| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf |
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| PHMPT-PFizerDocs/5.2-tabular-listing.pdf |
1.7 MB |
| PHMPT-PFizerDocs/5.3.6-postmarketing-experience.pdf |
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| PHMPT-PFizerDocs/125742_S1_M1_356h.pdf |
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| PHMPT-PFizerDocs/125742_S1_M1_3674.pdf |
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| PHMPT-PFizerDocs/125742_S1_M1_cover.pdf |
1.3 MB |
| PHMPT-PFizerDocs/125742_S1_M1_debarment.pdf |
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| PHMPT-PFizerDocs/125742_S1_M1_exclusivity-claim.pdf |
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| PHMPT-PFizerDocs/125742_S1_M1_fast-track-designation.pdf |
649 KB |
| PHMPT-PFizerDocs/125742_S1_M1_financial-cert-3454.pdf |
3.4 MB |
| PHMPT-PFizerDocs/125742_S1_M1_financial-cert-bias.pdf |
696 KB |
| PHMPT-PFizerDocs/125742_S1_M1_ipsp-agreed-letter.pdf |
658 KB |
| PHMPT-PFizerDocs/125742_S1_M1_priority-review-request.pdf |
1.6 MB |
| PHMPT-PFizerDocs/125742_S1_M1_trans-of-oblig.pdf |
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| PHMPT-PFizerDocs/125742_S1_M1_us-agent-authorization.pdf |
1 MB |
| PHMPT-PFizerDocs/125742_S1_M1_userfee.pdf |
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| PHMPT-PFizerDocs/125742_S1_M1_waiver-req-designated-suffix.pdf |
2.7 MB |
| PHMPT-PFizerDocs/125742_S1_M2_22_introduction.pdf |
670 KB |
| PHMPT-PFizerDocs/125742_S1_M2_24_nonclinical-overview.pdf |
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| PHMPT-PFizerDocs/125742_S1_M2_26_pharmkin-tabulated-summary.pdf |
1.3 MB |
| PHMPT-PFizerDocs/125742_S1_M2_26_pharmkin-written-summary.pdf |
1.4 MB |
| PHMPT-PFizerDocs/125742_S1_M2_27_literature-references.pdf |
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| PHMPT-PFizerDocs/125742_S1_M2_27_synopses-indiv-studies.pdf |
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| PHMPT-PFizerDocs/125742_S1_M4_4223_185350.pdf |
1.4 MB |
| PHMPT-PFizerDocs/125742_S1_M4_4223_R-20-0072.pdf |
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| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf |
889 KB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf |
1.3 MB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf |
2 MB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf |
2.4 MB |
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2.3 MB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf |
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| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf |
1.8 MB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf |
4.8 MB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf |
12 MB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf |
2.3 MB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf |
31.3 MB |
| PHMPT-PFizerDocs/125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf |
13 MB |
| PHMPT-PFizerDocs/5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf |
8 MB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf |
602 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-adrg.pdf |
1.5 MB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf |
627 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf |
634 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf |
620 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-comorbidity-categories.pdf |
637 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf |
607 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf |
846 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf |
629 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf |
670 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf |
632 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-chf.pdf |
628 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-dementia.pdf |
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| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf |
626 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf |
627 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf |
626 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-leukemia.pdf |
631 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf |
640 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf |
636 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-mi.pdf |
624 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf |
628 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf |
626 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf |
625 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf |
632 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf |
630 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-renal.pdf |
629 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf |
629 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf |
2.2 MB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-T-S-roadmap.pdf |
703 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf |
667 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-T-S-suppl-arg.pdf |
738 KB |
| PHMPT-PFizerDocs/125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf |
17.4 MB |
| PHMPT-PFizerDocs/125742_S1_M5_CRF_c4591001-1085-10851018.pdf |
2.3 MB |
| PHMPT-PFizerDocs/125742_S1_M5_CRF_c4591001-1085-10851116.pdf |
1.2 MB |
| PHMPT-PFizerDocs/125742_S1_M5_CRF_c4591001-1085-10851129.pdf |
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| PHMPT-PFizerDocs/125742_S1_M5_CRF_c4591001-1085-10851246.pdf |
1.1 MB |
| PHMPT-PFizerDocs/BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt |
9 KB |
| PHMPT-PFizerDocs/BATES-93_tv.xpt |
16 KB |
| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt |
9 KB |
| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt |
9 KB |
| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt |
9 KB |
| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt |
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| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002376_relrec.xpt |
567 KB |
| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002377_supppr.xpt |
72 KB |
| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002378_ta.xpt |
8 KB |
| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002379_te.xpt |
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| PHMPT-PFizerDocs/BATES-FDA-CBER-2021-5683-0002380_ti.xpt |
37 KB |
| PHMPT-PFizerDocs/CRFs-for-site-1055.pdf |
6.4 MB |
| PHMPT-PFizerDocs/CRFs-for-site-1081.pdf |
13.2 MB |
| PHMPT-PFizerDocs/CRFs-for-site-1096.pdf |
11.3 MB |
| PHMPT-PFizerDocs/CRFs-for-site-1128.pdf |
13.6 MB |
| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0021888-to-0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0021902-to-0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0021916-to-0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0021930-to-0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0021944-to-0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0021964-to-0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0021981-to-0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022028-to-0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022041-to-0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022054-to-0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022063-to-0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022136-to-0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022326-to-0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022346-to-0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022365-to-0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022561-to-0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022568-to-0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022601-to-0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022618-to-0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022692-to-0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022766-to-0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022793-to-0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0022867-to-0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023007-to-0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023032-to-0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023455-to-0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023490-to-0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale-1.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023490-to-0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023500-to-0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023523-to-0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023550-to-0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023711-to-0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023895-to-0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023919-to-0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023936-to-0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023944-to-0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023955-to-0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023971-to-0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023975-to-0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023979-to-0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023983-to-0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx |
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| PHMPT-PFizerDocs/FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx |
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| PHMPT-PFizerDocs/Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdf |
12.3 MB |
| PHMPT-PFizerDocs/Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdf |
13.8 MB |
| PHMPT-PFizerDocs/signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf |
207 KB |
| PHMPT-PFizerDocs/STN-125742_0_0-Section-2.5-Clinical-Overview.pdf |
4.2 MB |
| PHMPT-PFizerDocs/STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf |
3.2 MB |
| PHMPT-PFizerDocs/STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf |
6.5 MB |
| PHMPT-PFizerDocs/Supplemental-Index-12-22-21.pdf |
1.9 MB |
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