Table 2.

Incidence rate ratio of malignancy by tumor type comparing dapagliflozin versus nondapagliflozin in 21 phase 2b and phase 3 clinical trials (dapagliflozin N = 5936 and control N = 3403).

Tumor origin	Patients with events	Incidence rate ratio	95% confidence interval
Overall	140	1.03	0.71, 1.51
Bladder	10	5.17	0.68, 233.55
Breast (female only)	15	2.47	0.64, 14.10
Pancreas	8	1.84	0.31, 19.46
Prostate (male only)	17	1.50	0.53, 5.35
Hepatobiliary	3	0.92	0.04, 61.49
Thyroid and endocrine	10	0.88	0.19, 4.46
Skin	31	0.83	0.37, 1.91
Respiratory and mediastinal	15	0.79	0.24, 2.81
Female reproductive (female only)	4	0.74	0.05, 10.74
Metastases and site unspecified	5	0.56	0.07, 8.96
Gastrointestinal	10	0.51	0.13, 3.19
Renal tract	5	0.40	0.03, 3.82
Blood/lymphatic	7	0.37	0.05, 2.35
Musculoskeletal and soft tissue	1	∞	0.010, ∞

Source: reference [20, 35]: data obtained from 21 phase 2b and 3 clinical trials, data cutoff date: Nov 4, 2013; a new case of bladder cancer found in an ongoing add-on to sulfonylurea and metformin phase 3 trial is not included. The incidence rate ratio with 95% CI including the case is 6.11 (0.827–272.00).