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Page properties

Title	Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 Version Date 4/26/2020 (PRO-CTCAE V1.0 VERSION DATE 4/26/2020)
CDISC Reference	QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name	PRO-CTCAE V1.0 VERSION DATE 4/26/2020
QRS Permission Status	Approved
Team	Pancreatic Cancer Therapeutic Area Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	1.0
Status	DRAFT
Date	2021-1112-0817
Notes	This supplement is intended to be used with other CDISC User Guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

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Revision History

Date	Version
2021-1112-0817	1.0 Draft

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Dataset wrap

Name	qs

Rowcaps

Rows 1320-14:	Questions 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Question 12 would not appear in the actual dataset and has result values of "XXX".
Rows 15-16:	Questions 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Question 14 would not appear in the actual dataset and has result values of "XXX".
Row 33:	The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with questions 13 and 14 that differ from the remaining questions on the CRF.
21	Represent the symptom hiccups did not occur and then the symptom hiccups severity was logically skipped.
Rows 24-26	Represent the symptom abdominal pain frequency did not occur and then the symptoms abdominal pain severity and abdominal pain interference were logically skipped.
Rows 126-129	Represent two additonal symptoms that existed for the subject.
Rows 130-145	Represent the symptoms "Other Sympton 3 and Other Symptom 3 Severity" through "Other Sympton 10 and Other Symptom 10 Severity" did not exist for the subject.

Dataset2

Row

STUDYID

DOMAIN

USUBJID

QSSEQ

QSTESTCD

QSTEST

QSCAT

QSSCAT

QSORRES

QSSTRESC

QSSTRESN

QSSTAT

QSREASND

QSLOBXFL

VISITNUM

QSDTC

QSEVLINT

1

STUDYX

QS

23-P0001

1

PT01001A

PT01-Dry Mouth Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ORAL

Mild

1

Y

1

2015-05-15

-P7D

2

STUDYX

QS

23-P0001

2

PT01002A

PT01-Difficulty Swallowing Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ORAL

Mild

1

Y

1

2015-05-15

-P7D

3

STUDYX

QS

23-P0001

3

PT01003A

PT01-Mouth/Throat Sores Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ORAL

Mild

1

Y

1

2015-05-15

-P7D

4

STUDYX

QS

23-P0001

4

PT01003B

PT01-Mouth/Throat Sores Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ORAL

A little bit

1

Y

1

2015-05-15

-P7D

5

STUDYX

QS

23-P0001

5

PT01004A

PT01-Cracking Corners of Mouth Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ORAL

Mild

1

Y

1

2015-05-15

-P7D

6

STUDYX

QS

23-P0001

6

PT01005A

PT01-Voice Quality Changes Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ORAL

No

0

Y

1

2015-05-15

-P7D

7

STUDYX

QS

23-P0001

7

PT01006A

PT01-Hoarseness Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ORAL

Mild

1

Y

1

2015-05-15

-P7D

8

STUDYX

QS

23-P0001

8

PT01007A

PT01-Taste Changes Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

9

STUDYX

QS

23-P0001

9

PT01008A

PT01-Decreased Appetite Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

10

STUDYX

QS

23-P0001

10

PT01008B

PT01-Decreased Appetite Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Somewhat

2

Y

1

2015-05-15

-P7D

11

STUDYX

QS

23-P0001

11

PT01009A

PT01-Nausea Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

12

STUDYX

QS

23-P0001

12

PT01009B

PT01-Nausea Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

13

STUDYX

QS

23-P0001

13

PT01010A

PT01-Vomiting Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

14

STUDYX

QS

23-P0001

14

PT01010B

PT01-Vomiting Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

15

STUDYX

QS

23-P0001

15

PT01011A

PT01-Heartburn Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

16

STUDYX

QS

23-P0001

16

PT01011B

PT01-Heartburn Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

17

STUDYX

QS

23-P0001

17

PT01012A

PT01-Gas Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

No

0

Y

1

2015-05-15

-P7D

18

STUDYX

QS

23-P0001

18

PT01013A

PT01-Bloating Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

19

STUDYX

QS

23-P0001

19

PT01013B

PT01-Bloating Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

20

STUDYX

QS

23-P0001

20

PT01014A

PT01-Hiccups Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Never

0

Y

1

2015-05-15

-P7D

21

STUDYX

QS

23-P0001

21

PT01014B

PT01-Hiccups Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

0

NOT DONE

LOGICALLY SKIPPED ITEM

Y

1

2015-05-15

-P7D

22

STUDYX

QS

23-P0001

22

PT01015A

PT01-Constipation Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

23

STUDYX

QS

23-P0001

23

PT01016A

PT01-Diarrhea Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Rarely

1

Y

1

2015-05-15

-P7D

24

STUDYX

QS

23-P0001

24

PT01017A

PT01-Abdominal Pain Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Never

0

Y

1

2015-05-15

-P7D

25

STUDYX

QS

23-P0001

25

PT01017B

PT01-Abdominal Pain Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

0

NOT DONE

LOGICALLY SKIPPED ITEM

Y

1

2015-05-15

-P7D

26

STUDYX

QS

23-P0001

26

PT01017C

PT01-Abdominal Pain Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

0

NOT DONE

LOGICALLY SKIPPED ITEM

Y

1

2015-05-15

-P7D

27

STUDYX

QS

23-P0001

27

PT01018A

PT01-Fecal Incontinence Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

28

STUDYX

QS

23-P0001

28

PT01018B

PT01-Fecal Incontinence Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GASTROINTESTINAL

Somewhat

2

Y

1

2015-05-15

-P7D

29

STUDYX

QS

23-P0001

29

PT01019A

PT01-Shortness of Breath Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

RESPIRATORY

Mild

1

Y

1

2015-05-15

-P7D

30

STUDYX

QS

23-P0001

30

PT01019B

PT01-Shortness of Breath Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

RESPIRATORY

Somewhat

2

Y

1

2015-05-15

-P7D

31

STUDYX

QS

23-P0001

31

PT01020A

PT01-Cough Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

RESPIRATORY

Mild

1

Y

1

2015-05-15

-P7D

32

STUDYX

QS

23-P0001

32

PT01020B

PT01-Cough Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

RESPIRATORY

Somewhat

2

Y

1

2015-05-15

-P7D

33

STUDYX

QS

23-P0001

33

PT01021A

PT01-Wheezing Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

RESPIRATORY

Mild

1

Y

1

2015-05-15

-P7D

34

STUDYX

QS

23-P0001

34

PT01022A

PT01-Swelling Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CARDIO/CIRCULATORY

Occasionally

2

Y

1

2015-05-15

-P7D

35

STUDYX

QS

23-P0001

35

PT01022B

PT01-Swelling Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CARDIO/CIRCULATORY

Mild

1

Y

1

2015-05-15

-P7D

36

STUDYX

QS

23-P0001

36

PT01022C

PT01-Swelling Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CARDIO/CIRCULATORY

Somewhat

2

Y

1

2015-05-15

-P7D

37

STUDYX

QS

23-P0001

37

PT01023A

PT01-Heart Palpitations Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CARDIO/CIRCULATORY

Occasionally

2

Y

1

2015-05-15

-P7D

38

STUDYX

QS

23-P0001

38

PT01023B

PT01-Heart Palpitations Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CARDIO/CIRCULATORY

Mild

1

Y

1

2015-05-15

-P7D

39

STUDYX

QS

23-P0001

39

PT01024A

PT01-Rash Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

40

STUDYX

QS

23-P0001

40

PT01025A

PT01-Skin Dryness Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

41

STUDYX

QS

23-P0001

41

PT01026A

PT01-Acne Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

42

STUDYX

QS

23-P0001

42

PT01027A

PT01-Hair Loss Amount

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

Quite a bit

3

Y

1

2015-05-15

-P7D

43

STUDYX

QS

23-P0001

43

PT01028A

PT01-Itching Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

44

STUDYX

QS

23-P0001

44

PT01029A

PT01-Hives Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

45

STUDYX

QS

23-P0001

45

PT01030A

PT01-Hand-Foot Syndrome Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

46

STUDYX

QS

23-P0001

46

PT01031A

PT01-Nail Loss Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

47

STUDYX

QS

23-P0001

47

PT01032A

PT01-Nail Ridging Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

48

STUDYX

QS

23-P0001

48

PT01033A

PT01-Nail Discoloration Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

49

STUDYX

QS

23-P0001

49

PT01034A

PT01-Sensitivity to Sunlight Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

50

STUDYX

QS

23-P0001

50

PT01035A

PT01-Bed/Pressure Sores Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

51

STUDYX

QS

23-P0001

51

PT01036A

PT01-Radiation Skin Reaction Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

52

STUDYX

QS

23-P0001

52

PT01037A

PT01-Skin Darkening Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

53

STUDYX

QS

23-P0001

53

PT01038A

PT01-Stretch Marks Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

54

STUDYX

QS

23-P0001

54

PT01039A

PT01-Numbness & Tingling Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

NEUROLOGICAL

Mild

1

Y

1

2015-05-15

-P7D

55

STUDYX

QS

23-P0001

55

PT01039B

PT01-Numbness & Tingling Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

NEUROLOGICAL

Somewhat

2

Y

1

2015-05-15

-P7D

56

STUDYX

QS

23-P0001

56

PT01040A

PT01-Dizziness Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

NEUROLOGICAL

Mild

1

Y

1

2015-05-15

-P7D

57

STUDYX

QS

23-P0001

57

PT01040B

PT01-Dizziness Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

NEUROLOGICAL

Somewhat

2

Y

1

2015-05-15

-P7D

58

STUDYX

QS

23-P0001

58

PT01041A

PT01-Blurred Vision Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

VISUAL/PERCEPTUAL

Mild

1

Y

1

2015-05-15

-P7D

59

STUDYX

QS

23-P0001

59

PT01041B

PT01-Blurred Vision Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

VISUAL/PERCEPTUAL

Somewhat

2

Y

1

2015-05-15

-P7D

60

STUDYX

QS

23-P0001

60

PT01042A

PT01-Flashing Lights in Eyes Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

VISUAL/PERCEPTUAL

No

0

Y

1

2015-05-15

-P7D

61

STUDYX

QS

23-P0001

61

PT01043A

PT01-Visual Floaters Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

VISUAL/PERCEPTUAL

No

0

Y

1

2015-05-15

-P7D

62

STUDYX

QS

23-P0001

62

PT01044A

PT01-Watery Eyes Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

VISUAL/PERCEPTUAL

Mild

1

Y

1

2015-05-15

-P7D

63

STUDYX

QS

23-P0001

63

PT01044B

PT01-Watery Eyes Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

VISUAL/PERCEPTUAL

Somewhat

2

Y

1

2015-05-15

-P7D

64

STUDYX

QS

23-P0001

64

PT01045A

PT01-Ringing in Ears Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

VISUAL/PERCEPTUAL

Mild

1

Y

1

2015-05-15

-P7D

65

STUDYX

QS

23-P0001

65

PT01046A

PT01-Concentration Problems Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ATTENTION/MEMORY

Mild

1

Y

1

2015-05-15

-P7D

66

STUDYX

QS

23-P0001

66

PT01046B

PT01-Concentration Problems Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ATTENTION/MEMORY

Somewhat

2

Y

1

2015-05-15

-P7D

67

STUDYX

QS

23-P0001

67

PT01047A

PT01-Memory Problems Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ATTENTION/MEMORY

Mild

1

Y

1

2015-05-15

-P7D

68

STUDYX

QS

23-P0001

68

PT01047B

PT01-Memory Problems Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

ATTENTION/MEMORY

Somewhat

2

Y

1

2015-05-15

-P7D

69

STUDYX

QS

23-P0001

69

PT01048A

PT01-General Pain Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Occasionally

2

Y

1

2015-05-15

-P7D

70

STUDYX

QS

23-P0001

70

PT01048B

PT01-General Pain Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Mild

1

Y

1

2015-05-15

-P7D

71

STUDYX

QS

23-P0001

71

PT01048C

PT01-General Pain Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Somewhat

2

Y

1

2015-05-15

-P7D

72

STUDYX

QS

23-P0001

72

PT01049A

PT01-Headache Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Occasionally

2

Y

1

2015-05-15

-P7D

73

STUDYX

QS

23-P0001

73

PT01049B

PT01-Headache Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Mild

1

Y

1

2015-05-15

-P7D

74

STUDYX

QS

23-P0001

74

PT01049C

PT01-Headache Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Somewhat

2

Y

1

2015-05-15

-P7D

75

STUDYX

QS

23-P0001

75

PT01050A

PT01-Muscle Pain Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Occasionally

2

Y

1

2015-05-15

-P7D

76

STUDYX

QS

23-P0001

76

PT01050B

PT01-Muscle Pain Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Mild

1

Y

1

2015-05-15

-P7D

77

STUDYX

QS

23-P0001

77

PT01050C

PT01-Muscle Pain Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Somewhat

2

Y

1

2015-05-15

-P7D

78

STUDYX

QS

23-P0001

78

PT01051A

PT01-Joint Pain Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Occasionally

2

Y

1

2015-05-15

-P7D

79

STUDYX

QS

23-P0001

79

PT01051B

PT01-Joint Pain Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Mild

1

Y

1

2015-05-15

-P7D

80

STUDYX

QS

23-P0001

80

PT01051C

PT01-Joint Pain Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

PAIN

Somewhat

2

Y

1

2015-05-15

-P7D

81

STUDYX

QS

23-P0001

81

PT01052A

PT01-Insomnia Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SLEEP/WAKE

Mild

1

Y

1

2015-05-15

-P7D

82

STUDYX

QS

23-P0001

82

PT01052B

PT01-Insomnia Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SLEEP/WAKE

Somewhat

2

Y

1

2015-05-15

-P7D

83

STUDYX

QS

23-P0001

83

PT01053A

PT01-Fatigue Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SLEEP/WAKE

Mild

1

Y

1

2015-05-15

-P7D

84

STUDYX

QS

23-P0001

84

PT01053B

PT01-Fatigue Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SLEEP/WAKE

Somewhat

2

Y

1

2015-05-15

-P7D

85

STUDYX

QS

23-P0001

85

PT01054A

PT01-Anxious Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Occasionally

2

Y

1

2015-05-15

-P7D

86

STUDYX

QS

23-P0001

86

PT01054B

PT01-Anxious Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Mild

1

Y

1

2015-05-15

-P7D

87

STUDYX

QS

23-P0001

87

PT01054C

PT01-Anxious Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Somewhat

2

Y

1

2015-05-15

-P7D

88

STUDYX

QS

23-P0001

88

PT01055A

PT01-Discouraged Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Occasionally

2

Y

1

2015-05-15

-P7D

89

STUDYX

QS

23-P0001

89

PT01055B

PT01-Discouraged Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Mild

1

Y

1

2015-05-15

-P7D

90

STUDYX

QS

23-P0001

90

PT01055C

PT01-Discouraged Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Somewhat

2

Y

1

2015-05-15

-P7D

91

STUDYX

QS

23-P0001

91

PT01056A

PT01-Sad Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Occasionally

2

Y

1

2015-05-15

-P7D

92

STUDYX

QS

23-P0001

92

PT01056B

PT01-Sad Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Mild

1

Y

1

2015-05-15

-P7D

93

STUDYX

QS

23-P0001

93

PT01056C

PT01-Sad Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MOOD

Somewhat

2

Y

1

2015-05-15

-P7D

94

STUDYX

QS

23-P0001

94

PT01057A

PT01-Irregular Menstrual Period Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

No

0

Y

1

2015-05-15

-P7D

95

STUDYX

QS

23-P0001

95

PT01058A

PT01-Missed Menstrual Period Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

No

0

Y

1

2015-05-15

-P7D

96

STUDYX

QS

23-P0001

96

PT01059A

PT01-Vaginal Discharge Amount

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Somewhat

2

Y

1

2015-05-15

-P7D

97

STUDYX

QS

23-P0001

97

PT01060A

PT01-Vaginal Dryness Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Mild

1

Y

1

2015-05-15

-P7D

98

STUDYX

QS

23-P0001

98

PT01061A

PT01-Painful Urination Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Mild

1

Y

1

2015-05-15

-P7D

99

STUDYX

QS

23-P0001

99

PT01062A

PT01-Urinary Urgency Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Occasionally

2

Y

1

2015-05-15

-P7D

100

STUDYX

QS

23-P0001

100

PT01062B

PT01-Urinary Urgency Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Somewhat

2

Y

1

2015-05-15

-P7D

191

STUDYX

QS

23-P0001

191

PT01063A

PT01-Urinary Frequency Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Occasionally

2

Y

1

2015-05-15

-P7D

102

STUDYX

QS

23-P0001

102

PT01063B

PT01-Urinary Frequency Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Somewhat

2

Y

1

2015-05-15

-P7D

103

STUDYX

QS

23-P0001

103

PT01064A

PT01-Urine Color Change Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

No

0

Y

1

2015-05-15

-P7D

104

STUDYX

QS

23-P0001

104

PT01065A

PT01-Urinary Incontinence Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Occasionally

2

Y

1

2015-05-15

-P7D

105

STUDYX

QS

23-P0001

105

PT01065B

PT01-Urinary Incontinence Interference

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

GYNECOLOGIC/URINARY

Somewhat

2

Y

1

2015-05-15

-P7D

106

STUDYX

QS

23-P0001

106

PT01066A

PT01-Achieve&Maintain Erection Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SEXUAL

Mild

1

Y

1

2015-05-15

-P7D

107

STUDYX

QS

23-P0001

107

PT01067A

PT01-Ejaculation Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SEXUAL

Occasionally

2

Y

1

2015-05-15

-P7D

108

STUDYX

QS

23-P0001

108

PT01068A

PT01-Decreased Libido Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SEXUAL

Mild

1

Y

1

2015-05-15

-P7D

109

STUDYX

QS

23-P0001

109

PT01069A

PT01-Delayed Orgasm Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SEXUAL

No

0

Y

1

2015-05-15

-P7D

110

STUDYX

QS

23-P0001

110

PT01070A

PT01-Unable to Have Orgasm Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SEXUAL

No

0

Y

1

2015-05-15

-P7D

111

STUDYX

QS

23-P0001

111

PT01071A

PT01-Pain w/Sexual Intercourse Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

SEXUAL

Mild

1

Y

1

2015-05-15

-P7D

112

STUDYX

QS

23-P0001

112

PT01072A

PT01-Breast Swelling&Tenderness Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

113

STUDYX

QS

23-P0001

113

PT01073A

PT01-Bruising Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

No

0

Y

1

2015-05-15

-P7D

114

STUDYX

QS

23-P0001

114

PT01074A

PT01-Chills Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Occasionally

2

Y

1

2015-05-15

-P7D

115

STUDYX

QS

23-P0001

115

PT01074B

PT01-Chills Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

116

STUDYX

QS

23-P0001

116

PT01075A

PT01-Increased Sweating Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Occasionally

2

Y

1

2015-05-15

-P7D

117

STUDYX

QS

23-P0001

117

PT01075B

PT01-Increased Sweating Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

118

STUDYX

QS

23-P0001

118

PT01076A

PT01-Decreased Sweating Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

No

0

Y

1

2015-05-15

-P7D

118

STUDYX

QS

23-P0001

118

PT01077A

PT01-Hot Flashes Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Occasionally

2

Y

1

2015-05-15

-P7D

120

STUDYX

QS

23-P0001

120

PT01077B

PT01-Hot Flashes Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

121

STUDYX

QS

23-P0001

121

PT01078A

PT01-Nosebleed Frequency

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Occasionally

2

Y

1

2015-05-15

-P7D

122

STUDYX

QS

23-P0001

122

PT01078B

PT01-Nosebleed Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

123

STUDYX

QS

23-P0001

123

PT01079A

PT01-Pain&Swelling at Inj Site Presence

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

No

0

Y

1

2015-05-15

-P7D

124

STUDYX

QS

23-P0001

124

PT01080A

PT01-Body Odor Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

125

STUDYX

QS

23-P0001

125

PT01081

PT01-Any Other Symptoms Reported

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

Yes

1

Y

1

2015-05-15

-P7D

126

STUDYX

QS

23-P0001

126

PT01082A

PT01-Other Symptom 1

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

Another symptom 1

Y

1

2015-05-15

-P7D

127

STUDYX

QS

23-P0001

127

PT01082B

PT01-Other Symptom 1 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

Mild

1

Y

1

2015-05-15

-P7D

128

STUDYX

QS

23-P0001

128

PT01083A

PT01-Other Symptom 2

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

Another symptom 2

Y

1

2015-05-15

-P7D

129

STUDYX

QS

23-P0001

129

PT01083B

PT01-Other Symptom 2 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

Mild

1

Y

1

2015-05-15

-P7D

130

STUDYX

QS

23-P0001

130

PT01084A

PT01-Other Symptom 3

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

131

STUDYX

QS

23-P0001

131

PT01084B

PT01-Other Symptom 3 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

132

STUDYX

QS

23-P0001

132

PT01085A

PT01-Other Symptom 4

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

133

STUDYX

QS

23-P0001

133

PT01085B

PT01-Other Symptom 4 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

134

STUDYX

QS

23-P0001

134

PT01086A

PT01-Other Symptom 5

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

135

STUDYX

QS

23-P0001

135

PT01086B

PT01-Other Symptom 5 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

136

STUDYX

QS

23-P0001

136

PT01087A

PT01-Other Symptom 6

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

137

STUDYX

QS

23-P0001

137

PT01087B

PT01-Other Symptom 6 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

138

STUDYX

QS

23-P0001

138

PT01088A

PT01-Other Symptom 7

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

139

STUDYX

QS

23-P0001

139

PT01088B

PT01-Other Symptom 7 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

140

STUDYX

QS

23-P0001

140

PT01089A

PT01-Other Symptom 8

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

141

STUDYX

QS

23-P0001

141

PT01089B

PT01-Other Symptom 8 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

142

STUDYX

QS

23-P0001

142

PT01090A

PT01-Other Symptom 9

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

143

STUDYX

QS

23-P0001

143

PT01090B

PT01-Other Symptom 9 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

144

STUDYX

QS

23-P0001

144

PT01091A

PT01-Other Symptom 10

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

145

STUDYX

QS

23-P0001

145

PT01091B

PT01-Other Symptom 10 Severity

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

The suppqs dataset relates the symptom term from the PRO-CTCAE ITEM LIBRARY (Version 1.0) to each symptom represented in the qs dataset.

Dataset wrap

Name	suppqs

dataset2

Dataset2

tableid	suppqs.xpt

STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG	QEVAL
STUDYX	QS	23-P0001	QSTESTCD	PT01001A	QSSYMTRM	Symptom Term	DRY MOUTH	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01002A	QSSYMTRM	Symptom Term	DIFFICULTY SWALLOWING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01003A	QSSYMTRM	Symptom Term	MOUTH/THROAT SORES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01003B	QSSYMTRM	Symptom Term	MOUTH/THROAT SORES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01004A	QSSYMTRM	Symptom Term	CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS)	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01005A	QSSYMTRM	Symptom Term	VOICE QUALITY CHANGES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01006A	QSSYMTRM	Symptom Term	HOARSENESS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01007A	QSSYMTRM	Symptom Term	TASTE CHANGES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01008A	QSSYMTRM	Symptom Term	DECREASED APPETITE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01008B	QSSYMTRM	Symptom Term	DECREASED APPETITE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01009A	QSSYMTRM	Symptom Term	NAUSEA	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01009B	QSSYMTRM	Symptom Term	NAUSEA	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01010A	QSSYMTRM	Symptom Term	VOMITING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01010B	QSSYMTRM	Symptom Term	VOMITING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01011A	QSSYMTRM	Symptom Term	HEARTBURN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01011B	QSSYMTRM	Symptom Term	HEARTBURN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01012A	QSSYMTRM	Symptom Term	GAS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01013A	QSSYMTRM	Symptom Term	BLOATING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01013B	QSSYMTRM	Symptom Term	BLOATING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01014A	QSSYMTRM	Symptom Term	HICCUPS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01014B	QSSYMTRM	Symptom Term	HICCUPS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01015A	QSSYMTRM	Symptom Term	CONSTIPATION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01016A	QSSYMTRM	Symptom Term	DIARRHEA	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01017A	QSSYMTRM	Symptom Term	ABDOMINAL PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01017B	QSSYMTRM	Symptom Term	ABDOMINAL PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01017C	QSSYMTRM	Symptom Term	ABDOMINAL PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01018A	QSSYMTRM	Symptom Term	FECAL INCONTINENCE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01018B	QSSYMTRM	Symptom Term	FECAL INCONTINENCE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01019A	QSSYMTRM	Symptom Term	SHORTNESS OF BREATH	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01019B	QSSYMTRM	Symptom Term	SHORTNESS OF BREATH	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01020A	QSSYMTRM	Symptom Term	COUGH	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01020B	QSSYMTRM	Symptom Term	COUGH	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01021A	QSSYMTRM	Symptom Term	WHEEZING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01022A	QSSYMTRM	Symptom Term	SWELLING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01022B	QSSYMTRM	Symptom Term	SWELLING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01022C	QSSYMTRM	Symptom Term	SWELLING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01023A	QSSYMTRM	Symptom Term	HEART PALPITATIONS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01023B	QSSYMTRM	Symptom Term	HEART PALPITATIONS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01024A	QSSYMTRM	Symptom Term	RASH	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01025A	QSSYMTRM	Symptom Term	SKIN DRYNESS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01026A	QSSYMTRM	Symptom Term	ACNE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01027A	QSSYMTRM	Symptom Term	HAIR LOSS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01028A	QSSYMTRM	Symptom Term	ITCHING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01029A	QSSYMTRM	Symptom Term	HIVES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01030A	QSSYMTRM	Symptom Term	HAND-FOOT SYNDROME	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01031A	QSSYMTRM	Symptom Term	NAIL LOSS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01032A	QSSYMTRM	Symptom Term	NAIL RIDGING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01033A	QSSYMTRM	Symptom Term	NAIL DISCOLORATION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01034A	QSSYMTRM	Symptom Term	SENSITIVITY TO SUNLIGHT	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01035A	QSSYMTRM	Symptom Term	BED/PRESSURE SORES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01036A	QSSYMTRM	Symptom Term	RADIATION SKIN REACTION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01037A	QSSYMTRM	Symptom Term	SKIN DARKENING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01038A	QSSYMTRM	Symptom Term	STRETCH MARKS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01039A	QSSYMTRM	Symptom Term	NUMBNESS & TINGLING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01039B	QSSYMTRM	Symptom Term	NUMBNESS & TINGLING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01040A	QSSYMTRM	Symptom Term	DIZZINESS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01040B	QSSYMTRM	Symptom Term	DIZZINESS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01041A	QSSYMTRM	Symptom Term	BLURRED VISION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01041B	QSSYMTRM	Symptom Term	BLURRED VISION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01042A	QSSYMTRM	Symptom Term	FLASHING LIGHTS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01043A	QSSYMTRM	Symptom Term	VISUAL FLOATERS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01044A	QSSYMTRM	Symptom Term	WATERY EYES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01044B	QSSYMTRM	Symptom Term	WATERY EYES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01045A	QSSYMTRM	Symptom Term	RINGING IN EARS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01046A	QSSYMTRM	Symptom Term	CONCENTRATION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01046B	QSSYMTRM	Symptom Term	CONCENTRATION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01047A	QSSYMTRM	Symptom Term	MEMORY	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01047B	QSSYMTRM	Symptom Term	MEMORY	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01048A	QSSYMTRM	Symptom Term	GENERAL PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01048B	QSSYMTRM	Symptom Term	GENERAL PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01048C	QSSYMTRM	Symptom Term	GENERAL PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01049A	QSSYMTRM	Symptom Term	HEADACHE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01049B	QSSYMTRM	Symptom Term	HEADACHE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01049C	QSSYMTRM	Symptom Term	HEADACHE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01050A	QSSYMTRM	Symptom Term	MUSCLE PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01050B	QSSYMTRM	Symptom Term	MUSCLE PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01050C	QSSYMTRM	Symptom Term	MUSCLE PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01051A	QSSYMTRM	Symptom Term	JOINT PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01051B	QSSYMTRM	Symptom Term	JOINT PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01051C	QSSYMTRM	Symptom Term	JOINT PAIN	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01052A	QSSYMTRM	Symptom Term	INSOMNIA	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01052B	QSSYMTRM	Symptom Term	INSOMNIA	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01053A	QSSYMTRM	Symptom Term	FATIGUE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01053B	QSSYMTRM	Symptom Term	FATIGUE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01054A	QSSYMTRM	Symptom Term	ANXIOUS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01054B	QSSYMTRM	Symptom Term	ANXIOUS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01054C	QSSYMTRM	Symptom Term	ANXIOUS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01055A	QSSYMTRM	Symptom Term	DISCOURAGED	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01055B	QSSYMTRM	Symptom Term	DISCOURAGED	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01055C	QSSYMTRM	Symptom Term	DISCOURAGED	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01056A	QSSYMTRM	Symptom Term	SAD	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01056B	QSSYMTRM	Symptom Term	SAD	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01056C	QSSYMTRM	Symptom Term	SAD	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01057A	QSSYMTRM	Symptom Term	IRREGULAR PERIODS/VAGINAL BLEEDING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01058A	QSSYMTRM	Symptom Term	MISSED EXPECTED MENSTRUAL PERIOD	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01059A	QSSYMTRM	Symptom Term	VAGINAL DISCHARGE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01060A	QSSYMTRM	Symptom Term	VAGINAL DRYNESS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01061A	QSSYMTRM	Symptom Term	PAINFUL URINATION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01062A	QSSYMTRM	Symptom Term	URINARY URGENCY	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01062B	QSSYMTRM	Symptom Term	URINARY URGENCY	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01063A	QSSYMTRM	Symptom Term	URINARY FREQUENCY	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01063B	QSSYMTRM	Symptom Term	URINARY FREQUENCY	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01064A	QSSYMTRM	Symptom Term	CHANGE IN USUAL URINE COLOR	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01065A	QSSYMTRM	Symptom Term	URINARY INCONTINENCE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01065B	QSSYMTRM	Symptom Term	URINARY INCONTINENCE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01066A	QSSYMTRM	Symptom Term	ACHIEVE AND MAINTAIN ERECTION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01067A	QSSYMTRM	Symptom Term	EJACULATION	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01068A	QSSYMTRM	Symptom Term	DECREASED LIBIDO	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01069A	QSSYMTRM	Symptom Term	DELAYED ORGASM	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01070A	QSSYMTRM	Symptom Term	UNABLE TO HAVE ORGASM	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01071A	QSSYMTRM	Symptom Term	PAIN W/SEXUAL INTERCOURSE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01072A	QSSYMTRM	Symptom Term	BREAST SWELLING AND TENDERNESS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01073A	QSSYMTRM	Symptom Term	BRUISING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01074A	QSSYMTRM	Symptom Term	CHILLS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01074B	QSSYMTRM	Symptom Term	CHILLS	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01075A	QSSYMTRM	Symptom Term	INCREASED SWEATING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01075B	QSSYMTRM	Symptom Term	INCREASED SWEATING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01076A	QSSYMTRM	Symptom Term	DECREASED SWEATING	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01077A	QSSYMTRM	Symptom Term	HOT FLASHES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01077B	QSSYMTRM	Symptom Term	HOT FLASHES	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01078A	QSSYMTRM	Symptom Term	NOSEBLEED	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01078B	QSSYMTRM	Symptom Term	NOSEBLEED	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01079A	QSSYMTRM	Symptom Term	PAIN AND SWELLING AT INJECTION SITE	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01080A	QSSYMTRM	Symptom Term	BODY ODOR	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01081	QSSYMTRM	Symptom Term	ANY OTHER SYMPTOMS REPORTED	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01082A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 1	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01082B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 1	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01083A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 2	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01083B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 2	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01084A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 3	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01084B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 3	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01085A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 4	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01085B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 4	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01086A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 5	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01086B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 5	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01087A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 6	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01087B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 6	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01088A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 7	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01088B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 7	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01089A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 8	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01089B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 8	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01090A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 9	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01090B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 9	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01091A	QSSYMTRM	Symptom Term	OTHER SYMPTOM 10	CRF
STUDYX	QS	23-P0001	QSTESTCD	PT01091B	QSSYMTRM	Symptom Term	OTHER SYMPTOM 10	CRF

Info

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

QORIG

Dataset wrap

Name	suppqs

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

QNAM

QLABEL

QVAL

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.

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