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Table 2 Eligibility and Evaluability of Non-Fatal and Fatal Cases

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

 

NPDS (n%)

FAERS (n%)

MFR (n%)

ML (n%)

News/Media (n%)

Multiple Sourcea (n%)

Total (n%)

Non-Fatal Unique Eligible Cases (n)

6094

272

497

78

10

61

7,012

Unevaluable (Unable to Determine Relatedness)

518 (8.5%)

27 (9.9%)

99 (19.9%)

7 (9.0%)

6 (60.0%)

13 (21.3%)

670 (9.6%)

Evaluable

5576 (91.5%)

245 (90.1%)

398 (80.1%)

71 (91.0%)

4 (40.0%)

48 (78.7%)

6342 (90.4%)

 At Least Potentially Related

5345 (95.9%)

55 (22.4%)

204 (51.3%)

18 (25.4%)

2 (50.0%)

22 (45.8%)

5646 (89.0%)

 Unlikely Related

231 (4.1%)

190 (77.6%)

194 (48.7%)

53 (74.6%)

2 (50.0%)

26 (54.2%)

696 (11.0%)

Fatal Unique Eligible Cases (n)

19

19

52

6

32

44

172

 Unevaluable (Unable to Determine Relatedness)

8 (42.1%)

5 (26.3%)

25 (48.1%)

2 (33.3%)

12 (37.5%)

15 (34.1%)

67 (39.0%)

Evaluable

11 (57.9%)

14 (73.7%)

27 (51.9%)

4 (66.7%)

20 (62.5%)

29 (65.9%)

105 (61.0%)

 At Least Potentially Related

7 (63.6%)

7 (50.0%)

19 (70.4%)

2 (50.0%)

17 (85.0%)

24 (82.8%)

76 (72.4%)

 Unlikely Related

4 (36.4%)

7 (50.0%)

8 (29.6%)

2 (50.0%)

3 (15.0%)

5 (17.2%)

29 (27.6%)

  1. aCase reports from more than one data source are combined to a unique case and are designated as Multiple Source