Table 3.
Proportion of simulated trials declaring non-inferiority and superiority
| Scenario | Strata | Non-inferiority | Superiority | ||||
|---|---|---|---|---|---|---|---|
| Backbone | Adjunctive | EOS | Backbone | Adjunctive | EOS | ||
| 1 | MSSA | 0.02 | – | 0.07 | 0.00 | 0.07 | – |
| PSSA | 0.06 | – | 0.03 | 0.01 | 0.07 | – | |
| MRSA | – | – | 0.04 | 0.01 | 0.07 | – | |
| 2 | MSSA | 0.99 | – | 0.95 | 0.77 | 0.93 | – |
| PSSA | 0.61 | – | 0.78 | 0.29 | 0.93 | – | |
| MRSA | – | – | 0.84 | 0.46 | 0.93 | – | |
Scenario 1 corresponds to an ‘all null’ scenario (odds ratio for non-inferiority: 1.2; odds ratio for superiority: 1.0); scenario 2 corresponds to ‘moderate effect’ scenario (odds ratio: 0.75 for all hypotheses)
EOS, early oral switch; MSSA, methicillin-susceptible S. aureus; PSSA, penicillin-susceptible S. aureus.; MRSA, methicillin-resistant S. aureus