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. Author manuscript; available in PMC: 2022 Jun 10.
Published in final edited form as: NEJM Evid. 2022 Apr 11;1(5):EVIDoa2100056. doi: 10.1056/EVIDoa2100056

Table 3:

Participants experiencing adverse events (ITT)

Randomized Arm
Nonavalent HPV Bivalent HPV Meningococcal All
 
Enrolled, n 758 760 757 2275
Any SAE, n(%) 34 (4.5%) 39 (5.1%) 39 (5.2%) 112 (4.9%)
  Any pregnancy related, n (%) 24 (3.2%) 19 (2.5%) 14 (1.8%) 57 (2.5%)
  Any infection/inflammation, n (%) 9 (1.2%) 16 (2.1%) 21 (2.8%) 46 (2.0%)
  Any injury, n (%) 0 (0.0%) 3 (0.4%) 4 (0.5%) 7 (0.3%)
  Any mental health, n (%) 2 (0.3%) 1 (0.1%) 2 (0.3%) 5 (0.2%)

NOTE: Participants may have more than one event across, but not within, event type categories. SAE: Serious adverse event