Date Initials Comments

Transcription

1 Month 18 Visit Data Processing Cover Sheet ID. No.: - Alpha Code: Visit: 18 FORMS NOTES Check all forms completed: Ocular Surface Disease Index (OSI) Brief Ocular Discomfort Inventory (ODI) Follow-up Health Review Form (FR) Follow-up Dietary Supplement Form (FS) Dry Eye Treatment Form (DT) Work Productivity and Activity Impairment Questionnaire (WP) Healthcare Utilization Form (UQ) SF-36v2 (SF36) If performing, Tear Osmolarity Assessment (TO) If performing, Keratography Assessment (KT) Follow-up Visual Acuity (VA) Mars Contrast Sensitivity Test (CS) If performing, Tear Collection Cyokines Form (TC) Follow-up Ocular Evaluation Form (OA) Impression Cytology Form (IC) Blood Collection Form (BF) Blood Sample Requisition Form If needed: Concomitant Medication Log (CM_Log) Adverse Event Log (AE_Log) Review Completed CRFs Entry Complete Date Initials Comments 07/11/2014

2 OCULAR SURFACE DISEASE INDEX (US English version of the OSDI) OSI (003.1) 02/21/2014 Page 1 of 1 Please answer the following questions by checking the box that best represents your answer. Have you experienced any of the following during the last week: All of the time Most of the time Half of the time Some of the time None of the time 1 Eyes that are sensitive to light? 2 Eyes that feel gritty? 3 Painful or sore eyes? 4 Blurred vision? 5 Poor vision? Have problems with your eyes limited you in performing any of the following during the last week: All of the time Most of Half of Some of None of Not applicable 6 Reading? 7 Driving at night? 8 Working with a computer or bank machine (ATM)? 9 Watching TV? Have your eyes felt uncomfortable in any of the following situations during the last week: All of the time Most of Half of Some of None of Not applicable 10 Windy conditions? 11 Places or areas with low humidity (very dry)? 12 Areas that are air conditioned? Copyright 1995 Allergan, Inc.

3 BRIEF OCULAR DISCOMFORT INVENTORY (BODI ) ODI (002.1) 04/09/2014 Page 1 of 2 1. Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort at its worst in the last week No Discomfort as bad as Discomfort you can imagine 2. Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort at its least in the last week No Discomfort as bad as Discomfort you can imagine 3. Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort on the average in the last week No Discomfort as bad as Discomfort you can imagine 4. Please rate your ocular discomfort by circling the one number that tells how much ocular discomfort you have right now No Discomfort as bad as Discomfort you can imagine Please continue to the next page

4 BRIEF OCULAR DISCOMFORT INVENTORY (BODI ) ODI (002.1) 04/09/2014 Page of 2 Circle the one number that describes how during the past week ocular discomfort has interfered with your: 5. General Activity Does not Completely Interfere interferes 6. Mood Does not Completely Interfere interferes 7. Walking Ability Does not Completely Interfere interferes 8. Normal work (includes both work outside the home and housework) Does not Completely Interfere interferes 9. Relations with other people Does not Completely Interfere interferes 10. Sleep Does not Completely Interfere interferes 11. Enjoyment of life Does not Completely Interfere interferes 12 In the last week, how much relief have ocular treatments or medications provided? Please circle the one percentage that most shows how much relief you have received. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% No Complete Relief Relief

5 FOLLOW-UP HEALTH REVIEW FR (021.3) 08/07/2016 Page 1 of 4 1. Does the patient report taking study supplements per protocol (5 pills/day)? ( ) 1 Yes ( ) 0 No 1A. Has the patient discontinued taking all study supplements? ( ) 1 Yes (specify reasons, and continue with question #2) a. Developed contraindication to omega 3 ( ) 1 Record on AE Log b. Physician recommendation ( ) 1 c. Patient unable to tolerate side effects ( ) 1 d. Other (Specify below) ( ) 1 ( ) 0 No (ask question 1B) 1B. Does the patient take some, but less than 5 study supplements per day? ( ) 1 Yes (specify reasons) a. Physician recommendation ( ) 1 b. Patient unable to tolerate side effects ( ) 1 c. Other (Specify below) ( ) 1 2. Ask the patient if they have developed any of the following conditions since the last DREAM study visit: No Yes a. Atrial Fibrillation 0 1 b. Hemophilia, thrombocytopenia or other bleeding issues 0 1 c. Liver disease 0 1 d. Uncontrolled ocular or systemic disease 0 1 e. Started taking an anti-coagulant such as Warfarin, Coumadin, Jantoven, Marevan, Uniwarfin, 0 1 Heparin or Warf? Instruct patient to discontinue study supplements. Record on AE Log and if required, on the CMED log.

6 FOLLOW-UP HEALTH REVIEW FR (021.3) 08/07/2016 Page 2 of 4 3. Are there any prescriptions or over-the counter (OTC) medications that have been started, discontinued, or changed since the last DREAM study visit? ( ) 1 Yes Update the Concomitant Medication Log. ( ) 0 No 4. Has the patient used antihistamine eye drops since the last study visit? ( ) 1 Yes Update the Concomitant Medication Log. ( ) 0 No 5. Is the patient currently taking omega-3, EPA, DHA, or ALA fatty acids or Vitamin E? Do not include DREAM study supplements ( ) 1 Yes ( ) 0 No Complete the Dietary Supplement Form. 6. Since the last DREAM visit or scheduled call, have you had any new symptoms, injuries or side effects or worsening of pre-existing conditions, or been diagnosed with illnesses such as Sjögren s Syndrome or thyroid disease? ( ) 1 Yes ( ) 0 No Record on the Adverse Event Log.

7 FOLLOW-UP HEALTH REVIEW FR (021.3) 08/07/2016 Page 3 of 4 7. Since the last DREAM visit or scheduled call, have you have any health event which required major medical intervention or hospitalization? ( ) 1 Yes Record on the Adverse Event Log. ( ) 0 No 8. Are there any events listed on the adverse event log that were unresolved as of the previous contact? ( ) 1 Yes ( ) 0 No Ask the patient about any unresolved AEs on the Adverse Event Log and update accordingly. 9. Return of DREAM bottles and gelcaps a. Number of returned supplement bottles b. Number of returned gelcaps 10. Has the address where the patient should receive study drug changed since their last shipment? Complete a Patient Change of ( ) 1 Yes Address Form for IDS and fax to the Investigational Drug Service ( ) 0 No

8 FOLLOW-UP HEALTH REVIEW FR (021.3) 08/07/2016 Page 4 of 4 11a. Print last name of staff completing this form: b. Certification #: 12. Date this form completed / / 201 Month Day Year

9 FOLLOW-UP DIETARY SUPPLEMENT FORM ID. No.: - Alpha Code: Visit: FS (029.1) 04/23/2014 Page 1 of 1 Instructions: Information must be obtained during the follow-up visit (months 03, 06, 12, 18 and 24) by reviewing the ingredient labels of all dietary supplements taken by the patient so that the dose can be accurately recorded. If a multivitamin is taken, review and list the dose of the specific ingredients listed below. Add the doses from separate bottles (if applicable) and record the total daily dose for each of the supplements listed below. DO NOT INCLUDE THE DREAM STUDY SUPPLEMENTS ON THIS FORM! 1. Total daily dose of Ω-3 Fatty acids (do not include ALA: Alpha- Linolenic Acid) a. EPA + mg b. DHA + mg c. Ω-3 Fatty acid, (if breakdown of EPA/DHA is not given) + mg d. Sum of 1a., 1b., and 1c. = mg Note: Only enter a value for 1c if EPA and DHA values are not listed individually on the supplement labels. 2. Total daily dose of ALA mg 3. Total daily dose of Vitamin E iu 4. Last name and certification number of person who completed this form a. PRINT last name: b. Certification #: 5. Date Form Completed / / Month Day Year

10 DRY EYE TREATMENT DT (011.2) 05/26/2015 Page 1 of 4 Instructions: This form is to be completed by the DREAM Clinic Coordinator by directly questioning the patient at every in-office study visit beginning with the month 03 Visit. 1. Have you used artificial tears or gel in the last week? ( ) 0 No ( ) 1 Yes a. About how many times a day did you use tears or gel? (check one) ( ) times ( ) times ( ) times ( ) 4 greater than 10 times 2. Have you used lubricating ointment in the last week? ( ) 0 No ( ) 1 Yes a. About how many times a day did you use lubricating ointment? (check one) ( ) 1 1 time ( ) 2 2 times ( ) 3 3 times ( ) 4 greater than 3 times 3. Have you used any of the following over-thecounter treatments for dry eye in the last week? a. Lid scrubs ( ) 0 No ( ) 1 Yes b. Baby Shampoo ( ) 0 No ( ) 1 Yes c. Warm Lid soaks ( ) 0 No ( ) 1 Yes d. Other OTC treatments ( ) 0 No ( ) 1 Yes 1. Specify, other:

11 DRY EYE TREATMENT DT (011.2) 05/26/2015 Page 2 of 4 4. Have you used Restasis in the last week? ( ) 0 No ( ) 1 Yes a. How many times per day did you use Restasis in each eye? (check one for each eye) Right eye Left eye None ( ) 0 ( ) 0 1 time ( ) 1 ( ) 1 5. Have you used autologous serum eye drops in the last week? ( ) 0 No ( ) 1 Yes 6. Have you used other eye drops in the last week? ( ) 0 No ( ) 1 Yes 2 times ( ) 2 ( ) 2 3 times ( ) 3 ( ) 3 > 3 times ( ) 4 ( ) 4 a. Check which eye drops were used (check all that apply) ( ) 1 a. Steroid eye drops ( ) 1 b. Antibiotic eye drops ( ) 1 c. Allergy eye drops ( ) 1 d. Combination Steroid and Antibiotic eye drops ( ) 1 e. Other specify: 7. Have you used prescription pills for dry eye such as doxycycline, Oracea, Vibramycin, Doryx or Monodox in the last week? ( ) 0 No ( ) 1 Yes If yes, check which pills were used ( ) 1 a. Doxycycline ( ) 1 b. Tetracycline ( ) 1 c. Minocycline ( ) 1 d. Oracea ( ) 1 e. Monodox ( ) 1 f. Vibramycin ( ) 1 g. Other pills for dry eye, specify:

12 DRY EYE TREATMENT DT (011.2) 05/26/2015 Page 3 of 4 8. Do you have punctal plugs in place? ( ) 0 No ( ) 1 Yes 9. Do you have a Prokera amniotic membrane device in place? ( ) 0 No ( ) 1 Yes 10. Have you used Lacriserts in the last week? ( ) 0 No ( ) 1 Yes 11. Have you used LipiFlow or intense light treatment in the last week? ( ) 0 No ( ) 1 Yes 12. Have you used any other treatment for dry eye In the last week? ( ) 0 No ( ) 1 Yes a. If yes, specify:

13 DRY EYE TREATMENT DT (011.2) 05/26/2015 Page 4 of Last name and certification number of person who completed this form a. PRINT last name: b. Certification #: 14. Date Form Completed / / Month Day Year

14 Dry Eye Evaluation and Management WP (026.1) 03/12/2014 Page 1 of 2 Work Productivity and Activity Impairment Questionnaire ID. No.: - Alpha Code: Visit #: The following questions ask about the effect of your health problems on your ability to work and perform regular activities. By health problems we mean any physical or emotional problem or symptom. 1. Are you currently employed (working for pay)? ( ) 1 ( ) 0 Yes No If No, skip to item 6 (next page). The next questions are about the past seven days, not including today. 2. During the past seven days, how many hours did you miss from work because of your health problems? Include hours you missed on sick days, times you went in late, left early, etc., because of your health problems. Do not include time you missed to participate in this study. HOURS 3. During the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study? HOURS 4. During the past seven days, how many hours did you actually work? HOURS (If "0", skip to item 6.) 5. During the past seven days, how much did health problems affect your productivity while you were working? Think about days you were limited in the amount or kind of work you could do, days you accomplished less than you would like, or days you could not do your work as carefully as usual. If health problems affected your work only a little, choose a low number. Choose a high number if health problems affected your work a great deal. Consider only how much health problems affected productivity while you were working. Health problems Health problems had no effect on completely prevented my work me from working CIRCLE A NUMBER

15 Dry Eye Evaluation and Management WP (026.1) 03/12/2014 Page 2 of 2 Work Productivity and Activity Impairment Questionnaire ID. No.: - Alpha Code: Visit #: 6. During the past seven days, how much did health problems affect your ability to do your regular daily activities, other than work at a job? By regular activities, we mean the usual activities you do, such as work around the house, shopping, childcare, exercising, studying, etc. Think about times you were limited in the amount or kind of activities you could do and times you accomplished less than you would like. If health problems affected your activities only a little, choose a low number. Choose a high number if health problems affected your activities a great deal. Consider only how much health problems affected your ability to do your regular daily activities, other than work at a job. Health problems had no effect on my ability to do my regular activities Health problems completely prevented me from doing my regular activities CIRCLE A NUMBER

16 Dry Eye Evaluation and Management Study HEALTHCARE UTILIZATION FORM UQ (025.1) 04/21/2014 Page 1 of 2 We ask about hospitalizations and other events that required major medical intervention during a different part of your DREAM visit. Now we are asking about appointments or visits with health care providers. 1. Please review the below list of health care providers. Over the past month have you seen any of these health care providers? ( ) 1 Yes, for the health care providers seen, provide number of visits and reason for visit ( ) 0 No, stop Reason for visit (check one) Health Care Provider Number of visits Routine Care 1 Other Reason 2 Short Description Primary Care Physician Internal Medicine Physician Acupuncturist Alllergist Audiologist Cardiologist (heart) Chiropractor (back, neck) Dentist Dermatologist (skin) Diabetes/Endocrinologist Gastroenterologist

17 Dry Eye Evaluation and Management Study HEALTHCARE UTILIZATION FORM UQ (025.1) 04/21/2014 Page 2 of 2 Reason for visit (check one) Health Care Provider Number of visits Routine Care 1 Other Reason 2 Short Description Gynecologist Home health-care aide Nephrologist Neurologist Oncologist Ophthalmologist (do not count DREAM study visits) Optometrist (do not count DREAM study visits) Physical therapist Podiatrist (feet) Psychiatrist Psychologist Pulmonologist (lungs) Rheumatologist (joints) Urologist Other healthcare provider, Please specify:

18 SF-36v2 SF36 (027.1) 04/09/2014 Page 1 of 6 Your Health and Well-Being This survey asks for your views about your health. This information will help keep track of how you feel and how well you are able to do your usual activities. Thank you for completing this survey! For each of the following questions, please mark an describes your answer. in the one box that best 1. In general, would you say your health is: Excellent Very good Good Fair Poor Compared to one year ago, how would you rate your health in general now? Much better now than one year ago Somewhat better now than one year ago About the same as one year ago Somewhat worse now than one year ago Much worse now than one year ago SF-36v2 Health Survey 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated. All rights reserved. SF-36 is a registered trademark of Medical Outcomes Trust. (SF-36v2 Health Survey Standard, United States (English))

19 SF (027.1) 04/09/2014 Page 2 of 6 3. The following questions are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Yes, limited a lot Yes, No, not limited limited a little at all a Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports b Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf c Lifting or carrying groceries d Climbing several flights of stairs e Climbing one flight of stairs f Bending, kneeling, or stooping g Walking more than a mile h Walking several hundred yards i Walking one hundred yards j Bathing or dressing yourself SF-36v2 Health Survey 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated. All rights reserved. SF-36 is a registered trademark of Medical Outcomes Trust. (SF-36v2 Health Survey Standard, United States (English))

20 SF (027.1) 04/09/2014 Page 3 of 6 4. During the past 4 weeks, how much of have you had any of the following problems with your work or other regular daily activities as a result of your physical health? All of Most of Some of A little of None of a b c d Cut down on the amount of time you spent on work or other activities Accomplished less than you would like Were limited in the kind of work or other activities Had difficulty performing the work or other activities (for example, it took extra effort) During the past 4 weeks, how much of have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? All of Most of Some of A little of None of a b c Cut down on the amount of time you spent on work or other activities Accomplished less than you would like Did work or other activities less carefully than usual SF-36v2 Health Survey 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated. All rights reserved. SF-36 is a registered trademark of Medical Outcomes Trust. (SF-36v2 Health Survey Standard, United States (English))

21 SF (027.1) 04/09/2014 Page 4 of 6 6. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors, or groups? Not at all Slightly Moderately Quite a bit Extremely How much bodily pain have you had during the past 4 weeks? None Very mild Mild Moderate Severe Very severe During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? Not at all A little bit Moderately Quite a bit Extremely SF-36v2 Health Survey 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated. All rights reserved. SF-36 is a registered trademark of Medical Outcomes Trust. (SF-36v2 Health Survey Standard, United States (English))

22 SF (027.1) 04/09/2014 Page 5 of 6 9. These questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of during the past 4 weeks All of Most of Some of A little of the time None of a Did you feel full of life? b Have you been very nervous? c Have you felt so down in the dumps that nothing could cheer you up? d Have you felt calm and peaceful? e Did you have a lot of energy? f Have you felt downhearted and depressed? g Did you feel worn out? h Have you been happy? i Did you feel tired? During the past 4 weeks, how much of has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? All of Most of Some of A little of None of SF-36v2 Health Survey 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated. All rights reserved. SF-36 is a registered trademark of Medical Outcomes Trust. (SF-36v2 Health Survey Standard, United States (English))

23 SF (027.1) 04/09/2014 Page 6 of How TRUE or FALSE is each of the following statements for you? Definitely true Mostly true Don t know Mostly false Definitely false a I seem to get sick a little easier than other people b I am as healthy as anybody I know c I expect my health to get worse d My health is excellent Thank you for completing these questions! SF-36v2 Health Survey 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated. All rights reserved. SF-36 is a registered trademark of Medical Outcomes Trust. (SF-36v2 Health Survey Standard, United States (English))

24 TEAR OSMOLARITY ASSESSMENT ID. No.: - Alpha Code: Visit: TO (024.2) 05/26/15 Page 1 of 1 NOTE: Measurement of tear osmolarity is performed at the Baseline visit (00) and at months 06, 12, 18, and 24 at the DREAM Clinical Centers that have the TearLab Osmometer. All measurements must be done by the DREAM certified technician or clinician. Recording out of range results: If test results display as Below Range, enter 000. If test results display as Above Range, enter Was Tear Osmolarity performed at this visit? ( ) 1 Yes ( ) 0 No Why was tear osmolarity testing not done? a. Osmometer malfunction ( ) 1 b. Osmometer not available ( ) 1 c. Patient refusal ( ) 1 d. Other (Specify below) ( ) 1 e. SKIP TO ITEM 4 2. Calibration: Following the TearLab instruction guide, calibrate each Pen using the Electronic Check Card. Record calibration results: a. Right Pen: mosms/l b. Left Pen: mosms/l 3. Tear Osmolarity Measurement: Following the TearLab Quick Reference Guide, test the right eye and the left eye of the study subject. Record the test results: a. Right Eye: mosms/l b. Left Eye: mosms/l 4. Last name & certification number of person performing testing (or person who completed this form if testing was not completed): a. Print Last Name: b. Certification #: 5. Date of Exam / / 201 Month Day Year

25 KERATOGRAPHY ASSESSMENT KT (017.1) 03/21/2014 Page 1 of 2 ID. No.: - Alpha Code: Visit: NOTE: Keratography is to be performed at the Baseline visit (00) and at visit 06, 12, 18, and 24 at the DREAM Clinical Centers that have the Oculus Keratograph. All grading must be done by the DREAM certified technician or clinician. 1. Was keratography done at this visit? ( ) 1 Yes Last name & certification number of person performing keratography a. Print Last Name: b. Certification #: c. Date keratography performed: / / 201 Month Day Year ( ) 0 No, required, but not done d. Reason keratography was not done: STOP FORM COMPLETION! Right Left 2. Tear break-up time. sec. sec Right Left 3. Bulbar redness score..

26 KERATOGRAPHY ASSESSMENT KT (017.1) 03/21/2014 Page 2 of 2 ID. No.: - Alpha Code: Visit: 4. Tear meniscus height (use keratography ruler) Right Left a. 5 o clock. mm. mm b. 6 o clock. mm. mm c. 7 o clock. mm. mm 5. Upper lid meibography - gland loss (use grading scale provided and select one for each eye) Right Left None ( ) 0 ( ) 0 25% ( ) 1 ( ) % ( ) 2 ( ) % ( ) 3 ( ) 3 >75% ( ) 4 ( ) 4 6. Lower lid meibography - gland loss (use grading scale provided and select one for each eye) Right Left None ( ) 0 ( ) 0 25% ( ) 1 ( ) % ( ) 2 ( ) % ( ) 3 ( ) 3 >75% ( ) 4 ( ) 4 7. Were images submitted to the Reading Center? ( ) 1 Yes, submitted ( ) 0 No, not submitted a. Reason not submitted:

27 Follow-up Visual Acuity Testing VA (023.1) 04/08/2014 Page 1 of 2 NOTE: Best corrected visual acuity is measured at months 03, 06, 12 (18 and 24). The refractive correction from the most recent manifest study refraction should be used for testing visual acuity. Circle each correct letter and put an X on each incorrect letter. Leave letters not attempted unmarked. 1. Subjective refraction used for VA testing (If Plano, enter zeros): Right Eye: + /. + /. X (Circle Sign) Sphere (Circle Sign) Cylinder Axis 2. Letters read correctly at 3.2-meter (10 feet, 6 inch) distance: RIGHT EYE - CHART 1 Acuity Number Equivalent Chart 1 Letters Correct a. 20/200 N C K Z O b. 20/160 R H S D K c. 20/125 D O V H R d. 20/100 C Z R H S e. 20/80 O N H R C f. 20/63 D K S N V g. 20/50 Z S O K N h. 20/40 C K D N R i. 20/32 S R Z K D j. 20/25 H Z O V C k. 20/20 N V D O K l. 20/16 V H C N O m. 20/12.5 S V H C Z n. 20/10 O Z D V K o. Total number correct If total number correct is 10 or more letters LESS than the previous study VA, perform manifest refraction and repeat VA testing

28 Follow-up Visual Acuity Testing VA (023.1) 04/08/2014 Page 2 of 2 3. Subjective refraction used for VA testing (If Plano, enter zeros): Left Eye: + /. + /. X (Circle Sign) Sphere (Circle Sign) Cylinder Axis Letters read correctly at 3.2-meter (10 feet, 6 inch) distance: LEFT EYE - CHART 2 Acuity Number Equivalent Chart 2 Letters Correct a. 20/200 D S R K N b. 20/160 C K Z O H c. 20/125 O N R K D d. 20/100 K Z V D C e. 20/80 V S H Z O f. 20/63 H D K C R g. 20/50 C S R H N h. 20/40 S V Z D K i. 20/32 N C V O Z j. 20/25 R H S D V k. 20/20 S N R O H l. 20/16 O D H K R m. 20/12.5 Z K C S N n. 20/10 C R H D V o. Total number correct 4. Last name and certification number of person who performed testing If total number correct is 10 or more letters LESS than the previous study VA, perform manifest refraction and repeat VA testing a. PRINT last name: b. Certification #: 5. Date Form Completed / / Month Day Year

29 MARS LETTER CONTRAST SENSITIVITY TEST CS (019.1) 04/07/2014 Page 1 of 1 NOTE: Contrast sensitivity is measured at the baseline visit (00) and at months 06, 12, 18 and 24. Patients should wear their refractive correction used for ETDRS testing with an add of D, and an occluder or patch on the untested eye. Viewing distance can range from inches. Instruct patient to read letters left to right for each line, from top to bottom of the chart. Encourage the patient to guess even when letters seem too faint Record a 1 for a correct response; record a 0 for an incorrect response. For an eye, stop test on 2 consecutive incorrect responses. Important: Allow only letters C D H K N O R S V Z as responses. Form 1 Right Eye (stop test for right eye on 2 consecutive incorrect responses) 1 C H V O S N 2 D S Z N R K 3 N D R H V Z 4 C S O N K H 5 K N V D S R 6 Z R D K H O 7 H Z C V R K 8 S C Z D V O Form 2 Left Eye (stop test for left eye on 2 consecutive incorrect responses) 1 K S H O N C 2 Z D C R V O 3 C K O N R S 4 N S Z K H D 5 H N C O R Z 6 V K S N D R 7 K R V Z O S 8 V Z C D V H 1. Last name and certification number of person who performed this test a. PRINT last name: b. Certification #: 2. Date Form Completed / / Month Day Year

30 Dry Eye Evaluation and Management Study Tear Collection for Cytokines Form TC (018.1) 04/11/2014 Page 1 of 2 NOTE: Tear collection for cytokines is done at the baseline visit (00) and at months 6, and 24 at centers that have a -80 ºC freezer or liquid nitrogen for storing samples. INSTRUCTIONS FOR COLLECTING TEARS FOR CYTOKINES Prepare a Tear Registration Form. Place a pre-printed label onto a standard 1.5mL Eppendorf collecting tube. Check the label for: subject number alpha ID code Write on label: date and visit number Place clear tape over the labeled section of the tube to prevent smudging Collect two 4-5 µl tear samples from each eye using separate 20 µl capillary tubes. Tears from both capillary tubes should be dispelled into the SAME Eppendorf collecting tube. Seal tube with parafilm. Tube must be placed on ice until it is transferred into a pre-labeled storage box in a - 80ºC environment (freezer, liquid nitrogen, or dry ice for temporary storage). Samples should be transferred within 30 minutes of collection. Tears must be shipped to the Biomarker Lab at MSSM within 6 months of collection. Refer the DREAM Manual of Procedures for specific collection and shipping instructions ( Appendix 7-4) 1. Were tear samples taken at this visit? ( ) 1 Yes, taken Last name & certification number of person collecting tear samples a. Print Last Name: b. Certification #: c. Date tear samples taken: / / 201 Month Day Year ( ) 0 No, tear samples not taken 1d. Reason tears not collected:

31 Dry Eye Evaluation and Management Study Tear Collection for Cytokines Form TC (018.1) 04/11/2014 Page 2 of 2 TEAR CYTOKINE REGISTRATION FORM FOR DREAM STUDY (One /patient/visit, send a COPY with tear sample shipment to the lab at Mount Sinai) 1 Date & Time of Collection: (mm/dd/yyyy); Time : ( e.g. 11:35 am, 4:00 pm ) 2 Transfer to C (Freezer, Liquid Nitrogen, or Dry Ice) within 30 minutes of collection. Date & Time: 3 Collector s Information: Name (print): ; Signature: Phone #: ; 4 Shipment to Biomarker Lab at Mount Sinai Must ship within 6 months of collection See Appendix 7-4 for specific shipping instructions Enclose a copy of this form Date: (mm/dd/yyyy) Shipped by: ; Contact phone #: DO NOT WRITE BELOW THIS LINE: FOR LAB PERSONNEL USE ONLY 5 Receipt by Biomarker Lab at MSSM : Month Date Year ; Check-in by: ; Print Name Report on any abnormal conditions: Seal ; Leak ; Mislabel: ; Missing label: ; Other: Transfer to Refrigerator: Refrigerator ID ; Tower ID Box ID 6 OSD-BRL Process : Month Date Year ; processed by: ; Assay Kit: Company: Cat # Lot #: EXP: DO NOT WRITE BELOW THIS LINE: FOR CENTER DIRECTOR/CHAIRPERSON USE ONLY 7 Director or Chairperson Special Notes (if any): Name (print): Signature: Date:

32 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 1 of 12 BEFORE COMPLETING THE OCULAR EXAMINATION, YOU MUST BE ABLE TO ANSWER YES TO THE FOLLOWING QUESTIONS: Have you done MMP9? (Month 03 only) The Following are done at Month 06, Month 12, Month 18, Month 24: Have you done Tear Osmolarity? (Centers with TearLab Osmometer) Have you done Keratography? (Centers with Oculus Keratograph) Have you done BCVA? if >10 letter change must redo manifest refraction. Have you done Contrast Sensitivity? Have you done Tear Cytokine Collection? (Centers with -80 C freezer) ITEMS 1 THOUGH 28 MUST BE PERFORMED BY THE CLINICIAN ONLY! 1. Conjunctiva Erythema (bulbar) Right Left None (normal) ( ) 0 ( ) 0 Mild (flush reddish color) ( ) 1 ( ) 1 Moderate (more prominent red color) ( ) 2 ( ) 2 Severe (definite redness) ( ) 3 ( ) 3 2. Conjunctiva Edema (bulbar) Right Left None (normal) ( ) 0 ( ) 0 Mild (slight localized swelling) ( ) 1 ( ) 1 Moderate (moderate/medium localized ( ) 2 ( ) 2 swelling or mild diffuse swelling) Severe (severe diffuse swelling) ( ) 3 ( ) 3 Very Severe (very prominent/ protruding diffuse swelling) ( ) 4 ( ) 4 3. Anterior Chamber Cells (Slit beam 0.3 mm wide, 1.0 mm long) Right Left Grade 0 (<1 cells in field) ( ) 0 ( ) 0 Grade 0.5 (1-5 cells in field) ( ) 1 ( ) 1 Grade 1+ (6-15 cells in field) ( ) 2 ( ) 2 Grade 2+ (16-25 cells in field) ( ) 3 ( ) 3 Grade 3+ (26-50 cells in field) ( ) 4 ( ) 4 Grade 4+ (>50 cells in field) ( ) 5 ( ) 5

33 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 2 of Anterior Chamber Flare (Slit beam 0.3 mm wide, 1.0 mm long) Right Left Grade 0 (None) ( ) 0 ( ) 0 Grade 1+ (Faint) ( ) 1 ( ) 1 Grade 2+ (Moderate; iris & lens ) ( ) 2 ( ) 2 details clear) Grade 3+ (Marked; iris & lens) ( ) 3 ( ) 3 details hazy) Grade 4+ (Intense: fibrin or plastic) ( ) 4 ( ) 4 Aqueous 5. Tear Film Debris Right Left None (absent) ( ) 0 ( ) 0 Mild (present in inferior tear meniscus) ( ) 1 ( ) 1 Moderate (present in inferior tear meniscus ( ) 2 ( ) 2 and in tear film overlying cornea) Severe (present in inferior tear meniscus ( ) 3 ( ) 3 + and in tear film overlying cornea. Presence of mucus strands in inferior fornix or on bulbar conjunctiva) 6. Lid Margin Debris (evaluate upper and lower eyelid) Right Left Normal (0 collarettes) ( ) 0 ( ) 0 Mild (1-5 collarettes) ( ) 1 ( ) 1 Moderate (6-20 collarettes, ( ) 2 ( ) 2 a few fragments) Severe (21-40 collarettes, 1-2 clumps) ( ) 3 ( ) 3 Very severe (40+ collarettes; > 3 clumps) ( ) 4 ( ) 4

34 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 3 of Eyelid Margin Erythema (redness & neovascularization of lid margin upper and lower eyelid) Right Left Normal ( ) 0 ( ) 0 Mild ( ) 1 ( ) 1 Moderate ( ) 2 ( ) 2 Severe ( ) 3 ( ) 3 8. Lid Foam (soapy look along lower eyelid margin Right Left Yes ( ) 1 ( ) 1 No ( ) 0 ( ) 0 9. Lashes Right Left Normal ( ) 1 ( ) 1 9a1. Specify right eye abnormality: Abnormal ( ) 0 ( ) 0 9b1. Specify left eye abnormality: 10. Eye lid skin Edema Right Left None (normal) ( ) 0 ( ) 0 Mild (localized to a small region of the lid) ( ) 1 ( ) 1 Moderate (diffuse, most/all lid but not prominent/protruding) ( ) 2 ( ) 2 Severe (diffuse, most or all lid AND prominent/protruding) ( ) 3 ( ) 3 Very Severe (diffuse AND prominent/protruding AND reversion of the lid) ( ) 4 ( ) 4

35 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 4 of Chalazion present on any eyelid? Right Left No ( ) 0 ( ) 0 Yes ( ) 1 ( ) Facial skin: rosacea: No ( ) 0 Yes ( ) 1 TEAR BREAK UP TIME RIGHT EYE Instructions Instill 5 µl of fluorescein 2% in the right eye. Allow patient to blink a few times. Wait 30 seconds after instillation. Measure the TBUT 3 times using a digital stopwatch within 1 minute of instillation. If the TBUT is >20 seconds, just record 20.0 seconds. 13. Time of drop instillation Right Eye: : AM/PM Hr Min circle one Wait 30 seconds after instillation before recording TBUT. 14. Record TBUT time Right Eye (USE STOPWATCH): 14a. 1st measure:. secs 14b. 2nd measure:. secs 14c. 3rd measure:. secs WAIT 2 MINUTES BEFORE PERFORMING CORNEAL STAINING EVALUATION OF THE RIGHT EYE

36 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 5 of 12 CORNEAL STAINING FLUORESCEIN RIGHT EYE Instructions Corneal staining must be performed approximately 2.5 minutes after fluorescein instillation. Allow patient to blink a few times. Use a yellow barrier filter with a cobalt blue illumination. Score each section from Grade Fluorescein staining Grade (0-3) Right Eye Grade Grade 15a. Top Top 0 15b. Center 1 15c. Temporal Temporal Center Nasal 2 15d. Bottom 15e. Nasal Bottom Filamentary Keratitis Right Eye No ( ) 0 Yes ( ) 1

37 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 6 of Other Corneal Abnormality Right Eye No ( ) 0 Yes ( ) 1 17A. Specify Abnormality Right Eye: a. Corneal infiltrates ( ) 1 b. Corneal abrasion ( ) 1 c. Corneal ulcer ( ) 1 d. Neovascularization ( ) 1 e. Other (Specify below) ( ) 1 ( ) Meibomian Gland Evaluation (Right Eye): Plugging USE THE MGE with mild pressure/depress shaft about half way (evaluate central 5 of the lower eyelid Meibomian gland openings in the midportion of the lower eyelid): Right Eye None plugged ( ) 0 Mild (1-2 glands plugged) ( ) 1 Moderate (3-4 glands plugged) ( ) 2 Severe (All 5 plugged) ( ) Lid Secretion from Meibomian Gland (Right Eye): (USE THE MGE- with mild pressure/depress shaft about half way) Right Eye Clear ( ) 0 Mild haze/cloudiness ( ) 1 Paste (like toothpaste) ( ) 2 Obstructed (no secretions) ( ) 3

38 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 7 of 12 LISSAMINE GREEN STAINING OF THE INTERPALPEBRAL CONJUNCTIVA RIGHT EYE INSTRUCTIONS 1. WITHOUT flushing the eye to remove fluorescein, instill 5 µl of 1% lissamine green into the lower conjunctival sac of the right eye. 2. Grade the lissamine green staining after 1-2 minutes have elapsed following instillation. Using white light of low intensity, grade the bulbar region of the nasal and temporal conjunctiva for staining. 3. Score each section from Grade 0-3 (maximum 6 per eye). Time of drop instillation Right Eye: : AM/PM Hr Mins circle one Wait 1-2 minutes after instillation before grading. 20. Lissamine green staining Grade (0-3/per each section) 20a. Temporal 20b. Nasal T Right Eye N 0= No coloration 1= Some punctations 2= Well defined punctations 3= Many punctations

39 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 8 of 12 TEAR BREAK UP TIME LEFT EYE Instructions Instill 5 µl of fluorescein 2% in the left eye. Allow patient to blink a few times. Wait 30 seconds after instillation. Measure the TBUT 3 times using a digital stopwatch within 1 minute of instillation. If the TBUT is >20 seconds, just record 20.0 seconds. 21. Time of drop instillation Left Eye: : AM/PM Hr Min circle one Wait 30 seconds after instillation before recording TBUT. 22. Record TBUT time Left Eye (USE STOPWATCH): 22a. 1st measure:. secs 22b. 2nd measure:. secs 22c. 3rd measure:. secs WAIT 2 MINUTES BEFORE PERFORMING CORNEAL STAINING EVALUATION OF THE LEFT EYE

40 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 9 of 12 CORNEAL STAINING FLUORESCEIN LEFT EYE Instructions Corneal staining must be performed approximately 2.5 minutes after fluorescein instillation. Allow patient to blink a few times. Use a yellow barrier filter with a cobalt blue illumination. Score each section from Grade Fluorescein staining Grade (0-3) Left Eye Grade 23a. Top Top 0 23b. Center 1 23c. Nasal 23d. Bottom Nasal Center Temporal 2 23e. Temporal Bottom Filamentary Keratitis (Left Eye) No ( ) 0 Yes ( ) 1

41 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 10 of Other Corneal Abnormality (Left Eye) No ( ) 0 Yes ( ) 1 25A. Specify Abnormality Left Eye: a. Corneal infiltrates ( ) 1 b. Corneal abrasion ( ) 1 c. Corneal ulcer ( ) 1 d. Neovascularization ( ) 1 e. Other (Specify below) ( ) 1 ( ) Meibomian Gland Evaluation (LEFT EYE): Plugging USE THE MGE with mild pressure/depress shaft about half way (evaluate central 5 of the lower eyelid Meibomian gland openings in the midportion of the lower eyelid): Left Eye None plugged ( ) 0 Mild (1-2 glands plugged) ( ) 1 Moderate (3-4 glands plugged) ( ) 2 Severe (All 5 are plugged) ( ) Lid Secretion from Meibomian Gland (Left Eye): (USE THE MGE- with mild pressure/ depress shaft about half way) Left Eye Clear ( ) 0 Mild haze/cloudiness ( ) 1 Paste (like toothpaste) ( ) 2 Obstructed (no secretions) ( ) 3

42 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 11 of 12 LISSAMINE GREEN STAINING OF THE INTERPALPEBRAL CONJUNCTIVA LEFT EYE INSTRUCTIONS 1. WITHOUT flushing the eye to remove fluorescein, instill 5 µl of 1% lissamine green into the lower conjunctival sac of the left eye. 2. Grade the lissamine green staining after 1-2 minutes have elapsed following instillation. Using white light of low intensity, grade the bulbar region of the nasal and temporal conjunctiva for staining. 3. Score each section from Grade 0-3(maximum 6 per eye).. Time of drop instillation Left Eye: : AM/PM Hr Min circle one Wait 1-2 minutes after instillation before grading. 28. Lissamine green staining Grade (0-3/per each section) GRADE Left Eye 28a. Nasal 28b. Temporal N T 0= No coloration 1= Some punctations 2= Well defined punctations 3= Many punctations 29. Last name & certification number of clinician performing examination: a. Print Last Name: b. Certification #: Signature of Clinician Performing Ocular Examination:

43 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 12 of Instrument used to measure IOP ( ) 1 Tonopen ( ) 2 Applanation INTRAOCULAR PRESSURE Time of anesthetic instillation: : AM/PM Hr Min circle one 31. Intraocular Pressure a. OD: mm Hg b. OS: mm Hg 32. Last name & certification number of person performing IOP: a. Print Last Name: b. Certification #: Wait 5 min after instillation of anesthetic before doing Schirmer s Test. SCHIRMER S TEST Perform a Schirmer s Test WITH anesthesia (5 minutes after anesthesia) 33. Record the mm of wetting after 5 minutes: a. Right Eye: mm b. Left Eye: mm 34. Last name & certification number of person performing Schirmer s: a. Print Last Name: b. Certification #: 35. Date of Exam / / 201 Month Day Year

44 Dry Eye Evaluation and Management Study Impression Cytology Form IC (030.1) 04/21/2014 Page 1 of 2 NOTE: Impression cytology is done at the baseline visit (00) and at months 6, 12, 18 and 24. Ensure that at least 20 minutes has passed since administration of lissamine dye. INSTRUCTIONS FOR COLLECTING SAMPLES FOR IMPRESSION CYTOLOGY Instill a drop of anesthetic (Proparacaine) in each eye prior to starting Prepare an IC Registration Form. Write the date and R or L with Sharpie on two assigned pre-printed labels and place on two tubes from the refrigerator. Check the label for the subject number and alpha code! Wrap the labels with scotch tape and put the tubes on ice. Carefully hold a Supor-6 filter membrane (circle) with the forceps and cut it in half with scissors. o Do not touch filter membrane with fingers. We only want to collect cells from the conjunctiva. Samples will only be collected from the temporal (outer) side of the eye. Collect samples from right eye (OD) first. For Superior (upper) Temporal sample, have patient fixate on object DOWN and to the LEFT. For Inferior (lower) Temporal sample, have patient to fixate on an object UP and to the LEFT. Wrap each collection tube (right and left) with parafilm, and immediately place them back on ice. Place a drop of Antibiotic Ophthalmic Solution (Polytrim) in both eyes. Transfer the samples to the refrigerator. Do NOT freeze IC samples.. Refer to the DREAM Manual of Procedures for specific collection and shipping instructions ( Appendix 7-6). 1. Were samples taken at this visit? ( ) 1 Yes, taken Last name & certification number of person collecting samples a. Print Last Name: b. Certification #: c. Date samples taken: / / 201 Month Day Year ( ) 0 No, samples not taken 1d. Reason samples not collected:

45 Dry Eye Evaluation and Management Study Impression Cytology Form IC (030.1) 04/21/2014 Page 2 of 2 IMPRESSION CYTOLOGY REGISTRATION FORM FOR DREAM STUDY (One /patient/visit, send a COPY with tear sample shipment to the lab at Mount Sinai) Date & Time of Collection: (mm/dd/yyyy); Time : (e.g. 11:35 am, 4:00 pm ) Place sample on ice within 30 minutes of collection. Time: Transfer to Refrigerator (4-8 0 C) same day as collection. Date & Time: Collector s Information: Name (print): Signature: Phone #: Shipment to Biomarker Lab at Mount Sinai Must ship within 2 weeks of collection See DREAM Manual of Procedures, Appendix 7-6 for specific shipping instructions Enclose a copy of this form Date: (mm/dd/yyyy) Shipped by: ; Contact phone #: DO NOT WRITE BELOW THIS LINE: FOR LAB PERSONNEL USE ONLY Receipt by Biomarker Lab at MSSM : Month Date Year ; Check-in by: ; Print Name Report on any abnormal conditions: Seal ; Leak ; Mislabel: ; Missing label: ; Other: Transfer to Refrigerator: Refrigerator ID ; Box ID OSD-BRL Process : Month Date Year ; processed by: ; Assay Kit: Company Cat # Lot #: EXP: DO NOT WRITE BELOW THIS LINE: FOR CENTER DIRECTOR/CHAIRPERSON USE ONLY Director or Chairperson Special Notes (if any): Name (print): Signature: Date:

46 Dry Eye Evaluation and Management Study Blood Collection for Fatty Acids Form BF (015.1) 07/30/14 Page 1 of 1 NOTE: Blood collection for Fatty Acids testing is done at the Baseline visit (Month 00) and at visits 06, 12, 18 and 24. INSTRUCTIONS FOR BLOOD COLLECTION FOR FATTY ACIDS Collect blood only on Mondays through Thursdays for next day delivery. Use an EDTA-Lavender top vacutainer tube. Collect 3-5 ml of blood. Place pre-printed label with patient ID number/alpha code and fill in date of collection. Blood may remain at room temperature until packed for shipping. Blood samples must be shipped to the Kennedy Krieger lab the same day as collected! Include the Kennedy Krieger Blood Sample Requisition Form with shipment. 1. Was blood for Fatty Acids testing drawn at this visit? ( ) 1 Yes, taken 1.a. PRINT last name of person who drew blood: 1.b. Date of blood draw: / / 201 Month Day Year 1.c. PRINT last name of person who shipped blood sample to the Kennedy Krieger lab: 1.d. Date blood shipped to lab / / 201 Month Day Year ( ) 0 No, blood not drawn 1.e. Reason blood not drawn: ( ) 1 No one qualified to draw blood available ( ) 2 Patient refused ( ) 3 Visit not on Monday through Thursday ( ) 4 Other (specify)

47 BLOOD SAMPLE REQUISTION FORM (No data entry required) Version 1 05/01/14 Page 1 of 1 Send this page along with the blood sample to: Kennedy Krieger Institute Genetics Laboratory Peroxisomal Diseases Section 707 North Broadway, Baltimore, MD Director: Richard I. Kelley, M.D., Ph.D. Section Director: Richard Jones, Ph.D. Complete Sample Information: Phone: Fax: jonesri@kennedykrieger.org EIN #: CAP #: CLIA #: 21D Blood Sample Date Other Sample Information / / 201 Month Day Year Indicate Where to Send Bill: (Institutional or Client/Physician Self Pay)** DREAM STUDY Test Requisition and Sample Information FASTING ( > 4 hours since last meal) PREPRANDIAL ( < 4 hours since last meal) Indicate Where to Send Report CPT DREAM STUDY X Red Blood Cell Total Lipid Fatty Acid Profile: Includes C8 to C26 saturated, monounsaturated, Polyunsaturated fatty acids and plasmlogens ml (bare minimum) -3 ml whole EDTA blood; fasting or preprandial. Sample must be received by us within 48 hours of collection. Shipping: Blood and plasma/serum samples may be sent at room temperature by overnight express. Ship samples to arrive on weekdays only to: Kennedy Krieger Institute Peroxisomal Diseases Section, Room North Broadway Baltimore, MD DREAM COORDINATORS: Retain a copy of this form and file it with the FedEx shipping paperwork

48 CONCOMITANT MEDICATION LOG CM (009.1) 03/21/14 Page 1 of ID. No.: - Alpha Code: Instructions: At baseline enter all prescription and over the counter medications the patient is taking when they enter the study. At follow-up visits, review medications with the patient and record changes. If the dose changed, close out the original entry and re-enter the medication with the new dose. If the patient stopped the medication, enter the stop date. If the patient is taking new medications, enter all the information. Drug Code Medication Name (Generic name preferred) Indication/Reason Eye Treated (if applicable) R L Dose per Administration (check box if unknown) Unit Freq. Route of Admin. Start Date MMDDYYYY Stop Date MMDDYYYY 1 / / / / 1 / / / / 1 / / / / 1 / / / / 1 / / / / 1 / / / / Unit Frequency Route of Administration 1 = tablespoon 10 = microcurie (mcc) 2 = teaspoon 11 = grain 3 = ounce 12 = units 4 = gram 88 = unknown unit 5 = milligram (mg) 98 = other 6 = microgram (mcg) 7 = milliliter (ml) 8 = microliter (mcl) 9 = millicure (mlc) 1 = 1X per day (qd) 2 = 2X per day (bid) 3 = 3X per day (tid) 4 = 4X per day (qid) 5= as needed (PRN) 88 = unknown 98 = other 1 = S.C. - subcutaneous 10 = nasal 2 = I.V. - intravenous 11 = sublingual 3 = eye drops 12 = intravitreal 4 = I.M. - intramuscular 13 = peribulbar 5 = P.O. - by mouth 14 = intra-articular 6 = P.R. - by rectum 15 = transdermal 7 = topical 16 = by ear 8 = vaginal 88 = unknown 9 = oral inhalation 98 = other Start and Stop Dates Enter best estimate of start/stop dates. If any part of the dates are unknown for the Month, Day or Year, enter 99 for each unknown value. Completed by: Certification #: Date Completed:

49 Adverse Event Log AE (006.1) 02/21/2014 Page of ID. No.: - Alpha Code: Instructions: Review all new or unresolved adverse events (currently on the Adverse Event Log in the DREAM clinical database) with the patient. If the Serious Event Type is greater than 1, complete a Serious Adverse Event Initial Reporting Form for the first report or a Serious Adverse Event Follow-up Form for new additional information. If this is an ocular adverse event involving one eye, please check the R or L boxes; if this is an ocular adverse event involving both eyes check both the R and L boxes. Adverse Event Coding (NIH) DREAM AE Coding AE # (Record from database) MedDRA Code MedDRA Short Name MedDRA Grade Was Event Serious? No Yes Serious Event Type Tx for AE No Yes Outcome DREAM Tx Ocular AE Eye(s) R L Start Date (MMDDYYYY) Stop Date (MMDDYYYY) Completed by: Certification #: Date Completed: DREAM AE Code Table Grade Serious Event Type Outcome DREAM Supplements (Tx) 1 = Mild 2 = Moderate 3 = Severe 4 = Life Threatening/disabling 5 = Death 1 = None 2 = Congenital Anomaly 3 = Hospitalization 4 = Disability 5 = Medically Significant 6 = Life Threatening 7 = Death 1 = Not Recovered 2 = Recovered 3 = Resolved with Sequelae 4 = Recovering/ Resolving 5 = Fatal 1 = Supplements continued 2 = Supplements temporarily stopped 3 = Supplements withdrawn