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CCI_Mild liver MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Mild liverCode: 90002941Extension: CCIReport Date/Time: 27-Oct-2020:10:50:21 AM EDT Term Code Level Category Weight Scope Venoocclusive liver disease 10047216 PT Steatohepatitis 10076331 PT Radiation hepatitis 10051015 PT Portal fibrosis 10074726 PT Peliosis hepatis 10034229 PT Non-cirrhotic portal hypertension 10077259 PT Non-alcoholic steatohepatitis 10053219 PT Nonalcoholic fatty liver disease 10082249 PT Lupus…
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CCI_Mod sev liver MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Mod sev liverCode: 90002937Extension: CCIReport Date/Time: 27-Oct-2020:10:51:50 AM EDT Term Code Level Category Weight Scope Varices oesophageal 10056091 PT Subacute hepatic failure 10056956 PT Portal hypertension 10036200 PT Oesophageal varices haemorrhage 10030210 PT Hepatorenal syndrome 10019846 PT Hepatorenal failure 10019845 PT Hepatic vein occlusion 10058991 PT Hepatic necrosis 10019692 PT Hepatic failure…
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CCI_Metastatic tumou r MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Metastatic tumourCode: 90002954Extension: CCIReport Date/Time: 27-Oct-2020:10:48:51 AM EDT Term Code Level Category Weight Scope Metastatic neoplasm 10061289 PT Metastatic malignant melanoma 10027480 PT Metastatic lymphoma 10071541 PT Metastatic glucagonoma 10075245 PT Metastatic glioma 10063157 PT Metastatic gastric cancer 10063916 PT Metastatic choriocarcinoma 10071532 PT Metastatic carcinoma of the bladder…
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CCI_MI MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_MICode: 90002929Extension: CCIReport Date/Time: 27-Oct-2020:10:48:20 AM EDT Term Code Level Category Weight Scope Silent myocardial infarction 10049768 PT Postinfarction angina 10058144 PT Papillary muscle infarction 10033697 PT Myocardial infarction 10028596 PT ECG signs of myocardial infarction 10075299 PT Coronary artery occlusion 10011086 PT Acute myocardial infarction 10000891 PT 090177e196edd238\Final\Final On:…
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CCI_Any malignancy MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Any malignancyCode: 90002950Extension: CCIReport Date/Time: 27-Oct-2020:10:42:05 AM EDT Term Code Level Category Weight Scope Ovarian germ cell embryonal carcinoma stage I 10033196 PT Ovarian germ cell choriocarcinoma stage IV 10033195 PTOvarian germ cell choriocarcinoma stage III 10033191 PTOvarian germ cell choriocarcinoma stage II 10033187 PTOvarian germ cell choriocarcinoma stage I 10033183 PTOvarian germ cell…
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Unique Subject Identifier C4591001 1001 10011081C4591001 1001 10011082C4591001 1001 10011083C4591001 1001 10011084C4591001 1001 10011085C4591001 1001 10011086C4591001 1001 10011087C4591001 1001 10011088C4591001 1001 10011089C4591001 1001 10011090C4591001 1001 10011091C4591001 1001 10011092C4591001 1001 10011093C4591001 1001 10011094C4591001 1001 10011095C4591001 1001 10011096C4591001 1001 10011097C4591001 1001 10011098C4591001 1001 10011099C4591001 1001 10011100C4591001 1001 10011101C4591001…
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CCI_AIDS HI V MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_AIDS HIVCode: 90002940Extension: CCIReport Date/Time: 27-Oct-2020:10:39:40 AM EDT Term Code Level Category Weight Scope Blood HIV RNA increased 10049827 PT Blood HIV RNA fluctuation 10076287 PT Asymptomatic HIV infection 10003581 PT AIDS retinopathy 10053227 PT AIDS related complex 10001513 PT AIDS cholangiopathy 10067092 PT Acute HIV infection 10000807 PT Acquired immunodeficiency syndrome 10000565 PT Perinatal HIV…
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Site Subject ID 1001 10011081 1001 10011084 1001 10011085 1001 10011086 1001 10011087 1001 10011088 1001 10011089 1001 10011090 1001 10011091 1001 10011092 1001 10011093 1001 10011094 1001 10011095 1001 10011096 1001 10011097 1001 10011098 1001 10011099 1001 10011100 1001 10011101 1001 10011102 1001 10011103 1001 10011104 1003 10031088 1003 10031089 1003 10031090 1003 10031091 1003 10031092 1003 10031093 1003 10031094 1003 10031095 1003 10031096 1003 10031097 1003 10031098 1003 10031099 1003…
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CCI_Diabetes without comp MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Diabetes without compCode: 90002932Extension: CCIReport Date/Time: 27-Oct-2020:10:45:46 AM EDT Term Code Level Category Weight Scope Type 3 diabetes mellitus 10072659 PT Type 2 diabetes mellitus 10067585 PTType 1 diabetes mellitus 10067584 PTSomogyi phenomenon 10052093 PTShock hypoglycaemic 10040576 PTPancreatogenous diabetes 10033660 PTMonogenic diabetes 10075980 PTMauriac syndrome 10060761 PTLatent…
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Category Sheet AIDS/HIV Report_CCI_AIDS HIV Any Malignancy Report_CCI_Any malignancy Cerebrovascular Disease Report_CCI_Cerebrovascular Chronic Pulmonary Disease Report_CCI_Pulmonary Congestive Heart Failure Report_CCI_CHF Dementia Report_CCI_Dementia Diabetes With Chronic Complication Report_CCI_Diabetes with comp Diabetes Without Chronic Complication Report_CCI_Diabetes without comp Hemiplegia or Paraplegia Report_CCI_Hemiplegia Leukemia Report_CCI_Leukemia Lymphoma Report_CCI_Lymphoma…
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CCI_Diabetes with comp MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Diabetes with compCode: 90002931Extension: CCIReport Date/Time: 27-Oct-2020:10:45:08 AM EDT Term Code Level Category Weight Scope Diabetic vascular disorder 10061815 PT Diabetic ulcer 10056340 PTDiabetic retinopathy 10012689 PTDiabetic neuropathy 10012680 PTDiabetic nephropathy 10061835 PTDiabetic mononeuropathy 10012676 PTDiabetic microangiopathy 10054044 PTDiabetic macroangiopathy 10063547 PTDiabetic gangrene…
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CCI_CHF MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_CHFCode: 90002959Extension: CCIReport Date/Time: 27-Oct-2020:10:43:25 AM EDT Term Code Level Category Weight Scope Cardiac failure acute 10007556 PT Cardiac failure 10007554 PT Cardiac asthma 10007522 PT Cardiac amyloidosis 10007509 PTAcute right ventricular failure 10063082 PTAcute pulmonary oedema 10001029 PTAcute left ventricular failure 10063081 PTViral cardiomyopathy 10068767 PTVentricular failure 10060953 PTThyrotoxic…
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CCI_Dementia MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_DementiaCode: 90002953Extension: CCIReport Date/Time: 27-Oct-2020:10:44:39 AM EDT Term Code Level Category Weight Scope Vascular dementia 10057678 PT Senile psychosis 10039987 PT Senile dementia 10039966 PT Progressive supranuclear palsy 10036813 PT Prodromal Alzheimer's disease 10074616 PT Presenile dementia 10036631 PT Posterior cortical atrophy 10078207 PT Neurodegenerative disorder 10053643 PT Mixed dementia 10075174…
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CCI_Cerebrovascular MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_CerebrovascularCode: 90002958Extension: CCIReport Date/Time: 27-Oct-2020:10:44:05 AM EDT Term Code Level Category Weight Scope Vertebrobasilar insufficiency 10047334 PT Vertebral artery thrombosis 10057777 PT Vertebral artery stenosis 10047330 PT Vertebral artery perforation 10075735 PT Vertebral artery occlusion 10048965 PT Vertebral artery dissection 10071716 PT Vascular encephalopathy 10063661 PT Transient…
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EXTERNAL DATA MONITO RING COMMITTEE PFIZER INTERNAL USE ONLY The official version of this form is located in the electronic document management system. CT22-GSOP-RF02 6.0External Data Monitoring Committee and Internal Review Committee Charter Template 01-Nov-2019 Page 1of 34 TMF Doc ID: 64.05 and 713.02 C459 Investigational BNT162 Vaccine Program PF-07302048 Version: 5.0 Date: 04-Nov-2020 090177e19574a416\Approved\Approved On: 06-Nov-2020 15:39 (GMT) Page 1 FDA-CBER-2021-5683-0015467…
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FDA-CBER-2021-5683-0000013 FDA-CBER-2021-5683-0000014 FDA-CBER-2021-5683-0000015 FDA-CBER-2021-5683-0000016 FDA-CBER-2021-5683-0000017 FDA-CBER-2021-5683-0000018 FDA-CBER-2021-5683-0000019 FDA-CBER-2021-5683-0000020 FDA-CBER-2021-5683-0000021 FDA-CBER-2021-5683-0000022 FDA-CBER-2021-5683-0000023 FDA-CBER-2021-5683-0000024 FDA-CBER-2021-5683-0000025 FDA-CBER-2021-5683-0000026 FDA-CBER-2021-5683-0000027 FDA-CBER-2021-5683-0000028 FDA-CBER-2021-5683-0000029 FDA-CBER-2021-5683-0000030…
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FDA-CBER-2021-5683-0000001 FDA-CBER-2021-5683-0000002 FDA-CBER-2021-5683-0000003 FDA-CBER-2021-5683-0000004 FDA-CBER-2021-5683-0000005 FDA-CBER-2021-5683-0000006 FDA-CBER-2021-5683-0000007 FDA-CBER-2021-5683-0000008 FDA-CBER-2021-5683-0000009 FDA-CBER-2021-5683-0000010 FDA-CBER-2021-5683-0000011 FDA-CBER-2021-5683-0000012
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Re ports CONFIDENTIAL Page 15.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 Report Prepared by: Worldwide Safety Pfizer The information contained in this document is proprietary and confidential. Any disclosure, reproduction, distribution, or other dissemination of this information outside of Pfizer, its Affiliates, its Licensees, or Regulatory…
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U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Our STN: BL 125742/45 SUPPLEMENT APPROVAL PMR FULFILLED BioNTech Manufacturing GmbH July 8, 2022 Attention: Gosia Mineo, M.S. Pfizer, Inc. 1 Pfizer Way 190/004/4405 Pearl River, NY 10965 Dear Ms. Mineo: We have approved your request received on De cember 16, 2021, to supplement your Biologics License Application (BLA) submitte d under section 351(a) of the Public Health …
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Statistical Review STN: 125742/45 Page i Application T ype BLA Supplement STN 125742/45 CBER Received Date December 16, 2021 PDUFA Goal Date June 17, 2022 Division / Office DVRPA/OVRR Committee Chair Ramachandra Naik Clinical Reviewer(s) Susan Wollersheim Project Mana ger Michael Smith; Laura Gottschalk Priorit y Review Yes Reviewer Name Ye Yang, Mathem atical Statistician, DB/VEB Review Completion Date / Stamped Date Concurrence Lei Huan g, Concurrin g Reviewer,…