Table 2.

Serious adverse events after gene therapy

		0–6 months after gene therapy (n=8)		6–12 months after gene therapy (n=8)		1–2 years after gene therapy (n=7)		2–3 years after gene therapy (n=6)		≥3 years after gene therapy (n=5)*		Total after gene therapy (n=8)
		Patients	Events	Patients	Events	Patients	Events	Patients	Events	Patients	Events	Patients	Events
Any serious adverse event		6	19	1	1	3	4	1	1	1	2	6	27
Infection-related event
	Pyrexia	2	2	1	1	1	2	0	0	0	0	3	5
	Device-related infection	2	2	0	0	1	1	0	0	0	0	2	3
	Acute respiratory distress syndrome†	1	1	0	0	0	0	0	0	0	0	1	1
	Aspergillus infection	1	1	0	0	0	0	0	0	0	0	1	1
	Bacterial sepsis†	1	1	0	0	0	0	0	0	0	0	1	1
	Device-related sepsis	1	1	0	0	0	0	0	0	0	0	1	1
	Disseminated intravascular coagulation†	1	1	0	0	0	0	0	0	0	0	1	1
	Influenza	1	1	0	0	0	0	0	0	0	0	1	1
	Interstitial lung disease	1	1	0	0	0	0	0	0	0	0	1	1
	Gastroenteritis	1	2	0	0	0	0	0	0	0	0	1	2
	Pneumonia aspiration	1	1	0	0	0	0	0	0	0	0	1	1
	Viral infection	1	1	0	0	0	0	0	0	0	0	1	1
	Gastroenteritis rotavirus	0	0	0	0	1	1	0	0	0	0	1	1
	Tooth abscess	0	0	0	0	0	0	1	1	0	0	1	1
	Cellulitis	0	0	0	0	0	0	0	0	1	1	1	1
	Pneumonia bacterial	0	0	0	0	0	0	0	0	1	1	1	1
Other type of event
	Electrolyte imbalance	1	1	0	0	0	0	0	0	0	0	1	1
	Food allergy	1	1	0	0	0	0	0	0	0	0	1	1
	Irritability	1	1	0	0	0	0	0	0	0	0	1	1
	Neutropenia	1	1	0	0	0	0	0	0	0	0	1	1

MedDRA (version 19.0) preferred terms are used. MedDRA=Medical Dictionary for Regulatory Activities.

^*Range 3·0–5·6 years.

^†These three events were linked, occurring in patient 2, and were considered to be part of the same condition.