Table 2.
Safety and efficacy outcomes
| Lower-dose osocimab (n = 232) | Higher-dose osocimab (n = 224) | Placebo (n = 230) | |
|---|---|---|---|
| Clinically relevant bleeding (primary outcome) | |||
| n (%) | 16 (6.9) | 11 (4.9) | 18 (7.8) |
| Events (90% CI) per 100 patient-years | 9.7 (6.1–14.1) | 6.7 (3.7–10.3) | 10.8 (7.0–15.3) |
| Composite of moderate, severe or serious adverse events (primary outcome) | |||
| n (%) | 118 (50.9) | 106 (47.3) | 99 (43.0) |
| Major bleeding | |||
| n (%) | 3 (1.3) | 2 (0.9) | 7 (3.0) |
| Events (90% CI) per 100 patient-years | 1.8 (0.5–3.8) | 1.2 (0.2–2.9) | 4.2 (2.0–7.1) |
| Clinically relevant nonmajor bleeding | |||
| n (%) | 13 (5.6) | 9 (4.0) | 11 (4.8) |
| Events (90% CI) per 100 patient-years | 7.9 (4.7–11.8) | 5.5 (2.9–8.8) | 6.6 (3.7–10.2) |
| Types of major bleeding, n (%) | |||
| Gastrointestinal | 1 (0.4) | 0 | 1 (0.4) |
| Urogenital (kidney or bladder) | 0 | 0 | 2 (0.9) |
| Intracranial | 0 | 0 | 1 (0.4) |
| Eye (intraocular or retinal) | 1 (0.4) | 0 | 2 (0.9) |
| Skin (any vascular access site) | 0 | 2 (0.9) | 0 |
| Respiratory (pulmonary) | 1 (0.4) | 0 | 0 |
| Procedural | 0 | 0 | 1 (0.4) |
| Types of clinically relevant nonmajor bleeding, n (%) | |||
| Gastrointestinal | 1 (0.4) | 1 (0.4) | 0 |
| Epistaxis | 2 (0.9) | 1 (0.4) | 2 (0.9) |
| Urogenital | 3 (1.3) | 2 (0.9) | 1 (0.4) |
| Skin | 4 (1.7) | 2 (0.9) | 2 (0.9) |
| Vascular access site | 2 (0.9) | 4 (1.8) | 6 (2.6) |
| Conjunctival | 1 (0.4) | 0 | 0 |
| Major adverse vascular eventsa | |||
| n (%) | 3 (1.3) | 6 (2.7) | 7 (3.0) |
| Events (90% CI) per 100 patient-years | 1.7 (0.5–3.7) | 3.6 (1.6–6.3) | 4.1 (1.9–6.9) |
| Type of event, n (%) | |||
| Myocardial infarction | 2 (0.9) | 4 (1.8) | 4 (1.7) |
| Ischemic stroke | 1 (0.4) | 1 (0.4) | 2 (0.9) |
| Major amputation | 0 | 0 | 1 (0.4) |
| Systemic embolism | 0 | 1 (0.4) | 0 |
| Atherosclerotic subgroupa | |||
| n/n (%) | 2/81 (2.5) | 2/86 (2.3) | 6/82 (7.3) |
| Events (90% CI) per 100 patient-years | 3.7 (0.7–8.7) | 3.3 (0.6–7.8) | 11.0 (4.8–19.2) |
| Dialysis circuit clotting, n (%) | |||
| Score of 2 or 3 | 68 (29.3) | 61 (27.2) | 95 (41.3) |
| Score of 3 | 4 (1.7) | 4 (1.8) | 10 (4.3) |
| Access thrombosis, n (%) | 6 (2.6) | 8 (3.6) | 11 (4.8) |
| Serious adverse events, n (%) | |||
| Serious adverse event | 70 (30.2) | 64 (28.6) | 63 (27.4) |
| Serious adverse event leading to discontinuation of study drug | 8 (3.4) | 10 (4.5) | 13 (5.7) |
| All-cause death | |||
| n (%) | 12 (5.2%) | 9 (4.0%) | 11 (4.8%) |
| Events (90% CI) per 100 patient-years | 7.0 (4.0–10.6) | 5.4 (2.8–8.6) | 6.4 (3.6–9.8) |
| Injection-site reactions, n (%) | 14 (6.0) | 17 (7.6) | 1 (0.4) |
Incidences are reported by the number of participants having the specific event up to 30 days after the end of study treatment for that individual.
aVascular death (due to myocardial infarction, stroke, pulmonary or systemic embolism), nonfatal myocardial infarction or stroke, major amputation for vascular etiology, acute limb ischemia and symptomatic venous thromboembolism or incidence of thrombosis of arteriovenous fistulas or grafts.