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Posted On: 03/30/2021 11:21:47 AM
Post# of 148902
I don’t understand the push back on the 14-day data.
Per the trial protocol:
Secondary Outcome Measures :
All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.
Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
We have been told that the Statistical Analysis Plan pre-specified a distinction between severe and critical patient subtypes. So the analysis of the above secondary endpoints in the critical subgroup is according to plan and cannot be labeled as post-hoc data mining.
Furthermore, I don’t understand how 14-day mortality is being perceived as not relevant. Saying most patients die after 14 days is what’s totally irrelevant to this discussion. This data announcement shows that quite a few patients expired by day 14 and that the leronlimab arm demonstrated statistically significant reduction in this metric. Period.
Per the trial protocol:
Secondary Outcome Measures :
All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.
Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
We have been told that the Statistical Analysis Plan pre-specified a distinction between severe and critical patient subtypes. So the analysis of the above secondary endpoints in the critical subgroup is according to plan and cannot be labeled as post-hoc data mining.
Furthermore, I don’t understand how 14-day mortality is being perceived as not relevant. Saying most patients die after 14 days is what’s totally irrelevant to this discussion. This data announcement shows that quite a few patients expired by day 14 and that the leronlimab arm demonstrated statistically significant reduction in this metric. Period.
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