From Public Health and Medical Professionals for Transparency
| FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.xpt | May 2, 2022 | 163 MB | Download |
| FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.xpt | May 2, 2022 | 4 GB | Download |
| FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.xpt | May 2, 2022 | 394 MB | Download |
| FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xpt | May 2, 2022 | 44 MB | Download |
| FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xml | May 2, 2022 | 985 KB | Download |
| FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xml | May 2, 2022 | 300 KB | Download |
| FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xsl | May 2, 2022 | 828 KB | Download |
| FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xml | May 2, 2022 | 904 KB | Download |
| FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xml | May 2, 2022 | 692 KB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061098.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061176.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061094.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061040.pdf | May 2, 2022 | 4 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061052.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061020.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051411.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051387.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051293.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051347.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051214.pdf | May 2, 2022 | 1 MB | Download |
| File Name | Date Produced | File Size | Link |
|---|
| 125742_S1_M5_CRF_c4591001 1005 10051054.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051069.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031038.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_CRF_c4591001 1001 10011100.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1001 10011135.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1001 10011093.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051047.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031197.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031207.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031186.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031149.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031113.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031111.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031065.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_bnt162 01 S acrf.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_bnt162 01 A adrg.pdf | May 2, 2022 | 891 KB | Download |
| 125742_S1_M5_c4591001 S csdrg.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_c4591001 S Supp acrf.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_c4591001 S acrf.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_bnt162 01 S csdrg.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdf | May 2, 2022 | 12 MB | Download |
| 125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdf | May 2, 2022 | 5 MB | Download |
| 125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdf | May 2, 2022 | 65 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdf | May 2, 2022 | 9 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 report body.pdf | May 2, 2022 | 42 MB | Download |
| File Name | Date Produced | File Size | Link |
|---|
| 125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 protocol.pdf | May 2, 2022 | 10 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdf | May 2, 2022 | 4 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 sap.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdf | May 2, 2022 | 91 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 demographics.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 compliance.pdf | May 2, 2022 | 7 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 adverse events.pdf | May 2, 2022 | 7 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 investigators.pdf | May 2, 2022 | 6 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdf | May 2, 2022 | 634 KB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01_10075.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01_10010.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_bnt162 01_20215.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01_20242.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01_20116.pdf | May 2, 2022 | 2 MB | Download |
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