Table 4.

Occurrence of important safety risks among parecoxib-treated subjects (derived from postmarketing data based on 69,567,300 standard units of parecoxib)^a

Risk	Total (n)	Serious (n)	Outcome
GI-related eventb	35	35	Recovered=12
			Recovering=3
			Not recovered=4
			Unknown=12
			Fatal=4
Renal failure and impairmentc	77	68	Recovered=32
			Recovering=9
			Recovering with sequela=1
			Not recovered=8
			Unknown=21
			Fatal=6
Embolic and thrombotic eventd	66	64	Recovered=20
			Recovering=4
			Recovering with sequela=2
			Not recovered=2
			Unknown=18
			Fatal=20
Hypersensitivity reactione	190	98	Recovered=125
			Recovering=15
			Recovering with sequela=1
			Not recovered=8
			Unknown=34
			Fatal=7
Hypotension-related eventsf	32	25	Recovered=20
			Recovering=3
			Unknown=6
			Fatal=3
Severe cutaneous reactiong	17	17	Recovered=9
			Recovering=1
			Not recovered=2
			Unknown=3
			Fatal=2
Masking signs of inflammationh	18	18	Recovered=7
			Recovering=1
			Not recovered=3
			Unknown=3
			Fatal=4

Notes:

^aIncludes medically confirmed cases of each event through March 31, 2014.

^bBased on the MedDRA version 16.1 SMQs of GI hemorrhage, GI perforation, and GI ulceration.

^cBased on the MedDRA version 16.1 HLT of renal failure and impairment.

^dBased on the MedDRA version 16.1 SMQs of embolic and thrombotic events arterial, embolic and thrombotic events venous, and embolic and thrombotic events vessel type unspecified and mixed arterial and venous.

^eBased on the MedDRA version 16.1 SMQ of hypersensitivity.

^fBased on the MedDRA version 16.1 PT of hypotension.

^gBased on the MedDRA version 16.1 SMQ of severe cutaneous adverse reactions.

^hBased on the MedDRA version 16.1 serious AEs with a PT whose primary allocation is to the system organ class category of infections and infestations.

Abbreviations: AEs, adverse events; GI, gastrointestinal; HLT, high-level term; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SMQs, standard MedDRA queries.