125742 S1 M5 5351 c4591001 fa interim protocol deviations

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16.2.2.1 Listing of Important Protocol Deviations – Phase 1, 2 Doses, 21 Days Apar t 
Protocol  
Deviation  
Category  Protocol Deviation Subcategory  Number 
of 
Subjects  Subject  
(Number of  
Deviations if >1)  
  
Inclusion/E xclusion  Participant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood 
chemistry laboratory value that meets the definition of a >=grade 1 abnormality)  1 C4591001 1002 
10021053  
Inclusion/Exclusion  Participant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood 
chemistry laboratory value that meets the definition of a >=grade 1 abnormality)  1 C4591001 1003 
10031021  
Inclusion/Exclusion  Participant met exclusion criterion  #19 ( Phase 1 only: any screening hematology and/or blood 
chemistry laboratory value that meets the definition of a >=grade 1 abnormality)  1 C4591001 1003 
10031047  
Inclusion/Exclusion  Participant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood 
chemistry laboratory value that meets the definition of a >=grade 1 abnormality)  2 C4591001 1003 
10031017  
      C4591001 1003 
10031070  
  
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: addv Table Generation: 31AU G2020 (09:18)  
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: (CDISC)/C4591001_IA_P1/adsl_l005_pd_p1   
 
 
090177e194d7854f\Final\Final On: 07-Sep-2020 03:52 (GMT) 
Page 1
FDA-CBER-2021-5683-0029230
16.2.2.1.1 Listing of Important Protocol Deviations – Phase 1 – BNT162b1 (100 μg ) 
Protocol  
Deviation  
Category  Protocol Deviation Subcategory  Number of  
Subjects  Subject  
(Number of  
Deviations if >1)  
  
No subject me ets the reporting criteria.    
 
  
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: addv Table Generation: 19SEP2020 (10:20)  
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: ./nda3/C4591001_IA_P1_100/adsl_l005_pd_100_p1   
 
 
090177e194fbc508\Final\Final On: 22-Sep-2020 14:24 (GMT) 
Page 2
FDA-CBER-2021-5683-0029231