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Table 2 Types of ADEs reported at category level for studies using different assessment methods (number of studies presented in table)

From: A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients

Adverse events at CTCAE category level

Medicalrecord review

HCP surveill-ance

Patient survey

Admini-strative data

Lab/clinical values

Non specified

Gastrointestinal

9

14

3

  

5

Neurology

3

6

1

  

3

Cardiac General

9

9

 

4

1

4

Blood/Bone Marrow

2

4

  

5

1

Pulmonary/Upper Respiratory

1

2

   

2

Hepatobiliary/Pancreas

3

7

 

1

11

2

Auditory/Ear

 

1

   

1

Ocular/Visual

 

1

    

Dermatology/Skin

1

4

   

3

Musculoskelal/Soft Tissue

 

1

   

1

Renal/Genitourinary

1

1

  

2

2

Constitutional symptoms:

      

- weight

 

6

  

12

 

- other

1

3

1

   

Pain

3

7

2

   

Endocrine

 

1

    

Infection

 

1

   

3

Allergy/Immunology

 

1

    

Sexual/Reproductive Function

1

     

Metabolic:

      

- hypoglycaemia

7

7

8

 

3

5

- other

 

4

1

 

7

1

General ADEs/Tolerability*

3

12

3

 

3

5

  1. CTCAE Common Terminology Criteria for Adverse Events v3.0; * not categorized