Table 2

Adverse and special interest events up to week 102

Placebo + metformin

Dapagliflozin 2.5 mg + metformin

Dapagliflozin

5 mg + metformin

Dapagliflozin 10 mg + metformin

N

137

137

137

135

At least one adverse event

111 (81.0)

111 (81.0)

111 (81.0)

111 (82.2)

At least one related adverse event

28 (20.4)

36 (26.3)

33 (24.1)

45 (33.3)

Adverse event leading to discontinuation

9 (6.6)

7 (5.1)

5 (3.6)

6 (4.4)

At least one serious adverse event

14 (10.2)

15 (10.9)

9 (6.6)

14 (10.4)

Deaths

1 (0.7)

2 (1.5)

0

0

Most common adverse events (>10% in any treatment group):

Back pain

11 (8.0)

11 (8.0)

7 (5.1)

18 (13.3)

Influenza

15 (10.9)

19 (13.9)

20 (14.6)

17 (12.6)

Diarrhea

10 (7.3)

7 (5.1)

9 (6.6)

16 (11.9)

Urinary tract infection

8 (5.8)

6 (4.4)

8 (5.8)

16 (11.9)

Headache

8 (5.8)

10 (7.3)

13 (9.5)

15 (11.1)

Nasopharyngitis

12 (8.8)

16 (11.7)

8 (5.8)

12 (8.9)

Upper respiratory tract infection

14 (10.2)

9 (6.6)

5 (3.7)

5 (3.7)

Adverse events of special interest:

Suggestive of urinary tract infection

11 (8.0)

11 (8.0)

12 (8.8)

18 (13.3)

Experiencing a single event

8/11 (72.7)

8/11 (72.7)

10/12 (83.3)

11/18 (61.1)

Men

3/76 (3.9)

2/70 (2.9)

2/69 (2.9)

4/77 (5.2)

Women

8/61 (13.1)

9/67 (13.4)

10/68 (14.7)

14/58 (24.1)

Suggestive of genital infection

7 (5.1)

16 (11.7)

20 (14.6)

17 (12.6)

Experiencing a single event

7/7 (100)

15/16 (93.8)

16/20 (80.0)

14/17 (82.4)

Men

0/76

4/70 (5.7)

4/69 (5.8)

5/77 (6.5)

Women

7/61 (11.5)

12/67 (17.9)

16/68 (23.5)

12/58 (20.7)

Renal impairment or failure

2 (1.5)

6 (4.4)

4 (2.9)

2 (1.5)

Hypoglycemia:

Total patients with hypoglycemia

8 (5.8)

5 (3.6)

7 (5.1)

7 (5.2)

Major episode of hypoglycemiaa

0 (0)

0 (0)

0 (0)

0 (0)

Hypotension, dehydration, hypovolemia

2 (1.5)

0 (0)

3 (2.2)

2 (1.5)


Data are n (%) or n out of N (%); includes data after rescue. aMajor episode defined as a symptomatic episode requiring external assistance due to severe impairment in consciousness or behavior with a capillary or plasma glucose value <3 mmol/l and prompt recovery after glucose or glucagon administration.

Bailey et al. BMC Medicine 2013 11:43   doi:10.1186/1741-7015-11-43

Open Data