a brief outline of the Nov 1 PHMPT release.

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) Image
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. ImageImageImage
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? ImageImageImage
-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. ImageImageImage
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 Image
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 Image
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 Image
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. Image
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🤔 Image
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: ImageImage
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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More from @a_nineties

Jul 2
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
🚨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
page 12: and the reason we gotta boost is becaaaauuuuussseee boosties had more covid than un-boosties. what? Image
Read 7 tweets
Apr 2
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
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
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:
Image
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
Mar 6
just gonna give some thoughts on the hypervax paper from a kraut healthcare worker perspective. HIM is "overall healthy (no chronic medications)", yet received regular blood draws from november 2019 onwards 🤔that's not how it works, labs come out of the budget Image
the single most frequent measurement is creatinine with 23 measurements, next ist small haemogram (blutbild) with 20, then total protein and urea with 19 each. most likely being treated by a nephrologist or a hausarzt (gp) for kidney issues.
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the total number of measurements is striking: the study "only" drew blood 13 times, between august 2022 and october 2023, leaving ten blood draws between nov 2019 and july 2022. i reckon these ten blood draws were bunched towards the beginning and then once per quarter-year. Image
Read 12 tweets

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