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Table 6 Adverse event (AE) profile according to age (System Organ Class as a percentage of total reported AE*)

From: The position of mefloquine as a 21st century malaria chemoprophylaxis

No-SOC Abbrev

INFANT

(n = 35)

(>1 mth - 2 yrs)

CHILD

(n = 212)

(>2 yrs - 12 yrs)

ADOLESCENT

(n = 233)

(>12 yrs - 17 yrs)

ADULT

(n = 9896)

(>17 yrs - 65 yrs)

ELDERLY

(n = 451)

(over 65 yrs)

01-INFEC-Total

20.00

8.00

4.30

2.34

4.65

03-BLOOD-Total

5.70

4.70

3.40

1.77

3.76

04-IMMUN-Total

5.70

0.47

0.86

0.45

0.22

05-ENDO-Total

0.00

0.47

0.00

0.16

0.22

06-METAB-Total

0.00

3.00

4.29

2.78

6,2

07-PSYCH-Total

8.50

32.50

40.30

39.48

31.04

08-NERV-Total

17.10

27.30

39.48

35.08

35.90

09-EYE-Total

2.86

5.18

6.86

6.05

4.65

10-EAR-Total

0.00

5.18

6.43

6.55

7.09

11-CARD-Total

5.70

3.70

3.86

7.21

10.64

12-VASC-Total

2.86

1.40

2.14

2.67

4.65

13-RESP-Total

17.10

2.30

5.15

4.04

7.09

14-GASTR-Total

40

25.00

29.18

22.84

29.49

15-HEPAT-Total

0.00

0.94

1.28

1.00

2.66

16-SKIN-Total

14.28

16.98

12.87

12.42

15.52

17-MUSC-Total

0.00

2.83

7.72

5.66

8.65

18-RENAL-Total

0.00

2.83

1.28

1.18

3.99

19-PREG-Total

0.00

0.00

0.86

15.05

0.00

20-REPRO-Total

0.00

0.00

2.15

1.70

0.66

21-CONG-Total

2.86

0.00

0.00

0.92

0.22

22-GENRL-Total

31.42

25.0

18.88

19.64

20.18

23-INV-Total

8.50

6.60

7.30

4.78

8.86

24-INJ&P-Total

14.28

7.50

1.72

1.23

3.54

26-SOCCI-Total

0.00

0.00

0.43

2.13

0.00

02-NEOPL-Total

0.00

0.00

0.00

0.23

0.44

25-SURG -Total

0.00

0.00

0.00

0.18

0.00

Total

100%

100%

100%

100%

100%

  1. * Data on file - F. Hoffmann La Roche, Drug Safety Data Base, MedDRA version 12.1, cut off date August 16th, 2010
  2. Key:
  3. 01- Infections and infestations
  4. 02- Neoplasm benign, malignant and unspecified (incl. cysts and polyps)
  5. 03- Blood and lymphatic system disorders
  6. 04- Immune system disorders
  7. 05- Endocrine disorders
  8. 06- Metabolism and nutrition disorders
  9. 07- Psychiatric disorders
  10. 08- Nervous system disorders
  11. 09- Eye disorders
  12. 10- Ear and labyrinth disorders
  13. 11- Cardiac disorders
  14. 12- Vascular disorders
  15. 13- Respiratory, thoracic and mediastinal disorders
  16. 14- Gastrointestinal disorders
  17. 15- Hepatobiliary disorders
  18. 16- Skin and subcutaneous tissue disorders
  19. 17- Musculoskeletal and connective tissue disorders
  20. 18- Renal and urinary disorders
  21. 19- Pregnancy, puerperium and perinatal conditions
  22. 20- Reproductive system and breast disorders
  23. 21- Congenital, familial and genetic disorders
  24. 22- General disorders and administration site conditions
  25. 23- Investigations
  26. 24- Injury, poisoning and procedural complications
  27. 25- Surgical and medical procedures