Page History

...

Dataset wrap

Name	qs

Rowcaps

Rows 20-21:	Represent the electronic conditional branching on data entry for the symptom hiccups did not occur and then the symptom of hiccups severity was assigned 0 = “None”.
Rows 24-26:	Represent the electronic conditional branching on data entry for the symptom abdominal pain frequency did not occur. The symptom of abdominal pain severity is assigned 0 = “None” and abdominal pain interference is assigned 0 = “Not at all” for the standardized result values.
Rows 126-129:	Represent two additional symptoms that existed for the subject.
Rows 130-145:	Represent the symptoms "Other Symptom 3 and Other Symptom 3 Severity" through "Other Symptom 10 and Other Symptom 10 Severity" that did not exist for the subject. These symptoms are represented as "NOT DONE".

Dataset2

Row

STUDYID

DOMAIN

USUBJID

QSSEQ

QSTESTCD

QSTEST

QSCAT

QSSCAT

QSORRES

QSSTRESC

QSSTRESN

QSSTAT

QSREASND

QSLOBXFL

QSDRVFL

VISITNUM

QSDTC

QSEVLINT

1

STUDYX

QS

23-P0001

1

PT01001A

PT01-Dry Mouth Severity

PRO-CTCAE V1.0

ORAL

Mild

1

Y

1

2015-05-15

-P7D

2

STUDYX

QS

23-P0001

2

PT01002A

PT01-Difficulty Swallowing Severity

PRO-CTCAE V1.0

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

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

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

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

ORAL

No

0

Y

1

2015-05-15

-P7D

7

STUDYX

QS

23-P0001

7

PT01006A

PT01-Hoarseness Severity

PRO-CTCAE V1.0

ORAL

Mild

1

Y

1

2015-05-15

-P7D

8

STUDYX

QS

23-P0001

8

PT01007A

PT01-Taste Changes Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

9

STUDYX

QS

23-P0001

9

PT01008A

PT01-Decreased Appetite Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

10

STUDYX

QS

23-P0001

10

PT01008B

PT01-Decreased Appetite Interference

PRO-CTCAE V1.0

GASTROINTESTINAL

Somewhat

2

Y

1

2015-05-15

-P7D

11

STUDYX

QS

23-P0001

11

PT01009A

PT01-Nausea Frequency

PRO-CTCAE V1.0

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

12

STUDYX

QS

23-P0001

12

PT01009B

PT01-Nausea Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

13

STUDYX

QS

23-P0001

13

PT01010A

PT01-Vomiting Frequency

PRO-CTCAE V1.0

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

14

STUDYX

QS

23-P0001

14

PT01010B

PT01-Vomiting Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

15

STUDYX

QS

23-P0001

15

PT01011A

PT01-Heartburn Frequency

PRO-CTCAE V1.0

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

16

STUDYX

QS

23-P0001

16

PT01011B

PT01-Heartburn Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

17

STUDYX

QS

23-P0001

17

PT01012A

PT01-Gas Presence

PRO-CTCAE V1.0

GASTROINTESTINAL

No

0

Y

1

2015-05-15

-P7D

18

STUDYX

QS

23-P0001

18

PT01013A

PT01-Bloating Frequency

PRO-CTCAE V1.0

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

19

STUDYX

QS

23-P0001

19

PT01013B

PT01-Bloating Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

20

STUDYX

QS

23-P0001

20

PT01014A

PT01-Hiccups Frequency

PRO-CTCAE V1.0

GASTROINTESTINAL

Never

0

Y

1

2015-05-15

-P7D

21

STUDYX

QS

23-P0001

21

PT01014B

PT01-Hiccups Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

None

0

Y

1

2015-05-15

-P7D

22

STUDYX

QS

23-P0001

22

PT01015A

PT01-Constipation Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

Mild

1

Y

1

2015-05-15

-P7D

23

STUDYX

QS

23-P0001

23

PT01016A

PT01-Diarrhea Frequency

PRO-CTCAE V1.0

GASTROINTESTINAL

Rarely

1

Y

1

2015-05-15

-P7D

24

STUDYX

QS

23-P0001

24

PT01017A

PT01-Abdominal Pain Frequency

PRO-CTCAE V1.0

GASTROINTESTINAL

Never

0

Y

1

2015-05-15

-P7D

25

STUDYX

QS

23-P0001

25

PT01017B

PT01-Abdominal Pain Severity

PRO-CTCAE V1.0

GASTROINTESTINAL

None

0

Y

1

2015-05-15

-P7D

26

STUDYX

QS

23-P0001

26

PT01017C

PT01-Abdominal Pain Interference

PRO-CTCAE V1.0

GASTROINTESTINAL

Not at all

0

Y

1

2015-05-15

-P7D

27

STUDYX

QS

23-P0001

27

PT01018A

PT01-Fecal Incontinence Frequency

PRO-CTCAE V1.0

GASTROINTESTINAL

Occasionally

2

Y

1

2015-05-15

-P7D

28

STUDYX

QS

23-P0001

28

PT01018B

PT01-Fecal Incontinence Interference

PRO-CTCAE V1.0

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

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

RESPIRATORY

Somewhat

2

Y

1

2015-05-15

-P7D

31

STUDYX

QS

23-P0001

31

PT01020A

PT01-Cough Severity

PRO-CTCAE V1.0

RESPIRATORY

Mild

1

Y

1

2015-05-15

-P7D

32

STUDYX

QS

23-P0001

32

PT01020B

PT01-Cough Interference

PRO-CTCAE V1.0

RESPIRATORY

Somewhat

2

Y

1

2015-05-15

-P7D

33

STUDYX

QS

23-P0001

33

PT01021A

PT01-Wheezing Severity

PRO-CTCAE V1.0

RESPIRATORY

Mild

1

Y

1

2015-05-15

-P7D

34

STUDYX

QS

23-P0001

34

PT01022A

PT01-Swelling Frequency

PRO-CTCAE V1.0

CARDIO/CIRCULATORY

Occasionally

2

Y

1

2015-05-15

-P7D

35

STUDYX

QS

23-P0001

35

PT01022B

PT01-Swelling Severity

PRO-CTCAE V1.0

CARDIO/CIRCULATORY

Mild

1

Y

1

2015-05-15

-P7D

36

STUDYX

QS

23-P0001

36

PT01022C

PT01-Swelling Interference

PRO-CTCAE V1.0

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

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

CARDIO/CIRCULATORY

Mild

1

Y

1

2015-05-15

-P7D

39

STUDYX

QS

23-P0001

39

PT01024A

PT01-Rash Presence

PRO-CTCAE V1.0

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

40

STUDYX

QS

23-P0001

40

PT01025A

PT01-Skin Dryness Severity

PRO-CTCAE V1.0

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

41

STUDYX

QS

23-P0001

41

PT01026A

PT01-Acne Severity

PRO-CTCAE V1.0

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

42

STUDYX

QS

23-P0001

42

PT01027A

PT01-Hair Loss Amount

PRO-CTCAE V1.0

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

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

44

STUDYX

QS

23-P0001

44

PT01029A

PT01-Hives Presence

PRO-CTCAE V1.0

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

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

46

STUDYX

QS

23-P0001

46

PT01031A

PT01-Nail Loss Presence

PRO-CTCAE V1.0

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

47

STUDYX

QS

23-P0001

47

PT01032A

PT01-Nail Ridging Presence

PRO-CTCAE V1.0

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

48

STUDYX

QS

23-P0001

48

PT01033A

PT01-Nail Discoloration Presence

PRO-CTCAE V1.0

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

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

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

CUTANEOUS

Mild

1

Y

1

2015-05-15

-P7D

52

STUDYX

QS

23-P0001

52

PT01037A

PT01-Skin Darkening Presence

PRO-CTCAE V1.0

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

53

STUDYX

QS

23-P0001

53

PT01038A

PT01-Stretch Marks Presence

PRO-CTCAE V1.0

CUTANEOUS

No

0

Y

1

2015-05-15

-P7D

54

STUDYX

QS

23-P0001

54

PT01039A

PT01-Numbness & Tingling Severity

PRO-CTCAE V1.0

NEUROLOGICAL

Mild

1

Y

1

2015-05-15

-P7D

55

STUDYX

QS

23-P0001

55

PT01039B

PT01-Numbness & Tingling Interference

PRO-CTCAE V1.0

NEUROLOGICAL

Somewhat

2

Y

1

2015-05-15

-P7D

56

STUDYX

QS

23-P0001

56

PT01040A

PT01-Dizziness Severity

PRO-CTCAE V1.0

NEUROLOGICAL

Mild

1

Y

1

2015-05-15

-P7D

57

STUDYX

QS

23-P0001

57

PT01040B

PT01-Dizziness Interference

PRO-CTCAE V1.0

NEUROLOGICAL

Somewhat

2

Y

1

2015-05-15

-P7D

58

STUDYX

QS

23-P0001

58

PT01041A

PT01-Blurred Vision Severity

PRO-CTCAE V1.0

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

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

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

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

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

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

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

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

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

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

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

PAIN

Occasionally

2

Y

1

2015-05-15

-P7D

70

STUDYX

QS

23-P0001

70

PT01048B

PT01-General Pain Severity

PRO-CTCAE V1.0

PAIN

Mild

1

Y

1

2015-05-15

-P7D

71

STUDYX

QS

23-P0001

71

PT01048C

PT01-General Pain Interference

PRO-CTCAE V1.0

PAIN

Somewhat

2

Y

1

2015-05-15

-P7D

72

STUDYX

QS

23-P0001

72

PT01049A

PT01-Headache Frequency

PRO-CTCAE V1.0

PAIN

Occasionally

2

Y

1

2015-05-15

-P7D

73

STUDYX

QS

23-P0001

73

PT01049B

PT01-Headache Severity

PRO-CTCAE V1.0

PAIN

Mild

1

Y

1

2015-05-15

-P7D

74

STUDYX

QS

23-P0001

74

PT01049C

PT01-Headache Interference

PRO-CTCAE V1.0

PAIN

Somewhat

2

Y

1

2015-05-15

-P7D

75

STUDYX

QS

23-P0001

75

PT01050A

PT01-Muscle Pain Frequency

PRO-CTCAE V1.0

PAIN

Occasionally

2

Y

1

2015-05-15

-P7D

76

STUDYX

QS

23-P0001

76

PT01050B

PT01-Muscle Pain Severity

PRO-CTCAE V1.0

PAIN

Mild

1

Y

1

2015-05-15

-P7D

77

STUDYX

QS

23-P0001

77

PT01050C

PT01-Muscle Pain Interference

PRO-CTCAE V1.0

PAIN

Somewhat

2

Y

1

2015-05-15

-P7D

78

STUDYX

QS

23-P0001

78

PT01051A

PT01-Joint Pain Frequency

PRO-CTCAE V1.0

PAIN

Occasionally

2

Y

1

2015-05-15

-P7D

79

STUDYX

QS

23-P0001

79

PT01051B

PT01-Joint Pain Severity

PRO-CTCAE V1.0

PAIN

Mild

1

Y

1

2015-05-15

-P7D

80

STUDYX

QS

23-P0001

80

PT01051C

PT01-Joint Pain Interference

PRO-CTCAE V1.0

PAIN

Somewhat

2

Y

1

2015-05-15

-P7D

81

STUDYX

QS

23-P0001

81

PT01052A

PT01-Insomnia Severity

PRO-CTCAE V1.0

SLEEP/WAKE

Mild

1

Y

1

2015-05-15

-P7D

82

STUDYX

QS

23-P0001

82

PT01052B

PT01-Insomnia Interference

PRO-CTCAE V1.0

SLEEP/WAKE

Somewhat

2

Y

1

2015-05-15

-P7D

83

STUDYX

QS

23-P0001

83

PT01053A

PT01-Fatigue Severity

PRO-CTCAE V1.0

SLEEP/WAKE

Mild

1

Y

1

2015-05-15

-P7D

84

STUDYX

QS

23-P0001

84

PT01053B

PT01-Fatigue Interference

PRO-CTCAE V1.0

SLEEP/WAKE

Somewhat

2

Y

1

2015-05-15

-P7D

85

STUDYX

QS

23-P0001

85

PT01054A

PT01-Anxious Frequency

PRO-CTCAE V1.0

MOOD

Occasionally

2

Y

1

2015-05-15

-P7D

86

STUDYX

QS

23-P0001

86

PT01054B

PT01-Anxious Severity

PRO-CTCAE V1.0

MOOD

Mild

1

Y

1

2015-05-15

-P7D

87

STUDYX

QS

23-P0001

87

PT01054C

PT01-Anxious Interference

PRO-CTCAE V1.0

MOOD

Somewhat

2

Y

1

2015-05-15

-P7D

88

STUDYX

QS

23-P0001

88

PT01055A

PT01-Discouraged Frequency

PRO-CTCAE V1.0

MOOD

Occasionally

2

Y

1

2015-05-15

-P7D

89

STUDYX

QS

23-P0001

89

PT01055B

PT01-Discouraged Severity

PRO-CTCAE V1.0

MOOD

Mild

1

Y

1

2015-05-15

-P7D

90

STUDYX

QS

23-P0001

90

PT01055C

PT01-Discouraged Interference

PRO-CTCAE V1.0

MOOD

Somewhat

2

Y

1

2015-05-15

-P7D

91

STUDYX

QS

23-P0001

91

PT01056A

PT01-Sad Frequency

PRO-CTCAE V1.0

MOOD

Occasionally

2

Y

1

2015-05-15

-P7D

92

STUDYX

QS

23-P0001

92

PT01056B

PT01-Sad Severity

PRO-CTCAE V1.0

MOOD

Mild

1

Y

1

2015-05-15

-P7D

93

STUDYX

QS

23-P0001

93

PT01056C

PT01-Sad Interference

PRO-CTCAE V1.0

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

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

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

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

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

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

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

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

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

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

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

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

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

SEXUAL

Mild

1

Y

1

2015-05-15

-P7D

107

STUDYX

QS

23-P0001

107

PT01067A

PT01-Ejaculation Frequency

PRO-CTCAE V1.0

SEXUAL

Occasionally

2

Y

1

2015-05-15

-P7D

108

STUDYX

QS

23-P0001

108

PT01068A

PT01-Decreased Libido Severity

PRO-CTCAE V1.0

SEXUAL

Mild

1

Y

1

2015-05-15

-P7D

109

STUDYX

QS

23-P0001

109

PT01069A

PT01-Delayed Orgasm Presence

PRO-CTCAE V1.0

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

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

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

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

113

STUDYX

QS

23-P0001

113

PT01073A

PT01-Bruising Presence

PRO-CTCAE V1.0

MISCELLANEOUS

No

0

Y

1

2015-05-15

-P7D

114

STUDYX

QS

23-P0001

114

PT01074A

PT01-Chills Frequency

PRO-CTCAE V1.0

MISCELLANEOUS

Occasionally

2

Y

1

2015-05-15

-P7D

115

STUDYX

QS

23-P0001

115

PT01074B

PT01-Chills Severity

PRO-CTCAE V1.0

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

116

STUDYX

QS

23-P0001

116

PT01075A

PT01-Increased Sweating Frequency

PRO-CTCAE V1.0

MISCELLANEOUS

Occasionally

2

Y

1

2015-05-15

-P7D

117

STUDYX

QS

23-P0001

117

PT01075B

PT01-Increased Sweating Severity

PRO-CTCAE V1.0

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

118

STUDYX

QS

23-P0001

118

PT01076A

PT01-Decreased Sweating Presence

PRO-CTCAE V1.0

MISCELLANEOUS

No

0

Y

1

2015-05-15

-P7D

118

STUDYX

QS

23-P0001

118

PT01077A

PT01-Hot Flashes Frequency

PRO-CTCAE V1.0

MISCELLANEOUS

Occasionally

2

Y

1

2015-05-15

-P7D

120

STUDYX

QS

23-P0001

120

PT01077B

PT01-Hot Flashes Severity

PRO-CTCAE V1.0

MISCELLANEOUS

Mild

1

Y

1

2015-05-15

-P7D

121

STUDYX

QS

23-P0001

121

PT01078A

PT01-Nosebleed Frequency

PRO-CTCAE V1.0

MISCELLANEOUS

Occasionally

2

Y

1

2015-05-15

-P7D

122

STUDYX

QS

23-P0001

122

PT01078B

PT01-Nosebleed Severity

PRO-CTCAE V1.0

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

MISCELLANEOUS

No

0

Y

1

2015-05-15

-P7D

124

STUDYX

QS

23-P0001

124

PT01080A

PT01-Body Odor Severity

PRO-CTCAE V1.0

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

OTHER SYMPTOMS

NOT DONE

Y

1

2015-05-15

-P7D

The suppqs SUPPQS dataset shows the items in the QS dataset which have assigned responses (QSDRVFL = "Y") due to electronic conditional branching and also relates the symptom terms from the PRO-CTCAE ITEM LIBRARY (Version 1.0) to each symptom item represented in the QS dataset.

...

Dataset wrap

Name	qsxx

Dataset2

tableid	qsxx

Row

STUDYID

DOMAIN

USUBJID

QSSEQ

QSTESTCD

QSTEST

QSCAT

QSSCAT

QSORRES

QSSTRESC

QSSTRESN

QSSTAT

QSREASND

QSLOBXFL

VISITNUM

QSDTC

QSEVLINT

1

STUDYX

QS

23-P0001

1

PT01019A

PT01-Shortness of Breath Severity

PRO-CTCAE V1.0

RESPIRATORY

Mild

1

Y

1

2015-05-15

-P7D

2

STUDYX

QS

23-P0001

2

PT01019B

PT01-Shortness of Breath Interference

PRO-CTCAE V1.0

RESPIRATORY

Somewhat

2

Y

1

2015-05-15

-P7D

3

STUDYX

QS

23-P0001

3

PT01020A

PT01-Cough Severity

PRO-CTCAE V1.0

RESPIRATORY

Mild

1

Y

1

2015-05-15

-P7D

4

STUDYX

QS

23-P0001

4

PT01020B

PT01-Cough Interference

PRO-CTCAE V1.0

RESPIRATORY

Somewhat

2

Y

1

2015-05-15

-P7D

5

STUDYX

QS

23-P0001

5

PT01021A

PT01-Wheezing Severity

PRO-CTCAE V1.0

RESPIRATORY

Mild

1

Y

1

2015-05-15

-P7D

6

STUDYX

QS

23-P0001

6

PT01022A

PT01-Swelling Frequency

PRO-CTCAE V1.0

CARDIO/CIRCULATORY

Occasionally

2

Y

1

2015-05-15

-P7D

7

STUDYX

QS

23-P0001

7

PT01022B

PT01-Swelling Severity

PRO-CTCAE V1.0

CARDIO/CIRCULATORY

Mild

1

Y

1

2015-05-15

-P7D

8

STUDYX

QS

23-P0001

8

PT01022C

PT01-Swelling Interference

PRO-CTCAE V1.0

CARDIO/CIRCULATORY

Somewhat

2

Y

1

2015-05-15

-P7D

9

STUDYX

QS

23-P0001

9

PT01023A

PT01-Heart Palpitations Frequency

PRO-CTCAE V1.0

CARDIO/CIRCULATORY

Occasionally

2

Y

1

2015-05-15

-P7D

10

STUDYX

QS

23-P0001

10

PT01023B

PT01-Heart Palpitations Severity

PRO-CTCAE V1.0

CARDIO/CIRCULATORY

Mild

1

Y

1

2015-05-15

-P7D

11

STUDYX

QS

23-P0001

11

PT01039A

PT01-Numbness & Tingling Severity

PRO-CTCAE V1.0

NEUROLOGICAL

Mild

1

Y

1

2015-05-15

-P7D

12

STUDYX

QS

23-P0001

12

PT01039B

PT01-Numbness & Tingling Interference

PRO-CTCAE V1.0

NEUROLOGICAL

Somewhat

2

Y

1

2015-05-15

-P7D

13

STUDYX

QS

23-P0001

13

PT01040A

PT01-Dizziness Severity

PRO-CTCAE V1.0

NEUROLOGICAL

Mild

1

Y

1

2015-05-15

-P7D

14

STUDYX

QS

23-P0001

14

PT01040B

PT01-Dizziness Interference

PRO-CTCAE V1.0

NEUROLOGICAL

Somewhat

2

Y

1

2015-05-15

-P7D

15

STUDYX

QS

23-P0001

15

PT01046A

PT01-Concentration Problems Severity

PRO-CTCAE V1.0

ATTENTION/MEMORY

Mild

1

Y

1

2015-05-15

-P7D

16

STUDYX

QS

23-P0001

16

PT01046B

PT01-Concentration Problems Interference

PRO-CTCAE V1.0

ATTENTION/MEMORY

Somewhat

2

Y

1

2015-05-15

-P7D

17

STUDYX

QS

23-P0001

17

PT01047A

PT01-Memory Problems Severity

PRO-CTCAE V1.0

ATTENTION/MEMORY

Mild

1

Y

1

2015-05-15

-P7D

18

STUDYX

QS

23-P0001

18

PT01047B

PT01-Memory Problems Interference

PRO-CTCAE V1.0

ATTENTION/MEMORY

Somewhat

2

Y

1

2015-05-15

-P7D

19

STUDYX

QS

23-P0001

19

PT01081

PT01-Any Other Symptoms Reported

PRO-CTCAE V1.0

OTHER SYMPTOMS

Yes

1

Y

1

2015-05-15

-P7D

20

STUDYX

QS

23-P0001

20

PT01082A

PT01-Other Symptom 1

PRO-CTCAE V1.0

OTHER SYMPTOMS

Another symptom 1

Y

1

2015-05-15

-P7D

21

STUDYX

QS

23-P0001

21

PT01082B

PT01-Other Symptom 1 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

Mild

1

Y

1

2015-05-15

-P7D

22

STUDYX

QS

23-P0001

22

PT01083A

PT01-Other Symptom 2

PRO-CTCAE V1.0

OTHER SYMPTOMS

Another symptom 2

Y

1

2015-05-15

-P7D

23

STUDYX

QS

23-P0001

23

PT01083B

PT01-Other Symptom 2 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

Mild

1

Y

1

2015-05-15

-P7D

24

STUDYX

QS

23-P0001

24

PT01084A

PT01-Other Symptom 3

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

25

STUDYX

QS

23-P0001

25

PT01084B

PT01-Other Symptom 3 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

26

STUDYX

QS

23-P0001

26

PT01085A

PT01-Other Symptom 4

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

27

STUDYX

QS

23-P0001

27

PT01085B

PT01-Other Symptom 4 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

28

STUDYX

QS

23-P0001

28

PT01086A

PT01-Other Symptom 5

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

29

STUDYX

QS

23-P0001

29

PT01086B

PT01-Other Symptom 5 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

30

STUDYX

QS

23-P0001

30

PT01087A

PT01-Other Symptom 6

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

31

STUDYX

QS

23-P0001

31

PT01087B

PT01-Other Symptom 6 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

32

STUDYX

QS

23-P0001

32

PT01088A

PT01-Other Symptom 7

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

33

STUDYX

QS

23-P0001

33

PT01088B

PT01-Other Symptom 7 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

34

STUDYX

QS

23-P0001

34

PT01089A

PT01-Other Symptom 8

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

35

STUDYX

QS

23-P0001

35

PT01089B

PT01-Other Symptom 8 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

36

STUDYX

QS

23-P0001

36

PT01090A

PT01-Other Symptom 9

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

37

STUDYX

QS

23-P0001

37

PT01090B

PT01-Other Symptom 9 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

38

STUDYX

QS

23-P0001

38

PT01091A

PT01-Other Symptom 10

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

39

STUDYX

QS

23-P0001

39

PT01091B

PT01-Other Symptom 10 Severity

PRO-CTCAE V1.0

OTHER SYMPTOMS

NOT DONE

1

2015-05-15

-P7D

The suppqs SUPPQS dataset relates the symptom terms from the PRO-CTCAE ITEM LIBRARY (Version 1.0) to each symptom item represented in the subset of symptoms in the QS dataset.

...

Page tree

Versions Compared

Old Version 101

New Version 102

Key