CDISCPILOT01 CDISCPILOT01 Data Definition CDISCPILOT01 Data Guide Table 14-1.01 Table 14-1.02 SAP Section 9.1 Table 14-2.01 Table 14-3.01 Table 14-3.02 SAP Section 10.1.1 SAP Section 10.1.1 Table 14-3.12 SAP Section 10.2 Table 14-5.02 SAP Section 11.2 at14-5-02.sas Table 14-6.01 SAP Section 11.5 Table 14-6.02 Table 14-6.03 Table 14-6.04 Table 14-6.05 Table 14-6.06 Figure 14-1 adsl.xpt adae.xpt adlbc.xpt adlbh.xpt adlbhy.xpt adqsadas.xpt adqscibc.xpt adqsnpix.xpt adtte.xpt advs.xpt Chemistry Hematology Hy's Law NONE POSSIBLE PROBABLE REMOTE <65 65-80 >80 <65 65-80 >80 YEARS Placebo Xanomeline Low Dose Xanomeline High Dose Placebo Xanomeline Low Dose Xanomeline High Dose AFTER LYING DOWN FOR 5 MINUTES AFTER STANDING FOR 1 MINUTE AFTER STANDING FOR 3 MINUTES Baseline Week 2 Week 4 Week 6 Week 8 Week 10 Week 12 Week 14 Week 16 Week 18 Week 20 Week 22 Week 24 Week 26 Weeks 4-24 End of Treatment Baseline Week 2 Week 4 Week 6 Week 8 Week 10 Week 12 Week 14 Week 16 Week 18 Week 20 Week 22 Week 24 Week 26 Weeks 4-24 End of Treatment DAYS Normal Overweight Obese Event Censored COMPLETED ADVERSE EVENT DEATH LACK OF EFFICACY LOST TO FOLLOW-UP WITHDRAWAL BY SUBJECT STUDY TERMINATED BY SPONSOR PHYSICIAN DECISION PROTOCOL VIOLATION Completed Adverse Event Death I/E Not Met Lack of Efficacy Lost to Follow-up Physician Decision Protocol Violation Sponsor Decision Withdrew Consent Day imputed Day and Month imputed Date (Day, Month and Year) imputed Last Observation Carried Forward Average <12 >=12 NOT HISPANIC OR LATINO HISPANIC OR LATINO LOW NORMAL HIGH Low Normal High RECOVERED/RESOLVED NOT RECOVERED/NOT RESOLVED FATAL Albumin (g/L) Alkaline Phosphatase (U/L) Alanine Aminotransferase (U/L) Aspartate Aminotransferase (U/L) Bilirubin (umol/L) Blood Urea Nitrogen (mmol/L) Calcium (mmol/L) Cholesterol (mmol/L) Creatine Kinase (U/L) Chloride (mmol/L) Creatinine (umol/L) Gamma Glutamyl Transferase (U/L) Glucose (mmol/L) Potassium (mmol/L) Phosphate (mmol/L) Protein (g/L) Sodium (mmol/L) Urate (umol/L) Albumin (g/L) change from previous visit, relative to normal range Alkaline Phosphatase (U/L) change from previous visit, relative to normal range Alanine Aminotransferase (U/L) change from previous visit, relative to normal range Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range Bilirubin (umol/L) change from previous visit, relative to normal range Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range Calcium (mmol/L) change from previous visit, relative to normal range Cholesterol (mmol/L) change from previous visit, relative to normal range Creatine Kinase (U/L) change from previous visit, relative to normal range Chloride (mmol/L) change from previous visit, relative to normal range Creatinine (umol/L) change from previous visit, relative to normal range Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range Glucose (mmol/L) change from previous visit, relative to normal range Potassium (mmol/L) change from previous visit, relative to normal range Phosphate (mmol/L) change from previous visit, relative to normal range Protein (g/L) change from previous visit, relative to normal range Sodium (mmol/L) change from previous visit, relative to normal range Urate (umol/L) change from previous visit, relative to normal range Anisocytes Basophils (GI/L) Eosinophils (GI/L) Hematocrit Hemoglobin (mmol/L) Lymphocytes (GI/L) Macrocytes Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) Ery. Mean Corpuscular HGB Concentration (mmol/L) Ery. Mean Corpuscular Volume (fL) Microcytes Monocytes (GI/L) Platelet (GI/L) Poikilocytes Polychromasia Erythrocytes (TI/L) Leukocytes (GI/L) Anisocytes change from previous visit, relative to normal range Basophils (GI/L) change from previous visit, relative to normal range Eosinophils (GI/L) change from previous visit, relative to normal range Hematocrit change from previous visit, relative to normal range Hemoglobin (mmol/L) change from previous visit, relative to normal range Lymphocytes (GI/L) change from previous visit, relative to normal range Macrocytes change from previous visit, relative to normal range Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range Microcytes change from previous visit, relative to normal range Monocytes (GI/L) change from previous visit, relative to normal range Platelet (GI/L) change from previous visit, relative to normal range Poikilocytes change from previous visit, relative to normal range Polychromasia change from previous visit, relative to normal range Erythrocytes (TI/L) change from previous visit, relative to normal range Leukocytes (GI/L) change from previous visit, relative to normal range Alanine Aminotransferase (U/L) Aspartate Aminotransferase (U/L) Bilirubin (umol/L) Bilirubin 1.5 x ULN Transaminase 1.5 x ULN Total Bili 1.5 x ULN and Transaminase 1.5 x ULN Word Recall Task Naming Objects And Fingers (Refer To 5 C 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 Score NPI-X Item A (Delusion) Score NPI-X Item B (Hallucination) Score NPI-X Item C (Agitation/Agression) Score NPI-X Item D (Depression/Dysphoria) Score NPI-X Item E (Anxiety) Score NPI-X Item F (Eupohoria/Elation) Score NPI-X Item G (Apathy/Indifference) Score NPI-X Item H (Disinhibition) Score NPI-X Item I (Irritability/Lability) Score NPI-X Item J (Aberrant Motor Behavior) Score NPI-X Item K (Night-time Behavior) Score NPI-X Item L (Appetite/Eating Change) Score NPI-X (9) Total Score Mean NPI-X (9) Total (Week 4 to 24) Time to Derm. Event or End of Study Systolic Blood Pressure (mmHg) Diastolic Blood Pressure (mmHg) Pulse Rate (BEATS/MIN) Weight (kg) Height (cm) Temperature (C) Sodium (mmol/L) Potassium (mmol/L) Chloride (mmol/L) Bilirubin (umol/L) Alkaline Phosphatase (U/L) Gamma Glutamyl Transferase (U/L) Alanine Aminotransferase (U/L) Aspartate Aminotransferase (U/L) Blood Urea Nitrogen (mmol/L) Creatinine (umol/L) Urate (umol/L) Phosphate (mmol/L) Calcium (mmol/L) Glucose (mmol/L) Protein (g/L) Albumin (g/L) Cholesterol (mmol/L) Creatine Kinase (U/L) Sodium (mmol/L) change from previous visit, relative to normal range Potassium (mmol/L) change from previous visit, relative to normal range Chloride (mmol/L) change from previous visit, relative to normal range Bilirubin (umol/L) change from previous visit, relative to normal range Alkaline Phosphatase (U/L) change from previous visit, relative to normal range Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range Alanine Aminotransferase (U/L) change from previous visit, relative to normal range Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range Creatinine (umol/L) change from previous visit, relative to normal range Urate (umol/L) change from previous visit, relative to normal range Phosphate (mmol/L) change from previous visit, relative to normal range Calcium (mmol/L) change from previous visit, relative to normal range Glucose (mmol/L) change from previous visit, relative to normal range Protein (g/L) change from previous visit, relative to normal range Albumin (g/L) change from previous visit, relative to normal range Cholesterol (mmol/L) change from previous visit, relative to normal range Creatine Kinase (U/L) change from previous visit, relative to normal range Hemoglobin (mmol/L) Hematocrit Ery. Mean Corpuscular Volume (fL) Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) Ery. Mean Corpuscular HGB Concentration (mmol/L) Leukocytes (GI/L) Lymphocytes (GI/L) Monocytes (GI/L) Eosinophils (GI/L) Basophils (GI/L) Platelet (GI/L) Erythrocytes (TI/L) Anisocytes Macrocytes Microcytes Poikilocytes Polychromasia Hemoglobin (mmol/L) change from previous visit, relative to normal range Hematocrit change from previous visit, relative to normal range Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang Leukocytes (GI/L) change from previous visit, relative to normal range Lymphocytes (GI/L) change from previous visit, relative to normal range Monocytes (GI/L) change from previous visit, relative to normal range Eosinophils (GI/L) change from previous visit, relative to normal range Basophils (GI/L) change from previous visit, relative to normal range Platelet (GI/L) change from previous visit, relative to normal range Erythrocytes (TI/L) change from previous visit, relative to normal range Anisocytes change from previous visit, relative to normal range Macrocytes change from previous visit, relative to normal range Microcytes change from previous visit, relative to normal range Poikilocytes change from previous visit, relative to normal range Polychromasia change from previous visit, relative to normal range Alanine Aminotransferase (U/L) Aspartate Aminotransferase (U/L) Bilirubin (umol/L) Bilirubin 1.5 x ULN Transaminase 1.5 x ULN Total Bili 1.5 x ULN and Transaminase 1.5 x ULN Word Recall Task Naming Objects And Fingers (Refer To 5 C 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 Score NPI-X Item A (Delusion) Score NPI-X Item B (Hallucination) Score NPI-X Item C (Agitation/Agression) Score NPI-X Item D (Depression/Dysphoria) Score NPI-X Item E (Anxiety) Score NPI-X Item F (Eupohoria/Elation) Score NPI-X Item G (Apathy/Indifference) Score NPI-X Item H (Disinhibition) Score NPI-X Item I (Irritability/Lability) Score NPI-X Item J (Aberrant Motor Behavior) Score NPI-X Item K (Night-time Behavior) Score NPI-X Item L (Appetite/Eating Change) Score NPI-X (9) Total Score Mean NPI-X (9) Total (Week 4 to 24) Systolic Blood Pressure (mmHg) Diastolic Blood Pressure (mmHg) Pulse Rate (BEATS/MIN) Weight (kg) Height (cm) Temperature (C) DERIVED Albumin (g/L) Alkaline Phosphatase (U/L) Alanine Aminotransferase (U/L) Aspartate Aminotransferase (U/L) Bilirubin (umol/L) Blood Urea Nitrogen (mmol/L) Calcium (mmol/L) Cholesterol (mmol/L) Creatine Kinase (U/L) Chloride (mmol/L) Creatinine (umol/L) Gamma Glutamyl Transferase (U/L) Glucose (mmol/L) Potassium (mmol/L) Phosphate (mmol/L) Protein (g/L) Sodium (mmol/L) Urate (umol/L) Albumin (g/L) change from previous visit, relative to normal range Alkaline Phosphatase (U/L) change from previous visit, relative to normal range Alanine Aminotransferase (U/L) change from previous visit, relative to normal range Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range Bilirubin (umol/L) change from previous visit, relative to normal range Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range Calcium (mmol/L) change from previous visit, relative to normal range Cholesterol (mmol/L) change from previous visit, relative to normal range Creatine Kinase (U/L) change from previous visit, relative to normal range Chloride (mmol/L) change from previous visit, relative to normal range Creatinine (umol/L) change from previous visit, relative to normal range Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range Glucose (mmol/L) change from previous visit, relative to normal range Potassium (mmol/L) change from previous visit, relative to normal range Phosphate (mmol/L) change from previous visit, relative to normal range Protein (g/L) change from previous visit, relative to normal range Sodium (mmol/L) change from previous visit, relative to normal range Urate (umol/L) change from previous visit, relative to normal range Anisocytes Basophils (GI/L) Eosinophils (GI/L) Hematocrit Hemoglobin (mmol/L) Lymphocytes (GI/L) Macrocytes Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) Ery. Mean Corpuscular HGB Concentration (mmol/L) Ery. Mean Corpuscular Volume (fL) Microcytes Monocytes (GI/L) Platelet (GI/L) Poikilocytes Polychromasia Erythrocytes (TI/L) Leukocytes (GI/L) Anisocytes change from previous visit, relative to normal range Basophils (GI/L) change from previous visit, relative to normal range Eosinophils (GI/L) change from previous visit, relative to normal range Hematocrit change from previous visit, relative to normal range Hemoglobin (mmol/L) change from previous visit, relative to normal range Lymphocytes (GI/L) change from previous visit, relative to normal range Macrocytes change from previous visit, relative to normal range Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range Microcytes change from previous visit, relative to normal range Monocytes (GI/L) change from previous visit, relative to normal range Platelet (GI/L) change from previous visit, relative to normal range Poikilocytes change from previous visit, relative to normal range Polychromasia change from previous visit, relative to normal range Erythrocytes (TI/L) change from previous visit, relative to normal range Leukocytes (GI/L) change from previous visit, relative to normal range Alanine Aminotransferase (U/L) Aspartate Aminotransferase (U/L) Bilirubin (umol/L) Bilirubin 1.5 x ULN Transaminase 1.5 x ULN Total Bili 1.5 x ULN and Transaminase 1.5 x ULN Word Recall Task Naming Objects And Fingers (Refer To 5 C 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 Score NPI-X Item A (Delusion) Score NPI-X Item B (Hallucination) Score NPI-X Item C (Agitation/Agression) Score NPI-X Item D (Depression/Dysphoria) Score NPI-X Item E (Anxiety) Score NPI-X Item F (Eupohoria/Elation) Score NPI-X Item G (Apathy/Indifference) Score NPI-X Item H (Disinhibition) Score NPI-X Item I (Irritability/Lability) Score NPI-X Item J (Aberrant Motor Behavior) Score NPI-X Item K (Night-time Behavior) Score NPI-X Item L (Appetite/Eating Change) Score NPI-X (9) Total Score Mean NPI-X (9) Total (Week 4 to 24) Time to Derm. Event or End of Study Systolic Blood Pressure (mmHg) Diastolic Blood Pressure (mmHg) Pulse Rate (BEATS/MIN) Weight (kg) Height (cm) Temperature (C) WHITE BLACK OR AFRICAN AMERICAN AMERICAN INDIAN OR ALASKA NATIVE ASIAN WHITE BLACK OR AFRICAN AMERICAN AMERICAN INDIAN OR ALASKA NATIVE ASIAN MILD MODERATE SEVERE Female   Male   Unknown   High to Normal Normal to Normal Normal to High High to Normal Normal to Normal Normal to High SCREENING 1 UNSCHEDULED 1.1 UNSCHEDULED 1.2 UNSCHEDULED 1.3 SCREENING 2 BASELINE UNSCHEDULED 3.1 AMBUL ECG PLACEMENT WEEK 2 UNSCHEDULED 4.1 UNSCHEDULED 4.2 WEEK 4 UNSCHEDULED 5.1 AMBUL ECG REMOVAL UNSCHEDULED 6.1 WEEK 6 UNSCHEDULED 7.1 WEEK 8 WEEK 10 (T) UNSCHEDULED 8.2 WEEK 12 WEEK 14 (T) UNSCHEDULED 9.2 UNSCHEDULED 9.3 WEEK 16 WEEK 18 (T) UNSCHEDULED 10.2 WEEK 20 WEEK 22 (T) UNSCHEDULED 11.2 WEEK 24 UNSCHEDULED 12.1 WEEK 26 UNSCHEDULED 13.1 AE FOLLOW-UP RETRIEVAL Rash followup SCREENING 1 UNSCHEDULED 1.1 UNSCHEDULED 1.2 UNSCHEDULED 1.3 SCREENING 2 BASELINE UNSCHEDULED 3.1 AMBUL ECG PLACEMENT WEEK 2 UNSCHEDULED 4.1 UNSCHEDULED 4.2 WEEK 4 UNSCHEDULED 5.1 AMBUL ECG REMOVAL UNSCHEDULED 6.1 WEEK 6 UNSCHEDULED 7.1 WEEK 8 WEEK 10 (T) UNSCHEDULED 8.2 WEEK 12 WEEK 14 (T) UNSCHEDULED 9.2 UNSCHEDULED 9.3 WEEK 16 WEEK 18 (T) UNSCHEDULED 10.2 WEEK 20 WEEK 22 (T) UNSCHEDULED 11.2 WEEK 24 UNSCHEDULED 12.1 WEEK 26 UNSCHEDULED 13.1 AE FOLLOW-UP RETRIEVAL Rash followup No Yes No Yes Yes   proc freq data = pilot.adsl; tables (ittfl saffl efffl comp24fl disconfl)*trt01pn / missing; run; [ ITTFL="Y" ] Reasons for discontinuation are summarized for subjects discontinuing before Week 24 (visit 12) (i.e. COMP24FL ne ="Y" and VISNUMEN less than 12) proc freq data=adsl; table COMP24FL*TRT01P/chisq fisher exact; run; proc freq data=adsl; where COMP24FL="N"; table DCREASCD* TRT01P/ chisq fisher exact; run; [ ITTFL="Y" ] ANOVA treatment group comparison [ ITTFL="Y" ] Pearson s chisquare test [ EFFFL="Y" and ANL01FL="Y" and AVISIT="Week 24" and PARAMCD="ATOT" ] Linear model analysis of CHG for dose response; using randomized dose (0 for placebo; 54 for low dose; 81 for high dose) and site group in model. Used PROC GLM in SAS to produce p-value (from Type III SS for treatment dose). proc glm data = ADQSADAS; where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="ATOT"; class sitegr1; model CHG = trtpn sitegr1; run; [ EFFFL="Y" and ANL01FL="Y" and AVISIT="Week 24" and PARAMCD="ATOT" ] ANCOVA analysis of CHG performed to provide pairwise comparisons among treatment groups and adjusted means; using randomized treatment as class variable and site group as class variable in model and the baseline value as a covariate. proc glm data = ADQSADAS; where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="ATOT"; class trtpn sitegr1; model CHG = trtpn sitegr1 base; means trtpn; lsmeans trtpn / OM STDERR PDIFF CL; run; [ EFFFL="Y" and ANL01FL="Y" and AVISIT="Week 24" and PARAMCD="CIBICVAL" ] Summary statistics of AVAL at Week 24. Linear model analysis of AVAL for dose response; using randomized dose (0 for placebo; 54 for low dose; 81 for high dose) and site group in model. Used PROC GLM in SAS to produce p-value (from Type III SS for treatment dose); proc glm data = ADQSCIBC; where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="CIBICVAL"; class sitegr1; model AVAL = trtpn sitegr1; run; [ EFFFL="Y" and ANL01FL="Y" and AVISIT="Week 24" and PARAMCD="CIBICVAL" ] ANCOVA analysis of AVAL performed to provide pairwise comparisons among treatment groups and adjusted means; using randomized treatment as class variable and site group as class variable in model and the baseline value as a covariate. proc glm data = ADQSCIBC; where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="CIBICVAL"; class trtpn sitegr1; model AVAL = trtpn sitegr1; means trtpn; lsmeans trtpn / OM STDERR PDIFF CL; run; [ EFFFL="Y" and PARAMCD="NPTOTMN" and AVISIT="Weeks 4-24" and ANL01FL="Y" ] PROC UNIVARIATE data= ADQSNPIX (where =(EFFFL = 'Y' and PARAMCD = 'NPTOTMN' and AVISIT='Weeks 4-24' and ANL01FL= 'Y')); Var BASE AVAL; By TRTPN; Run; [ EFFFL="Y" and PARAMCD="NPTOTMN" and AVISIT="Weeks 4-24" and ANL01FL="Y" ] PROC MIXED data= ADQSNPIX (where =(EFFFL = 'Y' and PARAMCD = 'NPTOTMN' and AVISIT = 'Weeks 4-24' and ANL01FL= 'Y')); class sitegr1 trtpn; model aval = trtpn sitegr1 base; lsmeans trtpn / diff pdiff cl; Run; [ TRTEMFL="Y" and AESER="Y" ] [ SAFFL="Y" ] Unique count of subjects that experienced an Adverse Event by Preferred Term, System Organ Class, and Treatment Group and percentages based on the number of subjects in the safety population within each treatment group. The total number of times an event occurred was recorded by Preferred Term, System Organ Class, and Treatment Group. Fisher’s exact test was used for treatment comparison. [ PARAMCD not contains "_" ] [ PARAMCD not contains "_" ] [ SAFFL="Y" ] [ ANL01FL="Y" and PARAMCD not contains "_" ] [ ANL01FL="Y" and PARAMCD not contains "_" ] [ SAFFL="Y" ] PROC FREQ (WHERE=(SAFFL="Y" and ANL01FL ="Y" and index(PARAMCD,"_")=0)); BY PARCAT1 PARAMCD; TABLES TRTPN*LBNRIND/ALL FISHER; run; [ ANL01FL="Y" and PARAMCD contains "_" ] [ ANL01FL="Y" and PARAMCD contains "_" ] [ SAFFL="Y" ] PROC FREQ(WHERE=(SAFFL="Y" and ANL01FL ="Y" and index(PARAMCD,"_"))); BY PARCAT1 PARAMCD; TABLES TRTPN*ANRIND/ALL FISHER; RUN; [ PARAMCD not contains "_" ] [ PARAMCD not contains "_" ] [ SAFFL="Y" ] PROC FREQ (WHERE=(SAFFL="Y" and index(PARAMCD,"_")=0)); TABLES PARCAT1*PARAMCD*AVISITN*TRTPN*BNRIND*ANRIND; RUN; [ ANL01FL="Y" and PARAMCD not contains "_" ] [ ANL01FL="Y" and PARAMCD not contains "_" ] [ SAFFL="Y" ] PROC FREQ(WHERE=(SAFFL="Y" and ANL01FL="Y" and index(PARAMCD,"_")=0)) t; BY PARCAT1 PARAMCD; TABLES BNRIND*TRTPN*ANRIND / cmh ; RUN; [ PARAMCD in("TRANSHY","HYLAW") ] [ SAFFL="Y" ] Take the maximum AVAL per patient when patients were on treatment (AVISITN in (2,4,6,8,12,16,20,24,26)) for the Hy's Law parameters then perform a frequency count by treatment with Fisher's Exact test. [ SAFFL="Y" ] Kaplan-Meier estimates and log-rank analysis of time to first dermatological adverse event, safety population proc lifetest data = adtte (where=(saffl="Y")) plots=s; id usubjid; strata trtan; time aval*cnsr(1); test trtan; run;