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Pfizer’s Documents

TitleDateFile SizeLink
FDA CBER 2021 5683 0208521 to 0216666_125742_S1_M5_c4591001 S Supp D suppvs.zip (xpt)June 1, 2022917 KB
FDA CBER 2021 5683 0205318 to 0208520_125742_S1_M5_c4591001 S Supp D ex.zip (xpt)June 1, 20222 MB
FDA CBER 2021 5683 0196049 to 0205317_125742_S1_M5_c4591001 S Supp D ce.zip (xpt)June 1, 20228 MB
FDA CBER 2021 5683 0187906 to 0196048_125742_S1_M5_c4591001 S D suppvs.zip (xpt)June 1, 2022915 KB
FDA CBER 2021 5683 0182981 to 0187905_125742_S1_M5_c4591001 S D suppmh.zip (xpt)June 1, 2022616 KB
FDA CBER 2021 5683 0180191 to 0182980_125742_S1_M5_c4591001 S D suppis.zip (xpt)June 1, 2022350 KB
FDA CBER 2021 5683 0178319 to 0180190_125742_S1_M5_c4591001 S D suppho.zip (xpt)June 1, 2022259 KB
FDA CBER 2021 5683 0174607 to 0178318_125742_S1_M5_c4591001 S D suppdv.zip (xpt)June 1, 2022623 KB
FDA CBER 2021 5683 0171524 to 0174606_125742_S1_M5_c4591001 S D suppds.zip (xpt)June 1, 2022405 KB
FDA CBER 2021 5683 0169082 to 0171523_125742_S1_M5_c4591001 S D suppdm.zip (xpt)June 1, 2022334 KB
FDA CBER 2021 5683 0168683 to 0169081_125742_S1_M5_c4591001 S D suppcm.zip (xpt)June 1, 202271 KB
FDA CBER 2021 5683 0165893 to 0168682_125742_S1_M5_c4591001 S D is.zip (xpt)June 1, 20221 MB
FDA CBER 2021 5683 0162690 to 0165892_125742_S1_M5_c4591001 S D ex.zip (xpt)June 1, 20222 MB
FDA CBER 2021 5683 0159487 to 0162689_125742_S1_M5_c4591001 S D ec.zip (xpt)June 1, 20222 MB
FDA CBER 2021 5683 0158560 to 0159486_125742_S1_M5_c4591001 S D dv.zip (xpt)June 1, 2022558 KB
FDA CBER 2021 5683 0149082 to 0158559_125742_S1_M5_c4591001 S D ce.zip (xpt)June 1, 20228 MB
FDA CBER 2021 5683 0142307 to 0149081_125742_S1_M5_c4591001 A Supp D adcevd.zip (xpt)June 1, 20228 MB
125742_S1_M5_CRF_c4591001 1081 10811194 reissue.pdfJune 1, 20222 MB
STN 125742 0 0 Section 2.5 Clinical Overview reissue.pdfJune 1, 20225 MB
125742_S1_M5_CRF_c4591001 1128 11281009 reissue.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1015 10151101.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1015 10151089.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1015 10151071.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1015 10151238.pdfJune 1, 20223 MB
125742_S1_M5_CRF_c4591001 1015 10151225.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1015 10151134.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1015 10151035.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1015 10151011.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131786.pdfJune 1, 20223 MB
125742_S1_M5_CRF_c4591001 1013 10131718.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1013 10131699.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1013 10131658.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131656.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131653.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1015 10151047.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131517.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131386.pdfJune 1, 20221,008 KB
125742_S1_M5_CRF_c4591001 1013 10131255.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131229.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131190.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1013 10131176.pdfJune 1, 20223 MB
125742_S1_M5_CRF_c4591001 1013 10131165.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131089.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1013 10131084.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1012 10121163.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1013 10131554.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1012 10121097.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1011 10111181.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1011 10111029.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1009 10091149.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1009 10091135.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1009 10091128.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1009 10091123.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1008 10081667.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1008 10081628.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1012 10121112.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1008 10081337.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1008 10081184.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1008 10081152.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1008 10081056.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1007 10071443.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1007 10071441.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1007 10071347.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1007 10071315.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1007 10071306.pdfJune 1, 20223 MB
125742_S1_M5_CRF_c4591001 1008 10081603.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1007 10071276.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1007 10071192.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1007 10071159.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1007 10071124.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1007 10071117.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1007 10071101.pdfJune 1, 20221 MB
125742_S1_M5_CRF_c4591001 1007 10071097.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1007 10071050.pdfJune 1, 20223 MB
125742_S1_M5_CRF_c4591001 1007 10071280.pdfJune 1, 20222 MB
125742_S1_M5_5351_c4591001 interim mth6 publications.pdfJune 1, 202211 MB
125742_S1_M5_5351_c4591001 interim mth6 patient batches.pdfJune 1, 20221 MB
125742_S1_M5_5351_c4591001 fa interim protocol deviations sensitive.pdfJune 1, 20222 MB
125742_S1_M5_5351_c4591001 fa interim patient batches.pdfJune 1, 20221 MB
125742_S1_M5_5351_c4591001 fa interim discontinued patients.pdfJune 1, 20223 MB
125742_S1_M5_5351_c4591001 interim mth6 randomization.pdfJune 1, 20221 MB
125742_S1_M5_5314_shi sop 10011.pdfJune 1, 20222 MB
125742_S1_M2_summary biopharm.pdfJune 1, 20222 MB
125742_S1_M5_5351_c4591001 fa interim adverse events.pdfJune 1, 202232 MB
125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdfMay 2, 2022634 KB
125742_S1_M5_5351_bnt162 01 interim3 investigators.pdfMay 2, 20226 MB
125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdfMay 2, 20221 MB
125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 demographics.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 compliance.pdfMay 2, 20227 MB
125742_S1_M5_5351_bnt162 01 interim3 adverse events.pdfMay 2, 20227 MB
125742_S1_M5_5351_bnt162 01_20242.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01_20215.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01_20116.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01_10075.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01_10010.pdfMay 2, 20221 MB
125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdfMay 2, 202291 MB
125742_S1_M5_5351_bnt162 01 interim3 report body.pdfMay 2, 202242 MB
125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdfMay 2, 20221 MB
125742_S1_M5_5351_bnt162 01 interim3 protocol.pdfMay 2, 202210 MB
125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdfMay 2, 20223 MB
125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdfMay 2, 20221 MB
125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdfMay 2, 202212 MB
125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdfMay 2, 20225 MB
125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdfMay 2, 202265 MB
125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdfMay 2, 20224 MB
125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 sap.pdfMay 2, 20223 MB
125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdfMay 2, 20229 MB
125742_S1_M5_c4591001 S Supp acrf.pdfMay 2, 20223 MB
125742_S1_M5_c4591001 S csdrg.pdfMay 2, 20221 MB
125742_S1_M5_c4591001 S acrf.pdfMay 2, 20223 MB
125742_S1_M5_bnt162 01 S csdrg.pdfMay 2, 20221 MB
125742_S1_M5_bnt162 01 S acrf.pdfMay 2, 20221 MB
125742_S1_M5_bnt162 01 A adrg.pdfMay 2, 2022891 KB
125742_S1_M5_CRF_c4591001 1006 10061176.pdfMay 2, 20223 MB
125742_S1_M5_CRF_c4591001 1006 10061098.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1006 10061094.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1006 10061052.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1006 10061040.pdfMay 2, 20224 MB
125742_S1_M5_CRF_c4591001 1006 10061020.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1005 10051411.pdfMay 2, 20221 MB
125742_S1_M5_CRF_c4591001 1005 10051387.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1005 10051347.pdfMay 2, 20221 MB
125742_S1_M5_CRF_c4591001 1005 10051293.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1005 10051214.pdfMay 2, 20221 MB
125742_S1_M5_CRF_c4591001 1005 10051069.pdfMay 2, 20221 MB
125742_S1_M5_CRF_c4591001 1005 10051054.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1005 10051047.pdfMay 2, 20221 MB
125742_S1_M5_CRF_c4591001 1003 10031207.pdfMay 2, 20221 MB
125742_S1_M5_CRF_c4591001 1003 10031197.pdfMay 2, 20221 MB
125742_S1_M5_CRF_c4591001 1003 10031186.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1003 10031149.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1003 10031113.pdfMay 2, 20223 MB
125742_S1_M5_CRF_c4591001 1003 10031111.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1003 10031065.pdfMay 2, 20223 MB
125742_S1_M5_CRF_c4591001 1003 10031038.pdfMay 2, 20223 MB
125742_S1_M5_CRF_c4591001 1001 10011135.pdfMay 2, 20221 MB
125742_S1_M5_CRF_c4591001 1001 10011100.pdfMay 2, 20222 MB
125742_S1_M5_CRF_c4591001 1001 10011093.pdfMay 2, 20223 MB
FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xslMay 2, 2022183 KB
FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xmlMay 2, 2022985 KB
FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xslMay 2, 2022183 KB
FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xmlMay 2, 2022828 KB
FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xslMay 2, 2022183 KB
FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xmlMay 2, 2022300 KB
FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xslMay 2, 2022183 KB
FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xmlMay 2, 2022904 KB
FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xslMay 2, 2022183 KB
FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xmlMay 2, 2022692 KB
FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xptMay 2, 202244 MB
FDA-CBER-2021-5683-0059000-to-0065773_125742_S1_M5_c4591001-A-D-adcevd.zip (.xpt)May 2, 20228 MB
FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt)May 2, 202279 MB
FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt)May 2, 20226 MB
reissue_5.3.6 postmarketing experience.pdfApril 1, 2022958 KB
125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdfApril 1, 202228 MB
125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdfApril 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdfApril 1, 20225 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdfApril 1, 202259 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization.pdfApril 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-publications.pdfApril 1, 202210 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdfApril 1, 2022677 KB
125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdfApril 1, 20228 MB
125742_S1_M5_5351_c4591001-fa-interim-demographics.pdfApril 1, 202228 MB
125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdfApril 1, 2022869 KB
125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB
FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsxMarch 1, 202217 KB
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsxMarch 1, 202235 KB
FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsxMarch 1, 202284 KB
FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsxMarch 1, 202223 KB
FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsxMarch 1, 202218 KB
FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsxMarch 1, 202219 KB
FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsxMarch 1, 202222 KB
FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsxMarch 1, 202213 KB
FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsxMarch 1, 202229 KB
FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsxMarch 1, 202211 KB
FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsxMarch 1, 202224 KB
FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsxMarch 1, 202221 KB
FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsxMarch 1, 202214 KB
FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xslMarch 1, 2022183 KB
FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xmlMarch 1, 20221 MB
FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txtMarch 1, 2022197 KB
FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txtMarch 1, 202229 KB
FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txtMarch 1, 202224 KB
FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txtMarch 1, 202211 KB
FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txtMarch 1, 202249 KB
FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txtMarch 1, 202243 KB
FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txtMarch 1, 202245 KB
FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txtMarch 1, 202212 KB
FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txtMarch 1, 202272 KB
FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txtMarch 1, 202220 KB
FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txtMarch 1, 202219 KB
FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txtMarch 1, 202218 KB
FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txtMarch 1, 202281 KB
FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txtMarch 1, 202215 KB
FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txtMarch 1, 202215 KB
FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txtMarch 1, 202235 KB
FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txtMarch 1, 202214 KB
FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txtMarch 1, 202215 KB
FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txtMarch 1, 202232 KB
FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txtMarch 1, 2022156 KB
FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txtMarch 1, 202227 KB
FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txtMarch 1, 2022193 KB
125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-A-report-cci-rheumatic.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-report-cci-renal.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-report-cci-pulmonary.pdfMarch 1, 2022630 KB
125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdfMarch 1, 2022632 KB
125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdfMarch 1, 2022625 KB
125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdfMarch 1, 2022626 KB
125742_S1_M5_CRF_c4591001-1085-10851246.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851216.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851129.pdfMarch 1, 20222 MB
125742_S1_M5_CRF_c4591001-1085-10851116.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851018.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdfMarch 1, 202217 MB
125742_S1_M5_c4591001-T-S-suppl-arg.pdfMarch 1, 2022738 KB
125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdfMarch 1, 2022667 KB
125742_S1_M5_c4591001-T-S-roadmap.pdfMarch 1, 2022703 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdfMarch 1, 2022627 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-dementia.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-chf.pdfMarch 1, 2022628 KB
125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdfMarch 1, 2022632 KB
125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdfMarch 1, 2022670 KB
125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdfMarch 1, 2022846 KB
125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdfMarch 1, 2022607 KB
125742_S1_M5_c4591001-A-comorbidity-categories.pdfMarch 1, 2022637 KB
125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdfMarch 1, 2022620 KB
125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdfMarch 1, 2022634 KB
125742_S1_M5_c4591001-A-report-cci-mild-liver.pdfMarch 1, 2022628 KB
125742_S1_M5_c4591001-A-report-cci-mi.pdfMarch 1, 2022624 KB
125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdfMarch 1, 2022636 KB
125742_S1_M5_c4591001-A-report-cci-lymphoma.pdfMarch 1, 2022640 KB
125742_S1_M5_c4591001-A-report-cci-leukemia.pdfMarch 1, 2022631 KB
125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdfMarch 1, 2022626 KB
125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdfMarch 1, 202237 MB
125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdfMarch 1, 202213 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol.pdfMarch 1, 202231 MB
125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdfMarch 1, 20225 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdfMarch 1, 202212 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdfMarch 1, 202216 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-errata.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdfMarch 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-compliance.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdfMarch 1, 2022889 KB
125742_S1_M5_c4591001-A-bmi-12-15-scale.pdfMarch 1, 2022627 KB
125742_S1_M5_c4591001-A-adrg.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdfMarch 1, 2022602 KB
125742_S1_M1_us-agent-authorization.pdfMarch 1, 20221 MB
125742_S1_M1_trans-of-oblig.pdfMarch 1, 2022717 KB
125742_S1_M1_priority-review-request.pdfMarch 1, 20222 MB
125742_S1_M1_ipsp-agreed-letter.pdfMarch 1, 2022658 KB
125742_S1_M1_financial-cert-bias.pdfMarch 1, 2022696 KB
125742_S1_M1_financial-cert-3454.pdfMarch 1, 20223 MB
125742_S1_M1_fast-track-designation.pdfMarch 1, 2022649 KB
125742_S1_M1_exclusivity-claim.pdfMarch 1, 2022616 KB
125742_S1_M1_debarment.pdfMarch 1, 2022656 KB
125742_S1_M1_cover.pdfMarch 1, 20221 MB
125742_S1_M1_3674.pdfMarch 1, 20225 MB
125742_S1_M1_356h.pdfMarch 1, 2022714 KB
125742_S1_M4_4223_R-20-0072.pdfMarch 1, 20225 MB
125742_S1_M4_4223_185350.pdfMarch 1, 20221 MB
125742_S1_M2_27_synopses-indiv-studies.pdfMarch 1, 20222 MB
125742_S1_M2_27_literature-references.pdfMarch 1, 20222 MB
125742_S1_M2_26_pharmkin-written-summary.pdfMarch 1, 20221 MB
125742_S1_M2_26_pharmkin-tabulated-summary.pdfMarch 1, 20221 MB
125742_S1_M2_24_nonclinical-overview.pdfMarch 1, 20222 MB
125742_S1_M2_22_introduction.pdfMarch 1, 2022670 KB
125742_S1_M1_waiver-req-designated-suffix.pdfMarch 1, 20223 MB
125742_S1_M1_userfee.pdfMarch 1, 2022628 KB
CRFs-for-site-1128.pdfJanuary 31, 202214 MB
CRFs-for-site-1096.pdfJanuary 18, 202211 MB
CRFs-for-site-1081.pdfDecember 30, 202113 MB
Supplemental-Index-12-22-21.pdfDecember 22, 20212 MB
STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdfDecember 13, 20216 MB
STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdfDecember 13, 20213 MB
STN-125742_0_0-Section-2.5-Clinical-Overview.pdfDecember 13, 20214 MB
signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdfDecember 13, 2021207 KB
CRFs-for-site-1055.pdfDecember 13, 20216 MB
BATES-FDA-CBER-2021-5683-0002379_te.xptDecember 13, 20213 KB
BATES-FDA-CBER-2021-5683-0002380_ti.xptDecember 13, 202137 KB
BATES-FDA-CBER-2021-5683-0002377_supppr.xptDecember 13, 202172 KB
BATES-FDA-CBER-2021-5683-0002378_ta.xptDecember 13, 20218 KB
BATES-FDA-CBER-2021-5683-0002376_relrec.xptDecember 13, 2021567 KB
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txtDecember 13, 20215 KB
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdfDecember 1, 202114 MB
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdfDecember 1, 202112 MB
BATES-93_tv.xptNovember 17, 202116 KB
5.2-tabular-listing.pdfNovember 17, 20212 MB
5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdfNovember 17, 20218 MB
BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txtNovember 17, 20219 KB
5.3.6-postmarketing-experience.pdfNovember 17, 2021984 KB