Table 2. Early Clinical Response for the Intent-to-Treat (ITT) Population and Investigator Assessment of Clinical Response at Test of Cure in Modified ITT and Clinically Evaluable Populations.
| End Points | No. (%) | Between-Group Difference, % (1-Sided 97.5% CI)a |
|
|---|---|---|---|
| Lefamulin | Moxifloxacin | ||
| US FDA Primary End Point | |||
| Early clinical response in ITT population, No. of patients | 370 | 368 | |
| Responder | 336 (90.8) | 334 (90.8) | 0.1 (–4.4 to ∞) |
| Nonresponder | 29 (7.8) | 31 (8.4) | |
| Indeterminate | 5 (1.4) | 3 (0.8) | |
| EMA Coprimary End Points and US FDA Secondary End Points | |||
| Investigator assessment of clinical response at test of cure in modified ITT population, No. of patients | 368 | 368 | |
| Success | 322 (87.5) | 328 (89.1) | –1.6 (–6.3 to ∞) |
| Failure | 44 (12.0) | 32 (8.7) | |
| Indeterminate | 2 (0.5) | 8 (2.2) | |
| Investigator assessment of clinical response at test of cure in clinically evaluable population, No. of patients | 330 | 326 | |
| Success | 296 (89.7) | 305 (93.6) | –3.9 (–8.2 to ∞) |
| Failure | 34 (10.3) | 21 (6.4) | |
Abbreviations: EMA, European Medicines Agency; FDA, Food and Drug Administration.
a
Calculated using a continuity-corrected z statistic for early clinical response and the Miettinen and Nurminen method with adjustment for the randomization stratification factors for investigator assessment of clinical response. The margin for noninferiority was –10%; a lower bound of the CI that did not exceed this margin indicated noninferiority for lefamulin vs moxifloxacin.