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| Rows 20-21: | Represent the symptom hiccups did not occur and then the symptom of hiccups severity was logically skipped. | | Rows 24-26: | Represent the symptom abdominal pain frequency did not occur and then the symptoms of abdominal pain severity and abdominal pain interference were logically skipped. | | 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. |
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The suppqs dataset relates the symptom term from the PRO-CTCAE ITEM LIBRARY (Version 1.0) to each symptom item represented in the qs dataset.
| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | | 1 |
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| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVALQSTESTCDQSSYMTRM | Symptom Term | DRY MOUTH | CRF| PT01-Dry Mouth Severity | PRO-CTCAE V1.0 | ORAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 2 | STUDYX | QS | 23-P0001 |
QSTESTCDQSSYMTRM | Symptom Term | DIFFICULTY SWALLOWING | | PT01-Difficulty Swallowing Severity | PRO-CTCAE V1.0 | ORAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 3 |
CRFQSTESTCDQSSYMTRM | Symptom Term | MOUTH/THROAT SORES | | PT01-Mouth/Throat Sores Severity | PRO-CTCAE V1.0 | ORAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 4 |
CRFQSTESTCDQSSYMTRM | Symptom Term | MOUTH/THROAT SORES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01004A | QSSYMTRM | Symptom Term | CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS) | | PT01-Mouth/Throat Sores Interference | PRO-CTCAE V1.0 | ORAL | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 5 |
CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01006A | QSSYMTRM | Symptom Term | HOARSENESS | CRF | PT01005A | QSSYMTRM | Symptom Term | VOICE QUALITY CHANGES | CRF | | PT01004A | PT01-Cracking Corners of Mouth Severity | PRO-CTCAE V1.0 | ORAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 6 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01008A | QSSYMTRM | Symptom Term | DECREASED APPETITE | CRF | QSTESTCD | PT01007A | QSSYMTRM | Symptom Term | TASTE CHANGES | CRF | | PT01005A | PT01-Voice Quality Changes Presence | PRO-CTCAE V1.0 | ORAL | No | 0 |
| Y | 1 | 2015-05-15 | -P7D | | 7 |
QSTESTCDPT01008B | QSSYMTRM | Symptom Term | DECREASED APPETITE | CRF | | PT01006A | PT01-Hoarseness Severity | PRO-CTCAE V1.0 | ORAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 8 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01009A | QSSYMTRM | Symptom Term | NAUSEA | CRFQSTESTCDPT01009B | QSSYMTRM | Symptom Term | NAUSEA | CRF | | PT01007A | PT01-Taste Changes Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 9 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01010A | QSSYMTRM | Symptom Term | VOMITING | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01011A | QSSYMTRM | Symptom Term | HEARTBURN | CRF | PT01010B | QSSYMTRM | Symptom Term | VOMITING | CRF | | PT01008A | PT01-Decreased Appetite Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 10 |
QSTESTCDPT01011B | QSSYMTRM | Symptom Term | HEARTBURN | CRF | | PT01008B | PT01-Decreased Appetite Interference | PRO-CTCAE V1.0 | GASTROINTESTINAL | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 11 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01012A | QSSYMTRM | Symptom Term | GAS | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01013B | QSSYMTRM | Symptom Term | BLOATING | CRF | PT01013A | QSSYMTRM | Symptom Term | BLOATING | CRF | | PT01009A | PT01-Nausea Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 12 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01014B | QSSYMTRM | Symptom Term | HICCUPS | CRF | PT01014A | QSSYMTRM | Symptom Term | HICCUPS | CRF | | PT01009B | PT01-Nausea Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 13 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01016A | QSSYMTRM | Symptom Term | DIARRHEA | CRF | PT01015A | QSSYMTRM | Symptom Term | CONSTIPATION | CRF | | PT01010A | PT01-Vomiting Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 14 |
QSTESTCD | PT01017A | QSSYMTRM | Symptom Term | ABDOMINAL PAIN | | 14 | PT01010B | PT01-Vomiting Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 15 |
CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01017C | QSSYMTRM | Symptom Term | ABDOMINAL PAIN | CRF | PT01017B | QSSYMTRM | Symptom Term | ABDOMINAL PAIN | CRF | | PT01011A | PT01-Heartburn Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 16 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01018B | QSSYMTRM | Symptom Term | FECAL INCONTINENCE | CRF | PT01018A | QSSYMTRM | Symptom Term | FECAL INCONTINENCE | CRF | | PT01011B | PT01-Heartburn Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 17 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01019B | QSSYMTRM | Symptom Term | SHORTNESS OF BREATH | CRF | PT01019A | QSSYMTRM | Symptom Term | SHORTNESS OF BREATH | CRF | | PT01012A | PT01-Gas Presence | PRO-CTCAE V1.0 | GASTROINTESTINAL | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 18 |
QSTESTCDPT01020A | QSSYMTRM | Symptom Term | COUGH | CRF | | PT01013A | PT01-Bloating Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 19 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01020B | QSSYMTRM | Symptom Term | COUGH | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01022A | QSSYMTRM | Symptom Term | SWELLING | CRF | PT01021A | QSSYMTRM | Symptom Term | WHEEZING | CRF | | PT01013B | PT01-Bloating Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 20 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01022C | QSSYMTRM | Symptom Term | SWELLING | CRF | PT01022B | QSSYMTRM | Symptom Term | SWELLING | CRF | | PT01014A | PT01-Hiccups Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Never | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 21 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01023B | QSSYMTRM | Symptom Term | HEART PALPITATIONS | CRF | PT01023A | QSSYMTRM | Symptom Term | HEART PALPITATIONS | CRF | | PT01014B | PT01-Hiccups Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | None | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 22 |
QSTESTCDPT01024A | QSSYMTRM | Symptom Term | RASH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01025A | QSSYMTRM | Symptom Term | SKIN DRYNESS | CRF | | PT01015A | PT01-Constipation Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 23 | STUDYX | QS | 23-P0001 |
QSTESTCDPT01026A | QSSYMTRM | Symptom Term | ACNE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01027A | QSSYMTRM | Symptom Term | HAIR LOSS | | PT01016A | PT01-Diarrhea Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Rarely | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 24 |
CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01029A | QSSYMTRM | Symptom Term | HIVES | CRF | PT01028A | QSSYMTRM | Symptom Term | ITCHING | CRF | | PT01017A | PT01-Abdominal Pain Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Never | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 25 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01031A | QSSYMTRM | Symptom Term | NAIL LOSS | CRF | PT01030A | QSSYMTRM | Symptom Term | HAND-FOOT SYNDROME | CRF | | PT01017B | PT01-Abdominal Pain Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | None | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 26 |
QSTESTCDPT01032A | QSSYMTRM | Symptom Term | NAIL RIDGING | CRF | | PT01017C | PT01-Abdominal Pain Interference | PRO-CTCAE V1.0 | GASTROINTESTINAL | Not at all | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 27 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01033A | QSSYMTRM | Symptom Term | NAIL DISCOLORATION | CRFQSTESTCD | PT01034A | QSSYMTRM | Symptom Term | SENSITIVITY TO SUNLIGHT | | 27 | PT01018A | PT01-Fecal Incontinence Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 28 |
CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01036A | QSSYMTRM | Symptom Term | RADIATION SKIN REACTION | CRF | PT01035A | QSSYMTRM | Symptom Term | BED/PRESSURE SORES | CRF | | PT01018B | PT01-Fecal Incontinence Interference | PRO-CTCAE V1.0 | GASTROINTESTINAL | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 29 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01038A | QSSYMTRM | Symptom Term | STRETCH MARKS | CRF | PT01037A | QSSYMTRM | Symptom Term | SKIN DARKENING | CRF | | PT01019A | PT01-Shortness of Breath Severity | PRO-CTCAE V1.0 | RESPIRATORY | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 30 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01039B | QSSYMTRM | Symptom Term | NUMBNESS & TINGLING | CRF | PT01039A | QSSYMTRM | Symptom Term | NUMBNESS & TINGLING | CRF | | PT01019B | PT01-Shortness of Breath Interference | PRO-CTCAE V1.0 | RESPIRATORY | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 31 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01040B | QSSYMTRM | Symptom Term | DIZZINESS | CRF | PT01040A | QSSYMTRM | Symptom Term | DIZZINESS | CRF | | PT01020A | PT01-Cough Severity | PRO-CTCAE V1.0 | RESPIRATORY | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 32 |
QSTESTCDPT01041A | QSSYMTRM | Symptom Term | BLURRED VISION | CRF | | PT01020B | PT01-Cough Interference | PRO-CTCAE V1.0 | RESPIRATORY | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 33 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01041B | QSSYMTRM | Symptom Term | BLURRED VISION | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01043A | QSSYMTRM | Symptom Term | VISUAL FLOATERS | CRF | PT01042A | QSSYMTRM | Symptom Term | FLASHING LIGHTS | CRF | | PT01021A | PT01-Wheezing Severity | PRO-CTCAE V1.0 | RESPIRATORY | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 34 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01044B | QSSYMTRM | Symptom Term | WATERY EYES | CRF | PT01044A | QSSYMTRM | Symptom Term | WATERY EYES | CRF | | PT01022A | PT01-Swelling Frequency | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 35 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01046A | QSSYMTRM | Symptom Term | CONCENTRATION | CRF | PT01045A | QSSYMTRM | Symptom Term | RINGING IN EARS | CRF | | PT01022B | PT01-Swelling Severity | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 36 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01047A | QSSYMTRM | Symptom Term | MEMORY | CRF | PT01046B | QSSYMTRM | Symptom Term | CONCENTRATION | CRF | | PT01022C | PT01-Swelling Interference | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 37 |
QSTESTCDPT01047B | QSSYMTRM | Symptom Term | MEMORY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01048A | QSSYMTRM | Symptom Term | GENERAL PAIN | CRF | | PT01023A | PT01-Heart Palpitations Frequency | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 38 | STUDYX | QS | 23-P0001 |
QSTESTCDPT01048B | QSSYMTRM | Symptom Term | GENERAL PAIN | CRF | | PT01023B | PT01-Heart Palpitations Severity | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 39 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01048C | QSSYMTRM | Symptom Term | GENERAL PAIN | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01049B | QSSYMTRM | Symptom Term | HEADACHE | CRF | PT01049A | QSSYMTRM | Symptom Term | HEADACHE | CRF | | PT01024A | PT01-Rash Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 40 |
QSTESTCDPT01049C | QSSYMTRM | Symptom Term | HEADACHE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01050A | QSSYMTRM | Symptom Term | MUSCLE PAIN | CRF | | PT01025A | PT01-Skin Dryness Severity | PRO-CTCAE V1.0 | CUTANEOUS | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 41 | STUDYX | QS | 23-P0001 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01050C | QSSYMTRM | Symptom Term | MUSCLE PAIN | CRF | PT01050B | QSSYMTRM | Symptom Term | MUSCLE PAIN | CRF | | PT01026A | PT01-Acne Severity | PRO-CTCAE V1.0 | CUTANEOUS | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 42 |
QSTESTCDPT01051A | QSSYMTRM | Symptom Term | JOINT PAIN | CRF | | PT01027A | PT01-Hair Loss Amount | PRO-CTCAE V1.0 | CUTANEOUS | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | | 43 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01051B | QSSYMTRM | Symptom Term | JOINT PAIN | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01052A | QSSYMTRM | Symptom Term | INSOMNIA | CRF | PT01051C | QSSYMTRM | Symptom Term | JOINT PAIN | CRF | | PT01028A | PT01-Itching Severity | PRO-CTCAE V1.0 | CUTANEOUS | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 44 |
QSTESTCD | PT01052B | QSSYMTRM | Symptom Term | INSOMNIA | | 44 | PT01029A | PT01-Hives Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 45 |
CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01053B | QSSYMTRM | Symptom Term | FATIGUE | CRF | PT01053A | QSSYMTRM | Symptom Term | FATIGUE | CRF | | PT01030A | PT01-Hand-Foot Syndrome Severity | PRO-CTCAE V1.0 | CUTANEOUS | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 46 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01054B | QSSYMTRM | Symptom Term | ANXIOUS | CRF | PT01054A | QSSYMTRM | Symptom Term | ANXIOUS | CRF | | PT01031A | PT01-Nail Loss Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 47 |
QSTESTCDPT01054C | QSSYMTRM | Symptom Term | ANXIOUS | CRF | | PT01032A | PT01-Nail Ridging Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 48 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01055A | QSSYMTRM | Symptom Term | DISCOURAGED | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01055C | QSSYMTRM | Symptom Term | DISCOURAGED | CRF | PT01055B | QSSYMTRM | Symptom Term | DISCOURAGED | CRF | | PT01033A | PT01-Nail Discoloration Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 49 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01056B | QSSYMTRM | Symptom Term | SAD | CRF | PT01056A | QSSYMTRM | Symptom Term | SAD | CRF | | PT01034A | PT01-Sensitivity to Sunlight Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 50 |
QSTESTCDPT01056C | QSSYMTRM | Symptom Term | SAD | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01057A | QSSYMTRM | Symptom Term | IRREGULAR PERIODS/VAGINAL BLEEDING | CRF | | PT01035A | PT01-Bed/Pressure Sores Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 51 | STUDYX | QS | 23-P0001 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01059A | QSSYMTRM | Symptom Term | VAGINAL DISCHARGE | CRF | PT01058A | QSSYMTRM | Symptom Term | MISSED EXPECTED MENSTRUAL PERIOD | CRF | | PT01036A | PT01-Radiation Skin Reaction Severity | PRO-CTCAE V1.0 | CUTANEOUS | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 52 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01061A | QSSYMTRM | Symptom Term | PAINFUL URINATION | CRF | PT01060A | QSSYMTRM | Symptom Term | VAGINAL DRYNESS | CRF | | PT01037A | PT01-Skin Darkening Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 53 |
QSTESTCDPT01062A | QSSYMTRM | Symptom Term | URINARY URGENCY | CRF | | PT01038A | PT01-Stretch Marks Presence | PRO-CTCAE V1.0 | CUTANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 54 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01062B | QSSYMTRM | Symptom Term | URINARY URGENCY | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01063B | QSSYMTRM | Symptom Term | URINARY FREQUENCY | CRF | PT01063A | QSSYMTRM | Symptom Term | URINARY FREQUENCY | CRF | | PT01039A | PT01-Numbness & Tingling Severity | PRO-CTCAE V1.0 | NEUROLOGICAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 55 |
QSTESTCDPT01064A | QSSYMTRM | Symptom Term | CHANGE IN USUAL URINE COLOR | CRF | | PT01039B | PT01-Numbness & Tingling Interference | PRO-CTCAE V1.0 | NEUROLOGICAL | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 56 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01065A | QSSYMTRM | Symptom Term | URINARY INCONTINENCE | CRFQSTESTCDPT01065B | QSSYMTRM | Symptom Term | URINARY INCONTINENCE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01066A | QSSYMTRM | Symptom Term | ACHIEVE AND MAINTAIN ERECTION | CRF | | PT01040A | PT01-Dizziness Severity | PRO-CTCAE V1.0 | NEUROLOGICAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 57 | STUDYX | QS | 23-P0001 |
QSTESTCDPT01067A | QSSYMTRM | Symptom Term | EJACULATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01068A | QSSYMTRM | Symptom Term | DECREASED LIBIDO | CRF | | PT01040B | PT01-Dizziness Interference | PRO-CTCAE V1.0 | NEUROLOGICAL | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 58 | STUDYX | QS | 23-P0001 |
QSTESTCDPT01069A | QSSYMTRM | Symptom Term | DELAYED ORGASM | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01070A | QSSYMTRM | Symptom Term | UNABLE TO HAVE ORGASM | CRF | | PT01041A | PT01-Blurred Vision Severity | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 59 | STUDYX | QS | 23-P0001 |
QSTESTCDPT01071A | QSSYMTRM | Symptom Term | PAIN W/SEXUAL INTERCOURSE | CRF | | PT01041B | PT01-Blurred Vision Interference | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 60 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01072A | QSSYMTRM | Symptom Term | BREAST SWELLING AND TENDERNESS | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01074A | QSSYMTRM | Symptom Term | CHILLS | CRF | PT01073A | QSSYMTRM | Symptom Term | BRUISING | CRF | | PT01042A | PT01-Flashing Lights in Eyes Presence | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 61 |
QSTESTCDPT01074B | QSSYMTRM | Symptom Term | CHILLS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01075A | QSSYMTRM | Symptom Term | INCREASED SWEATING | | PT01043A | PT01-Visual Floaters Presence | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 62 |
CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01076A | QSSYMTRM | Symptom Term | DECREASED SWEATING | CRF | PT01075B | QSSYMTRM | Symptom Term | INCREASED SWEATING | CRF | | PT01044A | PT01-Watery Eyes Severity | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 63 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01077B | QSSYMTRM | Symptom Term | HOT FLASHES | CRF | PT01077A | QSSYMTRM | Symptom Term | HOT FLASHES | CRF | | PT01044B | PT01-Watery Eyes Interference | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 64 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01078B | QSSYMTRM | Symptom Term | NOSEBLEED | CRF | PT01078A | QSSYMTRM | Symptom Term | NOSEBLEED | CRF | | PT01045A | PT01-Ringing in Ears Severity | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 65 |
QSTESTCDPT01079A | QSSYMTRM | Symptom Term | PAIN AND SWELLING AT INJECTION SITE | CRF | | PT01046A | PT01-Concentration Problems Severity | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 66 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01080A | QSSYMTRM | Symptom Term | BODY ODOR | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01082A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 1 | CRF | PT01081 | QSSYMTRM | Symptom Term | ANY OTHER SYMPTOMS REPORTED | CRF | | PT01046B | PT01-Concentration Problems Interference | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 67 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01083A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 2 | CRF | QSTESTCD | PT01082B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 1 | CRF | | 67 | PT01047A | PT01-Memory Problems Severity | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 68 |
QSTESTCDPT01083B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 2 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01084A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 3 | CRF | | PT01047B | PT01-Memory Problems Interference | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 69 | STUDYX | QS | 23-P0001 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01085A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 4 | CRF | PT01084B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 3 | CRF | | PT01048A | PT01-General Pain Frequency | PRO-CTCAE V1.0 | PAIN | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 70 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01086A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 5 | CRF | PT01085B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 4 | CRF | | PT01048B | PT01-General Pain Severity | PRO-CTCAE V1.0 | PAIN | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 71 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01087A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 6 | CRF | PT01086B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 5 | CRF | | PT01048C | PT01-General Pain Interference | PRO-CTCAE V1.0 | PAIN | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 72 |
QSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01088A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 7 | CRF | PT01087B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 6 | CRF | | PT01049A | PT01-Headache Frequency | PRO-CTCAE V1.0 | PAIN | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 73 |
QSTESTCDPT01088B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 7 | CRF | | PT01049B | PT01-Headache Severity | PRO-CTCAE V1.0 | PAIN | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 74 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01089A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 8 | CRFQSTESTCDSTUDYX | QS | 23-P0001 | QSTESTCD | PT01090A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 9 | CRF | PT01089B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 8 | CRF | | PT01049C | PT01-Headache Interference | PRO-CTCAE V1.0 | PAIN | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 75 |
QSTESTCDPT01090B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 9 | CRF | | PT01050A | PT01-Muscle Pain Frequency | PRO-CTCAE V1.0 | PAIN | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 76 |
STUDYX | QS | 23-P0001 | QSTESTCD | PT01091A | QSSYMTRM | Symptom Term | OTHER SYMPTOM 10 | CRFQSTESTCDPT01091B | QSSYMTRM | Symptom Term | OTHER SYMPTOM 10 | CRF | |
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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.
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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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QSSCAT alignment with QSTESTCD
As stated in Section 3.1 assumptions, the PRO-CTCAE V1.0 is grouped into subcategories. The table below includes the subcategory names along with the applicable question numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.
| PT01050B | PT01-Muscle Pain Severity | PRO-CTCAE V1.0 | PAIN | Mild | 1 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 2 | Y | 1 | 2015-05-15 | -P7D | | 85 | STUDYX | QS | 23-P0001 | 85 | PT01054A | PT01-Anxious Frequency | PRO-CTCAE V1.0 | MOOD | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 86 | STUDYX | QS | 23-P0001 | 86 | PT01054B | PT01-Anxious Severity | PRO-CTCAE V1.0 | MOOD | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 87 | STUDYX | QS | 23-P0001 | 87 | PT01054C | PT01-Anxious Interference | PRO-CTCAE V1.0 | MOOD | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 88 | STUDYX | QS | 23-P0001 | 88 | PT01055A | PT01-Discouraged Frequency | PRO-CTCAE V1.0 | MOOD | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 89 | STUDYX | QS | 23-P0001 | 89 | PT01055B | PT01-Discouraged Severity | PRO-CTCAE V1.0 | MOOD | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 90 | STUDYX | QS | 23-P0001 | 90 | PT01055C | PT01-Discouraged Interference | PRO-CTCAE V1.0 | MOOD | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 91 | STUDYX | QS | 23-P0001 | 91 | PT01056A | PT01-Sad Frequency | PRO-CTCAE V1.0 | MOOD | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 92 | STUDYX | QS | 23-P0001 | 92 | PT01056B | PT01-Sad Severity | PRO-CTCAE V1.0 | MOOD | Mild | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | | 93 | STUDYX | QS | 23-P0001 | 93 | PT01056C | PT01-Sad Interference | PRO-CTCAE V1.0 | MOOD | Somewhat | 2 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 1 | Y | 1 | 2015-05-15 | -P7D | | 107 | STUDYX | QS | 23-P0001 | 107 | PT01067A | PT01-Ejaculation Frequency | PRO-CTCAE V1.0 | SEXUAL | Occasionally | 2 | 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 | 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 | 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 | 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 | 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 | 1 | Y | 1 | 2015-05-15 | -P7D | | 113 | STUDYX | QS | 23-P0001 | 113 | PT01073A | PT01-Bruising Presence | PRO-CTCAE V1.0 | MISCELLANEOUS | No | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | | 114 | STUDYX | QS | 23-P0001 | 114 | PT01074A | PT01-Chills Frequency | PRO-CTCAE V1.0 | MISCELLANEOUS | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 115 | STUDYX | QS | 23-P0001 | 115 | PT01074B | PT01-Chills Severity | PRO-CTCAE V1.0 | MISCELLANEOUS | Mild | 1 | 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 | 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 | 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 | 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 | 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 | 1 | Y | 1 | 2015-05-15 | -P7D | | 121 | STUDYX | QS | 23-P0001 | 121 | PT01078A | PT01-Nosebleed Frequency | PRO-CTCAE V1.0 | MISCELLANEOUS | Occasionally | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | | 122 | STUDYX | QS | 23-P0001 | 122 | PT01078B | PT01-Nosebleed Severity | PRO-CTCAE V1.0 | MISCELLANEOUS | Mild | 1 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 1 | Y | 1 | 2015-05-15 | -P7D | | 130 | STUDYX | QS | 23-P0001 | 130 | PT01084A | PT01-Other Symptom 3 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 131 | STUDYX | QS | 23-P0001 | 131 | PT01084B | PT01-Other Symptom 3 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 132 | STUDYX | QS | 23-P0001 | 132 | PT01085A | PT01-Other Symptom 4 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 133 | STUDYX | QS | 23-P0001 | 133 | PT01085B | PT01-Other Symptom 4 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 134 | STUDYX | QS | 23-P0001 | 134 | PT01086A | PT01-Other Symptom 5 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 135 | STUDYX | QS | 23-P0001 | 135 | PT01086B | PT01-Other Symptom 5 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 136 | STUDYX | QS | 23-P0001 | 136 | PT01087A | PT01-Other Symptom 6 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 137 | STUDYX | QS | 23-P0001 | 137 | PT01087B | PT01-Other Symptom 6 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 138 | STUDYX | QS | 23-P0001 | 138 | PT01088A | PT01-Other Symptom 7 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 139 | STUDYX | QS | 23-P0001 | 139 | PT01088B | PT01-Other Symptom 7 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 140 | STUDYX | QS | 23-P0001 | 140 | PT01089A | PT01-Other Symptom 8 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 141 | STUDYX | QS | 23-P0001 | 141 | PT01089B | PT01-Other Symptom 8 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 142 | STUDYX | QS | 23-P0001 | 142 | PT01090A | PT01-Other Symptom 9 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 143 | STUDYX | QS | 23-P0001 | 143 | PT01090B | PT01-Other Symptom 9 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 144 | STUDYX | QS | 23-P0001 | 144 | PT01091A | PT01-Other Symptom 10 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D | | 145 | STUDYX | QS | 23-P0001 | 145 | PT01091B | PT01-Other Symptom 10 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
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| Y | 1 | 2015-05-15 | -P7D |
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The suppqs dataset relates the symptom term from the PRO-CTCAE ITEM LIBRARY (Version 1.0) to each symptom item represented in the qs dataset.
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| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL | | STUDYX | QS | 23-P0001 | QSTESTCD | PT01001A | QSSYMPTM | Symptom Term | DRY MOUTH | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01002A | QSSYMPTM | Symptom Term | DIFFICULTY SWALLOWING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01003A | QSSYMPTM | Symptom Term | MOUTH/THROAT SORES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01003B | QSSYMPTM | Symptom Term | MOUTH/THROAT SORES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01004A | QSSYMPTM | Symptom Term | CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS) | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01005A | QSSYMPTM | Symptom Term | VOICE QUALITY CHANGES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01006A | QSSYMPTM | Symptom Term | HOARSENESS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01007A | QSSYMPTM | Symptom Term | TASTE CHANGES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01008A | QSSYMPTM | Symptom Term | DECREASED APPETITE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01008B | QSSYMPTM | Symptom Term | DECREASED APPETITE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01009A | QSSYMPTM | Symptom Term | NAUSEA | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01009B | QSSYMPTM | Symptom Term | NAUSEA | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01010A | QSSYMPTM | Symptom Term | VOMITING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01010B | QSSYMPTM | Symptom Term | VOMITING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01011A | QSSYMPTM | Symptom Term | HEARTBURN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01011B | QSSYMPTM | Symptom Term | HEARTBURN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01012A | QSSYMPTM | Symptom Term | GAS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01013A | QSSYMPTM | Symptom Term | BLOATING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01013B | QSSYMPTM | Symptom Term | BLOATING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01014A | QSSYMPTM | Symptom Term | HICCUPS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01014B | QSSYMPTM | Symptom Term | HICCUPS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01015A | QSSYMPTM | Symptom Term | CONSTIPATION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01016A | QSSYMPTM | Symptom Term | DIARRHEA | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017A | QSSYMPTM | Symptom Term | ABDOMINAL PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017B | QSSYMPTM | Symptom Term | ABDOMINAL PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017C | QSSYMPTM | Symptom Term | ABDOMINAL PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01018A | QSSYMPTM | Symptom Term | FECAL INCONTINENCE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01018B | QSSYMPTM | Symptom Term | FECAL INCONTINENCE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01019A | QSSYMPTM | Symptom Term | SHORTNESS OF BREATH | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01019B | QSSYMPTM | Symptom Term | SHORTNESS OF BREATH | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01020A | QSSYMPTM | Symptom Term | COUGH | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01020B | QSSYMPTM | Symptom Term | COUGH | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01021A | QSSYMPTM | Symptom Term | WHEEZING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022A | QSSYMPTM | Symptom Term | SWELLING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022B | QSSYMPTM | Symptom Term | SWELLING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022C | QSSYMPTM | Symptom Term | SWELLING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01023A | QSSYMPTM | Symptom Term | HEART PALPITATIONS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01023B | QSSYMPTM | Symptom Term | HEART PALPITATIONS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01024A | QSSYMPTM | Symptom Term | RASH | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01025A | QSSYMPTM | Symptom Term | SKIN DRYNESS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01026A | QSSYMPTM | Symptom Term | ACNE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01027A | QSSYMPTM | Symptom Term | HAIR LOSS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01028A | QSSYMPTM | Symptom Term | ITCHING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01029A | QSSYMPTM | Symptom Term | HIVES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01030A | QSSYMPTM | Symptom Term | HAND-FOOT SYNDROME | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01031A | QSSYMPTM | Symptom Term | NAIL LOSS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01032A | QSSYMPTM | Symptom Term | NAIL RIDGING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01033A | QSSYMPTM | Symptom Term | NAIL DISCOLORATION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01034A | QSSYMPTM | Symptom Term | SENSITIVITY TO SUNLIGHT | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01035A | QSSYMPTM | Symptom Term | BED/PRESSURE SORES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01036A | QSSYMPTM | Symptom Term | RADIATION SKIN REACTION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01037A | QSSYMPTM | Symptom Term | SKIN DARKENING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01038A | QSSYMPTM | Symptom Term | STRETCH MARKS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01039A | QSSYMPTM | Symptom Term | NUMBNESS & TINGLING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01039B | QSSYMPTM | Symptom Term | NUMBNESS & TINGLING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01040A | QSSYMPTM | Symptom Term | DIZZINESS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01040B | QSSYMPTM | Symptom Term | DIZZINESS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01041A | QSSYMPTM | Symptom Term | BLURRED VISION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01041B | QSSYMPTM | Symptom Term | BLURRED VISION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01042A | QSSYMPTM | Symptom Term | FLASHING LIGHTS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01043A | QSSYMPTM | Symptom Term | VISUAL FLOATERS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01044A | QSSYMPTM | Symptom Term | WATERY EYES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01044B | QSSYMPTM | Symptom Term | WATERY EYES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01045A | QSSYMPTM | Symptom Term | RINGING IN EARS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01046A | QSSYMPTM | Symptom Term | CONCENTRATION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01046B | QSSYMPTM | Symptom Term | CONCENTRATION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01047A | QSSYMPTM | Symptom Term | MEMORY | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01047B | QSSYMPTM | Symptom Term | MEMORY | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01048A | QSSYMPTM | Symptom Term | GENERAL PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01048B | QSSYMPTM | Symptom Term | GENERAL PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01048C | QSSYMPTM | Symptom Term | GENERAL PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01049A | QSSYMPTM | Symptom Term | HEADACHE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01049B | QSSYMPTM | Symptom Term | HEADACHE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01049C | QSSYMPTM | Symptom Term | HEADACHE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01050A | QSSYMPTM | Symptom Term | MUSCLE PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01050B | QSSYMPTM | Symptom Term | MUSCLE PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01050C | QSSYMPTM | Symptom Term | MUSCLE PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01051A | QSSYMPTM | Symptom Term | JOINT PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01051B | QSSYMPTM | Symptom Term | JOINT PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01051C | QSSYMPTM | Symptom Term | JOINT PAIN | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01052A | QSSYMPTM | Symptom Term | INSOMNIA | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01052B | QSSYMPTM | Symptom Term | INSOMNIA | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01053A | QSSYMPTM | Symptom Term | FATIGUE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01053B | QSSYMPTM | Symptom Term | FATIGUE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01054A | QSSYMPTM | Symptom Term | ANXIOUS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01054B | QSSYMPTM | Symptom Term | ANXIOUS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01054C | QSSYMPTM | Symptom Term | ANXIOUS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01055A | QSSYMPTM | Symptom Term | DISCOURAGED | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01055B | QSSYMPTM | Symptom Term | DISCOURAGED | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01055C | QSSYMPTM | Symptom Term | DISCOURAGED | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01056A | QSSYMPTM | Symptom Term | SAD | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01056B | QSSYMPTM | Symptom Term | SAD | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01056C | QSSYMPTM | Symptom Term | SAD | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01057A | QSSYMPTM | Symptom Term | IRREGULAR PERIODS/VAGINAL BLEEDING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01058A | QSSYMPTM | Symptom Term | MISSED EXPECTED MENSTRUAL PERIOD | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01059A | QSSYMPTM | Symptom Term | VAGINAL DISCHARGE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01060A | QSSYMPTM | Symptom Term | VAGINAL DRYNESS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01061A | QSSYMPTM | Symptom Term | PAINFUL URINATION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01062A | QSSYMPTM | Symptom Term | URINARY URGENCY | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01062B | QSSYMPTM | Symptom Term | URINARY URGENCY | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01063A | QSSYMPTM | Symptom Term | URINARY FREQUENCY | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01063B | QSSYMPTM | Symptom Term | URINARY FREQUENCY | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01064A | QSSYMPTM | Symptom Term | CHANGE IN USUAL URINE COLOR | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01065A | QSSYMPTM | Symptom Term | URINARY INCONTINENCE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01065B | QSSYMPTM | Symptom Term | URINARY INCONTINENCE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01066A | QSSYMPTM | Symptom Term | ACHIEVE AND MAINTAIN ERECTION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01067A | QSSYMPTM | Symptom Term | EJACULATION | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01068A | QSSYMPTM | Symptom Term | DECREASED LIBIDO | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01069A | QSSYMPTM | Symptom Term | DELAYED ORGASM | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01070A | QSSYMPTM | Symptom Term | UNABLE TO HAVE ORGASM | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01071A | QSSYMPTM | Symptom Term | PAIN W/SEXUAL INTERCOURSE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01072A | QSSYMPTM | Symptom Term | BREAST SWELLING AND TENDERNESS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01073A | QSSYMPTM | Symptom Term | BRUISING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01074A | QSSYMPTM | Symptom Term | CHILLS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01074B | QSSYMPTM | Symptom Term | CHILLS | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01075A | QSSYMPTM | Symptom Term | INCREASED SWEATING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01075B | QSSYMPTM | Symptom Term | INCREASED SWEATING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01076A | QSSYMPTM | Symptom Term | DECREASED SWEATING | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01077A | QSSYMPTM | Symptom Term | HOT FLASHES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01077B | QSSYMPTM | Symptom Term | HOT FLASHES | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01078A | QSSYMPTM | Symptom Term | NOSEBLEED | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01078B | QSSYMPTM | Symptom Term | NOSEBLEED | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01079A | QSSYMPTM | Symptom Term | PAIN AND SWELLING AT INJECTION SITE | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01080A | QSSYMPTM | Symptom Term | BODY ODOR | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01081 | QSSYMPTM | Symptom Term | ANY OTHER SYMPTOMS REPORTED | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01082A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 1 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01082B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 1 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01083A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 2 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01083B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 2 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01084A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 3 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01084B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 3 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01085A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 4 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01085B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 4 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01086A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 5 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01086B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 5 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01087A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 6 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01087B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 6 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01088A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 7 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01088B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 7 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01089A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 8 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01089B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 8 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01090A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 9 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01090B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 9 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01091A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 10 | CRF |
| | STUDYX | QS | 23-P0001 | QSTESTCD | PT01091B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 10 | CRF |
|
|
|
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.
...
QSSCAT alignment with QSTESTCD
...
PRO-CTCAE V1.0 supported languages
| QNAM | QLABEL | QVAL |
| QSLANGQSLANGDC | Questionnaire Language For CRF Responses | CHINESE |
|
| CZECH |
|
| DANISH |
|
| DUTCH |
|
| ENGLISH |
|
| FRENCH |
|
| GERMAN |
|
| GREEK |
|
| HUNGARIAN |
|
| ITALIAN |
|
| JAPANESE |
|
| KOREAN |
|
| POLISH |
|
| PORTUGUESE |
|
| RUSSIAN |
|
| SPANISH |
PRO-CTCAE ITEM LIBRARY (Version 1.0) symptom terms
| QNAM | QLABEL | QVAL |
| QSSYMTRMQSSYMPTM | Symptom Term | ABDOMINAL PAIN |
|
| ACHIEVE AND MAINTAIN ERECTION |
|
| ACNE |
|
| ANXIOUS |
|
| BED/PRESSURE SORES |
|
| BLURRED VISION |
|
| BODY ODOR |
|
| BREAST SWELLING AND TENDERNESS |
|
| BRUISING |
|
| CHANGE IN USUAL URINE COLOR |
|
| CHILLS |
|
| CONCENTRATION |
|
| CONSTIPATION |
|
| COUGH |
|
| DECREASED LIBIDO |
|
| DECREASED SWEATING |
|
| DELAYED ORGASM |
|
| DIARRHEA |
|
| DISCOURAGED |
|
| DIZZINESS |
|
| EJACULATION |
|
| FATIGUE |
|
| FECAL INCONTINENCE |
|
| FLASHING LIGHTS |
|
| GENERAL PAIN |
|
| HAIR LOSS |
|
| HAND-FOOT SYNDROME |
|
| HEADACHE |
|
| HEART PALPITATIONS |
|
| HIVES |
|
| HOT FLASHES/FLUSHES |
|
| INCREASED SWEATING |
|
| INSOMNIA |
|
| IRREGULAR PERIODS/VAGINAL BLEEDING |
|
| ITCHING |
|
| JOINT PAIN |
|
| MEMORY |
|
| MISSED EXPECTED MENSTRUAL PERIOD |
|
| MUSCLE PAIN |
|
| NAIL DISCOLORATION |
|
| NAIL LOSS |
|
| NAIL RIDGING |
|
| NOSEBLEED |
|
| NUMBNESS & TINGLING |
|
| OTHER SYMPTOM |
|
| PAIN AND SWELLING AT INJECTION SITE |
|
| PAIN W/SEXUAL INTERCOURSE |
|
| PAINFUL URINATION |
|
| RADIATION SKIN REACTION |
|
| RASH |
|
| RINGING IN EARS |
|
| SAD |
|
| SENSITIVITY TO SUNLIGHT |
|
| SHORTNESS OF BREATH |
|
| SKIN DARKENING |
|
| SKIN DRYNESS |
|
| STRETCH MARKS |
|
| SWELLING |
|
| UNABLE TO HAVE ORGASM |
|
| URINARY FREQUENCY |
|
| URINARY INCONTINENCE |
|
| URINARY URGENCY |
|
| VAGINAL DISCHARGE |
|
| VAGINAL DRYNESS |
|
| VISUAL FLOATERS |
|
| WATERY EYES |
|
| WHEEZING |
...