TABLE 2

Summary of Uncommon Adverse Events in Selected Subgroups Evaluated With Historical Comparison Groups Using MaxSPRT and CMaxSPRT

AEType of SPRT AnalysisaSubgroup, Sex, Age Group in yNo. Observed VaccinationsNo. Observed AENo. Comparator Vaccinations, Historical PeriodNo. AEs in the Historical PeriodNo. Expected AEsRRTest StatisticCritical ValuebSignal
AnaphylaxisMaximizedMale, 9–17334 38100.9002.7No
CMaxMale, 9–17334 38101 053 6422002.6No
AppendicitisMaximizedMale, 9–1778 8853325.61.30.973.5No
CMaxMale, 9–1778 885331 053 6423121.41.63.8No
GBSMaximizedFemale, 18–26128 64500.6002.6No
CMaxFemale, 18–26128 6450431 4013002.7No
PancreatitisMaximizedMale, 18–2651 94482.63.13.72.9Yes
CMaxMale, 18–2651 9448349 966291.91.13.4No
SeizuresMaximizedFemale, 9–17304 38444115.20.403.8No
CMaxFemale, 9–17304 38444698 2631051.003.7No
StrokeMaximizedFemale, 18–26128 64554.91.002.9No
CMaxFemale, 18–26128 6455431 401111.50.32.9No
VTEMaximizedFemale, 18–26128 64589.80.803.1No
CMaxFemale, 18–26128 6458431 401540.503.4No
  • 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.

  • a 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).

  • b Critical values are threshold values of the test statistic above, in which the null hypothesis would be rejected.