Ill give it a go Shelly. SAE is essentually a b
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Posted On: 07/22/2020 5:49:14 PM
Re: Shelly2626 #44608
Ill give it a go Shelly.
SAE is essentually a broad metric. If a patient in the placebo group for example progressed from Moderate to severe, this would be tallied as 1 SAE.
With respect to the primary end point, we would glean more data from the scoring system. So that same patient may have progressed from a starting score of 4 (for simplicity 1 in each of the 4 categories) to a score of say 8 (2 in each category).
This creates an more meaningful impact on the statistic probability due to the dept of the data.
NOW THE IMPORTANT PART
Conversely if a patient in leronlimab moved from a score of 4, to a score of 0 in 14 days, this wouldnt even register in the safety data, but is very meaningful to the clinical data and the primary endpoint.
CONCLUSION
This creates, IMO, an opportunity for the clinical data to be substantially more meaningful than the safety data (which already shows a substantial improvement over placebo). IMO it is highly unlikely that the intricate clinical data will show less improvement, but actually will show profoundly more improvement than the simple safety data.
SAE is essentually a broad metric. If a patient in the placebo group for example progressed from Moderate to severe, this would be tallied as 1 SAE.
With respect to the primary end point, we would glean more data from the scoring system. So that same patient may have progressed from a starting score of 4 (for simplicity 1 in each of the 4 categories) to a score of say 8 (2 in each category).
This creates an more meaningful impact on the statistic probability due to the dept of the data.
NOW THE IMPORTANT PART
Conversely if a patient in leronlimab moved from a score of 4, to a score of 0 in 14 days, this wouldnt even register in the safety data, but is very meaningful to the clinical data and the primary endpoint.
CONCLUSION
This creates, IMO, an opportunity for the clinical data to be substantially more meaningful than the safety data (which already shows a substantial improvement over placebo). IMO it is highly unlikely that the intricate clinical data will show less improvement, but actually will show profoundly more improvement than the simple safety data.
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