Download The Pfizer Documents - July 2022 Update Torrent

Torrent Contents Size: 11.71 GB

The Pfizer Documents - July 2022 Update

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pd-production-011822

CRFs-for-site-1096.pdf

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11.28 MB

pd-production-013122

CRFs-for-site-1128.pdf

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13.55 MB

pd-production-030122

125742_S1_M1_356h.pdf	PDF	714.46 KB
125742_S1_M1_3674.pdf	PDF	5.12 MB
125742_S1_M1_cover.pdf	PDF	1.32 MB
125742_S1_M1_debarment.pdf	PDF	656.42 KB
125742_S1_M1_exclusivity-claim.pdf	PDF	616.11 KB
125742_S1_M1_fast-track-designation.pdf	PDF	649.42 KB
125742_S1_M1_financial-cert-3454.pdf	PDF	3.44 MB
125742_S1_M1_financial-cert-bias.pdf	PDF	695.81 KB
125742_S1_M1_ipsp-agreed-letter.pdf	PDF	657.84 KB
125742_S1_M1_priority-review-request.pdf	PDF	1.59 MB
125742_S1_M1_trans-of-oblig.pdf	PDF	717.14 KB
125742_S1_M1_us-agent-authorization.pdf	PDF	1.03 MB
125742_S1_M1_userfee.pdf	PDF	627.8 KB
125742_S1_M1_waiver-req-designated-suffix.pdf	PDF	2.74 MB
125742_S1_M2_22_introduction.pdf	PDF	670.17 KB
125742_S1_M2_24_nonclinical-overview.pdf	PDF	1.61 MB
125742_S1_M2_26_pharmkin-tabulated-summary.pdf	PDF	1.34 MB
125742_S1_M2_26_pharmkin-written-summary.pdf	PDF	1.43 MB
125742_S1_M2_27_literature-references.pdf	PDF	1.75 MB
125742_S1_M2_27_synopses-indiv-studies.pdf	PDF	1.75 MB
125742_S1_M4_4223_185350.pdf	PDF	1.4 MB
125742_S1_M4_4223_R-20-0072.pdf	PDF	5.21 MB
125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf	PDF	889.15 KB
125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf	PDF	1.26 MB
125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf	PDF	2.04 MB
125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf	PDF	2.39 MB
125742_S1_M5_5351_c4591001-fa-interim-errata.pdf	PDF	2.27 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf	PDF	15.7 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf	PDF	1.81 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf	PDF	4.78 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf	PDF	12.02 MB
125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf	PDF	2.29 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf	PDF	31.31 MB
125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf	PDF	13 MB
125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf	PDF	36.94 MB
125742_S1_M5_CRF_c4591001-1085-10851018.pdf	PDF	2.25 MB
125742_S1_M5_CRF_c4591001-1085-10851116.pdf	PDF	1.19 MB
125742_S1_M5_CRF_c4591001-1085-10851129.pdf	PDF	1.94 MB
125742_S1_M5_CRF_c4591001-1085-10851216.pdf	PDF	1.22 MB
125742_S1_M5_CRF_c4591001-1085-10851246.pdf	PDF	1.14 MB
125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf	PDF	602.23 KB
125742_S1_M5_c4591001-A-adrg.pdf	PDF	1.54 MB
125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf	PDF	627.05 KB
125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf	PDF	634.25 KB
125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf	PDF	620.2 KB
125742_S1_M5_c4591001-A-comorbidity-categories.pdf	PDF	636.9 KB
125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf	PDF	606.89 KB
125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf	PDF	846.03 KB
125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf	PDF	629.08 KB
125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf	PDF	670.23 KB
125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf	PDF	631.62 KB
125742_S1_M5_c4591001-A-report-cci-chf.pdf	PDF	628.18 KB
125742_S1_M5_c4591001-A-report-cci-dementia.pdf	PDF	625.82 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf	PDF	625.67 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf	PDF	626.79 KB
125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf	PDF	625.58 KB
125742_S1_M5_c4591001-A-report-cci-leukemia.pdf	PDF	631.44 KB
125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf	PDF	640.12 KB
125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf	PDF	635.64 KB
125742_S1_M5_c4591001-A-report-cci-mi.pdf	PDF	624.25 KB
125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf	PDF	628.36 KB
125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf	PDF	625.68 KB
125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf	PDF	624.81 KB
125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf	PDF	631.6 KB
125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf	PDF	629.63 KB
125742_S1_M5_c4591001-A-report-cci-renal.pdf	PDF	628.94 KB
125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf	PDF	629.4 KB
125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf	PDF	2.22 MB
125742_S1_M5_c4591001-T-S-roadmap.pdf	PDF	702.77 KB
125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf	PDF	666.79 KB
125742_S1_M5_c4591001-T-S-suppl-arg.pdf	PDF	738.13 KB
125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf	PDF	17.43 MB
FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt	TXT	13.87 KB
FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt	TXT	14.67 KB
FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt	TXT	14.75 KB
FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txt	TXT	15.11 KB
FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt	TXT	35.46 KB
FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txt	TXT	17.94 KB
FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt	TXT	81.06 KB
FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt	TXT	19.55 KB
FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt	TXT	19.46 KB
FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt	TXT	12.27 KB
FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt	TXT	71.56 KB
FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt	TXT	192.86 KB
FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt	TXT	27.11 KB
FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt	TXT	32.19 KB
FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt	TXT	155.76 KB
FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt	TXT	11.04 KB
FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt	TXT	48.94 KB
FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt	TXT	24.03 KB
FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt	TXT	74.64 KB
FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt	TXT	74.71 KB
FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt	TXT	29.2 KB
FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt	TXT	75.39 KB
FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt	TXT	197.17 KB
FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt	TXT	43.24 KB
FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt	TXT	44.8 KB
FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xml	XML	1.37 MB
FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl	XSL	183.26 KB
FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx	XLSX	12.98 KB
FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx	XLSX	28.74 KB
FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx	XLSX	18.48 KB
FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx	XLSX	18.86 KB
FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx	XLSX	22.28 KB
FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx	XLSX	84.13 KB
FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx	XLSX	22.73 KB
FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx	XLSX	34.78 KB
FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx	XLSX	12.44 KB
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx	XLSX	10.25 KB
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx	XLSX	9.44 KB
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx	XLSX	9.2 KB
FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx	XLSX	9.77 KB
FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx	XLSX	9.58 KB
FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx	XLSX	11.67 KB
FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx	XLSX	17.02 KB
FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx	XLSX	14.32 KB
FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx	XLSX	8.9 KB
FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx	XLSX	10.35 KB
FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx	XLSX	9.2 KB
FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx	XLSX	9.15 KB
FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx	XLSX	11.71 KB
FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx	XLSX	11.55 KB
FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx	XLSX	11.09 KB
FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx	XLSX	23.94 KB
FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx	XLSX	21.34 KB

pd-production-032422

125742_S1_M1_priority-review-request.pdf

PDF

2.37 MB

pd-production-040122

125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf	PDF	869.17 KB
125742_S1_M5_5351_c4591001-fa-interim-demographics.pdf	PDF	27.74 MB
125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf	PDF	7.56 MB
125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdf	PDF	677.14 KB
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdf	PDF	1.17 MB
125742_S1_M5_5351_c4591001-fa-interim-publications.pdf	PDF	9.76 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf	PDF	59.43 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization.pdf	PDF	1.51 MB
125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf	PDF	5.4 MB
125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdf	PDF	2.31 MB
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf	PDF	1.2 MB
125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdf	PDF	1.28 MB
125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf	PDF	27.77 MB
125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdf	PDF	1.18 MB
reissue_5.3.6 postmarketing experience.pdf	PDF	957.62 KB

pd-production-050222

125742_S1_M5_5351_bnt162-01-interim3-adverse-events.pdf	PDF	7.08 MB
125742_S1_M5_5351_bnt162-01-interim3-compliance.pdf	PDF	7.44 MB
125742_S1_M5_5351_bnt162-01-interim3-demographics.pdf	PDF	2.33 MB
125742_S1_M5_5351_bnt162-01-interim3-discontinued-patients.pdf	PDF	1.99 MB
125742_S1_M5_5351_bnt162-01-interim3-excluded-patients.pdf	PDF	2.01 MB
125742_S1_M5_5351_bnt162-01-interim3-iec-irb.pdf	PDF	1.09 MB
125742_S1_M5_5351_bnt162-01-interim3-invest-signature.pdf	PDF	634.42 KB
125742_S1_M5_5351_bnt162-01-interim3-investigators.pdf	PDF	6.28 MB
125742_S1_M5_5351_bnt162-01-interim3-lab-measurements.pdf	PDF	91.06 MB
125742_S1_M5_5351_bnt162-01-interim3-notes-for-reader.pdf	PDF	1.21 MB
125742_S1_M5_5351_bnt162-01-interim3-patient-batches.pdf	PDF	2.56 MB
125742_S1_M5_5351_bnt162-01-interim3-protocol-deviations.pdf	PDF	1.47 MB
125742_S1_M5_5351_bnt162-01-interim3-protocol.pdf	PDF	10.46 MB
125742_S1_M5_5351_bnt162-01-interim3-report-body.pdf	PDF	41.63 MB
125742_S1_M5_5351_bnt162-01-interim3-sample-crf.pdf	PDF	9.1 MB
125742_S1_M5_5351_bnt162-01-interim3-sap.pdf	PDF	2.91 MB
125742_S1_M5_5351_bnt162-01-interim3-sponsor-personnel-list.pdf	PDF	1.97 MB
125742_S1_M5_5351_bnt162-01-interim3-sponsor-signature.pdf	PDF	1.52 MB
125742_S1_M5_5351_bnt162-01-interim3-synopsis.pdf	PDF	3.71 MB
125742_S1_M5_5351_bnt162-01_10010.pdf	PDF	1.46 MB
125742_S1_M5_5351_bnt162-01_10075.pdf	PDF	1.59 MB
125742_S1_M5_5351_bnt162-01_20116.pdf	PDF	1.51 MB
125742_S1_M5_5351_bnt162-01_20215.pdf	PDF	1.63 MB
125742_S1_M5_5351_bnt162-01_20242.pdf	PDF	1.66 MB
125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf	PDF	64.92 MB
125742_S1_M5_5351_c4591001-interim-mth6-sample-crf.pdf	PDF	5.39 MB
125742_S1_M5_5351_c4591001-interim-mth6-sponsor-signature.pdf	PDF	11.95 MB
125742_S1_M5_CRF_c4591001-1001-10011093.pdf	PDF	2.62 MB
125742_S1_M5_CRF_c4591001-1001-10011100.pdf	PDF	2.13 MB
125742_S1_M5_CRF_c4591001-1001-10011135.pdf	PDF	1.42 MB
125742_S1_M5_CRF_c4591001-1003-10031038.pdf	PDF	2.71 MB
125742_S1_M5_CRF_c4591001-1003-10031065.pdf	PDF	2.66 MB
125742_S1_M5_CRF_c4591001-1003-10031111.pdf	PDF	1.71 MB
125742_S1_M5_CRF_c4591001-1003-10031113.pdf	PDF	3.22 MB
125742_S1_M5_CRF_c4591001-1003-10031149.pdf	PDF	1.63 MB
125742_S1_M5_CRF_c4591001-1003-10031186.pdf	PDF	2.42 MB
125742_S1_M5_CRF_c4591001-1003-10031197.pdf	PDF	1.48 MB
125742_S1_M5_CRF_c4591001-1003-10031207.pdf	PDF	1.44 MB
125742_S1_M5_CRF_c4591001-1005-10051047.pdf	PDF	1.39 MB
125742_S1_M5_CRF_c4591001-1005-10051054.pdf	PDF	1.88 MB
125742_S1_M5_CRF_c4591001-1005-10051069.pdf	PDF	1.46 MB
125742_S1_M5_CRF_c4591001-1005-10051214.pdf	PDF	1.38 MB
125742_S1_M5_CRF_c4591001-1005-10051293.pdf	PDF	2.41 MB
125742_S1_M5_CRF_c4591001-1005-10051347.pdf	PDF	1.45 MB
125742_S1_M5_CRF_c4591001-1005-10051387.pdf	PDF	1.69 MB
125742_S1_M5_CRF_c4591001-1005-10051411.pdf	PDF	1.35 MB
125742_S1_M5_CRF_c4591001-1006-10061020.pdf	PDF	1.52 MB
125742_S1_M5_CRF_c4591001-1006-10061040.pdf	PDF	3.82 MB
125742_S1_M5_CRF_c4591001-1006-10061052.pdf	PDF	2.12 MB
125742_S1_M5_CRF_c4591001-1006-10061094.pdf	PDF	2.08 MB
125742_S1_M5_CRF_c4591001-1006-10061098.pdf	PDF	1.57 MB
125742_S1_M5_CRF_c4591001-1006-10061176.pdf	PDF	2.63 MB
125742_S1_M5_bnt162-01-A-adrg.pdf	PDF	891.07 KB
125742_S1_M5_bnt162-01-S-acrf.pdf	PDF	1.4 MB
125742_S1_M5_bnt162-01-S-csdrg.pdf	PDF	1.2 MB
125742_S1_M5_c4591001-S-Supp-acrf.pdf	PDF	2.89 MB
125742_S1_M5_c4591001-S-acrf.pdf	PDF	2.89 MB
125742_S1_M5_c4591001-S-csdrg.pdf	PDF	1.43 MB
FDA-CBER-2021-5683-0058316 to -0058458_125742_S1_M5_c4591001-A-Supp-define.xml	XML	691.95 KB
FDA-CBER-2021-5683-0058459 to -0058478_125742_S1_M5_c4591001-A-Supp-define-2-0-0.xsl	XSL	183.26 KB
FDA-CBER-2021-5683-0058479 to -0058594_125742_S1_M5_c4591001-S-define.xml	XML	904.18 KB
FDA-CBER-2021-5683-0058595 to -0058614_125742_S1_M5_c4591001-S-define-2-0-0.xsl	XSL	183.26 KB
FDA-CBER-2021-5683-0058615 to -0058652_125742_S1_M5_c4591001-S-Supp-define.xml	XML	299.8 KB
FDA-CBER-2021-5683-0058653 to -0058675_125742_S1_M5_c4591001-S-Supp-define-2-0-0.xsl	XSL	183.26 KB
FDA-CBER-2021-5683-0058676 to -0058794_125742_S1_M5_bnt162-01-A-define.xml	XML	828.13 KB
FDA-CBER-2021-5683-0058795 to -0058828_125742_S1_M5_bnt162-01-A-define-2-0-0.xsl	XSL	183.26 KB
FDA-CBER-2021-5683-0058829 to -0058954_125742_S1_M5_bnt162-01-S-define.xml	XML	985.5 KB
FDA-CBER-2021-5683-0058955 to -0058999_125742_S1_M5_bnt162-01-S-define-2-0-0.xsl	XSL	183.26 KB
FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.xpt	XPT	394.37 MB
FDA-CBER-2021-5683-0065774 to -0066700_125742_S1_M5_c4591001-A-D-addv.xpt	XPT	43.54 MB
FDA-CBER-2021-5683-0066701 to -0123167_125742_S1_M5_c4591001-A-D-adfacevd.xpt	XPT	3.85 GB
FDA-CBER-2021-5683-0123168 to -0126026_125742_S1_M5_c4591001-A-D-adva.xpt	XPT	162.85 MB

pd-production-060122

125742_S1_M2_summary-biopharm.pdf	PDF	1.74 MB
125742_S1_M5_5314_shi-sop-10011.pdf	PDF	2.08 MB
125742_S1_M5_5351_c4591001-fa-interim-adverse-events.pdf	PDF	31.71 MB
125742_S1_M5_5351_c4591001-fa-interim-discontinued-patients.pdf	PDF	2.91 MB
125742_S1_M5_5351_c4591001-fa-interim-patient-batches.pdf	PDF	1.26 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations-sensitive.pdf	PDF	1.51 MB
125742_S1_M5_5351_c4591001-interim-mth6-patient-batches.pdf	PDF	1.34 MB
125742_S1_M5_5351_c4591001-interim-mth6-publications.pdf	PDF	11.18 MB
125742_S1_M5_5351_c4591001-interim-mth6-randomization.pdf	PDF	1.2 MB
125742_S1_M5_CRF_c4591001-1007-10071050.pdf	PDF	3 MB
125742_S1_M5_CRF_c4591001-1007-10071097.pdf	PDF	2.08 MB
125742_S1_M5_CRF_c4591001-1007-10071101.pdf	PDF	1.48 MB
125742_S1_M5_CRF_c4591001-1007-10071117.pdf	PDF	1.9 MB
125742_S1_M5_CRF_c4591001-1007-10071124.pdf	PDF	1.72 MB
125742_S1_M5_CRF_c4591001-1007-10071159.pdf	PDF	1.29 MB
125742_S1_M5_CRF_c4591001-1007-10071192.pdf	PDF	1.84 MB
125742_S1_M5_CRF_c4591001-1007-10071276.pdf	PDF	1.77 MB
125742_S1_M5_CRF_c4591001-1007-10071280.pdf	PDF	1.91 MB
125742_S1_M5_CRF_c4591001-1007-10071306.pdf	PDF	2.76 MB
125742_S1_M5_CRF_c4591001-1007-10071315.pdf	PDF	1.42 MB
125742_S1_M5_CRF_c4591001-1007-10071347.pdf	PDF	1.45 MB
125742_S1_M5_CRF_c4591001-1007-10071441.pdf	PDF	1.25 MB
125742_S1_M5_CRF_c4591001-1007-10071443.pdf	PDF	1.31 MB
125742_S1_M5_CRF_c4591001-1008-10081056.pdf	PDF	1.21 MB
125742_S1_M5_CRF_c4591001-1008-10081152.pdf	PDF	1.01 MB
125742_S1_M5_CRF_c4591001-1008-10081184.pdf	PDF	1.18 MB
125742_S1_M5_CRF_c4591001-1008-10081337.pdf	PDF	1.24 MB
125742_S1_M5_CRF_c4591001-1008-10081603.pdf	PDF	1.31 MB
125742_S1_M5_CRF_c4591001-1008-10081628.pdf	PDF	1.19 MB
125742_S1_M5_CRF_c4591001-1008-10081667.pdf	PDF	1.27 MB
125742_S1_M5_CRF_c4591001-1009-10091123.pdf	PDF	1.26 MB
125742_S1_M5_CRF_c4591001-1009-10091128.pdf	PDF	1.62 MB
125742_S1_M5_CRF_c4591001-1009-10091135.pdf	PDF	1.72 MB
125742_S1_M5_CRF_c4591001-1009-10091149.pdf	PDF	1.47 MB
125742_S1_M5_CRF_c4591001-1011-10111029.pdf	PDF	1.53 MB
125742_S1_M5_CRF_c4591001-1011-10111181.pdf	PDF	1.19 MB
125742_S1_M5_CRF_c4591001-1012-10121097.pdf	PDF	1.81 MB
125742_S1_M5_CRF_c4591001-1012-10121112.pdf	PDF	1.69 MB
125742_S1_M5_CRF_c4591001-1012-10121163.pdf	PDF	1.56 MB
125742_S1_M5_CRF_c4591001-1013-10131084.pdf	PDF	1.37 MB
125742_S1_M5_CRF_c4591001-1013-10131089.pdf	PDF	1.43 MB
125742_S1_M5_CRF_c4591001-1013-10131165.pdf	PDF	1.3 MB
125742_S1_M5_CRF_c4591001-1013-10131176.pdf	PDF	2.78 MB
125742_S1_M5_CRF_c4591001-1013-10131190.pdf	PDF	2.3 MB
125742_S1_M5_CRF_c4591001-1013-10131229.pdf	PDF	1.15 MB
125742_S1_M5_CRF_c4591001-1013-10131255.pdf	PDF	1.33 MB
125742_S1_M5_CRF_c4591001-1013-10131386.pdf	PDF	1008.3 KB
125742_S1_M5_CRF_c4591001-1013-10131517.pdf	PDF	1.18 MB
125742_S1_M5_CRF_c4591001-1013-10131554.pdf	PDF	2.32 MB
125742_S1_M5_CRF_c4591001-1013-10131653.pdf	PDF	1.23 MB
125742_S1_M5_CRF_c4591001-1013-10131656.pdf	PDF	1.22 MB
125742_S1_M5_CRF_c4591001-1013-10131658.pdf	PDF	1.07 MB
125742_S1_M5_CRF_c4591001-1013-10131699.pdf	PDF	2.34 MB
125742_S1_M5_CRF_c4591001-1013-10131718.pdf	PDF	2.18 MB
125742_S1_M5_CRF_c4591001-1013-10131786.pdf	PDF	3.13 MB
125742_S1_M5_CRF_c4591001-1015-10151011.pdf	PDF	1.35 MB
125742_S1_M5_CRF_c4591001-1015-10151035.pdf	PDF	1.24 MB
125742_S1_M5_CRF_c4591001-1015-10151047.pdf	PDF	1.15 MB
125742_S1_M5_CRF_c4591001-1015-10151071.pdf	PDF	1.23 MB
125742_S1_M5_CRF_c4591001-1015-10151089.pdf	PDF	1.24 MB
125742_S1_M5_CRF_c4591001-1015-10151101.pdf	PDF	1.05 MB
125742_S1_M5_CRF_c4591001-1015-10151134.pdf	PDF	1.47 MB
125742_S1_M5_CRF_c4591001-1015-10151225.pdf	PDF	1.47 MB
125742_S1_M5_CRF_c4591001-1015-10151238.pdf	PDF	2.52 MB
125742_S1_M5_CRF_c4591001-1081-10811194 reissue.pdf	PDF	1.76 MB
125742_S1_M5_CRF_c4591001-1128-11281009 reissue.pdf	PDF	1.88 MB
FDA-CBER-2021-5683-0142307 to -0149081_125742_S1_M5_c4591001-A-Supp-D-adcevd.xpt	XPT	425.98 MB
FDA-CBER-2021-5683-0149082 to -0158559_125742_S1_M5_c4591001-S-D-ce.xpt	XPT	368.08 MB
FDA-CBER-2021-5683-0158560 to -0159486_125742_S1_M5_c4591001-S-D-dv.xpt	XPT	11.43 MB
FDA-CBER-2021-5683-0159487 to -0162689_125742_S1_M5_c4591001-S-D-ec.xpt	XPT	46.56 MB
FDA-CBER-2021-5683-0162690 to -0165892_125742_S1_M5_c4591001-S-D-ex.xpt	XPT	44.73 MB
FDA-CBER-2021-5683-0165893 to -0168682_125742_S1_M5_c4591001-S-D-is.xpt	XPT	29.38 MB
FDA-CBER-2021-5683-0168683 to -0169081_125742_S1_M5_c4591001-S-D-suppcm.xpt	XPT	2.75 MB
FDA-CBER-2021-5683-0169082 to -0171523_125742_S1_M5_c4591001-S-D-suppdm.xpt	XPT	13.7 MB
FDA-CBER-2021-5683-0171524 to -0174606_125742_S1_M5_c4591001-S-D-suppds.xpt	XPT	16.94 MB
FDA-CBER-2021-5683-0174607 to -0178318_125742_S1_M5_c4591001-S-D-suppdv.xpt	XPT	23.37 MB
FDA-CBER-2021-5683-0178319 to -0180190_125742_S1_M5_c4591001-S-D-suppho.xpt	XPT	8.22 MB
FDA-CBER-2021-5683-0180191 to -0182980_125742_S1_M5_c4591001-S-D-suppis.xpt	XPT	7.99 MB
FDA-CBER-2021-5683-0182981 to -0187905_125742_S1_M5_c4591001-S-D-suppmh.xpt	XPT	21.61 MB
FDA-CBER-2021-5683-0187906 to -0196048_125742_S1_M5_c4591001-S-D-suppvs.xpt	XPT	39.15 MB
FDA-CBER-2021-5683-0196049 to -0205317_125742_S1_M5_c4591001-S-Supp-D-ce.xpt	XPT	361.39 MB
FDA-CBER-2021-5683-0205318 to -0208520_125742_S1_M5_c4591001-S-Supp-D-ex.xpt	XPT	44.73 MB
FDA-CBER-2021-5683-0208521 to -0216666_125742_S1_M5_c4591001-S-Supp-D-suppvs.xpt	XPT	39.16 MB
STN 125742-0-0 Section 2.5 Clinical Overview reissue.pdf	PDF	4.72 MB

pd-production-070122

125742_S1_M5_5351_c4591001-fa-interim-narrative-sensitive.pdf	PDF	18.85 MB
125742_S1_M5_5351_c4591001-fa-interim-sap.pdf	PDF	3.23 MB
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.pdf	PDF	183.44 MB
125742_S1_M5_5351_c4591001-interim-mth6-compliance-sensitive.pdf	PDF	1.2 MB
125742_S1_M5_5351_c4591001-interim-mth6-discontinued-patients.pdf	PDF	4.19 MB
125742_S1_M5_5351_c4591001-interim-mth6-efficacy-response.pdf	PDF	1.22 MB
125742_S1_M5_5351_c4591001-interim-mth6-errata.pdf	PDF	1.8 MB
125742_S1_M5_5351_c4591001-interim-mth6-excluded-patients-sensitive.pdf	PDF	2.79 MB
125742_S1_M5_5351_c4591001-interim-mth6-excluded-patients.pdf	PDF	1.29 MB
125742_S1_M5_5351_c4591001-interim-mth6-interlab-standard.pdf	PDF	10.87 MB
125742_S1_M5_5351_c4591001-interim-mth6-lab-measurements-sensitive.pdf	PDF	5.4 MB
125742_S1_M5_5351_c4591001-interim-mth6-protocol-deviations.pdf	PDF	1.63 MB
125742_S1_M5_5351_c4591001-interim-mth6-sap.pdf	PDF	5.4 MB
125742_S2_M1_com195lkz-carton-kzoo.pdf	PDF	1023.85 KB
125742_S2_M1_com195lpus-carton-puurs.pdf	PDF	691.06 KB
125742_S2_M1_com25ctkz-carton-kzoo.pdf	PDF	631.94 KB
125742_S2_M1_com25ctpus-carton-puurs.pdf	PDF	671.91 KB
125742_S2_M1_comvlabkz-vial-kzoo.pdf	PDF	863.25 KB
125742_S2_M1_comvlabp-vial-puurs.pdf	PDF	648.34 KB
125742_S2_M1_fk-diluent-carton.pdf	PDF	607.13 KB
125742_S2_M1_fk-diluent-stamp.pdf	PDF	598.24 KB
125742_S2_M1_hospira-diluent-carton.pdf	PDF	987.15 KB
125742_S2_M1_hospira-diluent-label.pdf	PDF	776.28 KB
125742_S2_M1_loa-dmf-011321-vials.pdf	PDF	1019.09 KB
125742_S2_M1_loa-dmf-011793-vials.pdf	PDF	701.08 KB
125742_S2_M1_loa-dmf-011820-vials.pdf	PDF	616.16 KB
125742_S2_M1_loa-dmf-012683-vials.pdf	PDF	630.9 KB
125742_S2_M1_loa-dmf-031786-vials.pdf	PDF	1.95 MB
125742_S2_M1_loa-dmf-10953-stopper.pdf	PDF	860.66 KB
125742_S2_M1_right-of-reference.pdf	PDF	1.73 MB
125742_S2_M5_5354_wi235284-protocol.pdf	PDF	15.5 MB
FDA-CBER-2021-5683-0225100 to -0225597_125742_S1_M5_c4591001-A-D-adcm.xpt	XPT	46.4 MB
FDA-CBER-2021-5683-0225598 to -0282129_125742_S1_M5_c4591001-A-Supp-D-adfacevd.xpt	XPT	3.95 GB
FDA-CBER-2021-5683-0282130 to -0282328_125742_S1_M5_c4591001-S-D-cm.xpt	XPT	3.99 MB
FDA-CBER-2021-5683-0282329 to -0282365_125742_S1_M5_c4591001-S-D-ie.xpt	XPT	479.61 KB
FDA-CBER-2021-5683-0282366 to -0285643_125742_S1_M5_c4591001-S-D-mb.xpt	XPT	48.15 MB
FDA-CBER-2021-5683-0285644 to -0285651_125742_S1_M5_c4591001-S-D-mo.xpt	XPT	75.78 KB
FDA-CBER-2021-5683-0285652 to -0286071_125742_S1_M5_c4591001-S-D-pe.xpt	XPT	8.89 MB
FDA-CBER-2021-5683-0286072 to -0286266_125742_S1_M5_c4591001-S-Supp-D-relrec.xpt	XPT	568.2 KB
FDA-CBER-2021-5683-0286267 to -0296903_125742_S1_M5_c4591001-S-Supp-D-suppce.xpt	XPT	83.19 MB
FDA-CBER-2021-5683-0296904 to -0307543_125742_S1_M5_c4591001-S-D-suppce.xpt	XPT	53.58 MB

pd-production-111721

5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf	PDF	8.01 MB
5.2-tabular-listing.pdf	PDF	1.72 MB
5.3.6-postmarketing-experience.pdf	PDF	983.55 KB
BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt	TXT	9.11 KB
BATES-93_tv.xpt	XPT	15.55 KB

pd-production-120121

	Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdf	PDF	12.29 MB
	Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdf	PDF	13.78 MB

pd-production-121321

BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt	TXT	8.5 KB
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt	TXT	8.52 KB
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt	TXT	9.11 KB
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt	TXT	4.53 KB
BATES-FDA-CBER-2021-5683-0002376_relrec.xpt	XPT	566.64 KB
BATES-FDA-CBER-2021-5683-0002377_supppr.xpt	XPT	71.8 KB
BATES-FDA-CBER-2021-5683-0002378_ta.xpt	XPT	8.44 KB
BATES-FDA-CBER-2021-5683-0002379_te.xpt	XPT	3.28 KB
BATES-FDA-CBER-2021-5683-0002380_ti.xpt	XPT	36.95 KB
CRFs-for-site-1055.pdf	PDF	6.42 MB
STN-125742_0_0-Section-2.5-Clinical-Overview.pdf	PDF	4.2 MB
STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf	PDF	3.15 MB
STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf	PDF	6.5 MB
signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf	PDF	206.58 KB

pd-production-122221

Supplemental-Index-12-22-21.pdf

PDF

1.94 MB

pd-production-123021

CRFs-for-site-1081.pdf

PDF

13.2 MB

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