mega.nz/file/yRgyQZzZ#…
these are all the BNT162-01 related .xpt files as .csv, the C4591001 file is too big to open in excel 😅 and you don't need me for the .pdf (i hope)
first file is -suppex.csv. it seems to be a protocol checklist, with six rows per patient except if there was a protocol deviation. includes medication nr's. the screenshots show the only two deviations recorded in this file.
which brings us to -suppec.csv
at a glance, it looks identical to -suppex.csv, but it isn't. while it also lists the two deviations shown above, it also lists a few more. in -suppex.csv, 1-dose patients only have three rows, -suppec.csv just provides add. info?
-suppds.csv is next. this seems to list patients by their cohort, group, and protocol version at time of enrollment.
group B is BNT162b1, group C is BNT162b2. So what's group A? will x-ref with the protocol amendments. not sure this has all Pts, will check.
next is suppcm.csv
this lists ATC codes (Anatomical Therapeutical Chemical) for patients that received medication (presumably due to AEs?). will be digging deeper into this one and x-ref'ing with my AE file
next is -suppae.csv
this seems to be a classification file for AEs. each AE has three rows, very rarely is there a "Y" under "Dose limiting toxicity". might be interesting to compare with the actual AEs
next is S-D-se.csv
seems to be a timeline per patient listing intervals between screening, pre-dose assessment, vax dates, and followup.
lots of patients with "NA" under followup🤔some patients don't even have a fifth "FUP" row. will look at prev files if theres smthg to x-ref
next is S-D-pe.csv
this is a list of medical assessments of different parts of the body per patient per visit(>20 rows/pt). very peculiar as many patients who had AEs get a clean sheet in this file. another one to x-ref with the AE listings.
last BNT162-01 file in this batch is S-D-ce.csv
this seems to be another AE list by type, time of onset, prime/boost related, and systemic or injection site related. at first glance there seems to be more AEs listed than made it into the other AE files🤔
pdata0916.s3.us-east-2.amazonaws.com/pdocs/110122/1…
the possibly juiciest item in this drop however is this rat fertility/teratogenicity study from june-oct 2020, which has a lot of very questionable results:
so that's it for the brief overview! looking forward to digging into this batch in greater detail, but now i'm off to work 💪💪 #stoptheshots#readthefiles
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#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/
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.
13.2. ergebnisprotokoll - asymptomatische sollen nicht getestet werden?
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.
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…
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
🚨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…
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 😵💫
page 12: and the reason we gotta boost is becaaaauuuuussseee boosties had more covid than un-boosties. what?
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
ADSYMPT - covid signs and symptoms
ADAE - adverse events
these are the symptoms that can lead to a "covid illness visit" except for 7 days after each dose.
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.
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:
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…
the US CTR entry for c4591007 lists spanish sites, yet the EU CTR only has finland and poland 🤔