. Author manuscript; available in PMC: 2016 Jan 31.

Published in final edited form as: Mol Genet Metab. 2014 Nov 7;114(2):203–208. doi: 10.1016/j.ymgme.2014.10.017

Table 2. Adverse Events Considered Possibly Related to rhGUS Treatment.

Week	Infusion	Time from Last Infusion to Start of AE	Duration of AE	Adverse Event	CTCAE Severity^a
Baseline	1	1 day	1 day	Non pruritic erythematous rash	1
Baseline	1	5 days	1 day	Coarse rales, non-productive cough and requires suction	1
4	3	1 day	7 days	Increased ETCO₂	1
6	4	7 days	1 day	Increased ETCO₂	1
8	5	same day	1 day	Increased ETCO₂	1
8	5	1 day	2 days	Desat, Fever Increased secretions	1
12	7	1 day	1 day	Elevated temp and heart rate	1
12	7	1 day	4 days	Blood-tinged secretions & Desat	2
14	8	11 days	2 days	Elevated temp and heart rate	1
14	8	11 days	2 days	Increased Secretions and Desat	2
16	-	16 days	3 days	Increased Secretions and Desat	2
22	11	10 days	1 day	Increased ETCO₂ and emesis	1
24	12	1 day	4 days	Fatigue	1
24	12	2 days	<1 day	Increased Temp	1

Common Terminology Criteria for Adverse Events (CTCAE) Severity: 1=Mild, 2= Moderate, 3=Severe/undesirable, 4=Life threatening/ debilitating, 5=Death; AE, adverse event; ETCO₂, end-tidal carbon dioxide; desat, desaturation; temp, temperature