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The CDISC documentation of this measurement system consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values (referred to hereafter as annotated Item Library v1.0 form).
Note: CDISC Controlled Terminology is maintained by NCI Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.
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The 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 1annotated Item Library v1.0 ) form to each symptom item represented in the QS dataset.
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Example 2: PRO-CTCAE V1.0 measuring the subset of symptoms from the following subcategories as represented in the PRO-CTCAE ITEM LIBRARY (Version 1.0)the Quick Guide to the Item Library:
- RESPIRATORY
- CARDIO/CIRCULATORY
- NEUROLOGICAL
- ATTENTION/MEMORY
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The SUPPQS dataset relates the symptom terms from the PRO-CTCAE ITEM LIBRARY (Version 1annotated Item Library v1.0 ) form to each symptom item represented in the subset of symptoms in the QS dataset.
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As stated in Section 3.1 assumptions, the PRO-CTCAE V1.0 symptom terms are grouped into subcategories as represented in the PRO-CTCAE ITEM LIBRARY (Version 1.0). Quick Guide to the Item Library. 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
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| QNAM | QLABEL | QVAL |
| QSLANGDC | Data Collection Language | CHINESE |
| CZECH | ||
| DANISH | ||
| DUTCH | ||
| ENGLISH | ||
| FRENCH | ||
| GERMAN | ||
| GREEK | ||
| HUNGARIAN | ||
| ITALIAN | ||
| JAPANESE | ||
| KOREAN | ||
| POLISH | ||
| PORTUGUESE | ||
| RUSSIAN | ||
| SPANISH |
PRO-CTCAE ITEM LIBRARY (Version 1V1.0 ) symptom terms
| QNAM | QLABEL | QVAL |
| QSSYMPTM | Symptom Term | ABDOMINAL PAIN |
| ACHIEVE AND MAINTAIN ERECTION | ||
| ACNE | ||
| ANXIOUS | ||
| ANY OTHER SYMPTOMS REPORTED | ||
| BED/PRESSURE SORES | ||
| BLOATING | ||
| BLURRED VISION | ||
| BODY ODOR | ||
| BREAST SWELLING AND TENDERNESS | ||
| BRUISING | ||
| CHANGE IN USUAL URINE COLOR | ||
| CHILLS | ||
| CONCENTRATION | ||
| CONSTIPATION | ||
| COUGH | ||
| CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS) | ||
| DECREASED APPETITE | ||
| DECREASED LIBIDO | ||
| DECREASED SWEATING | ||
| DELAYED ORGASM | ||
| DIARRHEA | ||
| DIFFICULTY SWALLOWING | ||
| DISCOURAGED | ||
| DIZZINESS | ||
| DRY MOUTH | ||
| EJACULATION | ||
| FATIGUE | ||
| FECAL INCONTINENCE | ||
| FLASHING LIGHTS | ||
| GAS | ||
| GENERAL PAIN | ||
| HAIR LOSS | ||
| HAND-FOOT SYNDROME | ||
| HEADACHE | ||
| HEARTBURN | ||
| HEART PALPITATIONS | ||
| HICCUPS | ||
| HIVES | ||
| HOARSENESS | ||
| HOT FLASHES | ||
| INCREASED SWEATING | ||
| INSOMNIA | ||
| IRREGULAR PERIODS/VAGINAL BLEEDING | ||
| ITCHING | ||
| JOINT PAIN | ||
| MEMORY | ||
| MISSED EXPECTED MENSTRUAL PERIOD | ||
| MOUTH/THROAT SORES | ||
| MUSCLE PAIN | ||
| NAIL DISCOLORATION | ||
| NAIL LOSS | ||
| NAIL RIDGING | ||
| NAUSEA | ||
| 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 | ||
| TASTE CHANGES | ||
| UNABLE TO HAVE ORGASM | ||
| URINARY FREQUENCY | ||
| URINARY INCONTINENCE | ||
| URINARY URGENCY | ||
| VAGINAL DISCHARGE | ||
| VAGINAL DRYNESS | ||
| VISUAL FLOATERS | ||
| VOICE QUALITY CHANGES | ||
| VOMITING | ||
| WATERY EYES | ||
| WHEEZING | ||
| OTHER SYMPTOM 1 | ||
| OTHER SYMPTOM 2 | ||
| OTHER SYMPTOM 3 | ||
| OTHER SYMPTOM 4 | ||
| OTHER SYMPTOM 5 | ||
| OTHER SYMPTOM 6 | ||
| OTHER SYMPTOM 7 | ||
| OTHER SYMPTOM 8 | ||
| OTHER SYMPTOM 9 | ||
| OTHER SYMPTOM 10 |
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