cdiscpilot01#
type: Ontology
imports: core
imports: cd01p
imports: code#
imports: sdtm
imports: study
version info: Created with TopBraid Composer

APPLICATION SITE ERYTHEMA
type: AdverseEvent
has code: m10003058
outcome: AEOutcome NRNR
action taken: none
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Probable
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
group ID: GRP1
has category: CAT1
has data collection date: 2014-01-16
has interval: Interval 2014-01-03 to
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse Y
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: ERYTHEMA
overdose: NoYesResponse N
reference ID: REFID1
relationship to non study drug: NONE
reported term: APPLICATION SITE ERYTHEMA
seq: 1
serious: NoYesResponse N
severity: Severity MILD
sponsordefined ID: E07
start day: 2
tox grade: 1

APPLICATION SITE PRURITUS
type: AdverseEvent
has code: m10003047
outcome: AEOutcome NRNR
action taken: none
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Probable
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
group ID: GRP1
has category: CAT1
has data collection date: 2014-01-16
has interval: Interval 2014-01-03 to
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse Y
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: PRURITIS
overdose: NoYesResponse N
reference ID: REFID2
relationship to non study drug: NONE
reported term: APPLICATION SITE PRURITUS
seq: 2
serious: NoYesResponse N
severity: Severity MILD
sponsordefined ID: E08
start day: 2
tox grade: 1

AE03 Diarrhoea
type: AdverseEvent
has code: m10012727
outcome: AEOutcome RR
action taken: none
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Remote
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
end day: 10
group ID: GRP1
has category: CAT1
has data collection date: 2014-01-16
has interval: Interval 2014-01-09 to 2014_01_11
has reference time point end date: 2014-01-13
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse N
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: DIARRHEA
overdose: NoYesResponse N
reference ID: REFID3
relationship to non study drug: NONE
reported term: DIARRHOEA
seq: 3
serious: NoYesResponse N
severity: Severity MILD
sponsordefined ID: E06
start day: 8
tox grade: 1

AE04AVBlock2nd deg
type: AdverseEvent
has code: m10003851
outcome: AEOutcome NRNR
action taken: none
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Possible
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
group ID: GRP2
has category: CAT1
has data collection date: 2012-08-27
has interval: Interval 2012-08-26 to
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse N
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: AV BLOCK
overdose: NoYesResponse N
reference ID: REFID4
relationship to non study drug: NONE
reported term: ATRIOVENTRICULAR BLOCK SECOND DEGREE
seq: 3
serious: NoYesResponse N
severity: Severity MILD
sponsordefined ID: E10
start day: 22
tox grade: 1

AE05 Erythema
type: AdverseEvent
has code: m10015150
outcome: AEOutcome NRNR
action taken: none
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Possible
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
end day: 26
group ID: GRP2
has category: CAT1
has data collection date: 2012-08-27
has interval: Interval 2012-08-07 to
has reference time point end date: 2012-08-06
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse N
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: ERYTHEMA
overdose: NoYesResponse N
reference ID: REFID5
relationship to non study drug: NONE
reported term: ERYTHEMA
seq: 1
serious: NoYesResponse N
severity: Severity MILD
sponsordefined ID: E08
start day: 3
tox grade: 2

AE06 Erythema
type: AdverseEvent
has code: m10024781
outcome: AEOutcome NRNR
action taken: dose reduction
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Probable
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
group ID: GRP2
has category: CAT1
has data collection date: 2012-08-27
has interval: Interval 2012-08-07 to
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse N
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: ERYTHEMA
overdose: NoYesResponse N
reference ID: REFID6
relationship to non study drug: NONE
reported term: ERYTHEMA
seq: 2
serious: NoYesResponse N
severity: Severity MODERATE
sponsordefined ID: E09
start day: 3
tox grade: 1

AE07 Erythema
type: AdverseEvent
has code: m10015150
outcome: AEOutcome RR
action taken: none
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Possible
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
group ID: GRP2
has category: CAT1
has data collection date: 2012-09-02
has interval: Interval 2012-08-07 to
has reference time point end date: 2012-08-14
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse N
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: ERYTHEMA
overdose: NoYesResponse N
reference ID: REFID7
relationship to non study drug: NONE
reported term: ERYTHEMA
seq: 4
serious: NoYesResponse N
severity: Severity MILD
sponsordefined ID: E08
start day: 3
tox grade: 1

AE08 App site erythema
type: AdverseEvent
has code: m10003041
outcome: AEOutcome NRNR
action taken: none
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Possible
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
end day: 26
group ID: GRP3
has category: CAT1
has data collection date: 2013-08-01
has interval: Interval 2013-07-21 to
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse Y
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: ERYTHEMA
overdose: NoYesResponse N
reference ID: REFID8
relationship to non study drug: NONE
reported term: APPLICATION SITE ERYTHEMA
seq: 1
serious: NoYesResponse N
severity: Severity MILD
sponsordefined ID: E04
start day: 3
tox grade: 1

AE09 App site pruritis
type: AdverseEvent
has code: m10003047
outcome: AEOutcome NRNR
action taken: none
action taken other: N/A
adverse event pattern: SINGLE EVENT
cancer: NoYesResponse N
causality: Causality Probable
concomitant treatment given: NoYesResponse N
congenital defect: NoYesResponse N
death: NoYesResponse N
disabling: NoYesResponse N
group ID: GRP3
has category: CAT1
has data collection date: 2013-08-14
has interval: Interval 2013-08-08 to
has subcategory: SCAT1
hospitalization: NoYesResponse N
is prespecified: NoYesResponse Y
life threatening: NoYesResponse N
medically important serious event: NoYesResponse N
modified term: PRURITUS
overdose: NoYesResponse N
reference ID: REFID9
relationship to non study drug: NONE
reported term: APPLICATION SITE PRURITIS
seq: 2
serious: NoYesResponse N
severity: Severity MILD
sponsordefined ID: E05
start day: 21
tox grade: 1

Person 01-701-1015 Screening 1 Age data collection
type: AgeDataCollection
outcome: 63 YEARS
activity status: ActivityStatus CO
has date: 2013-12-26

Person 01-701-1023 Screening 1 Age data collection
type: AgeDataCollection
outcome: 64 YEARS
activity status: ActivityStatus CO
has date: 2012-07-22

Person 01-701-1028 Screening 1 Age data collection
type: AgeDataCollection
outcome: 71 YEARS
activity status: ActivityStatus CO
has date: 2013-07-11

63 YEARS
type: AgeOutcome
has unit: unitYear
has value: 63

64 YEARS
type: AgeOutcome
has unit: unitYear
has value: 64

71 YEARS
type: AgeOutcome
has unit: unitYear
has value: 71

Assume standing position
type: Visit Screening 1 Person 01-701-1015
type: AssumeBodyPositionStanding
outcome: BodyPosition STANDING
activity status: ActivityStatus CO
has date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after lying down for 5 minutes

Assume supine position
type: Visit Screening 1 Person 01-701-1015
type: AssumeBodyPositionSupine
outcome: BodyPosition SUPINE
activity status: ActivityStatus CO
has date: 2013-12-26

129 mmHg
type: BloodPressureOutcome
has unit: Unit mmHG
has value: 129

131 mmHg
type: BloodPressureOutcome
has unit: Unit mmHG
has value: 131

147 mmHg
type: BloodPressureOutcome
has unit: Unit mmHG
has value: 147

57 mmHg
type: BloodPressureOutcome
has unit: Unit mmHG
has value: 57

64 mmHg
type: BloodPressureOutcome
has unit: Unit mmHG
has value: 64

83 mmHg
type: BloodPressureOutcome
has unit: Unit mmHG
has value: 83

Drug administration period 2014-01-02 to 2014-07-02
type: CumulativeDrugAdministration
activity status: ActivityStatus CO
has activity: Drug administration
has activity interval: Interval 2014-01-02 to 2014-07-02

Drug administration period 2012-08-05 to 2012-09-01
type: CumulativeDrugAdministration
activity status: ActivityStatus CO
has activity: Drug administration
has activity interval: Interval 2012-08-05 to 2012-09-01

Drug administration period 2013-07-19 to 2014-01-14
type: CumulativeDrugAdministration
activity status: ActivityStatus CO
has activity: Drug administration
has activity interval: Interval 2013-07-19 to 2014-01-14

Data cutoff 1
type: DataCutoff
activity description: Interim Analysis Data Cutoff Date
has date: Date 2015-03-31

1942-07-19
type: Birthdate
date time in XSD string: 1942-07-19

1948-08-05
type: Birthdate
date time in XSD string: 1948-08-05

1951-01-02
type: Birthdate
date time in XSD string: 1951-01-02

2012-07-22
type: DemogDataCollectionDate
type: InformedConsentBegin
type: StudyParticipationBegin
type: VisitDate
date time in XSD string: 2012-07-22

2012-08-05
type: CumulativeDrugAdministrationBegin
type: FixedDoseIntervalBegin
type: ReferenceBegin
date time in XSD string: 2012-08-05

2012-08-06
type: ReferenceEnd
date time in XSD string: 2012-08-06

2012-08-07
type: AdverseEventBegin
date time in XSD string: 2012-08-07

2012-08-14
type: ReferenceEnd
date time in XSD string: 2012-08-14

2012-08-26
type: AdverseEventBegin
date time in XSD string: 2012-08-26

2012-08-27
type: DataCollectionDate
type: FixedDoseIntervalEnd
type: VisitDate
date time in XSD string: 2012-08-27

2012-08-28
type: FixedDoseIntervalBegin
date time in XSD string: 2012-08-28

2012-08-30
type: AdverseEventEnd
date time in XSD string: 2012-08-30

2012-09-01
type: CumulativeDrugAdministrationEnd
type: FixedDoseIntervalEnd
date time in XSD string: 2012-09-01

2012-09-02
type: DataCollectionDate
type: ReferenceEnd
date time in XSD string: 2012-09-02

2013-02-18
type: StudyParticipationEnd
date time in XSD string: 2013-02-18

2013-07-11
type: DemogDataCollectionDate
type: InformedConsentBegin
type: StudyParticipationBegin
type: VisitDate
date time in XSD string: 2013-07-11

2013-07-19
type: CumulativeDrugAdministrationBegin
type: FixedDoseIntervalBegin
type: ReferenceBegin
date time in XSD string: 2013-07-19

2013-07-21
type: AdverseEventBegin
date time in XSD string: 2013-07-21

2013-08-01
type: DataCollectionDate
type: FixedDoseIntervalEnd
type: VisitDate
date time in XSD string: 2013-08-01

2013-08-02
type: FixedDoseIntervalBegin
date time in XSD string: 2013-08-02

2013-08-08
type: AdverseEventBegin
date time in XSD string: 2013-08-08

2013-08-14
type: DataCollectionDate
date time in XSD string: 2013-08-14

2013-12-26
type: Deathdate
type: DemogDataCollectionDate
type: InformedConsentBegin
type: StudyParticipationBegin
type: VisitDate
date time in XSD string: 2013-12-26

2014-01-02
type: CumulativeDrugAdministrationBegin
type: FixedDoseIntervalBegin
type: ReferenceBegin
type: VisitDate
date time in XSD string: 2014-01-02

2014-01-03
type: AdverseEventBegin
date time in XSD string: 2014-01-03

2014-01-06
type: VisitDate
date time in XSD string: 2014-01-06

2014-01-07
type: FixedDoseIntervalBegin
date time in XSD string: 2014-01-07

2014-01-09
type: AdverseEventBegin
date time in XSD string: 2014-01-09

2014-01-11
type: AdverseEventEnd
date time in XSD string: 2014-01-11

2014-01-13
type: ReferenceEnd
date time in XSD string: 2014-01-13

2014-01-14
type: CumulativeDrugAdministrationEnd
type: FixedDoseIntervalEnd
type: ReferenceEnd
type: VisitDate
date time in XSD string: 2014-01-14

2014-01-14T11:10
type: StudyParticipationEnd
date time in XSD string: 2014-01-14T11:10

2014-01-16
type: DataCollectionDate
type: FixedDoseIntervalEnd
type: VisitDate
date time in XSD string: 2014-01-16

2014-01-17
type: FixedDoseIntervalBegin
date time in XSD string: 2014-01-17

2014-06-18
type: FixedDoseIntervalEnd
type: VisitDate
date time in XSD string: 2014-06-18

2014-06-19
type: FixedDoseIntervalBegin
date time in XSD string: 2014-06-19

2014-07-02
type: CumulativeDrugAdministrationEnd
type: FixedDoseIntervalEnd
type: ReferenceEnd
type: VisitDate
date time in XSD string: 2014-07-02

2014-07-02T11:45
type: StudyParticipationEnd
date time in XSD string: 2014-07-02T11:45

Person 01-701-1015 Screening 1 Demographic data collection
type: VisitScreening1DemogDataColl
type: Visit Screening 1 Person 01-701-1015
type: DemographicDataCollection
outcome: Successfully Completed
activity status: ActivityStatus CO
has activity: Person 01-701-1015 Screening 1 Age data collection
has activity: Person 01-701-1015 Screening 1 Ethnicity data collection
has activity: Person 01-701-1015 Screening 1 Race data collection
has activity: Person 01-701-1015 Screening 1 Sex data collection
has date: 2013-12-26

Person 01-701-1023 Screening 1 Demographic data collection
type: VisitScreening1DemogDataColl
type: VisitScreening1Activity 01-701-1023
type: DemographicDataCollection
outcome: Successfully Completed
activity status: ActivityStatus CO
has activity: Person 01-701-1023 Screening 1 Age data collection
has activity: Person 01-701-1023 Screening 1 Ethnicity data collection
has activity: Person 01-701-1023 Screening 1 Race data collection
has activity: Person 01-701-1023 Screening 1 Sex data collection
has date: 2012-07-22

Person 01-701-1028 Screening 1 Demographic data collection
type: VisitScreening1DemogDataColl
type: VisitScreening1Activity 01-701-1028
type: DemographicDataCollection
outcome: Successfully Completed
activity status: ActivityStatus CO
has activity: Person 01-701-1028 Screening 1 Age data collection
has activity: Person 01-701-1028 Screening 1 Ethnicity data collection
has activity: Person 01-701-1028 Screening 1 Race data collection
has activity: Person 01-701-1028 Screening 1 Sex data collection
has date: 2013-07-11

DiastolicBloodPressure Screening1 01-701-1015 1
type: VisitScreening1DiastolicBloodPressure
type: Visit Screening 1 Person 01-701-1015
type: DiastolicBloodPressure
outcome: 64 mmHg
activity status: ActivityStatus CO
anatomic location: Arm
body position: BodyPosition SUPINE
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after lying down for 5 minutes
has subcategory: Subcategory 1
laterality: Laterality RIGHT
reason not done: not applicable
seq: 1
sponsordefined ID: 123

DiastolicBloodPressure Screening1 01-701-1015 2
type: VisitScreening1DiastolicBloodPressure
type: Visit Screening 1 Person 01-701-1015
type: DiastolicBloodPressure
outcome: 83 mmHg
activity status: ActivityStatus CO
anatomic location: Arm
body position: BodyPosition STANDING
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after standing for 1 minute
has subcategory: Subcategory 1
laterality: Laterality LEFT
reason not done: not applicable
seq: 2
sponsordefined ID: 719

DiastolicBloodPressure Screening1 01-701-1015 3
type: VisitScreening1DiastolicBloodPressure
type: Visit Screening 1 Person 01-701-1015
type: DiastolicBloodPressure
outcome: 57 mmHg
activity status: ActivityStatus CO
anatomic location: Arm
body position: BodyPosition STANDING
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after standing for 3 minutes
has subcategory: Subcategory 1
laterality: Laterality RIGHT
reason not done: not applicable
seq: 3
sponsordefined ID: 235

Drug administration
type: Visit Baseline Person 01-701-1015
type: FixedDoseDrugAdministration
outcome: DrugAdministrationComplete
activity status: ActivityStatus CO
administered drug: PlaceboDrug
has activity interval: Interval 2014-01-02 to 2014-01-16
has dosage frequency: ExDosFrq QD
has route of administration: ExRoute TRANSDERMAL

Drug administration
type: Visit Week 2 Person 01-701-1015
type: FixedDoseDrugAdministration
outcome: DrugAdministrationComplete
activity status: ActivityStatus CO
administered drug: PlaceboDrug
has activity interval: Interval 2014-01-17 to 2014-06-18
has dosage frequency: ExDosFrq QD
has route of administration: ExRoute TRANSDERMAL

Drug administration
type: Visit Week 24 Person 01-701-1015
type: FixedDoseDrugAdministration
outcome: DrugAdministrationComplete
activity status: ActivityStatus CO
administered drug: PlaceboDrug
has activity interval: Interval 2014-06-19 to 2014-07-02
has dosage frequency: ExDosFrq QD
has route of administration: ExRoute TRANSDERMAL

Drug administration
type: Visit Baseline Person 01-701-1023
type: FixedDoseDrugAdministration
outcome: DrugAdministrationComplete
activity status: ActivityStatus CO
administered drug: PlaceboDrug
has activity interval: Interval 2012-08-05 to 2012-08-27
has dosage frequency: ExDosFrq QD
has route of administration: ExRoute TRANSDERMAL

Drug administration
type: Visit Week 2 Person 01-701-1023
type: FixedDoseDrugAdministration
outcome: DrugAdministrationComplete
activity status: ActivityStatus CO
administered drug: PlaceboDrug
has activity interval: Interval 2012-08-28 to 2012-09-01
has dosage frequency: ExDosFrq QD
has route of administration: ExRoute TRANSDERMAL

Drug administration
type: Visit Baseline Person 01-701-1028
type: FixedDoseDrugAdministration
outcome: DrugAdministrationComplete
activity status: ActivityStatus CO
administered drug: Product 1
has activity interval: Interval 2013-07-19 to 2013-08-01
has dosage frequency: ExDosFrq QD
has route of administration: ExRoute TRANSDERMAL

Drug administration
type: Visit Week 2 Person 01-701-1028
type: FixedDoseDrugAdministration
outcome: DrugAdministrationComplete
activity status: ActivityStatus CO
administered drug: Product 2
has activity interval: Interval 2013-08-02 to 2014-01-06
has dosage frequency: ExDosFrq QD
has route of administration: ExRoute TRANSDERMAL

Drug administration
type: Visit Week 24 Person 01-701-1028
type: FixedDoseDrugAdministration
outcome: DrugAdministrationComplete
activity status: ActivityStatus CO
administered drug: Product 1
has activity interval: Interval 2014-01-07 to 2014-01-14
has dosage frequency: ExDosFrq QD
has route of administration: ExRoute TRANSDERMAL

Person 01-701-1015 Screening 1 Ethnicity data collection
type: EthnicityDataCollection
outcome: Ethnicity HISPANIC OR LATINO
activity status: ActivityStatus CO
has date: 2013-12-26

Person 01-701-1023 Screening 1 Ethnicity data collection
type: EthnicityDataCollection
outcome: Ethnicity HISPANIC OR LATINO
activity status: ActivityStatus CO
has date: 2012-07-22

Person 01-701-1028 Screening 1 Ethnicity data collection
type: EthnicityDataCollection
outcome: Ethnicity NOT HISPANIC OR LATINO
activity status: ActivityStatus CO
has date: 2013-07-11

58.0 in
type: HeightOutcome
has unit: Unit IN
has value: 58.0

Height Screening1 01-701-1015 43
type: VisitScreening1Height
type: Visit Screening 1 Person 01-701-1015
type: Height
outcome: 58.0 in
activity status: ActivityStatus CO
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has subcategory: Subcategory 1
reason not done: not applicable
seq: 43
sponsordefined ID: 1000

Informed consent Person 01-701-1015
type: InformedConsentAdult
outcome: InformedConsentOutcome 1
activity status: ActivityStatus CO
has activity interval: Interval 2013-12-26 to
has start rule: StartRuleDefault 1

Informed consent Person 01-701-1023
type: InformedConsentAdult
outcome: InformedConsentOutcome 1
activity status: ActivityStatus CO
has activity interval: Interval 2012-07-22 to

Informed consent Person 01-701-1028
type: InformedConsentAdult
outcome: InformedConsentOutcome 1
activity status: ActivityStatus CO
has activity interval: Interval 2013-07-11 to

Interval 1942-07-19 to
type: Lifespan
has beginning: 1942-07-19

Interval 1948-08-05 to
type: Lifespan
has beginning: 1948-08-05

Interval 1951-01-02 to 2013-12-26
type: Lifespan
has beginning: 1951-01-02
has end: 2013-12-26

Interval 2012-07-22 to
type: InformedConsentInterval
has beginning: 2012-07-22

Interval 2012-07-22 to 2013-02-18
type: StudyParticipationInterval
has beginning: 2012-07-22
has end: 2013-02-18

Interval 2012-08-05 to 2012-08-27
type: FixedDoseInterval
has beginning: 2012-08-05
has end: 2012-08-27

Interval 2012-08-05 to 2012-09-01
type: CumulativeDrugAdministrationInterval
has beginning: 2012-08-05
has end: 2012-09-01

Interval 2012-08-05 to 2012-09-02
type: ReferenceInterval
has beginning: 2012-08-05
has end: 2012-09-02

Interval 2012-08-07 to
type: AdverseEventInterval
has beginning: 2012-08-07

Interval 2012-08-07 to
type: AdverseEventInterval
has beginning: 2012-08-07
has end: 2012-08-30

Interval 2012-08-26 to
type: AdverseEventInterval
has beginning: 2012-08-26

Interval 2012-08-28 to 2012-09-01
type: FixedDoseInterval
has beginning: 2012-08-28
has end: 2012-09-01

Interval 2013-07-11 to
type: InformedConsentInterval
has beginning: 2013-07-11

Interval 2013-07-11 to 2014-01-14T11:10
type: StudyParticipationInterval
has beginning: 2013-07-11
has end: 2014-01-14T11:10

Interval 2013-07-19 to 2013-08-01
type: FixedDoseInterval
has beginning: 2013-07-19
has end: 2013-08-01

Interval 2013-07-19 to 2014-01-14
type: CumulativeDrugAdministrationInterval
type: ReferenceInterval
has beginning: 2013-07-19
has end: 2014-01-14

Interval 2013-07-21 to
type: AdverseEventInterval
has beginning: 2013-07-21

Interval 2013-08-02 to 2014-01-06
type: FixedDoseInterval
has beginning: 2013-08-02
has end: 2014-01-06

Interval 2013-08-08 to
type: AdverseEventInterval
has beginning: 2013-08-08

Interval 2013-12-26 to
type: InformedConsentInterval
has beginning: 2013-12-26

Interval 2013-12-26 to 2014-07-02T11:45
type: StudyParticipationInterval
has beginning: 2013-12-26
has end: 2014-07-02T11:45

Interval 2014-01-02 to 2014-01-16
type: FixedDoseInterval
has beginning: 2014-01-02
has end: 2014-01-16

Interval 2014-01-02 to 2014-07-02
type: CumulativeDrugAdministrationInterval
type: ReferenceInterval
has beginning: 2014-01-02
has end: 2014-07-02

Interval 2014-01-03 to
type: AdverseEventInterval
has beginning: 2014-01-03

Interval 2014-01-07 to 2014-01-14
type: FixedDoseInterval
has beginning: 2014-01-07
has end: 2014-01-14

Interval 2014-01-09 to 2014_01_11
type: AdverseEventInterval
has beginning: 2014-01-09
has end: 2014-01-11

Interval 2014-01-17 to 2014-06-18
type: FixedDoseInterval
has beginning: 2014-01-17
has end: 2014-06-18

Interval 2014-06-19 to 2014-07-02
type: FixedDoseInterval
has beginning: 2014-06-19
has end: 2014-07-02

123
type: InvestigatorIdentifier

Investigator 123
type: Investigator
has investigator ID: 123
has last name: Jones

Person 01-701-1015
type: EnrolledSubject
actual arm: Arm Pbo
afflicted by: APPLICATION SITE ERYTHEMA
afflicted by: APPLICATION SITE PRURITUS
afflicted by: AE03 Diarrhoea
death flag: Y
has lifespan: Interval 1951-01-02 to 2013-12-26
has reference interval: Interval 2014-01-02 to 2014-07-02
has site: Site 701
has study participation interval: Interval 2013-12-26 to 2014-07-02T11:45
has subject ID: 1015
has unique subject ID: 01-701-1015
participates in: Drug administration period 2014-01-02 to 2014-07-02
participates in: Person 01-701-1015 Screening 1 Demographic data collection
participates in: Informed consent Person 01-701-1015
participates in: PopFlagCOMPLT16 01-701-1015
participates in: PopFlagCOMPLT24 01-701-1015
participates in: PopFlagCOMPLT8 01-701-1015
participates in: PopFlagEFFICACY 01-701-1015
participates in: PopFlagITT 01-701-1015
participates in: PopFlagSAFETY 01-701-1015
participates in: Randomization Person 01-701-1015
participates in: VisitBaseline 01-701-1015
participates in: VisitScreening1 01-701-1015
participates in: VisitWk24 01-701-1015
participates in: VisitWk2 01-701-1015

Person 01-701-1023
type: EnrolledSubject
actual arm: Arm Pbo
afflicted by: AE04AVBlock2nd deg
afflicted by: AE05 Erythema
afflicted by: AE06 Erythema
afflicted by: AE07 Erythema
has lifespan: Interval 1948-08-05 to
has reference interval: Interval 2012-08-05 to 2012-09-02
has site: Site 701
has study participation interval: Interval 2012-07-22 to 2013-02-18
has subject ID: 1023
has unique subject ID: 01-701-1023
participates in: Drug administration period 2012-08-05 to 2012-09-01
participates in: Person 01-701-1023 Screening 1 Demographic data collection
participates in: Informed consent Person 01-701-1023
participates in: Randomization Person 01-701-1023
participates in: VisitBaseline 01-701-1023
participates in: VisitScreening1 01-701-1023
participates in: VisitWk2 01-701-1023

Person 01-701-1028
type: EnrolledSubject
actual arm: Arm Xan Hi
afflicted by: AE08 App site erythema
afflicted by: AE09 App site pruritis
has lifespan: Interval 1942-07-19 to
has reference interval: Interval 2013-07-19 to 2014-01-14
has site: Site 701
has study participation interval: Interval 2013-07-11 to 2014-01-14T11:10
has subject ID: 1028
has unique subject ID: 01-701-1028
participates in: Drug administration period 2013-07-19 to 2014-01-14
participates in: Person 01-701-1028 Screening 1 Demographic data collection
participates in: Informed consent Person 01-701-1028
participates in: Randomization Person 01-701-1028
participates in: VisitBaseline 01-701-1028
participates in: VisitScreening1 01-701-1028
participates in: VisitWk24 01-701-1028
participates in: VisitWk2 01-701-1028

PopFlagCOMPLT16 01-701-1015
type: PopFlagCOMPLT16
outcome: true
activity status: ActivityStatus CO
has performer: Sponsor 1

PopFlagCOMPLT24 01-701-1015
type: PopFlagCOMPLT24
outcome: true
activity status: ActivityStatus CO
has performer: Sponsor 1

PopFlagCOMPLT8 01-701-1015
type: PopFlagCOMPLT8
outcome: true
activity status: ActivityStatus CO
has performer: Sponsor 1

PopFlagEFFICACY 01-701-1015
type: PopFlagEFFICACY
outcome: true
activity status: ActivityStatus CO
has performer: Sponsor 1

PopFlagITT 01-701-1015
type: PopFlagITT
outcome: true
activity status: ActivityStatus CO
has performer: Sponsor 1

PopFlagSAFETY 01-701-1015
type: PopFlagSAFETY
outcome: true
activity status: ActivityStatus CO
has performer: Sponsor 1

57 beats/min
type: PulseOutcome
has unit: Unit BEATS MIN
has value: 57

62 beats/min
type: PulseOutcome
has unit: Unit BEATS MIN
has value: 62

65 beats/min
type: PulseOutcome
has unit: Unit BEATS MIN
has value: 65

Pulse Screening1 01-701-1015 44
type: VisitScreening1Pulse
type: Visit Screening 1 Person 01-701-1015
type: Pulse
outcome: 57 beats/min
activity status: ActivityStatus CO
body position: BodyPosition SUPINE
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after lying down for 5 minutes
has subcategory: Subcategory 1
laterality: Laterality RIGHT
reason not done: not applicable
seq: 44
sponsordefined ID: 125

Pulse Screening1 01-701-1015 45
type: VisitScreening1Pulse
type: Visit Screening 1 Person 01-701-1015
type: Pulse
outcome: 62 beats/min
activity status: ActivityStatus CO
body position: BodyPosition STANDING
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after standing for 1 minute
has subcategory: Subcategory 1
laterality: Laterality LEFT
reason not done: not applicable
seq: 45
sponsordefined ID: 721

Pulse Screening1 01-701-1015 46
type: VisitScreening1Pulse
type: Visit Screening 1 Person 01-701-1015
type: Pulse
outcome: 65 beats/min
activity status: ActivityStatus CO
body position: BodyPosition STANDING
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after standing for 3 minutes
has subcategory: Subcategory 1
laterality: Laterality RIGHT
reason not done: not applicable
seq: 46
sponsordefined ID: 237

Person 01-701-1015 Screening 1 Race data collection
type: RaceDataCollection
outcome: Race WHITE
activity status: ActivityStatus CO
has date: 2013-12-26

Person 01-701-1023 Screening 1 Race data collection
type: RaceDataCollection
outcome: Race WHITE
activity status: ActivityStatus CO
has date: 2012-07-22

Person 01-701-1028 Screening 1 Race data collection
type: RaceDataCollection
outcome: Race WHITE
activity status: ActivityStatus CO
has date: 2013-07-11

Randomization Person 01-701-1015
type: RandomizationBAL3
outcome: Arm Pbo
activity status: ActivityStatus CO

Randomization Person 01-701-1023
type: RandomizationBAL3
outcome: Arm Pbo
activity status: ActivityStatus CO

Randomization Person 01-701-1028
type: RandomizationBAL3
outcome: Arm Xan Hi
activity status: ActivityStatus CO

Person 01-701-1015 Screening 1 Sex data collection
type: SexDataCollection
outcome: Sex F
activity status: ActivityStatus CO
has date: 2013-12-26

Person 01-701-1023 Screening 1 Sex data collection
type: SexDataCollection
outcome: Sex M
activity status: ActivityStatus CO
has date: 2012-07-22

Person 01-701-1028 Screening 1 Sex data collection
type: SexDataCollection
outcome: Sex M
activity status: ActivityStatus CO
has date: 2013-07-11

Person 01-701-1015 Screening 1 Rule after lying down for 5 minutes
type: StartRuleLying5
has prerequisite: Assume supine position

Person 01-701-1015 Screening 1 Rule after standing for 1 minute
type: StartRuleStanding1
has prerequisite: Assume standing position

Person 01-701-1015 Screening 1 Rule after standing for 3 minutes
type: StartRuleStanding3
has prerequisite: Assume standing position

Study begin 1
type: StudyBegin
date time in XSD string: 2012-07-06

Study end 1
type: StudyEnd
date time in XSD string: 2015-03-05

1015
type: SubjectIdentifier

1023
type: SubjectIdentifier

1028
type: SubjectIdentifier

SystolicBloodPressure Screening1 01-701-1015 86
type: VisitScreening1SystolicBloodPressure
type: Visit Screening 1 Person 01-701-1015
type: SystolicBloodPressure
outcome: 131 mmHg
activity status: ActivityStatus CO
anatomic location: Arm
body position: BodyPosition SUPINE
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after lying down for 5 minutes
has subcategory: Subcategory 1
laterality: Laterality RIGHT
reason not done: not applicable
seq: 86
sponsordefined ID: 124

SystolicBloodPressure Screening1 01-701-1015 87
type: VisitScreening1SystolicBloodPressure
type: Visit Screening 1 Person 01-701-1015
type: SystolicBloodPressure
outcome: 129 mmHg
activity status: ActivityStatus CO
anatomic location: Arm
body position: BodyPosition STANDING
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after standing for 1 minute
has subcategory: Subcategory 1
laterality: Laterality LEFT
reason not done: not applicable
seq: 87
sponsordefined ID: 720

SystolicBloodPressure Screening1 01-701-1015 88
type: VisitScreening1SystolicBloodPressure
type: Visit Screening 1 Person 01-701-1015
type: SystolicBloodPressure
outcome: 147 mmHg
activity status: ActivityStatus CO
anatomic location: Arm
body position: BodyPosition STANDING
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has start rule: Person 01-701-1015 Screening 1 Rule after standing for 3 minutes
has subcategory: Subcategory 1
laterality: Laterality RIGHT
reason not done: not applicable
seq: 88
sponsordefined ID: 236

96.9 F
type: TemperatureOutcome
has unit: Unit F
has value: 96.9

Temperature Screening1 01-701-1015 128
type: VisitScreening1Temperature
type: Visit Screening 1 Person 01-701-1015
type: Temperature
outcome: 96.9 F
activity status: ActivityStatus CO
anatomic location: Oral Cavity
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has subcategory: Subcategory 1
reason not done: not applicable
seq: 128
sponsordefined ID: 3000

01-701-1015
type: UniqueSubjectIdentifier

01-701-1023
type: UniqueSubjectIdentifier

01-701-1028
type: UniqueSubjectIdentifier

Visit Baseline Person 01-701-1015
type: Class
subclass of: VisitBaselineActivity

Visit Baseline Person 01-701-1023
type: Class
subclass of: VisitBaselineActivity

Visit Baseline Person 01-701-1028
type: Class
subclass of: VisitBaselineActivity

Visit Screening 1 Person 01-701-1015
type: Class
subclass of: VisitScreening1Activity

Visit Week 24 Person 01-701-1015
type: Class
subclass of: VisitWk24Activity

Visit Week 24 Person 01-701-1028
type: Class
subclass of: VisitWk24Activity

Visit Week 2 Person 01-701-1015
type: Class
subclass of: VisitWk2Activity

Visit Week 2 Person 01-701-1023
type: Class
subclass of: VisitWk2Activity

Visit Week 2 Person 01-701-1028
type: Class
subclass of: VisitWk2Activity

119.0 LB
type: WeightOutcome
has unit: Unit LB
has value: 119.0

Weight Screening1 01-701-1015 142
type: VisitScreening1Weight
type: Visit Screening 1 Person 01-701-1015
type: Weight
outcome: 119.0 LB
activity status: ActivityStatus CO
derived flag: N
group ID: GRPID1
has category: Category 1
has scheduled date: 2013-12-26
has subcategory: Subcategory 1
reason not done: not applicable
seq: 142
sponsordefined ID: 5000