Page 154 - pfizervax

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

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)
Total Prespecifie If the True If the True If the True If the True If the True
Severe d Alert Ratio of Ratio of Ratio of Ratio of Ratio of
Cases Rule Value Severe Cases Severe Cases Severe Cases Severe Cases Severe Cases
(A): Between the Between the Between the Between the Between the
Number of Vaccine and Vaccine and Vaccine and Vaccine and Vaccine and
Severe Placebo Placebo Placebo Placebo Placebo
Cases in the Groups Is Groups Is Groups Is Groups Is Groups Is
Vaccine 1:1, 1:1, 2:1, 3:1, 4:1,
Group to Probability Probability Probability Probability Probability
Trigger of A Being of A or More of A or More of A or More of A or More
Further Observed in Being Being Being Being
Action the Vaccine Observed in Observed in Observed in Observed in
Group the Vaccine the Vaccine the Vaccine the Vaccine
Group Group Group Group
2 2 25.00% 25.00% 44.49% 56.25% 64.00%
3 2 37.50% 50.00% 74.12% 84.38% 89.60%
4 3 25.00% 31.25% 59.32% 73.83% 81.92%
5 4 15.63% 18.75% 46.16% 63.28% 73.73%
6 4 23.44% 34.38% 68.10% 83.06% 90.11%
7 5 16.41% 22.66% 57.14% 75.64% 85.20%
8 6 10.94% 14.45% 46.90% 67.85% 79.69%
9 6 16.41% 25.39% 65.11% 83.43% 91.44%
10 7 11.72% 17.19% 56.02% 77.59% 87.91%
11 8 8.06% 11.33% 47.35% 71.33% 83.89%
12 8 12.08% 19.38% 63.25% 84.24% 92.74%
13 9 8.73% 13.34% 55.31% 79.40% 90.09%
14 10 6.11% 8.98% 47.66% 74.15% 87.02%
15 10 9.16% 15.09% 61.94% 85.16% 93.89%
16 11 6.67% 10.51% 54.81% 81.03% 91.83%
17 12 4.72% 7.17% 47.88% 76.53% 89.43%
18 13 3.27% 4.81% 41.34% 71.75% 86.71%
19 13 5.18% 8.35% 54.43% 82.51% 93.24%
20 14 3.70% 5.77% 48.06% 78.58% 91.33%

Page 144