Table 3.

Adverse Events in the Safety Populations of the FAST-1 and FAST-2 Trials, According to Study Group.

Adverse Event	FAST-1		FAST-2
	Icatibant (N = 27)	Placebo (N = 29)	Icatibant (N = 36)	Tranexamic Acid (N = 38)
	no. of patients (%)
Any adverse event	12 (44)	19 (66)	19 (53)	16 (42)
Drug-related adverse event*	4 (15)	1 (3)	5 (14)	4 (11)
Serious adverse event†	0	0	4 (11)	1 (3)
Injection-site reaction	26 (96)	8 (28)	35 (97)	10 (26)

^*Drug-related adverse events in the icatibant groups were as follows: in the FAST-1 trial, injection-site pain in one patient, abnormal results on a liver-function test in one patient, dizziness in one patient, and nasal congestion in one patient; and in the FAST-2 trial, abdominal pain, nausea, and worsening of hereditary angioedema in one patient; asthenia in one patient; worsening of an acute attack of angioedema in one patient; injection-site reaction and two episodes of rash in one patient; and injection-site reaction in one patient.

^†Serious adverse events in the icatibant group in the FAST-2 trial were as follows: gastroenteritis and hypertensive crisis in one patient, laryngeal attack of angioedema in one patient, abdominal attack of angioedema in one patient, cholelithiasis in one patient, and laryngeal attack of angioedema requiring intubation in one patient. None were considered to be related to icatibant.