Correction to: Adv Ther (2019) 36:923–949 https://doi.org/10.1007/s12325-019-0895-1

In the original article, the Table 6 was published with some errors. The correct Table 6 is below.

Original

Table 6 Adverse drug reactions of special interest

 

STELLA-LONG TERM (safety analysis set n = 11,051)

Pre-approval clinical trials

 

Total number of patients experiencing an ADR

Serious

Non-serious

Total (n = 1669)

All ADRs

1616

(14.6)

107

(0.97)

1539

(13.9)

(32.9)

ADRs of special interest

       

 Polyuria/pollakiuria

571

(5.2)

1

(0.01)

570

(5.2)

(10.0)

 Volume depletion-related events, including dehydration

196

(1.8)

9

(0.08)

189

(1.7)

(4.5)

 Skin complications

166

(1.5)

4

(0.04)

162

(1.5)

(4.0)

 Genital infection

135

(1.2)

2

(0.02)

133

(1.2)

(2.0)

 Urinary tract infection

115

(1.0)

5

(0.05)

110

(1.0)

(1.8)

 Renal disorder

115

(1.0)

3

(0.03)

112

(1.0)

(4.8)

 Hepatic disorder

82

(0.74)

6

(0.05)

78

(0.71)

(1.0)

 Hypoglycemia

39

(0.35)

3

(0.03)

36

(0.33)

(1.4)

 Cardiovascular diseasea

30

(0.27)

19

(0.17)

11

(0.10)

(1.0)

 Cerebrovascular diseaseb

23

(0.21)

20

(0.18)

3

(0.03)

(0.2)

 Malignant tumor

22

(0.20)

19

(0.17)

3

(0.03)

(0.2)

 Ketoacidosis, events related to ketone-body increase

3

(0.03)

0

(0.00)

3

(0.03)

(1.0)

 Fracture

2

(0.02)

1

(0.01)

1

(0.01)

0

  1. Data are presented as number of events (%), unless otherwise indicated
  2. ADR adverse drug reaction
  3. aIncidence of cardiovascular disease was 4.4/1000 person-years [34] and 9.59/1000 person-years [35] in the JDDM and JDCS studies, respectively
  4. bIncidence of cerebrovascular disease was 3.1/1000 person-years [34] and 7.45/1000 person-years [35] in the JDDM and JDCS studies, respectively

Corrected

Table 6 Adverse drug reactions of special interest

 

STELLA-LONG TERM (safety analysis set n = 11,051)

Pre-approval clinical trials

 

Total number of patients experiencing an ADR

Serious

Non-serious

Total (n = 1669)

All ADRs

1616

(14.6)

107

(0.97)

1539

(13.9)

(32.9)

ADRs of special interest

       

 Polyuria/pollakiuria

571

(5.2)

1

(0.01)

570

(5.2)

(10.0)

 Volume depletion-related events, including dehydration

196

(1.8)

9

(0.08)

189

(1.7)

(4.5)

 Skin complications

166

(1.5)

4

(0.04)

162

(1.5)

(3.5)

 Genital infection

135

(1.2)

2

(0.02)

133

(1.2)

(2.0)

 Urinary tract infection

115

(1.0)

5

(0.05)

110

(1.0)

(1.8)

 Renal disorder

115

(1.0)

3

(0.03)

112

(1.0)

(4.6)

 Hepatic disorder

82

(0.74)

6

(0.05)

78

(0.71)

(1.0)

 Hypoglycemia

39

(0.35)

3

(0.03)

36

(0.33)

(1.4)

 Cardiovascular diseasea

30

(0.27)

19

(0.17)

11

(0.10)

(1.0)

 Cerebrovascular diseaseb

23

(0.21)

20

(0.18)

3

(0.03)

(0.2)

 Malignant tumor

22

(0.20)

19

(0.17)

3

(0.03)

(0.2)

 Ketoacidosis, events related to ketone-body increase

3

(0.03)

0

(0.00)

3

(0.03)

(0.7)

 Fracture

2

(0.02)

1

(0.01)

1

(0.01)

0

  1. Data are presented as number of events (%), unless otherwise indicated
  2. ADR adverse drug reaction
  3. aIncidence of cardiovascular disease was 4.4/1000 person-years [34] and 9.59/1000 person-years [35] in the JDDM and JDCS studies, respectively
  4. bIncidence of cerebrovascular disease was 3.1/1000 person-years [34] and 7.45/1000 person-years [35] in the JDDM and JDCS studies, respectively