cparry_Deliverable INSERT TRIAL TITLE HERE cparry_Deliverable HR INTP PRSB QRSSB QTCFSB QTSB RRSM EXC01 EXC02 EXC03 EXC04 EXC05 EXC06 EXC07 EXC08 EXC09 EXC10 EXC11 EXC12 EXC13 EXC14 EXC15 EXC16 EXC17 EXC18 EXC19 EXC20 EXC21 EXC22 EXC23 EXC24 EXC25 EXC26 EXC27 EXC28 EXC29 EXC30 EXC31 EXC32 EXC33 EXC34 EXC35 EXC36 EXC37 INC01 INC02 INC03 INC04 INC05 INC06 INC07 INC08 INC09 INC10 INC11 INC12 INC13 INC14 INC15 ALP ALT AMPHET APTT AST BARB BASO BASOLE BILDIR BILI BLOOD BNZDZPN CA CANNAB CHCNT COCAINE CREAT CRP CSCELL CSGRAN CSHYAL DOA EOS EOSLE ETHANOL FSH GLUC HCG HCT HGB INR K KETONES LBALL LYM LYMLE MCH MCV MONO MONOLE NCVP NEUT NEUTLE NITRITE OPIATE PH PLAT PROT PT RBC RBCCE RETC RETI SAMPRES SODIUM SPGRAV UREA UREAN UROBIL WBC WBCCE PEABD PECARD PEEXTRM PEGEA PEGI PEHEENT PELUNG PELYMPH PENEURO PEORA PEOTHD PESKIN PETHYR BAS101 BAS102 DLQI101 DLQI102 DLQI103 DLQI104 DLQI105 DLQI106 DLQI107 DLQI107A DLQI108 DLQI109 DLQI110 DLQI111 EASI101 EASI102 EASI103 EASI104 EASI105 EASI106 EASI107 EASI108 EASI109 EASI110 EASI111 EASI112 EASI113 EASI114 EASI115 EASI116 EASI117 EASI118 EASI119 EASI120 EASI121 EASI122 EASI123 EASI124 EASI125 FENO101 FENO102 FENO103 FENO104 IGA101 LSS101 LSS102 LSS103 LSS104 LSS105 LSS106 PASI0201 PASI0202 PASI0203 PASI0204 PASI0205 PASI0206 PASI0207 PASI0208 PASI0209 PASI0210 PASI0211 PASI0212 PASI0213 PASI0214 PASI0215 PASI0216 PASI0217 PASI0218 PASI0219 PASI0220 PASI0221 PASI0222 PASI0223 PASI0224 PASI0225 PASI0226 PASI0227 PASI0228 PASI0229 PGA101 PGA102 PGA103 PGA104 PNRS101 PNRS102 POEM101 POEM102 POEM103 POEM104 POEM105 POEM106 POEM107 POEM108 POEM109 SCRAD101 SCRAD201 SCRAD202 SCRAD203 SCRAD204 SCRAD205 SCRAD206 SCRAD207 SCRAD301 SCRAD302 SCRAD303 SCRAD304 FEV1 FEV1FVC FEV1PP FVC FVCPP PEF ACTSUB ADAPT ADDON AGEMAX AGEMIN COMPTRT CURTRT DCUTDESC DCUTDTC DOSE DOSFRQ DOSU EXTTIND FCNTRY HLTSUBJI INDIC INTMODEL INTTYPE LENGTH NARMS NCOHORT OBJEXP OBJPRIM OBJSEC OUTMSEXP OUTMSPRI OUTMSSEC PCLAS PDPSTIND PDSTIND PIPIND PLANSUB RANDOM RANDQT RDIND REGID ROUTE SDTIGVER SDTMVER SENDTC SEXPOP SPONSOR SSTDTC STOPRULE STRATFCT STYPE TBLIND TCNTRL TDIGRP THERAREA TINDTP TITLE TPHASE TRT TTYPE NUMPHOTO BMI DIABP DIAINTP HEIGHT HR HRINTP OXYINTP OXYSAT RESP RESPINTP SYSBP SYSINTP TEMP TEMPINTP WEIGHT COLLECTD DISPNSED AESCRIT AEWITH PSUBJID CMAE CMAENUM CMATC1 CMATC1CD CMATC2 CMATC2CD CMATC3 CMATC3CD CMATC4 CMATC4CD CMMH CMMHNAM PSUBJID COHORT DMCHIB DMCHIBC DMSCREEN PSUBJID RACEOTH RANDNM SITE ALLDOSE LFUCOMP REQDEST SENTSUBJ DVACN DVACN1 DVCLASS DVCOVID DVEFFFL DVIMPFL DVSCATOS DVYN PSUBJID DOSCAPN REASND UNDOSRES EGCLSIG EGSUPTIM PSUBJID PSUBJID LBCLSIG LBCLSIGP LBDRAW MICROAN PSUBJID MHCMED MHDUR1 MHONGO MHREL ONSTDTC PSUBJID PECLSIG PEOTHSP PEPERF PSUBJID PSUBJID REASND EASIMLTI FENOREF1 FENOREF2 PASIMLTI PSUBJID QSFAST PSUBJID PSUBJID PSUBJID VSCLSIG VSSITTIM COMPLETE DIARYAE DIARYCM REASND WITHDRAWAL OF INFORMED CONSENT ADVERSE EVENT COMPLETED OTHER SCREEN FAILURE WITHDRAWAL BY SUBJECT INFORMED RE-CONSENT OBTAINED ELIGIBILITY CRITERIA MET INFORMED CONSENT OBTAINED RANDOMIZED Trial Arms TA.xpt Trial Elements TE.xpt Trial Inclusion/Exclusion Criteria TI.xpt Trial Summary TS.xpt Trial Visits TV.xpt Comments CO.xpt Demographics DM.xpt Subject Elements SE.xpt Subject Visits SV.xpt Concomitant Medications CM.xpt Exposure as Collected EC.xpt Exposure EX.xpt Procedures PR.xpt Adverse Events AE.xpt Disposition DS.xpt Protocol Deviations DV.xpt Medical History MH.xpt ECG Test Results EG.xpt Inclusion/Exclusion Criteria Not Met IE.xpt Laboratory Test Results LB.xpt Physical Examinations PE.xpt Questionnaire QS.xpt Respiratory System Findings RE.xpt Tumor/Lesion Identification TU.xpt Vital Signs VS.xpt Participant Diary XA.xpt Supplemental Qualifiers for AE SUPPAE.xpt Supplemental Qualifiers for CM SUPPCM.xpt Supplemental Qualifiers for DM SUPPDM.xpt Supplemental Qualifiers for DS SUPPDS.xpt Supplemental Qualifiers for DV SUPPDV.xpt Supplemental Qualifiers for EC SUPPEC.xpt Supplemental Qualifiers for EG SUPPEG.xpt Supplemental Qualifiers for IE SUPPIE.xpt Supplemental Qualifiers for LB SUPPLB.xpt Supplemental Qualifiers for MH SUPPMH.xpt Supplemental Qualifiers for PE SUPPPE.xpt Supplemental Qualifiers for PR SUPPPR.xpt Supplemental Qualifiers for QS SUPPQS.xpt Supplemental Qualifiers for RE SUPPRE.xpt Supplemental Qualifiers for TU SUPPTU.xpt Supplemental Qualifiers for VS SUPPVS.xpt Supplemental Qualifiers for XA SUPPXA.xpt Study Identifier Preferred Term Code High Level Term High Level Term Code High Level Group Term High Level Group Term Code Body System or Organ Class Body System or Organ Class Code Primary System Organ Class Primary System Organ Class Code Severity/Intensity Domain Abbreviation Serious Event Action Taken with Study Treatment Causality Outcome of Adverse Event Congenital Anomaly or Birth Defect Persist or Signif Disability/Incapacity Results in Death Requires or Prolongs Hospitalization Is Life Threatening Unique Subject Identifier Other Medically Important Serious Event Concomitant or Additional Trtmnt Given Epoch Start Date/Time of Adverse Event End Date/Time of Adverse Event Study Day of Start of Adverse Event Study Day of End of Adverse Event End Relative to Reference Period Sequence Number Sponsor-Defined Identifier Reported Term for the Adverse Event Lowest Level Term Lowest Level Term Code Dictionary-Derived Term Study Identifier Dose Description Dose Units Dosing Frequency per Interval Route of Administration Epoch Start Date/Time of Medication End Date/Time of Medication Study Day of Start of Medication Study Day of End of Medication End Relative to Reference Period Domain Abbreviation Unique Subject Identifier Sequence Number Reported Name of Drug, Med, or Therapy Standardized Medication Name Category for Medication Indication Dose per Administration Study Identifier Evaluator Date/Time of Comment Study Day of Comment Domain Abbreviation Related Domain Abbreviation Unique Subject Identifier Sequence Number Identifying Variable Identifying Variable Value Comment Reference Comment Study Identifier Date/Time of End of Participation Date/Time of Death Subject Death Flag Study Site Identifier Date/Time of Birth Age Age Units Sex Race Ethnicity Domain Abbreviation Planned Arm Code Description of Planned Arm Actual Arm Code Description of Actual Arm Country Unique Subject Identifier Subject Identifier for the Study Subject Reference Start Date/Time Subject Reference End Date/Time Date/Time of First Study Treatment Date/Time of Last Study Treatment Date/Time of Informed Consent Study Identifier Subcategory for Disposition Event Epoch Start Date/Time of Disposition Event Study Day of Start of Disposition Event Domain Abbreviation Unique Subject Identifier Sequence Number Reference ID Sponsor-Defined Identifier Reported Term for the Disposition Event Standardized Disposition Term Category for Disposition Event Study Identifier Epoch Start Date/Time of Deviation Study Day of Start of Deviation Event Domain Abbreviation Unique Subject Identifier Sequence Number Protocol Deviation Term Category for Protocol Deviation Subcategory for Protocol Deviation Visit Number Visit Name Study Identifier Dose Units Dose Form Dosing Frequency per Interval Route of Administration Visit Number Visit Name Epoch Start Date/Time of Treatment End Date/Time of Treatment Study Day of Start of Treatment Domain Abbreviation Study Day of End of Treatment Unique Subject Identifier Sequence Number Name of Treatment Category of Treatment Pre-Specified Occurrence Dose Study Identifier Numeric Result/Finding in Standard Units Standard Units Completion Status Reason ECG Not Performed Baseline Flag Visit Number Visit Name Epoch Date/Time of ECG Study Day of ECG Domain Abbreviation Planned Time Point Name Planned Time Point Number Unique Subject Identifier Sequence Number ECG Test or Examination Short Name ECG Test or Examination Name Result or Finding in Original Units Original Units Character Result/Finding in Std Format Study Identifier Dosing Frequency per Interval Route of Administration Visit Number Visit Name Epoch Start Date/Time of Treatment End Date/Time of Treatment Study Day of Start of Treatment Study Day of End of Treatment Domain Abbreviation Unique Subject Identifier Sequence Number Name of Treatment Category of Treatment Dose Dose Units Dose Form Study Identifier Visit Number Visit Name Planned Study Day of Visit Epoch Date/Time of Collection Study Day of Collection Domain Abbreviation Unique Subject Identifier Sequence Number Inclusion/Exclusion Criterion Short Name Inclusion/Exclusion Criterion Inclusion/Exclusion Category I/E Criterion Original Result I/E Criterion Result in Std Format Study Identifier Original Units Reference Range Lower Limit in Orig Unit Reference Range Upper Limit in Orig Unit Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Reference Range Lower Limit-Std Units Reference Range Upper Limit-Std Units Reference Range Indicator Completion Status Domain Abbreviation Reason Test Not Done Specimen Type Baseline Flag Fasting Status Visit Number Visit Name Epoch Date/Time of Specimen Collection Study Day of Specimen Collection Unique Subject Identifier Sequence Number Specimen ID Lab Test or Examination Short Name Lab Test or Examination Name Category for Lab Test Result or Finding in Original Units Study Identifier High Level Term High Level Term Code High Level Group Term High Level Group Term Code Category for Medical History Body System or Organ Class Body System or Organ Class Code Primary System Organ Class Primary System Organ Class Code Start Date/Time of Medical History Event Domain Abbreviation End Date/Time of Medical History Event Study Day of Start of Medical History Study Day of End of Medical History End Relative to Reference Period Unique Subject Identifier Sequence Number Reported Term for the Medical History Lowest Level Term Lowest Level Term Code Dictionary-Derived Term Preferred Term Code Study Identifier Reason Not Examined Visit Number Visit Name Epoch Date/Time of Examination Study Day of Examination Domain Abbreviation Unique Subject Identifier Sequence Number Body System Examined Short Name Body System Examined Verbatim Examination Finding Character Result/Finding in Std Format Completion Status Study Identifier Standardized Procedure Name Category Pre-specified Occurrence Indication Dose Dose Units Domain Abbreviation Dosing Frequency per Interval Route of Administration Visit Number Visit Name Unique Subject Identifier Epoch Start Date/Time of Procedure End Date/Time of Procedure Study Day of Start of Procedure Study Day of End of Procedure Sequence Number Reported Name of Procedure Study Identifier Subcategory for Question Finding in Original Units Original Units Character Result/Finding in Std Format Numeric Finding in Standard Units Standard Units Completion Status Reason Not Performed Location of the Tumor Laterality Domain Abbreviation Directionality Baseline Flag Visit Number Visit Name Epoch Unique Subject Identifier Date/Time of Finding Study Day of Finding Sequence Number Question Short Name Question Name Category of Question Study Identifier Short Name of Respiratory Test Name of Respiratory Test Result or Finding in Original Units Original Units Character Result/Finding in Std Format Domain Abbreviation Numeric Result/Finding in Standard Units Standard Units Completion Status Reason Not Done Method of Test or Examination Unique Subject Identifier Baseline Flag Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection/Exam Sequence Number Study Identifier End Date/Time of Element Study Day of Start of Element Study Day of End of Element Description of Unplanned Element Domain Abbreviation Unique Subject Identifier Sequence Number Element Code Description of Element Planned Order of Element within Arm Epoch Start Date/Time of Element Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Evaluator Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Study Identifier Study Day of Start of Visit Study Day of End of Visit Description of Unplanned Visit Domain Abbreviation Unique Subject Identifier Visit Number Visit Name Planned Study Day of Visit Epoch Start Date/Time of Visit End Date/Time of Visit Study Identifier Epoch Domain Abbreviation Planned Arm Code Description of Planned Arm Planned Order of Element within Arm Element Code Description of Element Branch Transition Rule Study Identifier Domain Abbreviation Element Code Description of Element Rule for Start of Element Rule for End of Element Study Identifier Domain Abbreviation Incl/Excl Criterion Short Name Inclusion/Exclusion Criterion Inclusion/Exclusion Category Protocol Criteria Versions Study Identifier Parameter Value Code Name of the Reference Terminology Version of the Reference Terminology Domain Abbreviation Sequence Number Group ID Trial Summary Parameter Short Name Trial Summary Parameter Parameter Value Parameter Value 1 Parameter Null Flavor Study Identifier Tumor Identification Short Name Tumor Identification Test Name Tumor Identification Result Tumor Identification Result Std. Format Completion Status Reason Not Done Location of the Tumor Laterality Directionality Domain Abbreviation Method of Identification Baseline Flag Evaluator Visit Number Visit Name Unique Subject Identifier Epoch Date/Time of Tumor Identification Study Day of Tumor Identification Sequence Number Link ID Study Identifier Domain Abbreviation Visit Number Visit Name Planned Study Day of Visit Planned Arm Code Description of Planned Arm Visit Start Rule Visit End Rule Study Identifier Original Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Completion Status Reason Not Performed Method of Test or Examination Baseline Flag Visit Number Visit Name Domain Abbreviation Epoch Date/Time of Measurements Study Day of Vital Signs Unique Subject Identifier Sequence Number Vital Signs Test Short Name Vital Signs Test Name Category for Vital Signs Vital Signs Position of Subject Result or Finding in Original Units Study Identifier Result or Finding in Original Units Character Result/Finding in Std Format Completion Status Reason Not Done Baseline Flag Domain Abbreviation Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection/Exam Unique Subject Identifier Sequence Number Short Name of Measurement, Test, or Exam Name of Measurement, Test, or Exam HR INTP PRSB QRSSB QTCFSB QTSB RRSM EXC01 EXC02 EXC03 EXC04 EXC05 EXC06 EXC07 EXC08 EXC09 EXC10 EXC11 EXC12 EXC13 EXC14 EXC15 EXC16 EXC17 EXC18 EXC19 EXC20 EXC21 EXC22 EXC23 EXC24 EXC25 EXC26 EXC27 EXC28 EXC29 EXC30 EXC31 EXC32 EXC33 EXC34 EXC35 EXC36 EXC37 INC01 INC02 INC03 INC04 INC05 INC06 INC07 INC08 INC09 INC10 INC11 INC12 INC13 INC14 INC15 ALP ALT AMPHET APTT AST BARB BASO BASOLE BILDIR BILI BLOOD BNZDZPN CA CANNAB CHCNT COCAINE CREAT CRP CSCELL CSGRAN CSHYAL DOA EOS EOSLE ETHANOL FSH GLUC HCG HCT HGB INR K KETONES LBALL LYM LYMLE MCH MCV MONO MONOLE NCVP NEUT NEUTLE NITRITE OPIATE PH PLAT PROT PT RBC RBCCE RETC RETI SAMPRES SODIUM SPGRAV UREA UREAN UROBIL WBC WBCCE PEABD PECARD PEEXTRM PEGEA PEGI PEHEENT PELUNG PELYMPH PENEURO PEORA PEOTHD PESKIN PETHYR BAS101 BAS102 DLQI101 DLQI102 DLQI103 DLQI104 DLQI105 DLQI106 DLQI107 DLQI107A DLQI108 DLQI109 DLQI110 DLQI111 EASI101 EASI102 EASI103 EASI104 EASI105 EASI106 EASI107 EASI108 EASI109 EASI110 EASI111 EASI112 EASI113 EASI114 EASI115 EASI116 EASI117 EASI118 EASI119 EASI120 EASI121 EASI122 EASI123 EASI124 EASI125 FENO101 FENO102 FENO103 FENO104 IGA101 LSS101 LSS102 LSS103 LSS104 LSS105 LSS106 PASI0201 PASI0202 PASI0203 PASI0204 PASI0205 PASI0206 PASI0207 PASI0208 PASI0209 PASI0210 PASI0211 PASI0212 PASI0213 PASI0214 PASI0215 PASI0216 PASI0217 PASI0218 PASI0219 PASI0220 PASI0221 PASI0222 PASI0223 PASI0224 PASI0225 PASI0226 PASI0227 PASI0228 PASI0229 PGA101 PGA102 PGA103 PGA104 PNRS101 PNRS102 POEM101 POEM102 POEM103 POEM104 POEM105 POEM106 POEM107 POEM108 POEM109 SCRAD101 SCRAD201 SCRAD202 SCRAD203 SCRAD204 SCRAD205 SCRAD206 SCRAD207 SCRAD301 SCRAD302 SCRAD303 SCRAD304 FEV1 FEV1FVC FEV1PP FVC FVCPP PEF ACTSUB ADAPT ADDON AGEMAX AGEMIN COMPTRT CURTRT DCUTDESC DCUTDTC DOSE DOSFRQ DOSU EXTTIND FCNTRY HLTSUBJI INDIC INTMODEL INTTYPE LENGTH NARMS NCOHORT OBJEXP OBJPRIM OBJSEC OUTMSEXP OUTMSPRI OUTMSSEC PCLAS PDPSTIND PDSTIND PIPIND PLANSUB RANDOM RANDQT RDIND REGID ROUTE SDTIGVER SDTMVER SENDTC SEXPOP SPONSOR SSTDTC STOPRULE STRATFCT STYPE TBLIND TCNTRL TDIGRP THERAREA TINDTP TITLE TPHASE TRT TTYPE NUMPHOTO BMI DIABP DIAINTP HEIGHT HR HRINTP OXYINTP OXYSAT RESP RESPINTP SYSBP SYSINTP TEMP TEMPINTP WEIGHT COLLECTD DISPNSED Previous Subject Identifier Serious AE Criteria/Details Subject Withdrawn? Medical History Term Medication Name Parent Term 4 ID Medication Name Parent Term 2 ID Medication Name Parent Term 3 Medication Name Parent Term 4 Medication Name Parent Term 2 Given for a Medical History? Medication Name Parent Term 1 Previous Subject Identifier Given for an Adverse Event? Adverse Event Number Medication Name Parent Term 1 ID Medication Name Parent Term 3 ID Race Other Previous Subject ID Reasons of Non-Childbearing Potential Randomisation Number Cohort Is Participant of Childbearing Potential Previously Screened in the Current Study Site Subject Requested Destruction of Samples Subject Completed the Treatment Period? Complete Measures Is the Subject a Sentinel Subject? Important Deviation Flag Impact on Efficacy Deviation Flag Is the Deviation Major or Minor? Other specify Previous Subject Identifier Action Taken Action Taken 1 Covid Related Deviation Any Protocol Deviations Recorded? Reason for Unscheduled Dose Number of Capsules Taken Not as Expected Reason No Study Drug Was Taken Previous Subject Identifier Clinically Significant Supine Time Previous Subject Identifier Correct Volume Drawn and Adequate Previous Subject Identifier Clinically Significant Clinically Significant Parameter Sample Provided for Microscopic Analysis Previous Subject Identifier Date of Disease Onset Ongoing? Concomitant Medication Given? Duration (days) Any Relevant Medical History to Record? Any Changes Since Last Full PE? Clinically Significant Other Assessment, Specifiy Previous Subject Identifier Previous Subject Identifier Reason Not Done Fasting Status Previous Subject Identifier Refrain From Taking SABA Score Multiplier (EASI) Refrain From Eating Nitrate-Rich Foods Score Multiplier (PASI) Previous Subject Identifier Previous Subject Identifier Sitting Time Previous Subject Identifier Clinically Significant Concomitant Medications Recorded? Diary is Complete and Accurate? Any Adverse Event Recorded? Reason Not Complete/Accurate? Completion/Reason for Non-Completion Completion/Reason for Non-Completion Completion/Reason for Non-Completion Completion/Reason for Non-Completion Completion/Reason for Non-Completion Completion/Reason for Non-Completion Protocol Milestone Protocol Milestone Protocol Milestone Protocol Milestone HR INTP PRSB QRSSB QTSB QTCFSB RRSM Heart Rate Interpretation PR Interval, Single Beat QRS Duration, Single Beat QTcF Interval, Single Beat QT Interval, Single Beat RR Interval, Single Measurement INC02 INC10 EXC14 INC06 INC01 INC04 EXC23 EXC25 EXC21 EXC26 INC15 INC14 EXC01 EXC06 EXC34 EXC09 EXC11 EXC28 EXC36 EXC31 EXC24 INC03 INC12 INC13 EXC15 EXC10 EXC07 EXC05 INC09 INC08 INC11 EXC03 EXC02 EXC08 EXC22 EXC29 EXC04 EXC13 EXC12 INC07 EXC27 EXC30 EXC32 EXC33 EXC35 EXC17 INC05 EXC19 EXC20 EXC16 EXC18 EXC37 Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding, or sexually active with child-bearing potential who is not using a effective birth control method. Participant has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study (non-live vaccines are permitted). Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration. Participant requires treatment with an anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic. Participant has an active infection or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration. Has renal or liver impairment: CREAT level >= 1.0x ULN, or ALT, AST, ALP, and/or BILI >= 1.0 x upper limit of normal, or CREAT level >= 1.25x ULN, or ALT or AST > 2 x ULN and/or BILI > Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening. Participant has undergone major surgery within the 4 weeks prior to Screening. Known cardiac abnormality, cardiac impairment , or cardiac diseases, including: history of angina or acute myocardial infarction, arrhythmia, hypertension or use of antihypertensive treatment. Participant has a known history of human immunodeficiency virus (HIV); HIV testing is required as part of this study. Known, active hepatitis A, hepatitis B (HBV), or hepatitis C (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or hepatitis B surface antigen (HBsAg). Participant with previous or active central nervous system (CNS) malignancy. Participant with any type of GI tract disease, including that which could interfere with the GI delivery and transit time of EDP1867. Any psychiatric or medical conditions that could interfere with treatment, compliance, or the ability to give consent. Participants with a history of serious psychiatric condition will be excluded. Participant has a history of hypersensitivity or allergies to Viellonella, or has a history of hypersensitivity or allergies to placebo capsule or to the hard capsule shells. The participant has taken any over-the-counter or prescription medication including vitamins, herbal supplements and nutraceuticals but with the exception of paracetamol and anti-histamines. The participant has a history of drug abuse or regular use of illicit drugs or a history of alcohol abuse within 1 year prior to screening or has tested positive for drugs of abuse / alcohol. The participant intends to donate sperm during the course of this study and for a period of 90 days after the last dose. The participant has donated more than 400 mL of blood or blood products within 90 days prior to baseline (Day -1) or plans to donate blood during the study. The participant has had an acute, clinically significant illness within 30 days prior to the first dose of study intervention. Evidence of skin conditions that would interfere with atopic dermatitis evaluation. Participant is receiving systemic immunosuppressive or non-biologic atopic dermatitis therapy or phototherapy; or has received such therapy within 4 weeks prior to Screening. Dermatitis: Participant has received treatment with biologic agents within 12 months prior to first dose. Participant continues to use topical medications, other than emollients, that could affect atopic dermatitis 2 weeks prior to the start of dosing. Dermatitis: Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle for the duration of the study. Evidence of skin conditions that would interfere with psoriasis evaluation. Psoriasis restricted to scalp, palm, and/or soles only. Non-plaque type of psoriasis. Participant is receiving systemic immunosuppressive or nonbiologic psoriasis therapy or phototherapy; or has received such therapy within 4 weeks prior to Screening. Psoriasis: Participant has received treatment with biologic agents within 12 months prior to first dose. Participant continues to use topical medications that could affect psoriasis within 2 weeks prior to the start of dosing. Psoriasis: Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle for the duration of the study. Significant risk of exposure to a change in sensitizing environmental substances during the study. History of life-threatening asthma, or a visit to the emergency department for asthma in the 6 months prior to screening, or exacerbation requiring oral corticosteroids within the previous 3 months. Smoker or nicotine user within the 3 months prior to screening; or a previous smoker with a greater than 10 pack year history. Other significant non-reversible pulmonary disease (e.g. Cystic Fibrosis, Pulmonary Fibrosis, or COPD). Use of the following medicines within the specified time-frame prior to screening as defined in the protocol. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Age >= 18 years to 65 years, inclusive. Participant has a body mass index of >= 18 kg/m2 to <= 35 kg/m2 at Screening. Contraception: A male participant must use contraception and a female participant is not pregnant or breastfeeding, and either is not of child-bearing potential or agrees to follow the rules. The participant has clinical laboratory evaluations within the reference range for the testing laboratory, unless results are deemed not to be clinically significant by the investigator or Sponsor. CRP <= 10 mg/L Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG monitoring at Screening and at Baseline. Participant has moderate atopic dermatitis with a minimum of 5% and a maximum of 40% BSA involvement, and an IGA score of 2 or 3. Participant has had a confirmed diagnosis of atopic dermatitis for at least 6 months. All participants must be using an emollient and should continue to use this once daily for at least 14 days prior to randomisation, and must continue this treatment once daily throughout the study Participant has moderate plaque psoriasis with plaque covering BSA of >=3% and <=10% and meets both of the following additional criteria: PASI score of >=6 and <=15 and PGA score of 2 or 3 Participant has a confirmed diagnosis of plaque psoriasis for at least 6 months. Participant has a diagnosis of stable asthma for at least six months prior to the start of the study. FeNO of >=40ppb. FEV1 >=70% of predicted normal. APTT ALT ALP LBALL AMPHET AST BARB BASO BASOLE BNZDZPN BILI BLOOD CRP CA CANNAB CSCELL HCG COCAINE CHCNT CREAT BILDIR DOA EOS EOSLE MCH MCV RBC RBCCE ETHANOL FSH GLUC CSGRAN HCT HGB CSHYAL KETONES WBC WBCCE LYM LYMLE MONO MONOLE NEUT NEUTLE NITRITE OPIATE PLAT K PROT INR PT RETI RETC NCVP SODIUM SPGRAV UREA UREAN SAMPRES UROBIL PH Alkaline Phosphatase Alanine Aminotransferase Amphetamine Activated Partial Thromboplastin Time Aspartate Aminotransferase Barbiturates Basophils Basophils/Leukocytes Direct Bilirubin Bilirubin Blood Benzodiazepine Calcium Cannabinoids Corpuscular Hemoglobin Content Cocaine Creatinine C Reactive Protein Cellular Casts Granular Casts Hyaline Casts Drugs of Abuse Eosinophils Eosinophils/Leukocytes Ethanol Follicle Stimulating Hormone Glucose Choriogonadotropin Beta Hematocrit Hemoglobin Prothrombin Intl. Normalized Ratio Potassium Ketones All Labs Data Lymphocytes Lymphocytes/Leukocytes Ery. Mean Corpuscular Hemoglobin Ery. Mean Corpuscular Volume Monocytes Monocytes/Leukocytes SARS COV-2 RNA Neutrophils Neutrophils/Leukocytes Nitrite Opiate pH Platelets Protein Prothrombin Time Erythrocytes Erythrocytes/Total Cells Reticulocytes Percentage Reticulocytes Urine Sample Overall Result Sodium Specific Gravity Urea Urea Nitrogen Urobilinogen Leukocytes Leukocytes/Total Cells PEABD PECARD PEEXTRM PEGI PEGEA PEHEENT PELUNG PELYMPH PENEURO PEORA PEOTHD PESKIN PETHYR Abdomen (liver and spleen) Cardiovascular System Extremities General Appearance Gastro-Intestinal Head, eyes, ears, nose, throat Lungs Lymph Nodes Neurological System Oral Cavity Other Skin Thyroid BAS101 BAS102 DLQI105 DLQI109 DLQI102 DLQI101 DLQI110 DLQI104 DLQI103 DLQI106 DLQI107 DLQI108 DLQI107A DLQI111 EASI105 EASI102 EASI101 EASI103 EASI104 EASI106 EASI123 EASI120 EASI119 EASI121 EASI122 EASI124 EASI125 EASI117 EASI114 EASI113 EASI115 EASI116 EASI118 EASI111 EASI108 EASI107 EASI109 EASI110 EASI112 FENO101 FENO102 FENO103 FENO104 IGA101 LSS104 LSS106 LSS102 LSS103 LSS105 LSS101 PASI0204 PASI0203 PASI0201 PASI0218 PASI0219 PASI0217 PASI0202 PASI0216 PASI0215 PASI0213 PASI0227 PASI0228 PASI0226 PASI0214 PASI0229 PASI0212 PASI0211 PASI0209 PASI0224 PASI0225 PASI0223 PASI0210 PASI0208 PASI0207 PASI0205 PASI0221 PASI0222 PASI0220 PASI0206 PGA103 PGA101 PGA102 PGA104 PNRS101 PNRS102 POEM103 POEM105 POEM106 POEM101 POEM104 POEM107 POEM102 POEM109 POEM108 SCRAD101 SCRAD206 SCRAD201 SCRAD204 SCRAD205 SCRAD203 SCRAD202 SCRAD207 SCRAD302 SCRAD301 SCRAD304 SCRAD303 BSA01-Number of Handprints BSA01-Percentage Affected DLQI1-How Itchy, Sore, Painful, Stinging DLQI1-How Embarrassed, Self Conscious DLQI1-Interfered Shopping, Home, Yard DLQI1-Influenced Clothes You Wear DLQI1-Affected Social, Leisure Activity DLQI1-Made It Difficult to Do Any Sports DLQI1-Prevented Working or Studying DLQI1-Problem at Work or Studying DLQI1-Problem Partner, Friends, Relative DLQI1-Caused Any Sexual Difficulties DLQI1-How Much a Problem is Treatment DLQI1-Score EASI01-Head: Erythema EASI01-Head: Edema/Papulation EASI01-Head: Excoriation EASI01-Head: Lichenification EASI01-Head: Area Score EASI01-Head: Score per Body Region EASI01-Up Extrem: Erythema EASI01-Up Extrem: Edema/Papulation EASI01-Up Extrem: Excoriation EASI01-Up Extrem: Lichenification EASI01-Up Extrem: Area Score EASI01-Up Extrem: Score per Body Region EASI01-Trunk: Erythema EASI01-Trunk: Edema/Papulation EASI01-Trunk: Excoriation EASI01-Trunk: Lichenification EASI01-Trunk: Area Score EASI01-Trunk: Score per Body Region EASI01-Low Extrem: Erythema EASI01-Low Extrem: Edema/Papulation EASI01-Low Extrem: Excoriation EASI01-Low Extrem: Lichenification EASI01-Low Extrem: Area Score EASI01-Low Extrem: Score per Body Region EASI01-Total Score FENO01-Amount of Nitric Oxide 1 FENO01-Amount of Nitric Oxide 2 FENO01-Amount of Nitric Oxide 3 FENO01-Average Amount of Nitric Oxide IGA01-Atopic Dermatitis LSS01-Total Lesion Surface Area LSS01-Lesion Thickness LSS01-Redness (Erythema) LSS01-Induration (Thickness) LSS01-Scaling LSS01-LSS Score PASI02-Head: Erythema/Redness PASI02-Head: Thickness/Induration PASI02-Head: Desquamation/Scaling PASI02-Head: Area Score PASI02-Up Extrem: Erythema/Redness PASI02-Up Extrem: Thickness/Induration PASI02-Up Extrem: Desquamation/Scaling PASI02-Up Extrem: Area Score PASI02-Trunk: Erythema/Redness PASI02-Trunk: Thickness/Induration PASI02-Trunk: Desquamation/Scaling PASI02-Trunk: Area Score PASI02-Low Extrem: Erythema/Redness PASI02-Low Extrem: Thickness/Induration PASI02-Low Extrem: Desquamation/Scaling PASI02-Low Extrem: Area Score PASI02-Head: Sum of Symptom Scores PASI02-Head: Sum X Area PASI02-Head: Sum X Area X 0.1 PASI02-Up Extrem: Sum of Symptom Scores PASI02-Up Extrem: Sum X Area PASI02-Up Extrem: Sum X Area X 0.2 PASI02-Trunk: Sum of Symptom Scores PASI02-Trunk: Sum X Area PASI02-Trunk: Sum X Area X 0.3 PASI02-Low Extrem: Sum of Symptom Scores PASI02-Low Extrem: Sum X Area PASI02-Low Extrem: Sum X Area X 0.4 PASI02-Total Sum PGA01-Total Body Erythema PGA01-Total Body Induration PGA01-Total Body Desquamation PGA01-Total PGA Score PNRS01-How Was Itch, in Past 24 Hours? PNRS01-How Was Worst Itch Past 24 Hours? POEM01-Days Skin Has Been Itchy? POEM01-Nights Sleep Has Been Disturbed? POEM01-Days Skin Has Been Bleeding? POEM01-Days Skin Has Been Oozing Fluid? POEM01-Days Skin Has Been Cracked? POEM01-Days Skin Has Been Flaking Off? POEM01-Days Skin Has Felt Dry or Rough? POEM01-Total Score POEM01-Score Banding SCORAD01-Percentage of BSA Involved SCORAD02-Erythema (Redness) SCORAD02-Papulation / Oedema (Swelling) SCORAD02-Oozing / Crusting SCORAD02-Excoriation (Scratched) SCORAD02-Lichenification (leathery) SCORAD02-Dryness (ichthyosis) SCORAD02-Total Score (B) SCORAD03-Sleep Loss SCORAD03-Itch SCORAD03-Total Score (C) SCORAD03-Total SCORAD Score FEV1FVC FEV1 FVC PEF FEV1PP FVCPP Forced Expiratory Volume in 1 Second FEV1/FVC Percent Predicted FEV1 Forced Vital Capacity Percent Predicted Forced Vital Capacity Peak Expiratory Flow INC02 INC10 EXC14 INC06 INC01 INC04 EXC23 EXC25 EXC21 EXC26 INC15 INC14 EXC01 EXC06 EXC34 EXC09 EXC11 EXC28 EXC36 EXC31 EXC24 INC03 INC12 INC13 EXC15 EXC10 EXC07 EXC05 INC09 INC08 INC11 EXC03 EXC02 EXC08 EXC22 EXC29 EXC04 EXC13 EXC12 INC07 EXC27 EXC30 EXC32 EXC33 EXC35 EXC17 INC05 EXC19 EXC20 EXC16 EXC18 EXC37 Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding, or sexually active with child-bearing potential who is not using a effective birth control method. Participant has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study (non-live vaccines are permitted). Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration. Participant requires treatment with an anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic. Participant has an active infection or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration. Has renal or liver impairment: CREAT level >= 1.0x ULN, or ALT, AST, ALP, and/or BILI >= 1.0 x upper limit of normal, or CREAT level >= 1.25x ULN, or ALT or AST > 2 x ULN and/or BILI > Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening. Participant has undergone major surgery within the 4 weeks prior to Screening. Known cardiac abnormality, cardiac impairment , or cardiac diseases, including: history of angina or acute myocardial infarction, arrhythmia, hypertension or use of antihypertensive treatment. Participant has a known history of human immunodeficiency virus (HIV); HIV testing is required as part of this study. Known, active hepatitis A, hepatitis B (HBV), or hepatitis C (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or hepatitis B surface antigen (HBsAg). Participant with previous or active central nervous system (CNS) malignancy. Participant with any type of GI tract disease, including that which could interfere with the GI delivery and transit time of EDP1867. Any psychiatric or medical conditions that could interfere with treatment, compliance, or the ability to give consent. Participants with a history of serious psychiatric condition will be excluded. Participant has a history of hypersensitivity or allergies to Viellonella, or has a history of hypersensitivity or allergies to placebo capsule or to the hard capsule shells. The participant has taken any over-the-counter or prescription medication including vitamins, herbal supplements and nutraceuticals but with the exception of paracetamol and anti-histamines. The participant has a history of drug abuse or regular use of illicit drugs or a history of alcohol abuse within 1 year prior to screening or has tested positive for drugs of abuse / alcohol. The participant intends to donate sperm during the course of this study and for a period of 90 days after the last dose. The participant has donated more than 400 mL of blood or blood products within 90 days prior to baseline (Day -1) or plans to donate blood during the study. The participant has had an acute, clinically significant illness within 30 days prior to the first dose of study intervention. Evidence of skin conditions that would interfere with atopic dermatitis evaluation. Participant is receiving systemic immunosuppressive or non-biologic atopic dermatitis therapy or phototherapy; or has received such therapy within 4 weeks prior to Screening. Dermatitis: Participant has received treatment with biologic agents within 12 months prior to first dose. Participant continues to use topical medications, other than emollients, that could affect atopic dermatitis 2 weeks prior to the start of dosing. Dermatitis: Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle for the duration of the study. Evidence of skin conditions that would interfere with psoriasis evaluation. Psoriasis restricted to scalp, palm, and/or soles only. Non-plaque type of psoriasis. Participant is receiving systemic immunosuppressive or nonbiologic psoriasis therapy or phototherapy; or has received such therapy within 4 weeks prior to Screening. Psoriasis: Participant has received treatment with biologic agents within 12 months prior to first dose. Participant continues to use topical medications that could affect psoriasis within 2 weeks prior to the start of dosing. Psoriasis: Participant intends to continue to use sunbeds and/or increase their sun exposure significantly from their normal lifestyle for the duration of the study. Significant risk of exposure to a change in sensitizing environmental substances during the study. History of life-threatening asthma, or a visit to the emergency department for asthma in the 6 months prior to screening, or exacerbation requiring oral corticosteroids within the previous 3 months. Smoker or nicotine user within the 3 months prior to screening; or a previous smoker with a greater than 10 pack year history. Other significant non-reversible pulmonary disease (e.g. Cystic Fibrosis, Pulmonary Fibrosis, or COPD). Use of the following medicines within the specified time-frame prior to screening as defined in the protocol. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Age >= 18 years to 65 years, inclusive. Participant has a body mass index of >= 18 kg/m2 to <= 35 kg/m2 at Screening. Contraception: A male participant must use contraception and a female participant is not pregnant or breastfeeding, and either is not of child-bearing potential or agrees to follow the rules. The participant has clinical laboratory evaluations within the reference range for the testing laboratory, unless results are deemed not to be clinically significant by the investigator or Sponsor. CRP <= 10 mg/L Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG monitoring at Screening and at Baseline. Participant has moderate atopic dermatitis with a minimum of 5% and a maximum of 40% BSA involvement, and an IGA score of 2 or 3. Participant has had a confirmed diagnosis of atopic dermatitis for at least 6 months. All participants must be using an emollient and should continue to use this once daily for at least 14 days prior to randomisation, and must continue this treatment once daily throughout the study Participant has moderate plaque psoriasis with plaque covering BSA of >=3% and <=10% and meets both of the following additional criteria: PASI score of >=6 and <=15 and PGA score of 2 or 3 Participant has a confirmed diagnosis of plaque psoriasis for at least 6 months. Participant has a diagnosis of stable asthma for at least six months prior to the start of the study. FeNO of >=40ppb. FEV1 >=70% of predicted normal. ACTSUB ADAPT ADDON SPONSOR COMPTRT TCNTRL CURTRT DCUTDTC DCUTDESC TDIGRP DOSU DOSE DOSFRQ OUTMSEXP EXTTIND HLTSUBJI INTMODEL INTTYPE TRT NCOHORT PIPIND PDPSTIND PDSTIND PCLAS FCNTRY AGEMAX AGEMIN NARMS PLANSUB OUTMSPRI RANDQT RDIND REGID ROUTE SDTIGVER SDTMVER OUTMSSEC SEXPOP STRATFCT SENDTC SSTDTC STOPRULE STYPE THERAREA TBLIND INDIC OBJEXP TINDTP LENGTH TPHASE OBJPRIM OBJSEC TITLE TTYPE RANDOM Actual Number of Subjects Adaptive Design Added on to Existing Treatments Planned Maximum Age of Subjects Planned Minimum Age of Subjects Comparative Treatment Name Current Therapy or Treatment Data Cutoff Description Data Cutoff Date Dose per Administration Dosing Frequency Dose Units Extension Trial Indicator Planned Country of Investigational Sites Healthy Subject Indicator Trial Disease/Condition Indication Intervention Model Intervention Type Trial Length Planned Number of Arms Number of Groups/Cohorts Trial Exploratory Objective Trial Primary Objective Trial Secondary Objective Exploratory Outcome Measure Primary Outcome Measure Secondary Outcome Measure Pharmacologic Class Pediatric Postmarket Study Indicator Pediatric Study Indicator Pediatric Investigation Plan Indicator Planned Number of Subjects Trial is Randomized Randomization Quotient Rare Disease Indicator Registry Identifier Route of Administration SDTM IG Version SDTM Version Study End Date Sex of Participants Clinical Study Sponsor Study Start Date Study Stop Rules Stratification Factor Study Type Trial Blinding Schema Control Type Diagnosis Group Therapeutic Area Trial Intent Type Trial Title Trial Phase Classification Investigational Therapy or Treatment Trial Type NUMPHOTO Number of Lesions Photographed BMI DIABP HR HEIGHT DIAINTP HRINTP OXYINTP RESPINTP SYSINTP TEMPINTP OXYSAT RESP SYSBP TEMP WEIGHT Body Mass Index Diastolic Blood Pressure Interpretation (Diastolic BP) Height Heart Rate Interpretation (Heart Rate) Interpretation (Oxygen Saturation) Oxygen Saturation Respiratory Rate Interpretation (Respiratory Rate) Systolic Blood Pressure Interpretation (Systolic BP) Temperature Interpretation (Temperature) Weight COLLECTD DISPNSED Diary Collected Diary Dispensed Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Set to the number of days between the end of the event or intervention and the reference start period (SDTM.DM). For events or interventions which end after the start of the reference period add 1 day. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Set to the number of days between the end of the event or intervention and the reference start period (SDTM.DM). For events or interventions which end after the start of the reference period add 1 day. Set to either BEFORE, AFTER, DURING, ONGOING or UNKNOWN by comparing the event or intervention end date with the reference period (DM.RFSTDTC / DM.RFENDTC). Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to "SCRNFAIL" for screen failures. Set to "NOTASSGN" if subject was screened but not randomized. Otherwise set to the Arm randomized too, see SDTM.TA dataset. Set to "NOTASSGN" for subjects with ARMCD = "NOTASSGN". Set to "NOTTRT" when subject was randomized but has not received at least one dose. Otherwise if randomized and dosed set to SDTM.DM.ARMCD. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Set to the number of days between the end of the event or intervention and the reference start period (SDTM.DM). For events or interventions which end after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to Y for the latest record prior to dosing per subject and test. Not populated if subject was not yet dosed and or was a screen failure. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the date of the event or intervention and the reference start period (SDTM.DM). For assessments which start after the start of the reference period add 1 day. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Set to the number of days between the end of the event or intervention and the reference start period (SDTM.DM). For events or interventions which end after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to the number of days between the date of the event or intervention and the reference start period (SDTM.DM). For assessments which start after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to Y for the latest record prior to dosing per subject and test. Not populated if subject was not yet dosed and or was a screen failure. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the date of the event or intervention and the reference start period (SDTM.DM). For assessments which start after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Set to the number of days between the end of the event or intervention and the reference start period (SDTM.DM). For events or interventions which end after the start of the reference period add 1 day. Set to either BEFORE, AFTER, DURING, ONGOING or UNKNOWN by comparing the event or intervention start date with the reference period (DM.RFSTDTC / DM.RFENDTC). MHDUR1 will be derived using MH.MHSTDTC and MH.MHENDTC. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the date of the event or intervention and the reference start period (SDTM.DM). For assessments which start after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Set to the number of days between the end of the event or intervention and the reference start period (SDTM.DM). For events or interventions which end after the start of the reference period add 1 day. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to Y for the latest record prior to dosing per subject and test. Not populated if subject was not yet dosed and or was a screen failure. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Set to the number of days between the date of the assessment and the reference start period (SDTM.DM). For assessments after the start of the reference period add 1 day. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Set to Y for the latest record prior to dosing per subject and test. Not populated if subject was not yet dosed and or was a screen failure. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the date of the assessment and the reference start period (SDTM.DM). For assessments after the start of the reference period add 1 day. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to the proceeding records start date. For the last element set to SDTM.DM.RFPENDTC. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Set to the number of days between the end of the event or intervention and the reference start period (SDTM.DM). For events or interventions which end after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the informed consent date for the Screening element. Then set to the first date of dosing for the Treatment element (first treatment element for cohorts 1 &2). For cohorts 1 & 2 only, set to the earliest occurane of period 2 data for the second treatment element. Set to the first visit reported after the treatment visit for the follow-up element. Set to the number of days between the start of the event or intervention and the reference start period (SDTM.DM). For events or interventions which start after the start of the reference period add 1 day. Set to the number of days between the end of the event or intervention and the reference start period (SDTM.DM). For events or interventions which end after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to Y for the latest record prior to dosing per subject and test. Not populated if subject was not yet dosed and or was a screen failure. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the date of the assessment and the reference start period (SDTM.DM). For assessments after the start of the reference period add 1 day. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to Y for the latest record prior to dosing per subject and test. Not populated if subject was not yet dosed and or was a screen failure. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the date of the event or intervention and the reference start period (SDTM.DM). For assessments which start after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to Y for the latest record prior to dosing per subject and test. Not populated if subject was not yet dosed and or was a screen failure. Derive based on SDTM.SE. Using the assessment date, event start date or interventions start date and the subject elements start and end dates to determine where the assessment, event or intervention falls in the element sequence. Set to the number of days between the date of the event or intervention and the reference start period (SDTM.DM). For assessments which start after the start of the reference period add 1 day. Concatinate the study number, site number and subject number separated by a single hyphen. For subjects enrolled multiple times, and were reported as a screen failure with another subject number, the latest subject number will be used. Starting at 1 for each subject, sort the dataset by the key variables and increment the sequence number by +1. Set to parent domain CO.STUDYID Set to null Set to null Set to null Set to parent domain CO.DOMAIN Set to parent domain CO.USUBJID Set to null Using SDTM.SV to decode VISIT. Annotated Case Report Form Reviewers Guide