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. Author manuscript; available in PMC: 2018 May 1.
Published in final edited form as: Am J Med Genet A. 2017 Mar 30;173(5):1243–1250. doi: 10.1002/ajmg.a.38160

TABLE 2.

Adverse events with IN-OT

Systems affected (CTCAE 4.0) Attribution#
Total Serious-related Serious-unrelated Non-serious-related Non-serious-unrelated
Category AE term Number of
subjects out of
24 eligible		 Number
of adverse
events		 Number
of
subjects		 Number
of adverse
events		 Number
of
subjects		 Number
of adverse
events		 Number
of
subjects		 Number
of adverse
events		 Number
of
subjects		 Number
of adverse
events
General disorders and administration site conditions Fatigue 2 4 0 0 0 0 2 4 0 0
General disorders and administration site conditions –nasal irritation McNemar Test P-value = 0.125 10 26 0 0 0 0 10 25 1 1
Irritability 2 2 0 0 0 0 2 2 0 0
Skin and subcutaneous tissue disorders Pain of skin 1 1 0 0 0 0 0 0 1 1
Rash maculo-papular 1 2 0 0 0 0 1 2 0 0
Not serious Serious Total
Total number of adverse events 35 0 35
Attribution#
  Probably not related 2 0 2
  Possibly related 33 0 33
Outcome
  Recovered/resolved without sequelae 35 0 35