Table 3.

Summary of safety and efficacy trials

	Treatment doses	Subjects	Efficacy results			Safety results
Phase II	100 U/kg within 8 hours of attack onset	9 subjects with 13 severe attacks	80% achieved symptom relief in 2 hours and minimal symptoms by 12 hours			No drug-related adverse events or immunogenic reactions
			Time to symptom relief (min)	Time to minimal symptoms (min)	Treatment failure	No postexposure antibody response against either rhC1-INH or rabbit-related impurities
Phase III	Saline	n = 29	495	1220	59%
	50 U/kg	n = 12	122	247	0%
	100 U/kg	n = 29	66	266	10%*

Note:

^*The larger 95% CI of the odds ratios for the 50 U/kg group compared with that for the 100 U/kg group suggests no real difference in the percentage of therapeutic failures in either treatment group, which is in agreement with open label data.