Safety
TEAEs, CRS, anemia, Fatigue
ADVERSE EVENTS, EVENTS, ADVERSE EVENT, ANEMIA
Of the related treatment emergent adverse events (TEAEs), 93% of the events were Grade 1 or 2. A single occurrence of anemia was the only related Grade 3 TEAE; this occurred in a patient with Grade 2 anemia at baseline. Fatigue was the most common TEAE, reported in 6 participants, with 5 such AEs gauged as treatment related TEAEs (Treatment Related TEAEs. A. The number of instances of related TEAEs by the MedDRA Preferred Term. B. Summary of the related TEAEs by GradeOne participant in the Low Dose – Single Prime cohort experienced a Grade 2 CRS following the second administration of SQZ-PBMC-HPV. This was also the only treatment related serious adverse event (SAE). The CRS was treated with short term oxygen support and hydromorphone, and the individual was hospitalized (< 24 h) for monitoring. The CRS proved self-limiting within hours and the patient became afebrile and hemodynamically stable. No AESIs were reported following the third administration of SQZ-PBMC-HPV.