Table 2:
Rates of Clinical Improvement
| Timepoint | Analysis Population |
Treatment Group | Rate of Clinical Improvement, n [%, (95% CI)] |
Difference in Rates, % (95% CI) |
Non- inferior1 |
|---|---|---|---|---|---|
| Day 5 | |||||
| ITT-5 | Azithromycin (N=249) | 155 [69, (61, 77)] | −6 (−15,2) | No | |
| Placebo (N=250) | 148 [63, (54, 71)] | ||||
| ATP-5 | Azithromycin (N=204) | 136 [70, (62, 79)] | −5 (−14,4) | No | |
| Placebo (N=221) | 136 [65, (57, 74)] | ||||
| Day 11 | |||||
| ITT-11 | Azithromycin (N=249) | 187 [81, (74, 87)] | −4 (−12,3) | Yes | |
| Placebo (N=250) | 184 [76, (70, 83)] | ||||
| ATP-11 | Azithromycin (N=211) | 174 [80, (73, 87)] | −4 (−11,4) | Yes | |
| Placebo (N=225) | 177 [77, (70, 83)] | ||||
| Day 28 | |||||
| ITT-28 | Azithromycin (N=249) | 202 [88, (83, 93)] | −7 (−13,0) | No | |
| Placebo (N=250) | 194 [82, (77, 86)] | ||||
| ATP-28 | Azithromycin (N=210) | 185 [88, (83, 93)] | −6 (−12,1) | Yes | |
| Placebo (N=223) | 184 [82, (77, 87)] | ||||
ITT = Intention to treat. ATP = According to protocol. n = Number of subjects with clinical improvement.
1
Non-inferiority of placebo is concluded if the lower bound of the 95% CI for the difference in proportions is greater in below −12·5%.