Table 2:

Safety outcomes

	Double-blind short-term period only (24 weeks)		Open-label long-term period only (28 weeks)	Double-blind period plus open-label period (52 weeks)
n (%)	Dapagliflozin 10 mg (N=39)	Placebo (N=33)	Placebo switched to dapagliflozin 10 mg (N=27)	Dapagliflozin 10 mg (N=39)
Adverse events
≥1 AE	27 (69·2)	19 (57·6)	4 (14·8)	29 (74·4)
AE leading to discontinuation of study drug	1 (2·6)	0	0	1 (2·6)
≥1 SAE	1 (2·6)	2 (6·1)	1 (3·7)	2 (5·1)
Most common AEs *
Headache	4 (10·3)	3 (9·1)	1 (3·7)	5 (12·8)
Nasopharyngitis	4 (10·3)	0	2 (7·4)	5 (12·8)
Vitamin D deficiency	4 (10·3)	1 (3·0)	1 (3·7)	5 (12·8)
Oropharyngeal pain	3 (7·7)	1 (3·0)	0	4 (10·3)
Nausea	3 (7·7)	0	0	3 (7·7)
Urinary tract infection	2 (5·1)	1 (3·0)	0	3 (7·7)
Cough	2 (5·1)	1 (3·0)	1 (3·7)	2 (5·1)
Diarrhea	2 (5·1)	2 (6·1)	0	2 (5·1)
Gastroenteritis viral	2 (5·1)	0	0	2 (5·1)
Hypertension	2 (5·1)	1 (3·0)	0	2 (5·1)
Pharyngitis streptococcal	2 (5·1)	0	1 (3·7)	2 (5·1)
Sinus congestion	2 (5·1)	0	0	2 (5·1)
Vomiting	2 (5·1)	0	0	2 (5·1)
Increased weight	2 (5·1)	0	0	2 (5·1)
Hypertriglyceridaemia	1 (2·6)	2 (6·1)	1 (3·7)	1 (2·6)
Toothache	1 (2·6)	2 (6·1)	0	1 (2·6)
Hyperglycemia	0	3 (9·1)	1 (3·7)	0

^*≥5% of participants in either treatment group during the double-blind period; All safety analyses include data after glycemic rescue; AEs are recorded up to and including 4 days after the last dose or the end of treatment period, and SAEs up to and including 30 days after last dose or end of treatment period; AE=adverse event; SAE=serious adverse event