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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