" Listing of Subjects Withdrawn From the Study"
phmpt.org/wp-content/upl…
first two pages tell us that no patients of the phase 1 trial discontinued between doses. however, the 100ug data was not used in the calculations, despite the participants being boostered with a 10ug dose..
.., because the original 100ug dose had a shit safety profile! as for the first table, could it be referring to the bnt162b1 cohort, whose data also wasn't used?
so phase 2, the 180/180 group, only had one withdrawal? it appears so, see linked tweet#1
however, how did they manage so much better dose1+dose2 compliance compared to bnt162-01 b2 group and phase 3, as we're about to see?
here we go. all listed withdrawals phase 2/3 and open-label unblinded period, p 4/112! i'm scraping this manually to an excel file, see how long it takes
this poor person was discontinued for testing positive 21 days after their 2nd dose. wait what?? shouldnt that go into efficacy calcs??
a redacted exclusion criteria? intriguing
an hiv+ pregnancy 🤨😳😬the cross at the end of the pt# signifies hiv infection. 22 days after the jab... wonder how the baby's doing. and a screenshot of my excel autism
ALERT ALERT new disease CODIV-19 reported in argentina! #site1231
PAGING DR POLLACK, I REPEAT, PAGING DR POLLACK
YOUR PRESENCE IS REQUIRED IN THE HUMAN RESOURCES DEPARTMENT
you come up with that _after_ your jab? poor kid! also, #site1231 has the vast majority of pos+covid withdrawals 🤨🤨🤨🤨🤨🤨🤨🤨🤨
finding creative ways to beat ctrl-f. i'm wise to your tricks, fernando
was it perhaps... exclusion criterium #5, aka codiv-19? we may never know. wonderhow many more CRFs are in the pipeline
patient 1149 of site 1247, hope you're still alive, because i'm having some trouble believing someone would move without back notice one day after enrolling in a study.
i, too, would like to see the EOT page. what is an EOT page?
a clinical diagnosis of covid-19 ONE day after first dose. if they're specifying clinical, does that mean they didnt have a positive pcr? would love to see that CRF
refusing a swab after dozens of swabs, jabs, blood draws? #site4444 pt1224 would have been in the evaluable efficacy population. did 1224 refuse, or were they refused?
the only two withdrawals due to "travelling abroad" (in a pandemic) are two consecutive withdrawals from #site4444. for the coincidence theorists among us, thats a tough one to swallow.
done with the 18-55 age group. there were 117 covid-positive withdrawals across all sites.

53 of those occurred at #site1231, which we know enrolled 10% (4501 pts) of the total study pop.

what the hell are they gonna release next month?
no but it's totally fine to get two jabs at once!
"mr PI, why isn't patient 1141 returning his calls? should we call the emergency contact?"

"no!, no need, i talked to him, he's just had to move out of country, you know how it is..."
"withdrawal by subject due to ongoing medical issues" 33days after 2nd jab, yeah i'm gonna list that as an AE
inability to comply 30 days after the second jabberino 🤨
NoT rELaTeD tO tHe StUdY InTeRvEnTioN
more unrelated to the study intervention cardiovascular damage

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More from @a_nineties

Jul 24, 2024
#rkifiles ein inkohärenter strang mit entdeckungen aus dem leck. "nCoV hat eine zusätzliche multibasische furin-spaltstelle", zusatzmaterial 5.2.2020 🤔download hat für mich nur über diesen mirror geklappt: (h/t @DerCheapi ) dercheapi.de/files/rki/
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10.2.2020 zusatzmaterial, risikobewertung für DE. sehr interessant wie "anhaltende viruszirkulation" ausschlaggebender bestandteil der gefährdung gemacht wird und gleichzeitig der letzte kontaktmanagement-satz gestrichen wird. Image
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Read 199 tweets
Jul 2, 2024
wanna see something funny? final CSR for sanofi-moderna booster+flu jab study was released on EMA CDP. 3 groups with 100 patients each, 1) mrna 1273 50 ug + sanofi, 2) sanofi only 3) moderna only. all 60+, 90%+ 2020-2021 flu jab rate, inclusion criterium 2x moderna. Image
link didnt fit in the previous post, this is study QHD00028. so! of the six medically attended cases of covid, there were three in group 1 and three in group 3 and none in group 2😬imagine how salty bancel must have been, just imagine! mega.nz/folder/rBgl0Jy…

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this group dynamic remains remarkably constant throughout the safety reporting. i find the breakdown tables pretty interesting to look at given the split in group 1. also showcases neatly that pfizer-biontech are the only sponsors to have diarrhea as a solicited sytemic event

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Read 8 tweets
Jun 11, 2024
🚨FINAL MODERNA STUDY REPORT 🚨 uploaded on EMA CDP 30.5. 15k words with no end in sight into my pfizer CRF writeup, so im just gonna do a brief flyover of this 8500-page monstrosity. unlike AZ a few days ago, this is the pivotal phase 3 mega.nz/folder/nNAg3DZ…
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page 11: yeah so because incidence rates were similar in vaxed-months-ago and vaxed-just-now, there is duration of protection. but because BOTH groups got more covid later, gotta boost 😵‍💫 Image
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the very first goddamn email: daszak says baric is working on nanoparticles, and baric is asked about sars glycoproteins he's making for a DARPA grant and they're trying to get them into bats

from march 2018
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gonna read these closer tomorrow Image
jesus christ, "batized" mice, as in mice frankensteined into having a bats immune system? Image
Read 6 tweets
Mar 31, 2024
ADSYMPT - covid signs and symptoms
ADAE - adverse events
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these are the symptoms that can lead to a "covid illness visit" except for 7 days after each dose. Image
these are the scraped results from both files. some of the "signs and symptoms of disease" from ADSYMPT don't translate directly to ADAE MedDRA terminology, for example fever=pyrexia, sore throat=oropharyngeal pain. take a good long look at it and let me know if it makes sense. Image
Read 10 tweets
Mar 20, 2024
been looking at the latest pfizer puff piece. this is going to be a dump thread of links and files. both C4591031 and C4591007 are heavily represented on the EMA CDP portal. already did a thread on C4591031:
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firstly, c4591031 has results on the EU CTR. results have been updated three times by now 👀 this includes substudies A-E so it's REALLY really long. c4591007 only has a protocol posted clinicaltrialsregister.eu/ctr-search/tri…

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the US CTR entry for c4591007 lists spanish sites, yet the EU CTR only has finland and poland 🤔 Image
Read 61 tweets

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