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Table 2 Results of the 18 non-inferiority studies

From: Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance

  Δ Maximum difference % (hypothesis) δ (%)* UBCI§ of δ (%) Non-inferiority D-value (type of analysis) Superiority P-value (ITT) Abstract authors' conclusion as compared with active-control for primary endpoint
CNAAB3005 12 (E) 7.3 14.3 0.17 (OT) 0.90 Was equivalent to
NEFA 13.5 (NI)      
(a)   3.9 9.8 < 0.001 (ITT) 0.20 No conclusion
(b)   8.5 15.8 0.14 (OT) 0.035 A trend toward higher rate of [failure]
BEST 15 (NI) 15.7 (ITT) 25.9 (ITT) 1.0 (ITT) 0.003 Superiority of control in ITT
   0.7 (OT) 7.2 (OT) < 0.001 (OT) 1.0 (OT) Non-inferiority in OT
2NN 10 (E)      
(a)   5.9 14.0 0.36 (ITT) 0.15 Showed similar efficacy
(b)   7.7 14.6 0.56 (OT) 0.091** Showed similar efficacy
(c)   15.4 23.6 0.24 (ITT) 0.0003 Did not show efficacy
903 10 (NI) 4.1 10.3 0.07 (ITT) 0.19 Highly effective and comparable***
SOLO 12 (NI) -1.0 6.1 < 0.001 (ITT) 0.78 Provided durable [efficacy]
FTC-303 15 (NI) 5.0 12.9 < 0.01 (ITT) 0.234 Was equivalent to
EPV20001 12 (E) -0.1 3.6 < 0.001 (OT) 0.81 Regimens were equivalent
ALIZE 15 (NI*) -2.9 3.6 < 0.001 (ITT) 0.39 Associated with sustained [efficacy]
CNA30024 12 (NI) -0.8 -6.3 < 0.001 (ITT) 0.82 Not inferior to
BMS-2004 10 (NI) 3.9 9.7 0.043 (OT) 0.16 As efficacious as
ESS40013 12 (NI) 6.1 13.5 0.09 (OT) 0.77 Maintained [efficacy]
SEAL 12 (NI*) -1.5 4.3 < 0.001 (ITT) 0.61 Not inferior to
BMS-045 NA (NI)      
(a)   8.0*** 20.4*** NA (ITT) 0.21 As effective as
(b)   19.5*** 32.2*** NA (ITT) 0.003 Efficacy was lower than
CNA30021 12 (NI) 2.2 6.6 < 0.001 (OT) 0.61 Not inferior to
CONTEXT NA (NI)      
(a)   14.0*** 28.0*** NA (OT) 0.07 Not shown to be as effective as
(b)   10.0*** 23.0*** NA (ITT) 0.30 Not shown to be as effective as
SHAART 15 (NI) 2.1 17.4 0.13 (ITT) 0.784 Not inferior to
934 13 (NI) -3.5 0.5 < 0.001 (OT) < 0.005 Fulfilled criteria for non-inferiority and proved superior
  1. § Bold UBCI exceeded the pre-specified non-inferiority margin
  2. *A positive δ corresponds to a higher efficacy of the active-control group, as compared with the experimental group. We choose the OT or ITT in a worst case basis, unless the authors reached separate conclusions for OT and ITT. The numbers may differ from original reports because original reports were stratum-adjusted or used 90% confidence interval.
  3. ** If patients who never started treatment were excluded, P = 0.03
  4. ***Based on secondary endpoints
  5. Abbreviations: δ : Observed difference between the % of success observed in the control arm minus the % of success observed in the experimental arm ; UBCI : upper bound of the 95% confidence interval; E: equivalence; NI: non-inferiority