Table 1.
Analysis of noninferiority in published noninferiority trials
| Trial | Treated condition | Test drug | Comparator | Outcome for noninferiority analysis | Noninferiority margin (and corresponding preserved fraction) | Method of analysis |
|---|---|---|---|---|---|---|
| SAVE‐ABDO 24 | Thromboprophylaxis in patients with major abdominal surgery | Semuloparin (postoperatively) | Enoxaparin (preoperatively) | Composite endpoint of deep vein thrombosis, nonfatal pulmonary embolism, or all‐cause mortality | OR 1.25 (85%) | Fixed‐margin method |
| Natale et al. 25 | Advanced nonsmall‐cell lung cancer | Vandetanib | Erlotinib | Progression‐free survival (PFS), overall survival (OR) | PFS 1.25 (50%) | Synthesis method |
| OR 1.17 (50%) | ||||||
| Carbonell‐Estrany et al. 26 | Prophylaxis of respiratory syncytial virus (RSV) | Motavizumab | Palivizumab | RSV hospitalization | RR 1.265 (50%) | Point‐estimate method |
| RE‐COVER 27 | Acute venous thromboembolism | Dabigatran | Warfarin | Incidence of recurrent symptomatic, objectively confirmed venous thromboembolism, and related deaths | HR 2.75 (57%) | Fixed‐margin method |
| RD 3.6% (75%) | ||||||
| PEARL 3 Ext 28 | Chronic schizophrenia | Lurasidone | Quetiapine | Time‐to‐relapse of psychotic symptoms | HR 1.93 (50%) | Point‐estimate method |
Hazard ratio, HR; relative risk, RR.