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Table 3 Summary of the main safety data during the study

From: Management of cardiovascular risk factors with pioglitazone combination therapies in type 2 diabetes: an observational cohort study

 

Pio + SU

n = 1709

Pio + Met

n = 1496

SU + Met

n = 1380

Hypoglycemic episodes

   

At least one

175 (10.3) [2]

91 (6.1) [6]

134 (9.7) [1]

Severe

5 (0.3) [36]

4 (0.3) [36]

5 (0.4) [26]

Adverse events

[0]

[0]

[0]

At least one adverse event

113 (6.6)

98 (6.6)

73 (5.3)

Related to study treatments*

70 (4.1)

60 (4.0)

28 (2.0)

   Gastrointestinal disorders

13 (0.8)

15 (1.0)

15 (1.1)

   General disorders

28 (1.6)

25 (1.7)

3 (0.2)

Edema

26 (1.5)

22 (1.5)

2 (0.1)

At least one serious adverse event

13 (0.8)

10 (0.7)

12 (0.9)

Description of all serious AEs (by body system):

   

   Cardiac disorders

4 (0.2)

2 (0.1)

2 (0.1)

   Gastrointestinal disorders

-

-

1 (0.1)

   General disorders

-

-

1 (0.1)

   Infections and infestations

-

2 (0.1)

-

   Injury, poisoning, and procedural complications

1 (0.1)

-

-

   Metabolism and nutrition disorders

1 (0.1)

-

-

   Neoplasm

2 (0.1)

1 (0.1)

2 (0.1)

   Nervous system disorders

3 (0.2)

2 (0.1)

2 (0.1)

   Renal and urinary disorders

-

-

1 (0.1)

   Reproductive system and breast disorders

-

1 (0.1)

-

   Respiratory, thoracic, and mediastinal disorders

1 (0.1)

-

-

   Skin and subcutaneous tissue disorders

1 (0.1)

1 (0.1)

-

   Surgical and medical procedures

1 (0.1)

1 (0.1)

1 (0.1)

   Vascular disorders

-

-

2 (0.1)

  1. * Listed if >1% in at least one cohort. Values within brackets indicate the number of patients with missing data for that variable. Data represent the numbers of patients, with percentages within parentheses.