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Table 3 Comparison of Evaluable and Unevaluable Cases by Data Source

From: Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children

  NPDS FAERS MFR ML News/Media Multiple Source Total1
Evaluable YES NO YES NO YES NO YES NO YES NO YES NO YES NO
Non-Fatal Cases (n) 5,576 518 245 27 398 99 71 7 4 6 48 13 6,342 670
Age (years)
 Mean (sd) 3.8 (2.6) 4.2 (3.0) 5.8 (3.3) 4.9 (2.6) 4.9 (2.9) 5.0 (2.9) 4.3 (3.4) 4.0 (3.6) 2.9 (2.3) 5.8 (3.8) 5.3 (3.1) 3.5 (2.4) 4.0 (2.7) 4.3 (3.0)
 Median (min, max) 3 (0, 12) 3 (0, 11) 6 (0, 12) 4 (0, 10) 4 (0, 11) 5 (0, 11) 3 (0, 11) 3 (1, 9) 3 (1, 6) 5 (2, 11) 5 (1, 11) 4 (0, 7) 3 (0, 12) 3 (0, 11)
Gender (% male) 54.0% 51.7% 60.1% 48.1% 56.3% 56.0% 62.5% 50.0% 75.0% 40.0% 63.8% 38.5% 54.5% 51.8%
# of Products
 Mean (sd) 1.3 (0.7) 2.8 (2.8) 6.2 (7.8) 1.9 (2.5) 1.5 (1.0) 1.6 (1.3) 3.1 (3.1) 1.9 (2.3) 2.0 (2.0) 1.7 (0.5) 2.7 (2.7) 1.8 (1.1) 1.5 (2.0) 2.6 (2.6)
 Median (min, max) 1 (1, 13) 2 (1, 27) 3 (1, 52) 1 (1, 14) 1 (1, 9) 1 (1, 8) 2 (1, 15) 1 (1, 7) 1 (1, 5) 2 (1, 2) 2 (1, 15) 1 (1, 4) 1 (1, 52) 2 (1, 27)
# of Index Products
 Mean (sd) 1.1 (0.3) 1.2 (0.6) 1.1 (0.3) 1.1 (0.4) 1.2 (0.4) 1.1 (0.4) 1.0 (0.2) 1.0 (0.0) 2.0 (2.0) 1.0 (0.0) 1.1 (0.2) 1.1 (0.3) 1.1 (0.3) 1.2 (0.5)
 Median (min, max) 1 (1, 4) 1 (1, 7) 1 (1, 2) 1 (1, 3) 1 (1, 4) 1 (1, 4) 1 (1, 2) 1 (1, 1) 1 (1, 5) 1 (1, 1) 1 (1, 2) 1 (1, 2) 1 (1, 5) 1 (1, 7)
# of Adverse Events
 Mean (sd) 4.4 (3.0) 5.3 (4.1) 5.9 (5.0) 2.8 (2.7) 3.9 (2.8) 4.0 (3.3) 5.9 (5.7) 3.4 (6.0) 1.5 (0.6) 3.5 (1.8) 9.8 (9.4) 4.0 (1.9) 4.5 (3.3) 4.9 (4.0)
 Median (min, max) 4 (1, 34) 4 (1, 35) 4 (1, 31) 2 (1, 14) 3 (1, 22) 3 (1, 19) 4 (1, 29) 1 (1, 17) 2 (1, 2) 4 (1, 6) 6 (1, 38) 3 (2, 7) 4 (1, 38) 4 (1, 35)
Fatal Cases (n) 11 8 14 5 27 25 4 2 20 12 29 15 105 67
Age (years)
 Mean (sd) 2.6 (3.4) 2.0 (2.0) 4.0 (4.2) 1.7 (1.7) 1.1 (1.5) 1.7 (2.4) 2.6 (3.9) 0.8 (0.5) 2.8 (3.4) 3.3 (3.3) 1.5 (1.7) 1.1 (1.1) 2.1 (2.9) 1.9 (2.3)
 Median (min, max) 1 (0, 11) 2 (0, 5) 2 (0, 11) 1 (0, 4) 1 (0, 7) 1 (0, 8) 1 (0, 7) 1 (1, 1) 1 (0, 11) 3 (0, 11) 1 (0, 5) 1 (0, 4) 1 (0, 11) 1 (0, 11)
Gender (% male) 45.5% 50.0% 75.0% 75.0% 48.0% 57.9% 66.7% 50.0% 65.0% 36.4% 62.1% 73.3% 59.0% 57.6%
# of Products
 Mean (sd) 2.1 (0.7) 2.0 (1.2) 11.3 (15.5) 2.6 (2.5) 2.3 (1.8) 2.1 (2.0) 4.3 (2.5) 3.0 (2.8) 2.0 (1.2) 1.6 (1.2) 2.7 (1.9) 2.8 (1.9) 3.6 (6.5) 2.2 (1.8)
 Median (min, max) 2 (1, 3) 2 (1, 4) 4 (1, 44) 2 (1, 7) 2 (1, 7) 1 (1, 10) 5 (1, 7) 3 (1, 5) 2 (1, 5) 1 (1, 5) 2 (1, 9) 2 (1, 6) 2 (1, 44) 1 (1, 10)
# of Index Products
 Mean (sd) 1.1 (0.3) 1.1 (0.4) 1.4 (0.9) 1.2 (0.4) 1.5 (1.0) 1.2 (0.6) 1.8 (1.5) 1.0 (0.0) 1.1 (0.3) 1.1 (0.3) 1.6 (0.7) 1.7 (1.0) 1.4 (0.8) 1.3 (0.7)
 Median (min, max) 1 (1, 2) 1 (1, 2) 1 (1, 4) 1 (1, 2) 1 (1, 5) 1 (1, 4) 1 (1, 4) 1 (1, 1) 1 (1, 2) 1 (1, 2) 1 (1, 3) 1 (1, 4) 1 (1, 5) 1 (1, 4)
Autopsy Available 7 (63.6%) 3 (37.5%) 3 (21.4%) 1 (20.0%) 16 (59.3%) 2 (8.0%) 1 (25.0%) 0 (0.0%) 15 (75.0%) 0 (0.0%) 22 (75.9%) 8 (53.3%) 64 (61.0%) 14 (20.9%)
  1. 1Italicized numbers indicate statistical significance between Total Evaluable and Total Unevaluable at p<0