Problem

Clustering of adverse events. An investigation was prompted when the U.S. Food and Drug Ad...

Clustering of adverse events. An investigation was prompted when the U.S. Food and Drug Administration received a report of an increased frequency of an adverse drug-related event after a hospital switched from the innovator company’s product to a generic product. To address this issue, a team of investigators completed chart reviews of patients who had received the drugs in question. Table lists data for the first 25 patients in the study.

Table First 25 observations from a study of cerebellar toxicity.

I

AGE

SEX

MANUF

DIAG

STAGE

TOX

DOSE

SCR

WEIGHT

GENERIC

1

50

1

J

1

1

1

36.0

0.8

66

1

2

21

1

J

1

2

2

29.0

1.1

68

1

3

35

1

J

2

2

2

16.2

0.7

97

1

4

49

2

S

1

1

2

29.0

0.8

83

2

5

38

1

J

2

2

1

16.2

1.4

97

1

6

42

1

S

2

2

2

18.0

1.0

82

2

7

17

1

J

1

2

2

17.4

1.0

64

1

8

20

1

S

2

2

2

17.4

1.0

73

2

9

49

2

J

1

1

2

37.2

0.7

103

1

10

41

2

J

1

2

2

18.6

0.9

58

1

11

20

1

S

2

2

2

18.0

1.1

113

2

12

55

1

S

1

1

2

36.0

0.8

87

2

13

44

2

J

1

1

1

22.4

1.2

59

1

14

23

1

S

2

2

2

39.6

0.8

83

2

15

64

2

S

1

1

2

30.0

0.9

69

2

16

65

1

S

1

1

1

23.2

1.7

106

2

17

23

2

S

1

2

2

16.8

0.9

66

2

18

44

1

S

1

2

2

17.4

1.0

84

2

19

29

2

S

2

1

2

18.0

0.7

56

2

20

32

1

S

1

2

2

18.0

1.0

84

2

21

18

1

S

2

2

2

17.4

0.9

70

2

22

22

1

S

1

1

1

26.1

1.7

69

2

23

43

2

J

2

2

2

18.0

0.8

63

1

24

39

2

S

1

2

2

18.0

0.9

55

2

25

38

2

J

1

1

1

16.0

1.0

112

1

Here’s a codebook for the data:

Variable

Description

AGE

Age (years)

SEX

1 = male; 2 = female

MANUF

Manufacturer of the drug: Smith or Jones

DIAG

Underling diagnosis: 1 = leukemia; 2 = lymphoma

STAGE

Stage of disease: 1 = relapse; 2 = remission

TOX

Did cerebellar toxicity occur?: 1 = yes; 2 = no

DOSE

Dose of drug (g/m2)

SCR

Serum creatinine (mg/dl)

WEIGHT

Body weight (kg)

GENERIC

Generic drug: 1 = yes; 2 = no

(a) Classify each variable in the table as either quantitative, ordinal, or categorical.


(b) What is the value of the age variable for observation 4?


(c) What is the value of the diag (diagnosis) variable for observation 2?

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