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Table 3 Adverse events and adverse drug reactions classified by systemic organ class according to the World Health Organization Adverse Reaction Terminology

From: Safety and efficacy of Rapamune® (Sirolimus) in kidney transplant recipients: results of a prospective post-marketing surveillance study in Korea

Systemic organ class and preferred terma

Total (N = 209)

Adverse Event

Adverse Drug Reaction

Number of Subjects (%)

Number of Events

Number of Subjects (%)

Number of Events

Total

113 (54.07)

211

90 (43.06)

156

Resistance mechanism disorders

48 (22.97)

66

35 (16.75)

50

 Pharyngitis

24 (11.48)

32

23 (11.00)

31

 Upper respiratory tract infection

10 (4.78)

15

5 (2.39)

10

 Urinary tract infection

4 (1.91)

4

1 (0.48)

1

 Rhinitis

3 (1.44)

3

0 (0.00)

0

 Pneumonia

3 (1.44)

3

2 (0.96)

2

 Herpes simplex

2 (0.96)

2

2 (0.96)

2

 Cystitis

2 (0.96)

2

1 (0.48)

1

 Infection susceptibility increased

1 (0.48)

1

1 (0.48)

1

 Abscess

1 (0.48)

1

0 (0.00)

0

 Herpes zoster

1 (0.48)

1

1 (0.48)

1

 Dermatitis fungal

1 (0.48)

1

1 (0.48)

1

 Polyomavirus infection

1 (0.48)

1

0 (0.00)

0

Gastro-intestinal system disorders

39 (18.66)

49

34 (16.27)

38

 Diarrhoea

12 (5.74)

13

11 (5.26)

11

 Stomatitis

7 (3.35)

7

7 (3.35)

7

 Stomatitis ulcerative

7 (3.35)

7

7 (3.35)

7

 Abdominal pain

4 (1.91)

4

4 (1.91)

4

 Gastritis

3 (1.44)

3

2 (0.96)

2

 Constipation

2 (0.96)

2

1 (0.48)

1

 Dyspepsia

2 (0.96)

3

2 (0.96)

3

 Nausea

2 (0.96)

2

1 (0.48)

1

 Enteritis

2 (0.96)

2

1 (0.48)

1

 Vomiting

1 (0.48)

2

0 (0.00)

0

 Ileus

1 (0.48)

2

0 (0.00)

0

 Tooth caries

1 (0.48)

1

0 (0.00)

0

 Periodontal destruction

1 (0.48)

1

1 (0.48)

1

Urinary system disorders

15 (7.18)

16

11 (5.26)

11

 Azotaemia

10 (4.78)

10

7 (3.35)

7

 Albuminuria

2 (0.96)

2

2 (0.96)

2

 Nephropathy toxic

1 (0.48)

1

0 (0.00)

0

 Urinary tract disorder

1 (0.48)

1

0 (0.00)

0

 Oliguria

1 (0.48)

1

1 (0.48)

1

 Renal artery occlusion

1 (0.48)

1

1 (0.48)

1

Skin and appendages disorders

15 (7.18)

17

13 (6.22)

14

 Acne

5 (2.39)

5

5 (2.39)

5

 Rash

4 (1.91)

4

4 (1.91)

4

 Onychomycosis

2 (0.96)

2

1 (0.48)

1

 Rash erythematous

2 (0.96)

2

2 (0.96)

2

 Folliculitis

1 (0.48)

1

0 (0.00)

0

 Eczema

1 (0.48)

1

1 (0.48)

1

 Dermatitis contact

1 (0.48)

1

0 (0.00)

0

 Dermatitis

1 (0.48)

1

1 (0.48)

1

Metabolic and nutritional disorders

13 (6.22)

14

11 (5.26)

12

 Diabetes mellitus

3 (1.44)

3

3 (1.44)

3

 Hyperlipemia

4 (1.91)

4

4 (1.91)

4

 Hyperkalemia

2 (0.96)

2

2 (0.96)

2

 Diabetes mellitus aggravated

2 (0.96)

2

2 (0.96)

2

 Hyperphosphatemia

1 (0.48)

1

0 (0.00)

0

 Glycosuria

1 (0.48)

1

1 (0.48)

1

 Plasma osmolality increased

1 (0.48)

1

0 (0.00)

0

Body as a whole– general disorders

11 (5.26)

11

8 (3.83)

8

 Edema peripheral

2 (0.96)

2

2 (0.96)

2

 Face edema

2 (0.96)

2

2 (0.96)

2

 Fever

2 (0.96)

2

1 (0.48)

1

 Allergic reaction

1 (0.48)

1

1 (0.48)

1

 Leg pain

1 (0.48)

1

0 (0.00)

0

 Ascites

1 (0.48)

1

0 (0.00)

0

 Anaphylactic reaction

1 (0.48)

1

1 (0.48)

1

 Fatigue

1 (0.48)

1

1 (0.48)

1

Liver and biliary system disorders

6 (2.87)

7

3 (1.44)

4

 SGOT increased

2 (0.96)

2

1 (0.48)

1

 Hepatic enzymes increased

2 (0.96)

2

0 (0.00)

0

 SGPT increased

1 (0.48)

1

1 (0.48)

1

 Hepatic function abnormal

1 (0.48)

1

1 (0.48)

1

 Cholangitis

1 (0.48)

1

1 (0.48)

1

Musculo-skeletal system disorders

6 (2.87)

6

4 (1.91)

4

 Osteoporosis

2 (0.96)

2

2 (0.96)

2

 Fracture

2 (0.96)

2

0 (0.00)

0

 Myalgia

1 (0.48)

1

1 (0.48)

1

 Avascular necrosis bone

1 (0.48)

1

1 (0.48)

1

Secondary terms – events

6 (2.87)

6

3 (1.44)

3

 Transplant rejection

6 (2.87)

6

3 (1.44)

3

Respiratory system disorders

4 (1.91)

4

3 (1.44)

3

 Coughing

3 (1.44)

3

3 (1.44)

3

 Dysonoea

1 (0.48)

1

0 (0.00)

0

White cell and RES disorders

3 (1.44)

3

2 (0.96)

2

 Leucopenia

2 (0.96)

2

2 (0.96)

2

 Granulocyopenia

1 (0.48)

1

0 (0.00)

0

Central & peripheral nervous system disorders

3 (1.44)

4

2 (0.96)

3

 Headache

2 (0.96)

2

1 (0.48)

1

 Hypoaesthesia

1 (0.48)

1

1 (0.48)

1

 Tremor

1 (0.48)

1

1 (0.48)

1

Red blood cell disorders

2 (0.96)

2

2 (0.96)

2

 Anaemia

1 (0.48)

1

1 (0.48)

1

 Polycythaemia

1 (0.48)

1

1 (0.48)

1

Endocrine disorders

1 (0.48)

1

0 (0.00)

0

 Hyperparathyroidism

1 (0.48)

1

0 (0.00)

0

Vision disorders

1 (0.48)

1

1 (0.48)

1

 Meibomianitis

1 (0.48)

1

1 (0.48)

1

Myo-, endo-, pericardial & valve disorders

1 (0.48)

1

0 (0.00)

0

 Angina pectoris aggravated

1 (0.48)

1

0 (0.00)

0

Cardiovascular disorders, general

1 (0.48)

1

0 (0.00)

0

 Hypertension

1 (0.48)

1

0 (0.00)

0

Psychiatric disorders

1 (0.48)

1

1 (0.48)

1

 Insomnia

1 (0.48)

1

1 (0.48)

1

Platelet, bleeding & clotting disorders

1 (0.48)

1

0 (0.00)

0

 Thrombocytopenia

1 (0.48)

1

0 (0.00)

0

  1. Abbreviations: RES reticuloendothelial system
  2. aAdverse drug reactions classified according to the World Health Organization Adverse Reaction Terminology (WHO-ART) version 092 coding dictionary
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