PRO-CTCAE PATIENT-REPORTED SYMPTOMATIC ADVERSE EVENTS. Lori Minasian, MD, FACP Deputy Director, Division of Cancer Prevention, NCI
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1 1 RO-CTCAE ATIENT-REORTED YMTOMATIC ADVERE EVENT Lori Minasian, MD, FAC Deputy Director, Division of Cancer revention, NCI
2 2 Disclosures I work for the UA Federal Government I have no financial conflicts to disclose resenting on behalf of the NCI RO-CTCAE cientific Leadership Team
3 3 Outline Introduce RO-CTCAE Identify key factors to include RO-CTCAE items in clinical trials Discuss how to present RO-CTCAE data Where to find the tool for use
4 4 Adverse Event Reporting Common Terminology Criteria for Adverse Event (CTCAE) tandard terminology (~ 800 items) for NCI trials All Items NOT required for use, but available for use Items are selected to be monitored over the course of the trial including baseline. Items are collected and reviewed for patient AFETY Any unexpected events are reported/reviewed in real time All adverse events reviewed during the course of the trial erious unexpected reports are reported/reviewed in expedited manner Clinical and protocol specific decisions made based upon AE events occurrence and outcomes
5 5 Why Include atient Reporting in Adverse Event Reporting? Clinician and atients rovide Complimentary Information Clinicians Focus on afety or Toxicities Requiring Action atients Focus on Day to Day Effects of Therapies afety data typically presented as CTCAE reports of most severe event experienced over the course of the study. atient reported data has typically been collected as HRQOL and presented as a longitudinal trajectory of specific domains.
6 6 What is RO-CTCAE? RO-CTCAE is designed for patient reporting of symptomatic adverse events RO-CTCAE is an item bank of questions Derived from the CTCAE adverse event items Complimentary to CTCAE (and to be used with) RO-CTCAE is ONLY for descriptive reporting Not ready for clinical and protocol specific decisionmaking based upon individual RO-CTCAE scores
7 ATIENT-REORTED OUTCOME VERION OF THE COMMON TERMINOLOGY CRITERIA FOR ADVERE EVENT (RO-CTCAE ) ITEM LIBRARY (Version 1.0) Gastrointestinal Taste changes Decreased appetite Nausea Vomiting Heartburn Gas Bloating Hiccups Constipation Diarrhea Oral Dry mouth Difficulty swallowing Mouth/throat sores Cracking at the corners of the mouth (cheilosis/cheilitis) Voice quality changes Hoarseness Abdominal pain Fecal incontinence I I F F F F F F FI FI Cardio/Circulatory welling Heart palpitations Cutaneous Rash kin dryness Acne Hair loss Itching Hives Hand-foot syndrome Nail loss Nail ridging Nail discoloration ensitivity to sunlight Bed/pressure sores Radiation skin reaction kin darkening tretch marks FI F Neurological Numbness & tingling Dizziness Visual/erceptual Blurred vision Flashing lights Visual floaters Watery eyes Ringing in ears Attention/Memory Concentration Memory ain General pain Headache Muscle pain Joint pain I I I I I I FI FI FI FI leep/wake Insomnia Fatigue Anxious Mood Discouraged ad I I Gynecologic/Urinary Irregular periods/vaginal bleeding Missed expected menstrual period Vaginal discharge Vaginal dryness ainful urination Urinary urgency Urinary frequency Change in usual urine color Urinary incontinence FI FI FI FI I FI exual Achieve and maintain erection Ejaculation Decreased libido Delayed orgasm Unable to have orgasm ain w/sexual intercourse Miscellaneous Breast swelling and tenderness Bruising Chills Increased sweating Decreased sweating Hot flashes Nosebleed ain and swelling at injection site Body odor F F F F F Respiratory hortness of breath Cough Wheezing I I Dimensions F: Frequency I: Interference : everity : resence/absence /Amount
8 CTCAE vs. RO-CTCAE Item tructures Adverse Event Mucositis oral CTCAE Grade Asymptomatic or mild symptoms; intervention not indicated Moderate pain; not interfering with oral intake; modified diet indicated evere pain; interfering with oral intake Life-threatening consequences; urgent intervention indicated - lease think back over the past 7 days: RO-CTCAE What was the severity of your MOUTH OR THROAT ORE at their WORT? None / Mild / Moderate / evere / Very severe How much did MOUTH OR THROAT ORE interfere with your usual or daily activities? Not at all / A little bit / omewhat / Quite a bit / Very much
9 9 How to Use RO-CTCAE RO-CTCAE intended to be complimentary to CTCAE rinciples for use Item selection Timeframe for assessments coring versus Grading Data resentation Work in rogress Regulatory Interest (FDA & EMA) Translations: English, panish, Others under development (Italian, Korean, French, wedish, etc)
10 10 RO-CTCAE Item election RO-CTCAE items selected based upon expectation for symptomatic adverse events imilar to CTCAE items selection: identify those items which need to be monitored for safety and tolerability based upon re-clinical or animal data AE items from early clinical data Mechanism based or drug class effects Choose limited number of symptomatic adverse events to mointo Use all the dimensions available for a symptomatic toxicity Need baseline and off-study assessments Allow for unanticipated symptomatic adverse events to be reported through a write-in feature
11 11 RO-CTCAE Item election Consider: Ascertainment Bias What you ask and when you ask affect the prevalence estimates Baseline assessment Expectations for recovery of symptomatic adverse events ost progression assessment of symptomatic adverse events ampling Bias Missing data is not at random, (patients on early phase trials experience toxicity, declining performance status, and progressive disease)
12 12 RO-CTCAE Item election Early (non-randomized) phase trials atients with advanced stage hase 1 patients with different diseases tart with a provisional list of items and add new items as needed through the course of the study Typical of AE reporting and early phase trials in general Incorporate new information into study design as the study progresses Frequently, new AE items are identified in early phase
13 13 RO-CTCAE Item election Late hase (Randomized) trials Better defined cohort of patients More known about agent/regimen specific symptomatic toxicities Include same items in all arms irrespective of expectation To define and confirm relative symptomatic toxicity profiles of each arm Arm A has 5 symptomatic AEs Arm B has 4 symptomatic AEs, (one of which is in A) Use = 8 symptomatic AEs
14 14 Timeframe for Assessments Recall period is 7 days Anticipate weekly reporting Currently, data to demonstrate ~ 90% compliance for weekly reporting up to 20 weeks with reminders. Baseline and off-study assessment are essential Need to balance data quality with the number of items & the frequency of assessment over the course of the study If asking questions with an interval of longer than one week, the recall period remains the last 7 days
15 RO-CTCAE core vs. CTCAE Grade RO-CTCAE responses are scored from 0 to 4 Up to three questions per AE Item Frequency, everity, Interference Clinician CTCAE Grade Bundles the constructs of severity, frequency and interference Grading dependent upon clinician judgement of medical significance Clinician Grade RO-CTCAE core One grade by clinician Up to three patient reported scores per Item CTCAE Grade 4 does not exist for most of the RO-CTCAE items
16 16 Data resentation No best approach to present RO-CTCAE data CTCAE data presented in table ingle point in time worst severity No longitudinal data No baseline comparison RO-CTCAE data need not look the same as CTCAE data No ummation core for RO-CTCAE
17 Moore HCF et al. N Engl J Med 2015;372: Example of CTCAE Table.
18 Neuropathy & Diarrhea: CTCAE and RO-CTCAE CTCAE Maximum Grade ostbaseline RO-CTCAE Maximum core ost-baseline
19 RO-CTCAE Distributions at uccessive Time oints Example: Diarrhea between Arms Arm A Arm B
20 20 ummary RO-CTCAE is ONLY for descriptive reporting CTCAE grade RO-CTCAE score Item election Anticipated symptomatic toxicities from agents/regimens Time-points of assessment Baseline and off-study is required Frequency of assessments depends on the study design Timeframes should be consistent with clinician grading
21 21 Where do I Find RO-CTCAE? ymptom Library publically released on April 1, 2016 Available in English and panish for all to use imple registration No cost to use Form builder function at website to maintain instrument fidelity harmaceutical companies will likely create their own ero modules for use
22
23 23 sychometric Development ymptom Benefit Committee resentation Content Validity Validity and Reliability Mode Equivalence Recall eriod
24 NCI RO-CTCAE tudy Group upported through NCI contracts HHN C and HHN C Organizational Affiliations: NCI Community Cancer Centers rogram (NCCC), RTOG, Alliance, FDA We gratefully acknowledge our study participants and patient representatives! NCI Community Cancer Centers rogram (NCCC), RTOG, Alliance, FDA We gratefully acknowledge our study participants and patient representatives!
25 Questions? 25
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Ayurvedic Intake Form Name: Today s Date Date of birth: Time of birth: Place of birth: Place of childhood: Other Places lived: Current address: Home phone: Work phone: Email address: Occupation: Age: Sex:
Name: Date of Birth: Age: Address: City State Zip
Today s Date: Client History Name: Date of Birth: Age: Address: City State Zip Cell Phone: Home Phone: Work Phone: Email Address: Female Male Emergency Contact: Phone Number: How did you hear about us?
Candida Questionnaire
Candida Questionnaire The total score will help you and your physician decide if your health problems are yeast connected. Scores in women will run higher, as seven items in the questionnaire apply exclusively
THE MANY SYMPTOMS ROOTED IN HORMONE IMBALANCES
abdominal pain acne aging process accelerated allergies, including asthma, hives, rashes, sinus congestion anemia (blood hemoglobin low) anorexia anovulatory (no ovulation) anxiety anxious depression appetite
Chagrin Valley Chiropractic and Acupuncture Center, LLC Acupuncture Chief Complaint and Health History
Chagrin Valley Chiropractic and Acupuncture Center, LLC Acupuncture Chief Complaint and Health History Name: Date: PRESENT HEALTH CONCERNS: Please list your most important health concerns in order of their
Patient Name: Date: Address: Primary Care Physician: Online Website On TV In print On the radio
927 W. Myrtle St. Boise, ID 83702 (208) 947-0100 NEW PATIENT INTAKE Patient Name: Date: Email Address: Primary Care Physician: How did you hear about AVT? (Please mark all that apply) Online Website On
Wynne Huang, M.D. Family Medicine
PATIENT INFORMATION Last Name: First Name: Middle Initial: Date of Birth: SS#: - - Address: City, State, Zip Code Single( ) Married( ) Partner( ) Divorced( ) Widowed( ) Legally Separated( ) Male( ) Female(
Camas Acupuncture & Nutrition Stephanie Meinhold, LAc 405 NE 6 th Avenue Camas, WA P F
Patient Information Camas Acupuncture & Nutrition General Information Name: Date: Address: City: State: Zip Code: Phone (H): (W): Cell: Email: Appt reminders via text? Y N via email? Y N Date of Birth:
Shiatsu Intake Form PURCHASED PRODUCT/SERVICE. Date of Birth Age Height Weight. Home Address City State ZIP
Shiatsu Intake Form DATE PURCHASED PRODUCT/SERVICE FIRST NAME LAST NAME Date of Birth Age Height Weight Home Address City State ZIP Home Phone Cell Phone Email Name of Emergency Contact Would you like
Bodily Conditions Rooted in Hormone Imbalance
Check this list for all conditions that apply to you. The total possible score is 209. Count the number of symptoms you check. The higher your score, the more likely you need to address hormone imbalances.
Patient Health History Questionnaire
Patient Health History Questionnaire Manitou Springs Acupuncture Randall Johnson, L.Ac., LLC Certified Seitai Shinpo Acupuncturist License Number: Acu-0002072 Phone: (719) 237-4547 Email: 719acupuncture@gmail.com
Women s and Men s Health Intake Form Comprehensive Physical Therapy Center
Name: (Last, First) DOB: Date: Age: Referring Physician: Next Physician Appointment: Today s visit: What is the main reason you came to the office today? When did it start? What treatments have you had
ACUPUNCTURE FOR HEALTH WENDY STALKER R.Ac. Dip.Ac. B.Sc. Name: Date of Birth: Date:
Name: Date of Birth: Date: Address: Postal Code: Occupation: Telephone: Day: Cell Phone: E-mail address: Emergency Contact: Evening: Telephone: Male Female Where did you hear about Acupuncture for Health?
Chinese Medicine Adult Intake Form. Name (Last, First): Home address: Phone: Emergency contact name & phone number: Relationship Status:
Chinese Medicine Adult Intake Form Name (Last, First): Date of Birth: Occupation: Hours per week: Home address: Phone: Email: Preferred contact method (circle one): Phone / Email Emergency contact name
Initial Patient Intake Form
Initial Patient Intake Form Patient Registration Today s Date Patient Name (last) (first) (middle) Address (city) (state) (zip) Date of birth (mm/dd/yyyy) SSN # Current Gender Identity: Male Female Transgender
PATIENT INTRODUCTION
PATIENT INTRODUCTION Personal History: Mr. Mrs. Miss Ms. Dr. Name: First Middle Last Your Address: _ City: Prov: Postal Code: Telephone: Home: Bus: Cell: E-Mail: Check this box if we may contact you via
Integrative Consult Patient Background Form
Let Us Know More - So We Can Help Thank you for choosing to schedule an integrative medicine consultation with UC Health. To help us meet your needs during your visit, please take some time to sit in a