Table 1. Design of the four non-interventional phase IV studies included in this safety analysis, using Octagam after changes in the preparation of the raw material used to manufacture it were implemented.

Study ID (Registration)	Study design	Country	Octagam strength	Study start and end dates	Period for integrated analysis (no. of patients)
Study 1 (ISRCTN58800347)	OL, MC, NIS, one-arm, non-controlled	Germany	10%	September 2008 – December 2013	June 2011 – November 2013 (803)
Study 2 (ISRCTN02245668)	OL, MC, NIS, one-arm, non-controlled	Austria, France, Spain, UK	5% and 10%	August 2011 – Ongoing	August 2011 – March 2014 (291)
Study 3 (NCT01859754)	OL, MC, two arms, controlled	USA	5%	May 2013 – Ongoing	May 2013 – March 2014 (83)
Study 4 (not registered)	OL, MC, NIS, one-arm, non-controlled	Germany	5%	February 1995 – December 2013	June 2011 – March 2013 (1,220)

MC = multicenter; NIS = non-interventional study; OL = open label.