Table 4.

Numbers of participants developing malignancies and selected non-malignant neoplasms in RECORD

Variable	Background sulfonylurea		Background metformin
	Metformin	Rosiglitazone	Sulfonylurea	Rosiglitazone
n	1,122	1,103	1,105	1,117
Study exposure (person-years)	6,126	6,110	6,146	6,228
Neoplasms/cancer
All	81 (7.2)	70 (6.3)	89 (8.1)	73 (6.5)
Malignant neoplasms (non-skin)	69 (6.1)	56 (5.1)	74 (6.7)	57 (5.1)
Genitourinary	22 (2.0)	23 (2.1)	27 (2.4)	18 (1.6)
Prostate	10 (1.8)	5 (0.9)	11 (1.9)	10 (1.7)
Renal	1 (<0.1)	4 (0.4)	6 (0.5)	3 (0.3)
Uterine	7 (1.3)	7 (1.2)	5 (1.0)	1 (0.2)
Ovarian	1 (0.2)	3 (0.5)	3 (0.6)	2 (0.4)
Bladder	3 (0.3)	4 (0.4)	2 (0.2)	2 (0.2)
Gastrointestinal	24 (2.1)	12 (1.1)	21 (1.9)	17 (1.5)
Pancreatic	6 (0.5)	1 (<0.1)	7 (0.6)	1 (<0.1)
Gall bladder/biliary	3 (0.3)	0	1 (<0.1)	3 (0.3)
Gastric	1 (<0.1)	5 (0.5)	2 (0.2)	2 (0.2)
Liver	2 (0.2)	0	1 (<0.1)	1 (<0.1)
Breast	8 (1.4)	4 (0.7)	9 (1.7)	7 (1.4)
Melanoma	0	2 (0.2)	2 (0.2)	2 (0.2)
Skin (non-melanoma)	3 (0.3)	8 (0.7)	5 (0.5)	7 (0.6)
Metastases (unknown primary)	8 (0.7)	4 (0.4)	5 (0.5)	5 (0.4)
Lung	3 (0.3)	9 (0.8)	6 (0.5)	3 (0.3)
Haematological	2 (0.2)	2 (0.2)	3 (0.3)	4 (0.4)
Leukaemia	1 (<0.1)	2 (0.2)	0	2 (0.2)
Lymphoma	1 (<0.1)	0	1 (<0.1)	1 (<0.1)
Head and neck	2 (0.2)	1 (<0.1)	4 (0.4)	1 (<0.1)
Endocrine	3 (0.3)	1 (<0.1)	2 (0.2)	2 (0.2)
Neurological	0	2 (0.2)	2 (0.2)	1 (<0.1)
Other	2 (0.2)	0	1 (<0.1)	0
Benign neoplasms	12 (1.1)	10 (0.9)	12 (1.1)	10 (0.9)
Colon/rectal polyp	4 (0.4)	1 (<0.1)	1 (<0.1)	0
Lipoma	0	0	1 (<0.1)	0

Data are number (n) of people (%) with a neoplasm reported as a serious adverse event

Per cent values for prostate and for breast, cervix/uterine and ovarian cancer are based on men only and women only

Selected benign neoplasms of interest are included