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Transcript
Safety and
Adverse events I
Edward A. Stadtmauer et al. Blood 2014;124:2921-2929
Adverse events:
solicited: local reactions (pain, redness, oedema) vs general (fever,
headache, fatigue, myalgia, gi tract symptoms) – reported by
“educated” pts on diary cards for 7 days after each vaccination
unsolicited: reported by pts on cards throughout the study and up
to 3o days after last vaccination – cause of AE investigated by
researchers
Recurrence of malignancy, new onset auto-immune disease,
immune-mediated inflammatory disorders – documented
throughout the study