | 21.8 | 96.9 | 281.0 |
| TE event rate, no. per 100 patient-years | 0.00 | 4.38 | 0.00 | 2.06 | 1.07‖ |
| TE events . | Pilot* . | TRIUMPH . | SHEPHERD . | Extension† (all studies) . | |
|---|---|---|---|---|---|
| Placebo group . | Eculizumab group . | ||||
| Before treatment | |||||
| Patients, no. | 11 | 44 | 43 | 97 | 195 |
| TE events, no. | 5 | 11 | 16 | 91 | 124 |
| Patient-years, no. | 161.7 | 470.4 | 309.0 | 718.3 | 1683.4 |
| TE event rate, no. per 100 patient-years | 3.09 | 2.34 | 5.18 | 12.67 | 7.37 |
| Eculizumab treatment‡ | |||||
| Patients, no. | 11 | 44 | 43 | 97 | 195 |
| TE events, no. | 0 | 1 | 0 | 2 | 3§ |
| Patient-years, no. | 34.2 | 22.9 | 21.8 | 96.9 | 281.0 |
| TE event rate, no. per 100 patient-years | 0.00 | 4.38 | 0.00 | 2.06 | 1.07‖ |
Includes a 1-year and a 2-year extension study.
Includes TRIUMPH placebo-treated patients who transitioned to eculizumab treatment in the phase 3 extension study.
Three of 195 patients began anticoagulant treatment during eculizumab, 2 of whom started the treatment after a TE event.
The 3 TE events occurring during eculizumab treatment included 2 events during SHEPHERD and 1 event during the extension.
P < .001 for comparisons of eculizumab treatment versus before treatment, signed rank test.