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Posted On: 07/21/2020 9:21:07 AM
Post# of 145880
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Re: mountaineer #44151
Let the seller beware!
The SP will drop in the opening minutes because people don't understand the PR...irritation and confusion at the apparent error in the subhead and not understanding that the much higher SAE event count for the placebo group likely translates into leronlimab crushing the primary endpoint.
The number of patients with SAEs (5/56 for leronlimab vs 6/28 for placebo) is marginally non-significant (p-value approx 0.06 for one-sided test), but the total number of SAEs for the placebo group was 11 vs 8 for leronlimab because some patients were apparently double dipping in SAEs, which include hospitalizations and other interventions that correlate strongly with the clinical score in the primary outcome. Also, CCR5 occupancy is not complete until about day 7, so adverse events in the first few days are registered as "adverse events" but they would have time to resolve themselves (or at least separate from the placebo arm) by day 14. The p-value for the primary outcome is likely to be substantially lower than the 0.06 for the SAEs.
The SP will drop in the opening minutes because people don't understand the PR...irritation and confusion at the apparent error in the subhead and not understanding that the much higher SAE event count for the placebo group likely translates into leronlimab crushing the primary endpoint.
The number of patients with SAEs (5/56 for leronlimab vs 6/28 for placebo) is marginally non-significant (p-value approx 0.06 for one-sided test), but the total number of SAEs for the placebo group was 11 vs 8 for leronlimab because some patients were apparently double dipping in SAEs, which include hospitalizations and other interventions that correlate strongly with the clinical score in the primary outcome. Also, CCR5 occupancy is not complete until about day 7, so adverse events in the first few days are registered as "adverse events" but they would have time to resolve themselves (or at least separate from the placebo arm) by day 14. The p-value for the primary outcome is likely to be substantially lower than the 0.06 for the SAEs.
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