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| 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) |
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| CDISC Reference | QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | PRO-CTCAE V1.0 VERSION DATE 4/26/2020 |
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| QRS Permission Status | Approved |
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| Team | Pancreatic Cancer Therapeutic Area Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 2021-11-0405 |
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| 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 |
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| 2021-11-0405 | 1.0 Draft |
© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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The NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH (NCI) owns the copyright for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 instrument and has made the it exempt from copyright restrictions. Use of the PRO-CTCAE V1.0 is VERSION DATE 4/26/2020 is subject to NCI terms of use (See https://healthcaredelivery.cancer.gov/pro-ctcae/terms_of_use.html). CDISC has included this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.
While the PRO-CTCAE is in the public domain, this measure is copyrighted and available from the the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE (NCI) at the NATIONAL INSTITUTES OF HEALTH (NIH) (TBD). CDISC has included the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.
The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.
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| Dataset wrap |
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| QNAM | QLABEL | QVAL |
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| QSLANG | Questionnaire Language | ENGLISH |
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| CHINESE |
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| CZECH |
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| DANISH |
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| DUTCH |
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| FRENCH |
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| GERMAN |
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| GREEK |
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| HUNGARIAN |
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| ITALIAN |
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| JAPANESE |
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| KOREAN |
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| POLISH |
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| PORTUGUESE |
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| RUSSIAN |
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| SPANISH | QSSYMTRM
| Symptom Term | DRY MOUTH
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| DIFFICULTY SWALLOWING |
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| MOUTH/THROAT SORES |
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| CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS) |
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| VOICE QUALITY CHANGES |
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| HOARSENESS |
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| TASTE CHANGES |
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| DECREASED APPETITE |
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| NAUSEA |
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| VOMITING |
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| HEARTBURN |
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| GAS |
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| BLOATING |
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| HICCUPS |
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| CONSTIPATION |
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| DIARRHEA/DIARRHOEA |
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| ABDOMINAL PAIN |
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| FECAL INCONTINENCE |
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| SHORTNESS OF BREATH |
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| COUGH |
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| WHEEZING |
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| SWELLING |
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| HEART PALPITATIONS |
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| RASH |
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| SKIN DRYNESS |
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| ACNE |
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| HAIR LOSS |
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| ITCHING |
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| HIVES |
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| HAND-FOOT SYNDROME |
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| NAIL LOSS |
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| NAIL RIDGING |
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| NAIL DISCOLORATION |
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| SENSITIVITY TO SUNLIGHT |
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| BED/PRESSURE SORES |
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| RADIATION SKIN REACTION |
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| SKIN DARKENING |
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| STRETCH MARKS |
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| NUMBNESS & TINGLING |
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| DIZZINESS |
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| BLURRED VISION |
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| FLASHING LIGHTS |
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| VISUAL FLOATERS |
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| WATERY EYES |
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| RINGING IN EARS |
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| CONCENTRATION |
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| MEMORY |
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| GENERAL PAIN |
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| HEADACHE |
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| MUSCLE PAIN |
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| JOINT PAIN |
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| INSOMNIA |
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| FATIGUE |
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| ANXIOUS |
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| DISCOURAGED |
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| SAD |
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| IRREGULAR PERIODS/VAGINAL BLEEDING |
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| MISSED EXPECTED MENSTRUAL PERIOD |
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| VAGINAL DISCHARGE |
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| VAGINAL DRYNESS |
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| PAINFUL URINATION |
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| URINARY URGENCY |
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| URINARY FREQUENCY |
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| CHANGE IN USUAL URINE COLOR |
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| URINARY INCONTINENCE |
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| ACHIEVE AND MAINTAIN ERECTION |
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| EJACULATION |
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| DECREASED LIBIDO |
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| DELAYED ORGASM |
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| UNABLE TO HAVE ORGASM |
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| PAIN W/SEXUAL INTERCOURSE |
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| BREAST SWELLING AND TENDERNESS |
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| BRUISING |
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| CHILLS |
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| INCREASED SWEATING |
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| DECREASED SWEATING |
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| HOT FLASHES/FLUSHES |
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| NOSEBLEED |
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| PAIN AND SWELLING AT INJECTION SITE |
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| BODY ODOR |
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| OTHER SYMPTOM |
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