Unified Parkinson's Disease Rating Scale UPDRS

Transcription

1 Unified Parkinson's Disease Rating Scale Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by CDISC and National Institute of Neurological Disorders and Strokes (NINDS) Notes to Readers This implementation guide 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. Revision History Date Version Summary of Changes Unified Parkinson's Disease Rating Scale () Draft Unified Parkinson's Disease Rating Scale () Unified Parkinson's Disease Rating Scale () Updated Controlled Terminology (Package 5). Uppercased QSSCAT values. Removed use of QSGRPID and combined with QSSCAT. Update assumption 3 to include QSEVAL of in addition to INVESTIGATOR. Revised QSSTREC/QSSTRESN values for UPD43. Updated annotations and document to current standards.

2 CDISC SDTM Questionnaire Supplement (Version.) Introduction This document describes the CDISC implementation of the questionnaire, a standard questionnaire administered on a CRF that is typically used in clinical trials. contains data elements about non-motor and motor features of Parkinson's disease. (Examples of CDEs included: Non-motor examination; Motor examination; etc.). The CRF preceded the CDISC CDASH CRF standards and based on its copyright status, cannot be modified to CDASH standards. The representation of data collected for this questionnaire is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) QS domain table, which can be found at the CDISC website at These implementation details for this specific questionnaire are meant to be used in conjunction with the SDTMIG. All questionnaire documentation can be found on the CDISC web site ( The CDISC Intellectual Property Policy can be found on the CDISC web site at: ( Representations and Warranties, Limitations of Liability, and Disclaimers This document is a supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material. 2 Copyright Status CDISC has obtained permission to include the questionnaire as part of CDISC Data Standards. This means that CDISC developed QSTESTCD and QSTEST for each question based on the actual question text on the questionnaire. The instrument itself was not changed. The CDISC documentation of this instrument consists of: () controlled terminology, (2) standard database structure with examples and (3) case report forms annotated with the CDISC SDTMIG submission values. This is a separate document bundled with the documentation. Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should be accessed through the CDISC website. ( CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder. CDISC acknowledges Fahn S, Marsden CD, Calne DB, Goldstein M, eds. (Recent Developments in Parkinson's Disease, Vol 2. Florham Park, NJ. Macmillan Health Care 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Final

3 CDISC SDTM Questionnaire Supplement (Version.) Information 987, pp , ) for the agreement to include the UPDSR scale in the CDISC data standards. Copyright information for the scale is: the Movement Disorder Society (MDS), All Right Reserved. The author s consent ensures that the data captured using this instrument will be done so in a standardized manner thereby facilitating collection, database storage, reporting and regulatory review of that data. CDISC wants to emphasize that the existing copyright status as well as the existing procedures for licensing fees and using the instrument will remain exactly as they have been. Please follow the instrument owner s own mechanisms for permissions and licenses if you have a need to use this questionnaire. 3 The QS Domain Model 3. Assumptions for the Questionnaire Domain Model All assumptions for the QS domain from the SDTMIG apply for this supplemental implementation guide including those referenced in the CDISC notes. Additionally, the following assumptions apply to the Unified Parkinson's Disease Rating Scale:. The Unified Parkinson's Disease Rating Scale (): The is a rating tool to follow the longitudinal course of Parkinson's Disease, it has six sections: Part I (evaluation of Mentation, behavior, and mood), Part II (self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, cutting food), Part III (clinicianscored motor evaluation), Part IV (complications of therapy in the past week), Part V (Hoehn and Yahr stating of severity of Parkinson s disease), Part VI (Schwab and England ADL scale). These are evaluated by interview. Some sections require multiple grades assigned to each extremity. The QSSCAT values representing the six sections can be found in Section 4: SDTM Mapping Strategy. 2. The time period of evaluation is populated in the QSEVLINT field in ISO 860 format when the evaluation interval can be precisely described as duration. Specific points in time should use the QSDTC field. 3. The evaluator of the questionnaire is stored in QSEVAL. Part II is the self-evaluation of the daily life portion of the in which QSEVAL =. For the remainder of the form, the Investigator provides the evaluations. 4. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for qualifier, timing, result and unit fields is provided in Section 4: SDTM Mapping Strategy. 3.2 Example for the UNIFIED PARKINSON S DISEASE RATING SCALE Domain Model The example below shows the terminology for QSCAT, QSTEST, QSTESTCD, QSORRESU, QSSTRESU and standard values QSORRES, QSSTRESC and QSSTRESN that should be utilized for this scale. Values for QSORRES are for prospective data collection. Sponsors mapping legacy data should retain legacy values for QSORRES. 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Final

4 CDISC SDTM Questionnaire Supplement (Version.) Example: The Unified Parkinson's Disease Rating Scale () The example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for one subject collected at one visit. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, QSCAT, QSORRESU and QSSTRESU. All original results are represented with the preferred terminology in QSORRES. This result is then transformed into a standard numeric score in QSSTRESN and character representation of the standard numeric score in QSSTRESC. QSEVLINT is only applicable to the section S OF THERAPY. Rows -68: Represent the 68 questions from the CRF. ID=0, DOMAIN=QS, USUBJID=2324-P000 and QSBLFL=Y are not shown in the example due to the foot print of the table. qs.xpt Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT UPD0 Mentation:Intellectual Impairment I. MENTATION, BEHAVIOR AND MOOD INVESTIGATOR UPD02 UPD UPD04 Mentation:Thought Disorder Mentation:Depression Mentation:Motivation/Ini tiative 5 5 UPD05 Activities:Speech 6 6 UPD UPD UPD08 Activities:Salivation Activities:Swallowing Activities:Handwriting I. MENTATION, BEHAVIOR AND MOOD I. MENTATION, BEHAVIOR AND MOOD I. MENTATION, BEHAVIOR AND MOOD Vivid dreaming Sustained depression ( week or more) Loss of initiative or disinterest in day to day (routine) activities Mildly affected. No difficulty being understood Marked excess of saliva with some drooling Occasional choking The majority of words are not legible INVESTIGATOR INVESTIGATOR INVESTIGATOR UPD09 Activities:Cut Somewhat 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 CDISC SDTM Questionnaire Supplement (Version.) Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT Food/Handle Utensil slow and clumsy, but no 0 0 UPD0 Activities:Dressing UPD Activities:Hygiene 2 2 UPD2 Activities:Turn Bed/Adj Clothes UPD3 Activities:Falling 4 4 UPD4 Activities:Freezing When Walking 5 5 UPD5 Activities:Walking 6 6 UPD6 Activities:Tremor 7 7 UPD7 Activities:Sensory Complaints 8 8 UPD8 Motor:Speech 9 9 UPD9 Motor:Facial Expression help needed Occasional assistance with buttoning, getting arms in sleeves Needs help to shower or bathe; or very slow in hygienic care Can initiate, but not turn or adjust sheets alone Rare falling Occasional freezing when walking Mild difficulty. May not swing arms or may tend to drag leg Slight and infrequently present Marked impairment, difficult to understand Masked or fixed facies with severe or complete loss of facial expression; lips parted /4 inch or more INVESTIGATOR 4 4 INVESTIGATOR UPD20A Motor:Tremor at Mild in INVESTIGATOR 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

6 CDISC SDTM Questionnaire Supplement (Version.) Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT Rest:Face Lips Chin amplitude and persistent. Or moderate in amplitude, but only intermittently present 2 2 UPD20B 22 UPD20C UPD20D UPD20E UPD2A UPD2B UPD22A UPD22B UPD22C UPD22D UPD22E UPD23A 33 UPD23B Motor:Tremor at Rest:Hands: Right Motor:Tremor at Rest:Hands: Left Motor:Tremor at Rest:Feet: Right Motor:Tremor at Rest:Feet: Left -Motor:Action Tremor:Hand: Right -Motor:Action Tremor:Hand: Left Motor:Rigidity Neck Motor:Rigidity Upper Extrem: Right Motor:Rigidity Upper Extrem: Left Motor:Rigidity Lower Extrem: Right Motor:Rigidity Lower Extrem: Left Motor:Finger Taps: Right Motor:Finger Taps: Left Marked in amplitude and present most of the time 4 4 INVESTIGATOR Absent 0 0 INVESTIGATOR Slight and infrequently present Moderate in amplitude and present most of the time Slight; present with action Moderate in amplitude with posture holding as well as action Mild to moderate Severe, range of motion achieved with difficulty Marked, but full range of motion easily achieved Slight or detectable only when activated by mirror or other movements INVESTIGATOR INVESTIGATOR INVESTIGATOR INVESTIGATOR INVESTIGATOR 4 4 INVESTIGATOR INVESTIGATOR INVESTIGATOR Absent 0 0 INVESTIGATOR INVESTIGATOR Moderately impaired. INVESTIGATOR 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

7 CDISC SDTM Questionnaire Supplement (Version.) Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT Definite and early fatiguing. May have occasional arrests in movement UPD24A UPD24B UPD25A UPD25B UPD26A UPD26B UPD27 Motor:Hand Grips: Right Motor:Hand Grips: Left Motor:Hand Pronate/Supinate: Right Motor:Hand Pronate/Supinate: Left Motor:Leg Agility: Right Motor:Leg Agility: Left Motor:Arising from Chair Severely impaired. Frequent hesitation in initiating movements or arrests in ongoing movement Moderately impaired. Definite and early fatiguing. May have occasional arrests in movement INVESTIGATOR INVESTIGATOR INVESTIGATOR Mild slowing and/or reduction in amplitude walking aid Can barely perform the task Severely impaired. Frequent hesitation in initiating movements or arrests in ongoing movement Slow; or may need more than one attempt INVESTIGATOR 4 4 INVESTIGATOR INVESTIGATOR INVESTIGATOR 4 4 UPD28 Motor:Posture Moderately INVESTIGATOR 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7

8 CDISC SDTM Questionnaire Supplement (Version.) Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT stooped posture, definitely abnormal; can be slightly leaning to one side Severe UPD29 Motor:Gait assistance. disturbance of gait, requiring INVESTIGATOR UPD UPD UPD UPD UPD UPD UPD36 Motor:Postural Stability Motor:Bradykinesia and Hypokinesia Complications:Dyskinesi as Duration Complications:Dyskinesi as Disable Complications:Dyskinesi as Painful Complications:Dyskinesi as Dystonia Complications:Fluct Predictable A. DYSKINESIA A. DYSKINESIA A. DYSKINESIA A. DYSKINESIA B. CLINICAL Absence of postural response; would fall if not caught by examiner Minimal slowness, giving movement a deliberate character; could be normal for some persons. Possibly reduced amplitude INVESTIGATOR INVESTIGATOR 26-50% of day INVESTIGATOR -PW Moderately disabling INVESTIGATOR -PW Slight INVESTIGATOR -PW No 0 0 INVESTIGATOR -PW Yes INVESTIGATOR -PW 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8

9 CDISC SDTM Questionnaire Supplement (Version.) Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT FLUCTUATIONS UPD37 Complications:Fluct Unpredictable B. CLINICAL FLUCTUATIONS No 0 0 INVESTIGATOR -PW 5 5 UPD UPD UPD UPD UPD UPD42A UPD42B UPD42C Complications:Fluct Suddenly Complications:Fluct Average Complications:Anorex Nausea Vomit Complications:Insomnia Hypersomnol Complications:Symptom Orthostasis Blood Pressure: Seated Blood Pressure: Supine Blood Pressure: Standing B. CLINICAL FLUCTUATIONS B. CLINICAL FLUCTUATIONS C. OTHER S C. OTHER S C. OTHER S C. OTHER S C. OTHER S No 0 0 INVESTIGATOR -PW 26-50% of day INVESTIGATOR -PW No 0 0 INVESTIGATOR -PW Yes INVESTIGATOR -PW No 0 0 INVESTIGATOR -PW 20/80 mmhg 20/80 mmhg INVESTIGATOR -PW 5/77 mmhg 5/77 mmhg INVESTIGATOR -PW 7/78 mmhg 7/78 mmhg INVESTIGATOR -PW 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9

10 CDISC SDTM Questionnaire Supplement (Version.) Row QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSEVAL VISITNUM QSEVLINT C. OTHER S UPD42D Weight C. OTHER 67 kg kg INVESTIGATOR -PW S UPD42E Pulse: Seated C. OTHER 55 BEATS/MIN BEATS/MIN INVESTIGATOR -PW S 6 6 UPD42F Pulse: Standing C. OTHER 57 BEATS/MIN BEATS/MIN INVESTIGATOR -PW UPD UPD44A UPD44B UPD UPD46 Modified Hoehn and Yahr Staging Schwab/England % ADL Score (PD) Schwab/England % ADL (Dyskinesia) Mentation, Behavior, Mood Sub- Total Activities Daily Living Sub-Total S V. MODIFIED HOEHN AND YAHR STAGING VI. SCHWAB AND ENGLAND ACTIVITIES OF DAILY SCALE VI. SCHWAB AND ENGLAND ACTIVITIES OF DAILY SCALE I. MENTATION, BEHAVIOR AND MOOD Unilateral plus axial involvement. Completely independent in most chores. Takes twice as long. Conscious of difficulty and slowness With effort, now and then does a few chores alone or begins alone. Much help needed STAGE.5 INVESTIGATOR % INVESTIGATOR % INVESTIGATOR INVESTIGATOR INVESTIGATOR UPD47 Motor Examination Sub-Total INVESTIGATOR UPD48 Total INVESTIGATOR 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 0

11 CDISC SDTM Questionnaire Supplement (Version.) 4 SDTM Mapping Strategy specific mapping strategy: This section is used for reference with the annotated CRF for further details on the CRF data capture and to understand the alignment of the questionnaire to the SDTM QS domain. It also provides guidance on how the QSSCAT and result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated for the questionnaire. If a result variable is not included in the table for a questionnaire, it should not be populated. QSTESTCD = UPD0 QSTEST = Mentation:Intellectual Impairment Mild. Consistent forgetfulness with partial recollection of events and no other difficulties Moderate memory loss, with disorientation and moderate difficulty handling complex problems. Mild but definite impairment of function at home with need of occasional prompting Severe memory loss with disorientation for time and often to place. Severe impairment in handling problems Severe memory loss with orientation preserved to person only. Unable to make judgements or solve problems. Requires much help with personal care. Cannot be left alone at all 4 4 QSTESTCD = UPD02 QSTEST = Mentation:Thought Disorder Vivid dreaming "Benign" hallucinations with insight retained Occasional to frequent hallucinations or delusions; without insight; could interfere with daily activities Persistent hallucinations, delusions, or florrid psychosis. Not able to care for self 4 4 QSTESTCD = UPD03 QSTEST = Mentation:Depression Periods of sadness or guilt greater than normal, never sustained for days or weeks Sustained depression ( week or more) Sustained depression with vegetative symptoms (insomnia, anorexia, weight loss, loss of interest) Sustained depression with vegetative symptoms and suicidal thoughts or intent 4 4 QSTESTCD = UPD04 QSTEST = Mentation:Motivation/Initiative Less assertive than usual; more passive Loss of initiative or disinterest in elective (nonroutine) activities Loss of initiative or disinterest in day to day (routine) activities Withdrawn, complete loss of motivation Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page

12 CDISC SDTM Questionnaire Supplement (Version.) QSTESTCD = UPD05 QSTEST =Activities:Speech Mildly affected. No difficulty being understood Moderately affected. Sometimes asked to repeat statements Severely affected. Frequently asked to repeat statements Unintelligible most of the time 4 4 QSTESTCD = UPD06 QSTEST = Activities:Salivation Slight but definite excess of saliva in mouth; may have nighttime drooling Moderately excessive saliva; may have minimal drooling Marked excess of saliva with some drooling Marked drooling, requires constant tissue or handkerchief 4 4 QSTESTCD = UPD07 QSTEST = Activities:Swallowing Rare choking Occasional choking Requires soft food Requires NG tube or gastrotomy feeding 4 4 QSTESTCD = UPD08 QSTEST = Activities:Handwriting Slightly slow or small Moderately slow or small; all words are legible Severely affected; not all words are legible The majority of words are not legible 4 4 QSTESTCD = UPD09 QSTEST = Activities:Cut Food/Handle Utensil Somewhat slow and clumsy, but no help needed Can cut most foods, although clumsy and slow; some help needed Food must be cut by someone, but can still feed slowly Needs to be fed 4 4 QSTESTCD = UPD0 QSTEST = Activities:Dressing Somewhat slow, but no help needed 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2

13 CDISC SDTM Questionnaire Supplement (Version.) Occasional assistance with buttoning, getting arms in sleeves Considerable help required, but can do some things alone Helpless 4 4 QSTESTCD = UPD QSTEST = Activities:Hygiene Somewhat slow, but no help needed Needs help to shower or bathe; or very slow in hygienic care Requires assistance for washing, brushing teeth, combing hair, going to bathroom Foley catheter or other mechanical aids 4 4 QSTESTCD = UPD2 QSTEST = Activities:Turn Bed/Adj Clothes Normal. 0 0 Somewhat slow and clumsy, but no help needed Can turn alone or adjust sheets, but with great difficulty Can initiate, but not turn or adjust sheets alone Helpless 4 4 QSTESTCD = UPD3 QSTEST = Activities:Falling Rare falling Occasionally falls, less than once per day Falls an average of once daily Falls more than once daily 4 4 QSTESTCD = UPD4 QSTEST = Activities:Freezing When Walking Rare freezing when walking; may have starthesitation Occasional freezing when walking Frequent freezing. Occasionally falls from freezing Frequent falls from freezing 4 4 QSTESTCD = UPD5 QSTEST = Activities:Walking Mild difficulty. May not swing arms or may tend to drag leg Moderate difficulty, but requires little or no assistance Severe disturbance of walking, requiring assistance Cannot walk at all, even with assistance Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

14 CDISC SDTM Questionnaire Supplement (Version.) QSTESTCD = UPD6 QSTEST = Activities:Tremor Absent 0 0 Slight and infrequently present Moderate; bothersome to patient Severe; interferes with many activities Marked; interferes with most activities 4 4 QSTESTCD = UPD7 QSTEST = Activities:Sensory Complaints Occasionally has numbness, tingling, or mild aching Frequently has numbness, tingling, or aching; not distressing Frequent painful sensations Excruciating pain 4 4 QSTESTCD = UPD8 QSTEST = Motor:Speech Slight loss of expression, diction and/or volume Monotone, slurred but understandable; moderately impaired Marked impairment, difficult to understand Unintelligible 4 4 QSTESTCD = UPD9 QSTEST = Motor:Facial Expression Minimal hypomimia, could be normal "Poker Face" Slight but definitely abnormal diminution of facial expression Moderate hypomimia; lips parted some of the time Masked or fixed facies with severe or complete loss of facial expression; lips parted /4 inch or more 4 4 QSTESTCD = UPD20A QSTESTCD = UPD20B QSTESTCD = UPD20C QSTESTCD = UPD20D QSTESTCD = UPD20E QSTEST =Motor:Tremor at Rest:Face Lips Chin QSTEST =Motor:Tremor at Rest:Hands: Right QSTEST =Motor:Tremor at Rest:Hands: Left QSTEST =Motor:Tremor at Rest:Feet: Right QSTEST =Motor:Tremor at Rest:Feet: Left Absent 0 0 Slight and infrequently present Mild in amplitude and persistent. Or moderate in amplitude, but only intermittently present 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

15 CDISC SDTM Questionnaire Supplement (Version.) Moderate in amplitude and present most of the time Marked in amplitude and present most of the time 4 4 QSTESTCD = UPD2A QSTESTCD = UPD2B QSTEST = -Motor:Action Tremor:Hand: Right QSTEST = -Motor:Action Tremor:Hand: Left Absent 0 0 Slight; present with action Moderate in amplitude, present with action Moderate in amplitude with posture holding as well as action Marked in amplitude; interferes with feeding 4 4 QSTESTCD = UPD22A QSTESTCD = UPD22B QSTESTCD = UPD22C QSTESTCD = UPD22E QSTESTCD = UPD22F QSTEST = Motor:Rigidity Neck QSTEST = Motor:Rigidity Upper Extrem: Right QSTEST = Motor:Rigidity Upper Extrem: Left QSTEST = Motor:Rigidity Lower Extrem: Right QSTEST = Motor:Rigidity Lower Extrem: Left Absent 0 0 Slight or detectable only when activated by mirror or other movements Mild to moderate Marked, but full range of motion easily achieved Severe, range of motion achieved with difficulty 4 4 QSTESTCD = UPD23A QSTESTCD = UPD23B QSTEST = Motor:Finger Taps: Right QSTEST = Motor:Finger Taps: Left Norma 0 0 Mild slowing and/or reduction in amplitude Moderately impaired. Definite and early fatiguing. May have occasional arrests in movement Severely impaired. Frequent hesitation in initiating movements or arrests in ongoing movement Can barely perform the task 4 4 QSTESTCD = UPD24A QSTESTCD = UPD24B QSTEST = Motor:Hand Grips: Right QSTEST = Motor:Hand Grips: Left Mild slowing and/or reduction in amplitude Moderately impaired. Definite and early fatiguing. May have occasional arrests in movement Severely impaired. Frequent hesitation in initiating movements or arrests in ongoing movement Can barely perform the task Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

16 CDISC SDTM Questionnaire Supplement (Version.) QSTESTCD = UPD25A QSTESTCD = UPD25B QSTEST = Motor:Hand Pronate/Supinate: Right QSTEST = Motor:Hand Pronate/Supinate: Left Mild slowing and/or reduction in amplitude Moderately impaired. Definite and early fatiguing. May have occasional arrests in movement Severely impaired. Frequent hesitation in initiating movements or arrests in ongoing movement Can barely perform the task 4 4 QSTESTCD = UPD26A QSTESTCD = UPD26B QSTEST = Motor:Leg Agility: Right QSTEST = Motor:Leg Agility: Left Mild slowing and/or reduction in amplitude Moderately impaired. Definite and early fatiguing. May have occasional arrests in movement Severely impaired. Frequent hesitation in initiating movements or arrests in ongoing movement Can barely perform the task 4 4 QSTESTCD = UPD27 QSTEST = Motor:Arising from Chair Slow; or may need more than one attempt Pushes self up from arms of seat Tends to fall back and may have to try more than one time, but can get up without help Unable to arise without help 4 4 QSTESTCD = UPD28 QSTEST = Motor:Posture Normal erect Not quite erect, slightly stooped posture; could be normal for older person 0 0 Moderately stooped posture, definitely abnormal; can be slightly leaning to one side Severely stooped posture with kyphosis; can be moderately leaning to one side Marked flexion with extreme abnormality of posture 4 4 QSTESTCD = UPD29 QSTEST = Motor:Gait Walks slowly, may shuffle with short steps, but no festination (hastening steps) or propulsion Walks with difficulty, but requires little or no assistance; may have some festination, short steps, or propulsion Severe disturbance of gait, requiring assistance 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

17 CDISC SDTM Questionnaire Supplement (Version.) Cannot walk at all, even with assistance 4 4 QSTESTCD = UPD30 QSTEST = Motor:Postural Stability Retropulsion, but recovers unaided Absence of postural response; would fall if not caught by examiner Very unstable, tends to lose balance spontaneously Unable to stand without assistance 4 4 QSTESTCD = UPD3 QSTEST = Motor:Bradykinesia and Hypokinesia Minimal slowness, giving movement a deliberate character; could be normal for some persons. Possibly reduced amplitude Mild degree of slowness and poverty of movement which is definitely abnormal. Alternatively, some reduced amplitude Moderate slowness, poverty or small amplitude of movement Marked slowness, poverty or small amplitude of movement 4 4 QSTESTCD = UPD32 QSTEST = Complications:Dyskinesias Duration -25% of day 26-50% of day 5-75% of day 76-00% of day 4 4 QSTESTCD = UPD33 QSTEST = Complications:Dyskinesias Disable Not disabling 0 0 Mildly disabling Moderately disabling Severely disabling Completely disabled 4 4 QSTESTCD= UPD34 QSTEST = Complications:Dyskinesias Painful No painful dyskinesias 0 0 Slight Moderate Severe Marked 4 4 QSTESTCD = UPD35 QSTEST = Complications:Dyskinesias Dystonia 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7

18 CDISC SDTM Questionnaire Supplement (Version.) QSTESTCD = UPD36 QSTESTCD = UPD37 QSTESTCD = UPD38 QSTEST = Complications:Fluct Predictable QSTEST = Complications:Fluct Unpredictable QSTEST = Complications:Fluct Suddenly No 0 0 Yes QSTESTCD = UPD39 QSTEST = Complications:Fluct Average -25% of day 26-50% of day 5-75% of day 76-00% of day 4 4 QSTESTCD = UPD40 QSTESTCD = UPD4 QSTESTCD = UPD42 QSTEST = Complications:Anorex Nausea Vomit QSTEST = Complications:Insomnia Hypersomnol QSTEST = Complications:Symptom Orthostasis No 0 0 Yes QSTESTCD = UPD43 QSTEST = Modified Hoehn and Yahr Staging QSORRES QSSTRESC No signs of disease STAGE 0 Unilateral disease STAGE Unilateral plus axial involvement STAGE.5 Bilateral disease, without impairment of balance STAGE 2 Mild bilateral disease, with recovery on pull test STAGE 2.5 Mild to moderate bilateral disease; some postural instability; physically independent STAGE 3 Severe disability; still able to walk or stand unassisted STAGE 4 Wheelchair bound or bedridden unless aided STAGE Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8

19 CDISC SDTM Questionnaire Supplement (Version.) QSTESTCD = UPD44A QSTESTCD = UPD44B QSTEST = Schwab/England % ADL Score (PD) QSTEST = Schwab/England % ADL (Dyskinesia) QSSTRESU Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty % Completely independent. Able to do all chores with some degree of slowness, difficulty and impairment. Might take twice as long. Beginning to be aware of difficulty % Completely independent in most chores. Takes twice as long. Conscious of difficulty and slowness % Not completely independent. More difficulty with some chores. Three to four times as long in some. Must spend a large part of the day with chores % Some dependency. Can do most chores, but exceedingly slowly and with much effort. Errors; some impossible % More dependent. Help with half, slower, etc. Difficulty with everything % Very dependent. Can assist with all chores, but few alone % With effort, now and then does a few chores alone or begins alone. Much help needed % Nothing alone. Can be a slight help with some chores. Severe invalid % Totally dependent, helpless. Complete invalid 0 0 % Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden 0 0 % As stated in Assumption, the is grouped into categories. The table below includes the category names along with the applicable question numbers for each category. These values are used to populate QSSCAT and are annotated on the Case Report Form. QSSCAT QSTESTCD I. MENTATION, BEHAVIOR AND MOOD UPD0 - UPD04 UPD05 UPD7 UPD8 UPD3 A. DYSKINESIA UPD32 UPD35 B. CLINICAL FLUCTUATIONS UPD36 UPD39 C. OTHER S UPD40 UPD42F V. MODIFIED HOEHN AND YAHR STAGING UPD43 VI. SCHWAB AND ENGLAND ACTIVITIES SCALE UPD44A UPD44B I. MENTATION, BEHAVIOR AND MOOD UPD45 UPD46 UPD47 End of Document 204 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9