Table 5.
Time to recovery as defined by improvement to a score of 1 or less on the WHO Ordinal Scale for Clinical Improvement in the mITT population.
| Parameter | Opaganib (N = 230) | Placebo (N = 233) |
|---|---|---|
| Time to recovery as defined by improvement to a score of 1 or less on the WHO Ordinal Scale for Clinical Improvement, up to 14 days | ||
| Number of events (%) | 86 (37.4) | 65 (27.9) |
| Number of censored observations (%) | 144 (62.6) | 168 (72.1) |
| Log-rank test statistic 1 | 14.89 | |
| p-value 1 | 0.013 | |
| Hazard ratio (HR) and 95% CI 2 | 1.49 (1.08–2.05) | |
| Kaplan–Meier median estimate and 95% CI 3 | NA (NA–NA) | NA (NA–NA) |
| Cumulative incidence, % 3 | ||
| Day 7 | 12.61 | 7.30 |
| Day 14 | 37.39 | 27.90 |
CI = confidence interval; HR = hazard ratio; NA = not achieved. 1 Analysis statistics were estimated using a log-rank test stratified by study stratification factors used for randomization. A negative (positive) statistic is associated with longer (shorter) time to the event. 2 Estimates and confidence intervals were obtained from the Cox proportional hazards regression model with treatment group as an explanatory variable and stratification factors as covariates. 3 Estimated using the Kaplan–Meier estimator. NA = Not applicable due to fewer than 50% of the group having reached the necessary event.