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misiu143

07/21/20 3:46 PM

#96757 RE: bobshmob #96755

You are right thank you , I made a mistake , it should be 5 patients not 5 SAE , since some patients had more then one adverse event.

Thank you.
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misiu143

07/21/20 3:47 PM

#96759 RE: bobshmob #96755

Bobshmob , ---

Thank you.
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CYDYWinning

07/21/20 3:54 PM

#96763 RE: bobshmob #96755

Would you consider this a strong P value ?
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KobeF

07/21/20 4:01 PM

#96771 RE: bobshmob #96755

Oh Shix. So p=0.06 > 0.05!!!! Statistically Insignificant?!?!
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JMDB

07/21/20 4:02 PM

#96772 RE: bobshmob #96755

P=0.06?
P = ????
More than twice the SAE in the placebo arm as those receiving the drug. This does seem to be more effective, as well as more safe than Remdesivir which is still the SOC , correct?

And what about that steroid everyone lauded for a week..? Superior there as well no? In any case, these numbers absolutely merit consideration for combination therapy. And I think Severe/Critical numbers will be even better.

Question :
What is the Safety Committee event next week?
When do we expect interim analysis from the severe trial? Date of start after enrollment? 2 weeks after that should be interim and 4 weeks hence unblinding whole study, no?
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treedonkey24

07/21/20 4:04 PM

#96773 RE: bobshmob #96755

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Wealthnotriches

07/21/20 4:11 PM

#96779 RE: bobshmob #96755

Actually,

Placebo Arm, 28 patients:

6 patients reported a total of 11 SAE's, altogether


Drug Arm, 56 patients:

5 patients reported a total of 8 SAE's, altogether (none related to Leronlimab)


Obviously, some patients reported more than one SAE.

To reach equivalency between 28 patients vs. 56 patients, I suppose you could simply multiply the placebo arm numbers by a factor of 2 therefore, theorizing 12 patients in placebo arm reporting a total of 22 SAE's. .

The total of SAE's by the entire group=22 theoretical placebo plus 8 actual for drug = 30 total SAE's for both arms.

Then: Placebo = 22/30 or 73% Drug = 8/30 or 26%

So out of total SAE's the placebo group experienced 73% of total SAE's in the trial and Leronlimab group experienced 26% of the total reported SAE's. Thus, control arm experienced 2.8 times as many Serious Adverse Effects.

There's my creative analysis. We don't know how many of the SAE's were related to having Covid-19, and we'll find this out soon, I'm sure.