Table 2.

Reports of gastrointestinal (GI) events and anaemia followed up and causality assessment.

				Sex					Concomitant medication
Event	Number of all events	Number reported*	Follow-up response	Male	Female	Median age (IQR), years	Past history of dyspeptic symptoms or other upper GI conditions	NSAID prescribed within 3 months prior to starting rofecoxib	Gastro irritant‡	Gastro protective§	Assessed as ‘possibly’ or probably’ related
Upper GI bleed/pepticulceration	105	76	57/76 (75%)	18	27	77 (60, 79)	37	22	15	18	45
Lower GI bleed	48	33	26/33 (79%)	11	11	69 (66, 77)	7	1	7	3	22
Anaemia	98	74	34/48 (71%)†	6	16	74 (61, 80)	18	10	8	9	22
Perforated colon	3	1	1/1 (100%)	1	0	71	1	0	0	1	1

^*During treatment or within a month of stopping.

^†Twenty-six not selected for follow-up: secondary to other disease (19), GI bleed (5), deaths (2) and no further information available.

^‡Gastroirritant drugs: aspirin, anticoagulants and antiplatelet drugs.

^§Gastroprotective drugs: misoprostol, antacids, proton-pump inhibitors/histamine-2 antagonists.