mega.nz/file/yRgyQZzZ#β¦
these are all the BNT162-01 related .xpt files as .csv, the C4591001 file is too big to open in excel π 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 followupπ€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 filesπ€
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 πͺπͺ #stoptheshots#readthefiles
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Study BNT162-01 dosed its first patient on April 23rd.
On April 29th, BioNTech reported that the first cohort had been dosed, implying 12 pts per candidate.
This is not factual. The first BNT162b2 patient in Cohort 1 was dosed on 15th June. >>
C4591001 dosed its first patient April 29th.
The first two doses of BNT162b2 were administered on June 8th.
So the first 1.5 months of clinical trials were spent testing BNT162a1, -b1, and -c2. >>
Looking at the BNT162-01 protocol, BNT162c1 (saRNA encoding only the RBD of S protein) was replaced by BNT162c2 (saRNA encoding full 2P-spike) prior to any patients being dosed.
Did the same happen with BNT162b1/b2, just a little bit later on? >>
" Listing of Subjects Withdrawn From the Study" phmpt.org/wp-content/uplβ¦
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
casually scrolling through this months phmpt.org pfizer pfraud pfiles, and what dost mine eyes behold! famotidine and ivermectine are covid-19 therapeutics in a clinical trial setting, whatever the fuck that means. is the #gtmp not given in a trial setting? fuckers
phmpt.org/wp-content/uplβ¦
19/334 good to know it wasn't just bnt162b2 being tested in the clinical trials. somehow that fact rarely finds mention. and yeah, stabilising the cleavage site is gonna enhance "immunogenicity" aka damage.
was there evidence of "non-vaccine-related" disease enhancement or fertility/fetal dev/postnatal dev, though?
some interesting details on the april 2020 german human dose finding study