CDISC_Pilot SDTM data sets CDISCPILOT01 Annotated Case Report Form Reviewer's Guide Table 14-1.01 SAP Section 9.1 SAP Template 1 Table 14-1.02 SAP Section 9.1 SAP Template 2 Table 14-1.03 SAP Template 4 Table 14-2.01 SAP Section 9.2 SAP Template 3 Table 14-3.01 SAP Section 10.1.1 SAP Template 5 Table 14-3.02 SAP Section 10.1.2 SAP Template 6 Table 14-3.03 SAP Section 10.1.1 SAP Template 5 Table 14-3.04 SAP Section 10.1.2 SAP Template 6 Table 14-3.05 SAP Section 10.1.1 SAP Template 5 Table 14-3.06 SAP Section 10.1.2 SAP Template 6 Table 14-3.07 SAP Section 10.1.1 SAP Template 7 Table 14-3.08 SAP Section 7.2 SAP Section 10.1.1 SAP Template 8 Table 14-3.09 SAP Section 7.2 SAP Section 10.1.1 SAP Template 8 Table 14-3.10 SAP Section 10.1.1 SAP Template 9 Table 14-3.11 SAP Section 10.1.1 SAP Template 10 Table 14-3.12 SAP Section 10.2.1 SAP Template 11 Table 14-3.13 SAP Section 16.1 SAP Template AH1 Table 14-4.01 SAP Section 11.1 SAP Template 12 Table 14-5.01 SAP Section 11.2 SAP Template 13 Table 14-5.02 SAP Section 11.3 SAP Template 14 Table 14-6.01 SAP Section 11.5 SAP Template 15 Table 14-6.02 SAP Section 11.5 SAP Template 16 Table 14-6.03 SAP Section 11.5 SAP Template 17 Table 14-6.04 SAP Section 11.5 SAP Template 18 Table 14-6.05 SAP Section 11.5 SAP Template 19 Table 14-6.06 SAP Section 11.5 SAP Template 20 Table 14-7.01 SAP Section 11.6 SAP Template 21 Table 14-7.02 SAP Section 11.6 SAP Template 22 Table 14-7.03 SAP Section 11.6 SAP Template 23 Table 14-7.04 SAP Section 11.6 SAP Template 24 Figure 14-1 SAP Section 11.2 SAP Template F1 if aedecod contains any of the character strings of ('APPLICATION','DERMATITIS','ERYTHEMA','BLISTER') OR if aebodsys='SKIN AND SUBCUTANEOUS TISSUE DISORDERS' but aedecod is not in ('COLD SWEAT','HYPERHIDROSIS','ALOPECIA') then AEDERMFN=1 Otherwise AEDERMFN=null All records have a value of "MedDRA version 8.0 (partially masked by request of MSSO)" AE.AEENDTC, converted to SAS date ADAE.AEENDT-ADSL.TRTSTDT+1 AEFN=1 for the record with the first treatment emergent occurrence of any AETERM. Missing otherwise. If AESER='Y' then AESERN=1. If AESER='N' then AESERN=0. AE.AESTDTC, converted to SAS date. Some events had missing month and day components. Partial dates for events that had a value of start year that was prior to treatment exposure were not imputed. Only those events that had the same year as treatment exposure w ere imputed if necessary. If day component was missing, a value of '01' was used. There were no events with missing month componen ts. adae.xpt adlbc.xpt adlbh.xpt adlbhy.xpt adqsadas.xpt adqscibc.xpt adqsnpix.xpt adsl.xpt adtte.xpt advs.xpt te.xpt ta.xpt tv.xpt ti.xpt ts.xpt se.xpt sv.xpt dm.xpt cm.xpt ex.xpt ae.xpt ds.xpt mh.xpt lb.xpt qs.xpt sc.xpt vs.xpt relrec.xpt suppae.xpt suppds.xpt suppmh.xpt supplb.xpt suppdm.xpt AFRICAN DESCENT (NEGRO, BLACK) CAUCASIAN EAST/SOUTHEST ASIAN (BURMESE, CHINESE, JAPANSE, KOREAN, MONGOLIAN, VIETNAMESE) HISPANIC (MEXICAN - AMERICAN, MEXICO, CENTRAL AND SOUTH AMERICA) OTHER (MIXED - RACIAL HERITAGE, AMERICAN INDIAN, ESKIMO) WESTERN ASIAN (PAKISTANI, INDIAN SUB-CONTINENT) CAUCASIAN AFRICAN DESCENT EAST/SOUTHEST ASIAN WESTERN ASIAN HISPANIC OTHER N/A NONE POSSIBLE PROBABLE REMOTE 65-80 <65 >80 <65 65-80 >80 YEARS Placebo Xanomeline High Dose Xanomeline Low Dose Pbo Scrnfail Xan_Hi Xan_Lo Placebo Xanomeline Low Dose Xanomeline High Dose EVERY ARM N/A Baseline Week 16 Week 24 Week 8 N/A Week 16 Week 24 Week 24 Baseline Week 8 N/A Baseline Week 16 Week 24 Week 8 Overweight (25-<30) Normal (<25) Obese (>=30) Date not imputed Date was imputed ADVERSE EVENT PROTOCOL COMPLETED DEATH PROTOCOL ENTRY CRITERIA NOT MET LACK OF EFF.-PT./CAREGIVER/DR PERCEPTION UNABLE TO CONTACT PT. -LOST TO FOLLOW-UP PHYSICIAN DECISION PROTOCOL VIOLATION SPONSOR DECISION PERSONAL CONFLICT OR OTHER DECISION ADVERSE EVENT DEATH LACK OF EFFICACY, PATIENT CAREGIVER PERCEPTION LACK OF EFFICACY, PHYSICIAN PERCEPTION PERSONAL CONFLICT OR OTHER PATIENT/CAREGIVER DECISION PHYSICIAN DECISION PROTOCOL COMPLETED PROTOCOL ENTRY CRITERIA NOT MET PROTOCOL VIOLATION SPONSOR DECISION (STUDY OR PATIENT DISCONTINUED BY THE SPONSOR) UNABLE TO CONTACT PATIENT (LOST TO FOLLOW-UP) <12 Months >=12 Months ALBUMIN ALKALINE PHOSPHATASE ALANINE AMINOTRANSFERASE AMYLASE ANISOCYTOSIS ACTIVATED PARTIAL THROMBOPLASTIN TIME ASPARTATE AMINOTRANSFERASE BACTERIA BASOPHILS BASOPHILS/LEUKOCYTES DIRECT BILIRUBIN BILIRUBIN INDIRECT BILIRUBIN BLASTS/LEUKOCYTES UREA NITROGEN CALCIUM CHOLESTEROL CREATINE KINASE CREATINE KINASE BB CREATINE KINASE MB CREATINE KINASE MM CHLORIDE CARBON DIOXIDE COLOR CREATININE C REACTIVE PROTEIN ELLIPTOCYTES EOSINOPHILS EOSINOPHILS/LEUKOCYTES EPITHELIAL CELLS FIBRINOGEN GAMMA GLUTAMYL TRANSFERASE GLUCOSE HEMOGLOBIN A1C HEPATITIS B VIRUS SURFACE ANTIGEN CHORIOGONADOTROPIN BETA HEMATOCRIT HDL CHOLESTEROL HEMOGLOBIN HYPOCHROMIA PROTHROMBIN INTL. NORMALIZED RATIO POTASSIUM KETONES LACTATE DEHYDROGENASE LDL CHOLESTEROL LEUKOCYTE ESTERASE TRIACYLGLYCEROL LIPASE LYMPHOCYTES LYMPHOCYTES ATYPICAL LYMPHOCYTES ATYPICAL/LEUKOCYTES LYMPHOCYTES/LEUKOCYTES MACROCYTES ERY. MEAN CORPUSCULAR HEMOGLOBIN ERY. MEAN CORPUSCULAR HB CONCENTRATION ERY. MEAN CORPUSCULAR VOLUME MAGNESIUM MICROCYTES MONOCYTES MONOCYTES/LEUKOCYTES MYELOBLASTS/LEUKOCYTES MYELOCYTES/LEUKOCYTES SODIUM NEUTROPHILS NEUTROPHILS BAND FORM NEUTROPHILS BAND FORM/LEUKOCYTES NEUTROPHILS/LEUKOCYTES NITRITE PH PHOSPHATE PLATELET POIKILOCYTOSIS POLYCHROMASIA PROLYMPHOCYTES/LEUKOCYTES PROTEIN PROTHROMBIN TIME ERYTHROCYTES ERYTHROCYTES DISTRIBUTION WIDTH RETICULOCYTES RETICULOCYTES/ERYTHROCYTES SPECIFIC GRAVITY DACRYOCYTES TRIGLYCERIDES THYROTROPIN URATE UREA UROBILINOGEN VITAMIN B12 VLDL CHOLESTEROL LEUKOCYTES Blood Chemistry Hematology Other Lab Data Urinalysis N/A High Low Normal Yes No Absent Present ALZHEIMER'S DISEASE ASSESSMENT SCALE CLINICIAN'S INTERVIEW-BASED IMPRESSION OF CHANGE (CIBIC+) DISABILITY ASSESSMENT FOR DEMENTIA (DAD) MINI-MENTAL STATE MODIFIED HACHINSKI ISCHEMIC SCORE NEUROPSYCHIATRIC INVENTORY - REVISED (NPI-X) WORD RECALL TASK NAMING OBJECTS AND FINGERS (REFER TO 5C) DELAYED WORD RECALL COMMANDS CONSTRUCTIONAL PRAXIS IDEATIONAL PRAXIS ORIENTATION WORD RECOGNITION ATTENTION/VISUAL SEARCH TASK MAZE SOLUTION SPOKEN LANGUAGE ABILITY COMPREHENSION OF SPOKEN LANGUAGE WORD FINDING DIFFICULTY IN SPONTANEOUS S RECALL OF TEST INSTRUCTIONS ADAS-COG(11) Subscore CIBIC+ UNDERTAKE TO WASH HIMSELF/HERSELF UNDERTAKE TO BRUSH HIS/HER TEETH DECIDE TO CARE FOR HIS/HER HAIR PREPARE FOR WASHING, TAKING A BATH WASH AND DRY COMPLETELY SAFELY BRUSH HIS/HER TEETH CARE FOR HIS/HER HAIR UNDERTAKE TO DRESS HIMSELF/HERSELF CHOOSE APPROPRIATE CLOTHING DRESS HIMSELF/HERSELF DRESS HIMSELF/HERSELF COMPLETELY UNDRESS HIMSELF/HERSELF COMPLETELY DECIDE TO USE THE TOILET AT APPROPRIATE USE THE TOILET WITHOUT "ACCIDENTS" DECIDE THAT HE/SHE NEEDS TO EAT CHOOSE APPROPRIATE UTENSILS EAT HIS/HER MEALS AT A NORMAL PACE UNDERTAKE TO PREPARE A LIGHT MEAL ADEQUATELY PLAN A LIGHT MEAL OR SNACK PREPARE OR COOK A LIGHT MEAL OR A SNACK ATTEMPT TO TELEPHONE SOMEONE FIND AND DIAL A TELEPHONE NUMBER CORRECT CARRY OUT A TELEPHONE CONVERSATION WRITE AND CONVEY A TELEPHONE MESSAGE UNDERTAKE TO GO OUT ADEQUATELY ORGANIZE AN OUTING GO OUT AND REACH A FAMILIAR DESTINATION SAFELY TAKE CAR, BUS, TAXI RETURN FROM THE STORE INTEREST IN HIS/HER PERSONAL AFFAIRS PAY HIS/HER BILLS ORGANIZE HIS/HER CORRESPONDENCE HANDLE ADEQUATELY HIS/HER MONEY DECIDE TO TAKE HIS/HER MEDICATIONS TAKE HIS/HER MEDICATIONS AS PRESCRIBED SHOW AN INTEREST IN LEISURE ACTIVITY TAKE AN INTEREST IN HOUSEHOLD CHORES PLAN AND ORGANIZE HOUSEHOLD CHORES COMPLETE HOUSEHOLD CHORES STAY SAFELY AT HOME BY HIMSELF/HERSELF ABRUPT ONSET STEPWISE DETERIORATION FLUCTUATING COURSE NOCTURNAL CONFUSION RELATIVE PRESERVATION OF PERSONALITY DEPRESSION SOMATIC COMPLAINTS EMOTIONAL INCONTINENCE HISTORY OF HYPERTENSION HISTORY OF STROKES EVIDENCE OF ASSOCIATED ATHEROSCLEROSIS FOCAL NEUROLOGICAL SYMPTOMS FOCAL NEUROLOGICAL SIGNS WHAT IS THE (YEAR) (SEASON) (DATE) ? WHERE ARE WE: (STATE) (COUNTRY) (TOWN) ? NAME 3 OBJECTS: 1 SECOND TO SAY EACH. SERIAL 7'S. 1 POINT FOR EACH CORRECT. ASK FOR THE 3 OBJECTS REPEATED ABOVE. NAME A PENCIL, AND WATCH (2 POINTS) DELUSIONS Score DELUSIONS DISTRESS DELUSIONS FREQUENCY DELUSIONS PRESENT DELUSIONS SEVERITY HALLUCINATIONS Score HALLUCINATIONS DISTRESS HALLUCINATIONS FREQUENCY HALLUCINATIONS PRESENT HALLUCINATIONS SEVERITY AGITATION/AGRESSION Score AGITATION/AGRESSION DISTRESS AGITATION/AGRESSION FREQUENCY AGITATION/AGRESSION PRESENT AGITATION/AGRESSION SEVERITY DEPRESSION/DYSPHORIA Score DEPRESSION/DYSPHORIA DISTRESS DEPRESSION/DYSPHORIA FREQUENCY DEPRESSION/DYSPHORIA PRESENT DEPRESSION/DYSPHORIA SEVERITY ANXIETY Score ANXIETY DISTRESS ANXIETY FREQUENCY ANXIETY PRESENT ANXIETY SEVERITY EUPHORIA/ELATION Score EUPHORIA/ELATION DISTRESS EUPHORIA/ELATION FREQUENCY EUPHORIA/ELATION PRESENT EUPHORIA/ELATION SEVERITY APATHY/INDIFFERENCE Score APATHY/INDIFFERENCE DISTRESS APATHY/INDIFFERENCE FREQUENCY APATHY/INDIFFERENCE PRESENT APATHY/INDIFFERENCE SEVERITY DISINHIBITION Score DISINHIBITION DISTRESS DISINHIBITION FREQUENCY DISINHIBITION PRESENT DISINHIBITION SEVERITY IRRITABILITY/LABILITY Score IRRITABILITY/LABILITY DISTRESS IRRITABILITY/LABILITY FREQUENCY IRRITABILITY/LABILITY PRESENT IRRITABILITY/LABILITY SEVERITY ABERRANT MOTOR BEHAVIOR Score ABERRANT MOTOR BEHAVIOR DISTRESS ABERRANT MOTOR BEHAVIOR FREQUENCY ABERRANT MOTOR BEHAVIOR PRESENT ABERRANT MOTOR BEHAVIOR SEVERITY NIGHT-TIME BEHAVIOR Score NIGHT-TIME BEHAVIOR DISTRESS NIGHT-TIME BEHAVIOR FREQUENCY NIGHT-TIME BEHAVIOR PRESENT NIGHT-TIME BEHAVIOR SEVERITY APPETITE/EATING CHANGE Score APPETITE/EATING CHANGE DISTRESS APPETITE/EATING CHANGE FREQUENCY APPETITE/EATING CHANGE PRESENT APPETITE/EATING CHANGE SEVERITY NPI-X (9) Total Score MILD MODERATE SEVERE Female Male Unknown HIGHER LEVEL GROUP TERM HIGHER LEVEL TERM LOWER LEVEL TERM TREATMENT EMERGENT FLAG Completers of Week 16 Population Flag Completers of Week 24 Population Flag Completers of Week 8 Population Flag Efficacy Population Flag Intent to Treat Population Flag Safety Population Flag PROTOCOL ENTRY CRITERIA NOT MET ENDPOINT VALUE FLAG LAB RESULT/UPPER LIMIT OF NORMAL HIGHER LEVEL GROUP TERM HIGHER LEVEL TERM LOWER LEVEL TERM Placebo Xanomeline Low Dose Xanomeline High Dose AFTER STANDING FOR 1 MINUTE AFTER STANDING FOR 3 MINUTES AFTER LYING DOWN FOR 5 MINUTES N/A STANDING SUPINE DIASTOLIC BLOOD PRESSURE HEIGHT PULSE SYSTOLIC BLOOD PRESSURE TEMPERATURE WEIGHT C bpm cm kg mmHg No Yes No Yes No Yes No Yes