125742 S1 M5 5351 c4591001 interim mth6 randomization

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

2

Document text

16.1.7.2 Listing of Subjects Who Transferred to a Different Site – All Subjects ≥16 Years of Ag e 
Age Group  
(Years)  Subject  Transferred to Site  Reason for Transfer  
  
16-55 C4591001 1013 10131005  1117  Subject movin g to another site  
16-55 C4591001 1013 10131498  1015  Subject is moving  
16-55 C4591001 1013 10131518  1044  CTM request  
16-55 C4591001 1022 10221179  1015  Subject change of address  
16-55 C4591001 1055 10551061  1261  Subject moving to new site.  
16-55 C4591001 1055 10551071  1224  Subject request  
16-55 C4591001 1055 10551104  1269  Subject transfer to new site  
16-55 C4591001 1068 10681100  1146  Subject request  
16-55 C4591001 1080 10801135  1057  Subject transfer to new site.  
16-55 C4591001 1081 10811012  1110  subject transfer to new site  
16-55 C4591001 1081 10811023  1015  Subject request  
16-55 C4591001 1081 10811042  1091  Subject transfer to new site  
16-55 C4591001 1082 10821107  1156  Subject request  
16-55 C4591001 1090 10901291  1260  CTM requested subject transfer  
16-55 C4591001 1117 11171190  1114  subject moving to another site.  
16-55 C4591001 1126 11261082  1270  Study team request  
16-55 C4591001 1126 11261101  1270  Study team request  
16-55 C4591001 1126 11261196  1130  Study team request  
16-55 C4591001 1134 11341314  1156  Subject transfer based on request  
16-55 C4591001 1135 11351099  1126  CTM requested subject transfer  
16-55 C4591001 1135  11351100  1126  CTM requested subject transfer  
16-55 C4591001 1135 11351480  1133  Subject moved to another site based on subject's request  
16-55 C4591001 1140 11401176  1169  Subject change of address  
16-55 C4591001 1141 11411046  1009  Subject request  
16-55 C4591001 1162 11621304  1224  subject transfer to other site.  
16-55 C4591001 1170 11701364  1117  Subject transfers from site 1170 to site 1117  
16-55 C4591001 1170 11701365  1117  Subjec t transfers from site 1170 to site 1117  
090177e196af71f6\Final\Final On: 01-Apr-2021 13:33 (GMT) 
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16.1.7.2 Listing of Subjects Who Transferred to a Different Site – All Subjects ≥16 Years of Ag e 
Age Group  
(Years)  Subject  Transferred to Site  Reason for Transfer  
  
16-55 C4591001 1177 11771047  1152  Subject request  
16-55 C4591001 1204 12041107  1226  Subject 12041107 transferred to 1226 site.  
16-55 C4591001 1204 12041128  1091  Subject moving to another site  
16-55 C4591001 1204 12041129  1091  Subject moving to another site  
16-55 C4591001 1241 12412418  1226  Subject request  
>55 C4591001 1001 10011098  1223  Subject moving to another site  
>55 C4591001 1015 10151036  1260  Subject transferring to site 1260  
>55 C4591001 1015 10151037  1260  Subject transferring to site 1260  
>55 C4591001 1015 10151140  1083  Subject transfer to new site  
>55 C4591001 1015 10151141  1083  Subject transfer to new site  
>55 C4591001 1015 10151178  1260  CTM requested subject transfer  
>55 C4591001 1015 10151244  1013  Subject moving to another site  
>55 C4591001 1090 10901483  1027  subject transferring to new site  
>55 C4591001 1204 12041119  1091  Subject moving to another site  
>55 C4591001 1224 12241046  1168  Subject transfer to another site  
>55 C4591001 1235 12351111  1171  Subject request  
>55 C4591001 1260 12601113  1015  Subject transfer to new site  
  
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 27MAR2021 (01:37)  
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA/adsl_l003_site   
 
090177e196af71f6\Final\Final On: 01-Apr-2021 13:33 (GMT) 
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FDA-CBER-2021-5683-0128989