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. Author manuscript; available in PMC: 2020 Jun 2.
Published in final edited form as: J Neurosurg Pediatr. 2018 Dec 7;23(3):333–342. doi: 10.3171/2018.9.PEDS17225

TABLE 1.

Cumulative adverse events: severity and causality

Maximum Severity Any Relationship (n = 54) Attribution to Study Procedure (n = 21) Attribution to Study Drug (n = 16) Unrelated to Study (n = 17) Resolved (n = 39) Unresolved (n = 15)
Grade 1 29 (54%) 13 8 8 27 2
Grade 2 23 (43%) 8 8 7 11 12
Grade 3 2 (3%) 0 0 2 1 1
Grade 4 0 0 0 0 0 0
Grade 5* 0 0 0 0 0 0
*

All patients ultimately died from progression of the underlying disease (documented MRI progression of disease process beyond its extent at the time of infusion).