The FIBROID Registry--Report of Structure, Methods, and Initial Results, Table 11

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The FIBROID Registry

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Table 11. Summary of Adverse Events by Type

Adverse events by type	N	%
None	2,952	97%
Any event	89	3%
1 event	84	2.8%
2 events	5	0.2%
Major events (class C, D and E)	20 (in 18 patients)	0.6%
Nausea	4	0.1%
Drug reaction	1	0.03%
Prolonged pain^a	6	0.2%
Vessel injury	3	0.1%
Other complications	4	0.1%
Urinary retention	1	0.03%
Contrast reaction	1	0.03%
Minor events (class A and B)	74 (in 71 patients)	2.3%
Contrast reaction	3	0.1%
Drug reaction	5	0.2%
Device-related	1	0.03%
Groin hematoma	22	0.7%
Nausea	0	-
Non-target embolization	1	0.03%
Prolonged pain	0	-
Urinary retention	11	0.4%
Vessel injury	13	0.4%
Other	18	0.6%
Post-discharge adverse events (N = 2,729)
None	2,019	74%
Any event	710	26%
1 event	519	19%
2 events	128	4.6%
3 events	49	1.8%
4 or more events	14	0.5%
Major events (Class C, D and E)	135 (in 111 pts)	4.1%
Persistent bleeding	7	0.2%
Infection/possible infection	17	0.6%
New hot flashes	2	0.07%
Thromboembolism	4	0.15%
Recurrent pain	65	2.4%
Sloughing/passing fibroid	19	0.7%
Spinal headache	1	0.03%
Other adverse event	20	0.7%
Minor events (Class A and B)	848 (in 610)	22%
Bleeding	55	1.8%
Headache	18	0.6%
New hot flashes	156	5.7%
Infection/possible infection	82	3%
Pain	264	9.8%
Sloughing	123	4.5%
Other event	150	5.4%

^a Requiring additional hospitalization.

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