Based on past history, a pessimistic (but perhaps
Post# of 154867
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Posted On: 01/05/2022 12:13:23 PM
Quote:
Based on past history, a pessimistic (but perhaps realistic) take is that 700 mg did *not* meet the primary endpoint
Statistical significance goes to how likely the results are to be true. The more patients the easier it is to hit stat sig. That we hit stat sig in per protocol population with such a small population in both endpoints is supportive of it working.
Why didn't it hit ct1 in intention to treat? Per patient protocol is all patients that were treated as specified by the protocol, intention to treat is all patients that were randomized but either were not treated, withdrew from the trial or did not have follow up analysis. In a large trial it would be expected that the percentage difference between PPP and ITT would be very small and not affect the outcome unduly. In a small trial even one patient could be a large percentage of the total population and could affect the outcome greatly either way. So in small trials the PPP outcome is more likely to reflect real results.
Why no 700mg results yet? The simplest answer is they are still doing analysis. Analysis of the placebo side may have been done first rather than concurrently with the 700mg arm.
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