...

Dataset wrap

Name	qs

Dataset2

Row

STUDYID

DOMAIN

USUBJID

QSSEQ

QSTESTCD

QSTEST

QSCAT

QSORRES

QSSTRESC

QSSTRESN

QSSTAT

QSREASND

VISITNUM

QSDTC

QSTPT

QSTPTREF

QSRFTDTC

QSEVINTX

1

STUDYX

QS

P0001

1

EXACT101

EXACT1-Chest Feel Congested

EXACT

Slightly

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

2

STUDYX

QS

P0001

2

EXACT102

EXACT1-How Often Cough

EXACT

Frequently

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

3

STUDYX

QS

P0001

3

EXACT103

EXACT1-Bring Up Mucus When Coughing

EXACT

A little

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

4

STUDYX

QS

P0001

4

EXACT104

EXACT1-Difficult to Bring Up Mucus

EXACT

Moderately

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

5

STUDYX

QS

P0001

5

EXACT105

EXACT1-Chest Discomfort

EXACT

Moderate

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

6

STUDYX

QS

P0001

6

EXACT106

EXACT1-Chest Feel Tight

EXACT

Slightly

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

7

STUDYX

QS

P0001

7

EXACT107

EXACT1-Breathless

EXACT

Slightly

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

8

STUDYX

QS

P0001

8

EXACT108

EXACT1-Describe How Breathless

EXACT

Breathless during light activity

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

9

STUDYX

QS

P0001

9

EXACT109

EXACT1-Short Breath Personal Care

EXACT

Severely

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

10

STUDYX

QS

P0001

10

EXACT110

EXACT1-Short Breath Indoor Activities

EXACT

Moderately

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

11

STUDYX

QS

P0001

11

EXACT111

EXACT1-Short Breath Outside Activities

EXACT

Extremely

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

12

STUDYX

QS

P0001

12

EXACT112

EXACT1-Tired or Weak

EXACT

Slightly

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

13

STUDYX

QS

P0001

13

EXACT113

EXACT1-Night Sleep Disturbed

EXACT

Not at all

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

14

STUDYX

QS

P0001

14

EXACT114

EXACT1-Worried About Lung Problems

EXACT

Slightly

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

15

STUDYX

QS

P0001

15

EXACT115

EXACT1-Breathlessness Raw Score

EXACT

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

16

STUDYX

QS

P0001

16

EXACT116

EXACT1-Cough & Sputum Raw Score

EXACT

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

17

STUDYX

QS

P0001

17

EXACT117

EXACT1-Chest Symptoms Raw Score

EXACT

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

18

STUDYX

QS

P0001

18

EXACT118

EXACT1-EXACT Total Raw Score

EXACT

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

19

STUDYX

QS

P0001

19

EXACT119

EXACT1-Breathlessness Domain Score

EXACT

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

20

STUDYX

QS

P0001

20

EXACT120

EXACT1-Cough & Sputum Domain Score

EXACT

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

21

STUDYX

QS

P0001

21

EXACT121

EXACT1-Chest Symptoms Domain Score

EXACT

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

22

STUDYX

QS

P0001

22

EXACT122

EXACT1-EXACT Total Score

EXACT

xxx

1

2012-11-08

BEDTIME DAY -7

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

23

STUDYX

QS

P0001

23

EXACT101

EXACT1-Chest Feel Congested

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

24

STUDYX

QS

P0001

24

EXACT102

EXACT1-How Often Cough

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

25

STUDYX

QS

P0001

25

EXACT103

EXACT1-Bring Up Mucus When Coughing

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

26

STUDYX

QS

P0001

26

EXACT104

EXACT1-Difficult to Bring Up Mucus

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

27

STUDYX

QS

P0001

27

EXACT105

EXACT1-Chest Discomfort

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

28

STUDYX

QS

P0001

28

EXACT106

EXACT1-Chest Feel Tight

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

29

STUDYX

QS

P0001

29

EXACT107

EXACT1-Breathless

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

30

STUDYX

QS

P0001

30

EXACT108

EXACT1-Describe How Breathless

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

31

STUDYX

QS

P0001

31

EXACT109

EXACT1-Short Breath Personal Care

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

32

STUDYX

QS

P0001

32

EXACT110

EXACT1-Short Breath Indoor Activities

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

33

STUDYX

QS

P0001

33

EXACT111

EXACT1-Short Breath Outside Activities

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

34

STUDYX

QS

P0001

34

EXACT112

EXACT1-Tired or Weak

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

35

STUDYX

QS

P0001

35

EXACT113

EXACT1-Night Sleep Disturbed

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

36

STUDYX

QS

P0001

36

EXACT114

EXACT1-Worried About Lung Problems

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

37

STUDYX

QS

P0001

37

EXACT115

EXACT1-Breathlessness Raw Score

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

38

STUDYX

QS

P0001

38

EXACT116

EXACT1-Cough & Sputum Raw Score

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

39

STUDYX

QS

P0001

39

EXACT117

EXACT1-Chest Symptoms Raw Score

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

40

STUDYX

QS

P0001

40

EXACT118

EXACT1-EXACT Total Raw Score

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

41

STUDYX

QS

P0001

41

EXACT119

EXACT1-Breathlessness Domain Score

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

42

STUDYX

QS

P0001

42

EXACT120

EXACT1-Cough & Sputum Domain Score

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

43

STUDYX

QS

P0001

43

EXACT121

EXACT1-Chest Symptoms Domain Score

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

44

STUDYX

QS

P0001

44

EXACT122

EXACT1-EXACT Total Score

EXACT

NOT DONE

1

2012-11-09

BEDTIME DAY -6

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

45

STUDYX

QS

P0001

45

EXACT101

EXACT1-Chest Feel Congested

EXACT

Slightly

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

46

STUDYX

QS

P0001

46

EXACT102

EXACT1-How Often Cough

EXACT

Frequently

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

47

STUDYX

QS

P0001

47

EXACT103

EXACT1-Bring Up Mucus When Coughing

EXACT

A little

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

48

STUDYX

QS

P0001

48

EXACT104

EXACT1-Difficult to Bring Up Mucus

EXACT

Moderately

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

49

STUDYX

QS

P0001

49

EXACT105

EXACT1-Chest Discomfort

EXACT

Moderate

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

50

STUDYX

QS

P0001

50

EXACT106

EXACT1-Chest Feel Tight

EXACT

Slightly

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

51

STUDYX

QS

P0001

51

EXACT107

EXACT1-Breathless

EXACT

Slightly

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

52

STUDYX

QS

P0001

52

EXACT108

EXACT1-Describe How Breathless

EXACT

Breathless during light activity

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

53

STUDYX

QS

P0001

53

EXACT109

EXACT1-Short Breath Personal Care

EXACT

Severely

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

54

STUDYX

QS

P0001

54

EXACT110

EXACT1-Short Breath Indoor Activities

EXACT

Moderately

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

55

STUDYX

QS

P0001

55

EXACT111

EXACT1-Short Breath Outside Activities

EXACT

Extremely

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

56

STUDYX

QS

P0001

56

EXACT112

EXACT1-Tired or Weak

EXACT

Slightly

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

57

STUDYX

QS

P0001

57

EXACT113

EXACT1-Night Sleep Disturbed

EXACT

Not at all

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

58

STUDYX

QS

P0001

58

EXACT114

EXACT1-Worried About Lung Problems

EXACT

Slightly

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

59

STUDYX

QS

P0001

59

EXACT115

EXACT1-Breathlessness Raw Score

EXACT

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

60

STUDYX

QS

P0001

60

EXACT116

EXACT1-Cough & Sputum Raw Score

EXACT

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

61

STUDYX

QS

P0001

61

EXACT117

EXACT1-Chest Symptoms Raw Score

EXACT

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

62

STUDYX

QS

P0001

62

EXACT118

EXACT1-EXACT Total Raw Score

EXACT

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

63

STUDYX

QS

P0001

63

EXACT119

EXACT1-Breathlessness Domain Score

EXACT

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

64

STUDYX

QS

P0001

64

EXACT120

EXACT1-Cough & Sputum Domain Score

EXACT

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

65

STUDYX

QS

P0001

65

EXACT121

EXACT1-Chest Symptoms Domain Score

EXACT

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

66

STUDYX

QS

P0001

66

EXACT122

EXACT1-EXACT Total Score

EXACT

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

67

STUDYX

QS

P0001

45

EXACT101

EXACT1-Chest Feel Congested

EXACT

Slightly

xxx

1

2012-11-10

BEDTIME DAY -5

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

…

1

…

154

STUDYX

QS

P0001

154

EXACT122

EXACT1-EXACT Total Score

EXACT

xxx

1

2012-11-14

BEDTIME DAY -1

NEXT CLINIC VISIT DATE

2012-11-15

EVERY EVENING BEFORE BEDTIME

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

Based on assumption 1. above, the numeric values from the user manual is represented as "xxx" in QSSTRESC and QSSTRESN.

QSTESTCD = "EXACT101" QSTEST = "EXACT1-Chest Feel Congested"

...

QSORRES	QSSTRESC	QSSTRESN
Not at allNot at all	xxx	xxx
SlightlySlightly	xxx	xxx
Moderately	xxx	Moderatelyxxx
Severely	xxx	Severelyxxx
Extremely	xxx	Extremelyxxx

QSTESTCD = "EXACT102" QSTEST = "EXACT1-How Often Cough"

QSORRES	QSSTRESC	QSSTRESN
Not at allNot at all	xxx	xxx
RarelyRarely	xxx	xxx
Occasionally	xxx	Occasionallyxxx
Frequently	xxx	Frequentlyxxx
Almost constantly	xxx	Almost constantlyxxx

QSTESTCD = "EXACT103" QSTEST = "EXACT1-Bring Up Mucus When Coughing"

QSORRES	QSSTRESC	QSSTRESN
None at allNone at all	xxx	xxx
A littleA little	xxx	Somexxx
Some	xxx	xxxA great deal
A great deal	xxx	xxx
A very great dealA very great deal	xxx	xxx

QSTESTCD = "EXACT104" QSTEST = "EXACT1-Difficult to Bring Up Mucus"

QSORRES	QSSTRESC	QSSTRESN
Not at all	xxx	Not at allxxx
Slightly	xxx	Slightlyxxx
Moderately	xxx	Moderatelyxxx
Quite a bit	xxx	Quite a bitxxx
Extremely	xxx	Extremelyxxx

QSTESTCD = "EXACT105" QSTEST = "EXACT1-Chest Discomfort"

QSORRES	QSSTRESC	QSSTRESN
Not at all	xxx	Not at allxxx
Slight	xxx	Slightxxx
Moderate	xxx	Moderatexxx
Severe	xxx	Severexxx
Extreme	xxx	Extremexxx

QSTESTCD = "EXACT108" QSTEST = "EXACT1-Describe How Breathless"

QSORRES	QSSTRESC	QSSTRESN
Unaware of breathlessnessUnaware of breathlessness	xxx	xxx
Breathless during strenuous activityBreathless during strenuous activity	xxx	xxx
Breathless during light activityBreathless during light activity	xxx	xxx
Breathless when washing or dressingBreathless when washing or dressing	xxx	xxx
Present when resting	xxx	Present when restingxxx

QSTESTCD = "EXACT109" QSTEST = "EXACT1-Short Breath Personal Care"

...

QSORRES	QSSTRESC	QSSTRESN
Not at all	xxx	Not at allxxx
Slightly	xxx	Slightlyxxx
Moderately	xxx	Moderatelyxxx
SeverelySeverely	xxx	xxx
Extremely	xxx	Extremelyxxx
Too breathless to do theseToo breathless to do these	xxx	xxx

End of Document

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