Page 153 - pfizervax

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

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)
Total Severe Cases Prespecified Stopping Rule Value If the True Ratio of Severe Cases
(S): Number of Severe Cases in the Between Vaccine and Placebo
Vaccine Group to Stop Groups Is 1:1, Probability of S or
More Being Observed in the Vaccine
Group
4 4 N/A
5 5 3.13%
6 6 1.56%
7 7 0.78%
8 7 3.52%
9 8 1.95%
10 9 1.07%
11 9 3.27%
12 10 1.93%
13 10 4.61%
14 11 2.87%
15 12 1.76%
16 12 3.84%
17 13 2.45%
18 13 4.81%
19 14 3.18%
20 15 2.07%
Abbreviation: N/A = not applicable.

Page 143