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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

LIST OF TABLES

Table 1. Local Reaction Grading Scale ..................................................................60
Table 2. Systemic Event Grading Scale..................................................................61
Table 3. Scale for Fever ..........................................................................................62

Table 4. Power Analysis for Noninferiority Assessment .....................................100

Table 5. Probability of Observing at Least 1 AE by Assumed True Event
Rates With Different Sample Sizes ........................................................101

Table 6. Interim Analysis Plan and Boundaries for Efficacy and Futility ............112
Table 7. Statistical Design Operating Characteristics: Probability of Success
or Failure for Interim Analyses ...............................................................113
Table 8. Statistical Design Operating Characteristics: Probability of Success
for Final Analysis and Overall ................................................................113
Table 9. Laboratory Abnormality Grading Scale .................................................123

Table 10. Stopping Rule: Enrollment Is Stopped if the Number of Severe
Cases in the Vaccine Group Is Greater Than or Equal to the
Prespecified Stopping Rule Value (S) ....................................................143

Table 11. Alert Rule: Further Action Is Taken if the Number of Severe Cases
in the Vaccine Group Is Greater Than or Equal to the Prespecified
Alert Rule Value (A) ..............................................................................144

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