Pfizer vidste allerede 28. februar 2021,
at vi ville se et massivt antal bivirkninger og dødsfald,
helt specifikt 42.086 rapporter indeholdende
158.893 hændelser(herunder 1223 dødsfald).

FDA har frigivet den første omgang af dokumenter, som de har gennemgået, inden de licenserede Pfizers "vaccine". Efter at en gruppe på mere end 30 professorer og videnskabsmænd fra universiteter, herunder Yale, Harvard, UCLA og Brown, anlagde sag i september

FDA har produceret de første 91+ sider med dokumenter fra Pfizers COVID-19-vaccinefil, og foreslår en gradvis udgivelse på 500 sider om måneden indtil færdiggørelsen af udgivelsen i år 2076.

Et af de fremlagte dokumenter er en kumulativ analyse af rapporter om uønskede hændelser efter autorisation modtaget til og med 28. februar 2021, to en halv måned efter, at vaccinen modtog nødgodkendelse. Dette dokument afspejler uønskede bivirkninger efter "vaccination", både i og uden for USA, frem til den 28. februar 2021.

Pfizer forklarer på side 6, at "På grund af det store antal spontane bivirkninger, der er modtaget for produktet, har Pfizer prioriteret behandlingen af alvorlige sager...", og at Pfizer "også har truffet flere handlinger for at hjælpe med at afhjælpe den store stigning i rapporter om uønskede bivirkninger", herunder "øgning af antallet af dataindtastning og sagsbehandlingskolleger" og "har indsat ca. [antal fjernet fra dokumenet] yderligere fuldtidsansatte."

Hvad angår mængden af indrapporterede bivirkningr, modtog Pfizer i de 2½ måned efter deres nødgodkendelse i alt 42.086 rapporter indeholdende 158.893 hændelser (herunder . De fleste af disse rapporter var fra USA og uforholdsmæssigt involverede kvinder (29.914 mod 9.182 leveret af mænd) og dem mellem 31 og 50 år (13.886 mod 21.325 for alle andre aldersgrupper tilsammen, med yderligere 6.876, hvis alder var ukendt). 25.957 af hændelserne blev klassificeret som "nervesystemlidelser"

Fuld download af dokumenterne

pd-production-111721


5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf
5.2-tabular-listing.pdf
5.3.6-postmarketing-experience.pdf
BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt
BATES-93_tv.xpt

pd-production-120121


Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdf
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdf

pd-production-121321


BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt
BATES-FDA-CBER-2021-5683-0002376_relrec.xpt
BATES-FDA-CBER-2021-5683-0002377_supppr.xpt
BATES-FDA-CBER-2021-5683-0002378_ta.xpt
BATES-FDA-CBER-2021-5683-0002379_te.xpt
BATES-FDA-CBER-2021-5683-0002380_ti.xpt
CRFs-for-site-1055.pdf
signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf
STN-125742_0_0-Section-2.5-Clinical-Overview.pdf
STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf
STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf

pd-production-122221


Supplemental-Index-12-22-21.pdf

pd-production-123021


pd-production-123021/CRFs-for-site-1081.pdf

pd-production-011822


CRFs-for-site-1096.pdf

pd-production-013122


CRFs-for-site-1128.pdf

pd-production-030122


125742_S1_M1_356h.pdf
125742_S1_M1_3674.pdf
125742_S1_M1_cover.pdf
125742_S1_M1_debarment.pdf
125742_S1_M1_exclusivity-claim.pdf
125742_S1_M1_fast-track-designation.pdf
125742_S1_M1_financial-cert-3454.pdf
125742_S1_M1_financial-cert-bias.pdf
125742_S1_M1_ipsp-agreed-letter.pdf
125742_S1_M1_priority-review-request.pdf
125742_S1_M1_trans-of-oblig.pdf
125742_S1_M1_us-agent-authorization.pdf
125742_S1_M1_userfee.pdf
125742_S1_M1_waiver-req-designated-suffix.pdf
125742_S1_M2_22_introduction.pdf
125742_S1_M2_24_nonclinical-overview.pdf
125742_S1_M2_26_pharmkin-tabulated-summary.pdf
125742_S1_M2_26_pharmkin-written-summary.pdf
125742_S1_M2_27_literature-references.pdf
125742_S1_M2_27_synopses-indiv-studies.pdf
125742_S1_M4_4223_185350.pdf
125742_S1_M4_4223_R-20-0072.pdf
125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf
125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf
125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf
125742_S1_M5_5351_c4591001-fa-interim-errata.pdf
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf
125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf
125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf
125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf
125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf
125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf
125742_S1_M5_c4591001-A-adrg.pdf
125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf
125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf
125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf
125742_S1_M5_c4591001-A-comorbidity-categories.pdf
125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf
125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf
125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf
125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf
125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf
125742_S1_M5_c4591001-A-report-cci-chf.pdf
125742_S1_M5_c4591001-A-report-cci-dementia.pdf
125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf
125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf
125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf
125742_S1_M5_c4591001-A-report-cci-leukemia.pdf
125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf
125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf
125742_S1_M5_c4591001-A-report-cci-mi.pdf
125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf
125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf
125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf
125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf
125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf
125742_S1_M5_c4591001-A-report-cci-renal.pdf
125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf
125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf
125742_S1_M5_c4591001-T-S-roadmap.pdf
125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf
125742_S1_M5_c4591001-T-S-suppl-arg.pdf
125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf
125742_S1_M5_CRF_c4591001-1085-10851018.pdf
125742_S1_M5_CRF_c4591001-1085-10851116.pdf
125742_S1_M5_CRF_c4591001-1085-10851129.pdf
125742_S1_M5_CRF_c4591001-1085-10851216.pdf
125742_S1_M5_CRF_c4591001-1085-10851246.pdf
FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt
/FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt
FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt
FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txt
FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt
FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txt
FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt
FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt
FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt
FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt
FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt
FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt
FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt
FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt
FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt
FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt
FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt
FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt
FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt
FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt
FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt
FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt
FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt
FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt
FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt
FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xml
FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl
FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx
FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx
FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx
FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx
FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx
FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx
FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx
FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx
FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx
FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx
FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx
FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx
FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx
FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx
FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx
FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx
FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx
FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx
FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx
FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx
FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx
FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx
FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx

pd-production-032422


125742_S1_M1_priority-review-request.pdf

pd-production-040122


125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf
125742_S1_M5_5351_c4591001-fa-interim-demographics.pdf
125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf
125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdf
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdf
125742_S1_M5_5351_c4591001-fa-interim-publications.pdf
125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-randomization.pdf
125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf
125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdf
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf
125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdf
125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf
125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdf
reissue_5.3.6 postmarketing experience.pdf

pd-production-050222


125742_S1_M5_5351_bnt162-01-interim3-adverse-events.pdf
125742_S1_M5_5351_bnt162-01-interim3-compliance.pdf
125742_S1_M5_5351_bnt162-01-interim3-demographics.pdf
125742_S1_M5_5351_bnt162-01-interim3-discontinued-patients.pdf
125742_S1_M5_5351_bnt162-01-interim3-excluded-patients.pdf
125742_S1_M5_5351_bnt162-01-interim3-iec-irb.pdf
125742_S1_M5_5351_bnt162-01-interim3-invest-signature.pdf
125742_S1_M5_5351_bnt162-01-interim3-investigators.pdf
125742_S1_M5_5351_bnt162-01-interim3-lab-measurements.pdf
125742_S1_M5_5351_bnt162-01-interim3-notes-for-reader.pdf
125742_S1_M5_5351_bnt162-01-interim3-patient-batches.pdf
125742_S1_M5_5351_bnt162-01-interim3-protocol-deviations.pdf
125742_S1_M5_5351_bnt162-01-interim3-protocol.pdf
125742_S1_M5_5351_bnt162-01-interim3-report-body.pdf
125742_S1_M5_5351_bnt162-01-interim3-sample-crf.pdf
125742_S1_M5_5351_bnt162-01-interim3-sap.pdf
125742_S1_M5_5351_bnt162-01-interim3-sponsor-personnel-list.pdf
125742_S1_M5_5351_bnt162-01-interim3-sponsor-signature.pdf
125742_S1_M5_5351_bnt162-01-interim3-synopsis.pdf
125742_S1_M5_5351_bnt162-01_10010.pdf
125742_S1_M5_5351_bnt162-01_10075.pdf
125742_S1_M5_5351_bnt162-01_20116.pdf
125742_S1_M5_5351_bnt162-01_20215.pdf
125742_S1_M5_5351_bnt162-01_20242.pdf
125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf
125742_S1_M5_5351_c4591001-interim-mth6-sample-crf.pdf
125742_S1_M5_5351_c4591001-interim-mth6-sponsor-signature.pdf
125742_S1_M5_bnt162-01-A-adrg.pdf
125742_S1_M5_bnt162-01-S-acrf.pdf
125742_S1_M5_bnt162-01-S-csdrg.pdf
125742_S1_M5_c4591001-S-acrf.pdf
125742_S1_M5_c4591001-S-csdrg.pdf
125742_S1_M5_c4591001-S-Supp-acrf.pdf
125742_S1_M5_CRF_c4591001-1001-10011093.pdf
125742_S1_M5_CRF_c4591001-1001-10011100.pdf
125742_S1_M5_CRF_c4591001-1001-10011135.pdf
125742_S1_M5_CRF_c4591001-1003-10031038.pdf
125742_S1_M5_CRF_c4591001-1003-10031065.pdf
125742_S1_M5_CRF_c4591001-1003-10031111.pdf
125742_S1_M5_CRF_c4591001-1003-10031113.pdf
125742_S1_M5_CRF_c4591001-1003-10031149.pdf
125742_S1_M5_CRF_c4591001-1003-10031186.pdf
125742_S1_M5_CRF_c4591001-1003-10031197.pdf
125742_S1_M5_CRF_c4591001-1003-10031207.pdf
125742_S1_M5_CRF_c4591001-1005-10051047.pdf
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125742_S1_M5_CRF_c4591001-1005-10051347.pdf
125742_S1_M5_CRF_c4591001-1005-10051387.pdf
125742_S1_M5_CRF_c4591001-1005-10051411.pdf
125742_S1_M5_CRF_c4591001-1006-10061020.pdf
125742_S1_M5_CRF_c4591001-1006-10061040.pdf
125742_S1_M5_CRF_c4591001-1006-10061052.pdf
125742_S1_M5_CRF_c4591001-1006-10061094.pdf
125742_S1_M5_CRF_c4591001-1006-10061098.pdf
125742_S1_M5_CRF_c4591001-1006-10061176.pdf
FDA-CBER-2021-5683-0058316 to -0058458_125742_S1_M5_c4591001-A-Supp-define.xml
FDA-CBER-2021-5683-0058459 to -0058478_125742_S1_M5_c4591001-A-Supp-define-2-0-0.xsl
FDA-CBER-2021-5683-0058479 to -0058594_125742_S1_M5_c4591001-S-define.xml
FDA-CBER-2021-5683-0058595 to -0058614_125742_S1_M5_c4591001-S-define-2-0-0.xsl
FDA-CBER-2021-5683-0058615 to -0058652_125742_S1_M5_c4591001-S-Supp-define.xml
FDA-CBER-2021-5683-0058653 to -0058675_125742_S1_M5_c4591001-S-Supp-define-2-0-0.xsl
FDA-CBER-2021-5683-0058676 to -0058794_125742_S1_M5_bnt162-01-A-define.xml
FDA-CBER-2021-5683-0058795 to -0058828_125742_S1_M5_bnt162-01-A-define-2-0-0.xsl
FDA-CBER-2021-5683-0058829 to -0058954_125742_S1_M5_bnt162-01-S-define.xml
FDA-CBER-2021-5683-0058955 to -0058999_125742_S1_M5_bnt162-01-S-define-2-0-0.xsl
FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.xpt
FDA-CBER-2021-5683-0065774 to -0066700_125742_S1_M5_c4591001-A-D-addv.xpt
FDA-CBER-2021-5683-0066701 to -0123167_125742_S1_M5_c4591001-A-D-adfacevd.xpt
FDA-CBER-2021-5683-0123168 to -0126026_125742_S1_M5_c4591001-A-D-adva.xpt

pd-production-060122


125742_S1_M2_summary-biopharm.pdf
125742_S1_M5_5314_shi-sop-10011.pdf
125742_S1_M5_5351_c4591001-fa-interim-adverse-events.pdf
125742_S1_M5_5351_c4591001-fa-interim-discontinued-patients.pdf
125742_S1_M5_5351_c4591001-fa-interim-patient-batches.pdf
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations-sensitive.pdf
125742_S1_M5_5351_c4591001-interim-mth6-patient-batches.pdf
125742_S1_M5_5351_c4591001-interim-mth6-publications.pdf
125742_S1_M5_5351_c4591001-interim-mth6-randomization.pdf
125742_S1_M5_CRF_c4591001-1007-10071050.pdf
125742_S1_M5_CRF_c4591001-1007-10071097.pdf
125742_S1_M5_CRF_c4591001-1007-10071101.pdf
125742_S1_M5_CRF_c4591001-1007-10071117.pdf
125742_S1_M5_CRF_c4591001-1007-10071124.pdf
125742_S1_M5_CRF_c4591001-1007-10071159.pdf
125742_S1_M5_CRF_c4591001-1007-10071192.pdf
125742_S1_M5_CRF_c4591001-1007-10071276.pdf
125742_S1_M5_CRF_c4591001-1007-10071280.pdf
125742_S1_M5_CRF_c4591001-1007-10071306.pdf
125742_S1_M5_CRF_c4591001-1007-10071315.pdf
125742_S1_M5_CRF_c4591001-1007-10071347.pdf
125742_S1_M5_CRF_c4591001-1007-10071441.pdf
125742_S1_M5_CRF_c4591001-1007-10071443.pdf
125742_S1_M5_CRF_c4591001-1008-10081056.pdf
125742_S1_M5_CRF_c4591001-1008-10081152.pdf
125742_S1_M5_CRF_c4591001-1008-10081184.pdf
125742_S1_M5_CRF_c4591001-1008-10081337.pdf
125742_S1_M5_CRF_c4591001-1008-10081603.pdf
125742_S1_M5_CRF_c4591001-1008-10081628.pdf
125742_S1_M5_CRF_c4591001-1008-10081667.pdf
125742_S1_M5_CRF_c4591001-1009-10091123.pdf
125742_S1_M5_CRF_c4591001-1009-10091128.pdf
125742_S1_M5_CRF_c4591001-1009-10091135.pdf
125742_S1_M5_CRF_c4591001-1009-10091149.pdf
125742_S1_M5_CRF_c4591001-1011-10111029.pdf
125742_S1_M5_CRF_c4591001-1011-10111181.pdf
125742_S1_M5_CRF_c4591001-1012-10121097.pdf
125742_S1_M5_CRF_c4591001-1012-10121112.pdf
125742_S1_M5_CRF_c4591001-1012-10121163.pdf
125742_S1_M5_CRF_c4591001-1013-10131084.pdf
125742_S1_M5_CRF_c4591001-1013-10131089.pdf
125742_S1_M5_CRF_c4591001-1013-10131165.pdf
125742_S1_M5_CRF_c4591001-1013-10131176.pdf
125742_S1_M5_CRF_c4591001-1013-10131190.pdf
125742_S1_M5_CRF_c4591001-1013-10131229.pdf
125742_S1_M5_CRF_c4591001-1013-10131255.pdf
125742_S1_M5_CRF_c4591001-1013-10131386.pdf
125742_S1_M5_CRF_c4591001-1013-10131517.pdf
125742_S1_M5_CRF_c4591001-1013-10131554.pdf
125742_S1_M5_CRF_c4591001-1013-10131653.pdf
125742_S1_M5_CRF_c4591001-1013-10131656.pdf
125742_S1_M5_CRF_c4591001-1013-10131658.pdf
125742_S1_M5_CRF_c4591001-1013-10131699.pdf
125742_S1_M5_CRF_c4591001-1013-10131718.pdf
125742_S1_M5_CRF_c4591001-1013-10131786.pdf
125742_S1_M5_CRF_c4591001-1015-10151011.pdf
125742_S1_M5_CRF_c4591001-1015-10151035.pdf
125742_S1_M5_CRF_c4591001-1015-10151047.pdf
125742_S1_M5_CRF_c4591001-1015-10151071.pdf
125742_S1_M5_CRF_c4591001-1015-10151089.pdf
125742_S1_M5_CRF_c4591001-1015-10151101.pdf
125742_S1_M5_CRF_c4591001-1015-10151134.pdf
125742_S1_M5_CRF_c4591001-1015-10151225.pdf
125742_S1_M5_CRF_c4591001-1015-10151238.pdf
125742_S1_M5_CRF_c4591001-1081-10811194 reissue.pdf
125742_S1_M5_CRF_c4591001-1128-11281009 reissue.pdf
FDA-CBER-2021-5683-0142307 to -0149081_125742_S1_M5_c4591001-A-Supp-D-adcevd.xpt
FDA-CBER-2021-5683-0149082 to -0158559_125742_S1_M5_c4591001-S-D-ce.xpt
FDA-CBER-2021-5683-0158560 to -0159486_125742_S1_M5_c4591001-S-D-dv.xpt
FDA-CBER-2021-5683-0159487 to -0162689_125742_S1_M5_c4591001-S-D-ec.xpt
FDA-CBER-2021-5683-0162690 to -0165892_125742_S1_M5_c4591001-S-D-ex.xpt

FDA-CBER-2021-5683-0168683 to -0169081_125742_S1_M5_c4591001-S-D-suppcm.xpt
FDA-CBER-2021-5683-0169082 to -0171523_125742_S1_M5_c4591001-S-D-suppdm.xpt
FDA-CBER-2021-5683-0171524 to -0174606_125742_S1_M5_c4591001-S-D-suppds.xpt
FDA-CBER-2021-5683-0174607 to -0178318_125742_S1_M5_c4591001-S-D-suppdv.xpt
FDA-CBER-2021-5683-0178319 to -0180190_125742_S1_M5_c4591001-S-D-suppho.xpt
FDA-CBER-2021-5683-0180191 to -0182980_125742_S1_M5_c4591001-S-D-suppis.xpt
FDA-CBER-2021-5683-0182981 to -0187905_125742_S1_M5_c4591001-S-D-suppmh.xpt
FDA-CBER-2021-5683-0187906 to -0196048_125742_S1_M5_c4591001-S-D-suppvs.xpt
FDA-CBER-2021-5683-0196049 to -0205317_125742_S1_M5_c4591001-S-Supp-D-ce.xpt
FDA-CBER-2021-5683-0205318 to -0208520_125742_S1_M5_c4591001-S-Supp-D-ex.xpt
FDA-CBER-2021-5683-0208521 to -0216666_125742_S1_M5_c4591001-S-Supp-D-suppvs.xpt

pd-production-070122


125742_S1_M5_5351_c4591001-fa-interim-narrative-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-sap.pdf
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.pdf
125742_S1_M5_5351_c4591001-interim-mth6-compliance-sensitive.pdf
125742_S1_M5_5351_c4591001-interim-mth6-discontinued-patients.pdf
125742_S1_M5_5351_c4591001-interim-mth6-efficacy-response.pdf
125742_S1_M5_5351_c4591001-interim-mth6-errata.pdf
125742_S1_M5_5351_c4591001-interim-mth6-excluded-patients-sensitive.pdf
125742_S1_M5_5351_c4591001-interim-mth6-excluded-patients.pdf
125742_S1_M5_5351_c4591001-interim-mth6-interlab-standard.pdf
125742_S1_M5_5351_c4591001-interim-mth6-lab-measurements-sensitive.pdf
125742_S1_M5_5351_c4591001-interim-mth6-protocol-deviations.pdf
125742_S1_M5_5351_c4591001-interim-mth6-sap.pdf
125742_S2_M1_com195lkz-carton-kzoo.pdf
125742_S2_M1_com195lpus-carton-puurs.pdf
125742_S2_M1_com25ctkz-carton-kzoo.pdf
125742_S2_M1_com25ctpus-carton-puurs.pdf
125742_S2_M1_comvlabkz-vial-kzoo.pdf
125742_S2_M1_comvlabp-vial-puurs.pdf
125742_S2_M1_fk-diluent-carton.pdf
125742_S2_M1_fk-diluent-stamp.pdf
125742_S2_M1_hospira-diluent-carton.pdf
125742_S2_M1_hospira-diluent-label.pdf
125742_S2_M1_loa-dmf-011321-vials.pdf
125742_S2_M1_loa-dmf-011793-vials.pdf
125742_S2_M1_loa-dmf-011820-vials.pdf
125742_S2_M1_loa-dmf-012683-vials.pdf
125742_S2_M1_loa-dmf-031786-vials.pdf
125742_S2_M1_loa-dmf-10953-stopper.pdf
125742_S2_M1_right-of-reference.pdf
125742_S2_M5_5354_wi235284-protocol.pdf
FDA-CBER-2021-5683-0225100 to -0225597_125742_S1_M5_c4591001-A-D-adcm.xpt
FDA-CBER-2021-5683-0225598 to -0282129_125742_S1_M5_c4591001-A-Supp-D-adfacevd.xpt
FDA-CBER-2021-5683-0282130 to -0282328_125742_S1_M5_c4591001-S-D-cm.xpt
FDA-CBER-2021-5683-0282329 to -0282365_125742_S1_M5_c4591001-S-D-ie.xpt
FDA-CBER-2021-5683-0282366 to -0285643_125742_S1_M5_c4591001-S-D-mb.xpt
FDA-CBER-2021-5683-0285644 to -0285651_125742_S1_M5_c4591001-S-D-mo.xpt
FDA-CBER-2021-5683-0285652 to -0286071_125742_S1_M5_c4591001-S-D-pe.xpt
FDA-CBER-2021-5683-0286072 to -0286266_125742_S1_M5_c4591001-S-Supp-D-relrec.xpt
FDA-CBER-2021-5683-0286267 to -0296903_125742_S1_M5_c4591001-S-Supp-D-suppce.xpt
FDA-CBER-2021-5683-0296904 to -0307543_125742_S1_M5_c4591001-S-D-suppce.xpt

pd-production-080122


125742_S2_M5_54_ezeanolue-e-2019.pdf
FDA-CBER-2021-5683-0396187_125742_S1_M5_c4591001-S-D-pr.xpt
FDA-CBER-2021-5683-0396188 to -0396192_125742_S1_M5_c4591001-S-D-suppmo.xpt
FDA-CBER-2021-5683-0396193 to -0396194_125742_S1_M5_c4591001-S-D-supppe.xpt
FDA-CBER-2021-5683-0396195_125742_S1_M5_bnt162-01-S-D-relrec.xpt
FDA-CBER-2021-5683-0396196_125742_S1_M5_bnt162-01-S-D-supppe.xpt
FDA-CBER-2021-5683-0396197_125742_S1_M5_bnt162-01-S-D-supprp.xpt
FDA-CBER-2021-5683-0396198_125742_S1_M5_bnt162-01-S-D-te.xpt
FDA-CBER-2021-5683-0396199_125742_S1_M5_bnt162-01-S-D-tv.xpt

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