Summary of Uncommon Adverse Events in Selected Subgroups Evaluated With Historical Comparison Groups Using MaxSPRT and CMaxSPRT
| AE . | Type of SPRT Analysisa . | Subgroup, Sex, Age Group in y . | No. Observed Vaccinations . | No. Observed AE . | No. Comparator Vaccinations, Historical Period . | No. AEs in the Historical Period . | No. Expected AEs . | RR . | Test Statistic . | Critical Valueb . | Signal . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anaphylaxis | Maximized | Male, 9–17 | 334 381 | 0 | — | — | 0.9 | 0 | 0 | 2.7 | No |
| CMax | Male, 9–17 | 334 381 | 0 | 1 053 642 | 2 | — | 0 | 0 | 2.6 | No | |
| Appendicitis | Maximized | Male, 9–17 | 78 885 | 33 | — | — | 25.6 | 1.3 | 0.97 | 3.5 | No |
| CMax | Male, 9–17 | 78 885 | 33 | 1 053 642 | 312 | — | 1.4 | 1.6 | 3.8 | No | |
| GBS | Maximized | Female, 18–26 | 128 645 | 0 | — | — | 0.6 | 0 | 0 | 2.6 | No |
| CMax | Female, 18–26 | 128 645 | 0 | 431 401 | 3 | — | 0 | 0 | 2.7 | No | |
| Pancreatitis | Maximized | Male, 18–26 | 51 944 | 8 | — | — | 2.6 | 3.1 | 3.7 | 2.9 | Yes |
| CMax | Male, 18–26 | 51 944 | 8 | 349 966 | 29 | — | 1.9 | 1.1 | 3.4 | No | |
| Seizures | Maximized | Female, 9–17 | 304 384 | 44 | — | — | 115.2 | 0.4 | 0 | 3.8 | No |
| CMax | Female, 9–17 | 304 384 | 44 | 698 263 | 105 | — | 1.0 | 0 | 3.7 | No | |
| Stroke | Maximized | Female, 18–26 | 128 645 | 5 | — | — | 4.9 | 1.0 | 0 | 2.9 | No |
| CMax | Female, 18–26 | 128 645 | 5 | 431 401 | 11 | — | 1.5 | 0.3 | 2.9 | No | |
| VTE | Maximized | Female, 18–26 | 128 645 | 8 | — | — | 9.8 | 0.8 | 0 | 3.1 | No |
| CMax | Female, 18–26 | 128 645 | 8 | 431 401 | 54 | — | 0.5 | 0 | 3.4 | No |
| AE . | Type of SPRT Analysisa . | Subgroup, Sex, Age Group in y . | No. Observed Vaccinations . | No. Observed AE . | No. Comparator Vaccinations, Historical Period . | No. AEs in the Historical Period . | No. Expected AEs . | RR . | Test Statistic . | Critical Valueb . | Signal . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anaphylaxis | Maximized | Male, 9–17 | 334 381 | 0 | — | — | 0.9 | 0 | 0 | 2.7 | No |
| CMax | Male, 9–17 | 334 381 | 0 | 1 053 642 | 2 | — | 0 | 0 | 2.6 | No | |
| Appendicitis | Maximized | Male, 9–17 | 78 885 | 33 | — | — | 25.6 | 1.3 | 0.97 | 3.5 | No |
| CMax | Male, 9–17 | 78 885 | 33 | 1 053 642 | 312 | — | 1.4 | 1.6 | 3.8 | No | |
| GBS | Maximized | Female, 18–26 | 128 645 | 0 | — | — | 0.6 | 0 | 0 | 2.6 | No |
| CMax | Female, 18–26 | 128 645 | 0 | 431 401 | 3 | — | 0 | 0 | 2.7 | No | |
| Pancreatitis | Maximized | Male, 18–26 | 51 944 | 8 | — | — | 2.6 | 3.1 | 3.7 | 2.9 | Yes |
| CMax | Male, 18–26 | 51 944 | 8 | 349 966 | 29 | — | 1.9 | 1.1 | 3.4 | No | |
| Seizures | Maximized | Female, 9–17 | 304 384 | 44 | — | — | 115.2 | 0.4 | 0 | 3.8 | No |
| CMax | Female, 9–17 | 304 384 | 44 | 698 263 | 105 | — | 1.0 | 0 | 3.7 | No | |
| Stroke | Maximized | Female, 18–26 | 128 645 | 5 | — | — | 4.9 | 1.0 | 0 | 2.9 | No |
| CMax | Female, 18–26 | 128 645 | 5 | 431 401 | 11 | — | 1.5 | 0.3 | 2.9 | No | |
| VTE | Maximized | Female, 18–26 | 128 645 | 8 | — | — | 9.8 | 0.8 | 0 | 3.1 | No |
| CMax | Female, 18–26 | 128 645 | 8 | 431 401 | 54 | — | 0.5 | 0 | 3.4 | No |
Results were extracted from the final report (week starting October 1, 2017) for all events except for pancreatitis, which comes from the week when it first signaled (week 71). CIDP was not included because there were no events during the study period. AE, adverse event; CMax, conditional maximized; SPRT, sequential probability ratio test; —, not applicable.
MaxSPRT: analyses were conducted in combination with the general VSD population historic comparison group (2007–2014). CMaxSPRT: analyses were conducted in combination with the historic VSD population vaccinated with comparator vaccines (2007–2014).
Critical values are threshold values of the test statistic above, in which the null hypothesis would be rejected.