ID

38670

Description

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Keywords

Versions (2)
  1. 2/18/19 2/18/19 -
  2. 10/30/19 10/30/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 30, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

English

Investigational Product; Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medication; Non-Serious Adverse Events; Serious Adverse Events

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Blinded Dose Level
Description

e.g., 1

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
Investigational Product Start Date
Description

Investigational Product Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Investigational Product Stop Date
Description

Investigational Product Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Has the subject missed investigational product for >2 consecutive days?
Description

Has the subject missed investigational product for >2 consecutive days?

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C1707491
Investigational Product Container Number
Description

Investigational Product Container Number

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Investigational Product Container Number
Description

Investigational Product Container Number

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Description

If Yes, complete the following

Data type

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
Date blind broken
Description

Date blind broken

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason blind broken, check one:
Description

Complete Non-Serious Adverse Events or Serious Adverse Event pages, as appropriate.

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason for blind broken, specify.
Description

If other reason for blind broken, specify.

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Consent for Pharmacogenetic Research
Description

Consent for Pharmacogenetic Research

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx-Pharmacogenetic research?
Description

If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research If No, check one reason

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consent obtained for PGx-Pharmacogenetic research
Description

Date informed consent obtained for PGx-Pharmacogenetic research

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Reason for informed consent for PGx-Pharmacogenetic research not obtained
Description

Reason for informed consent for PGx-Pharmacogenetic research not obtained

Data type

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C1882120
UMLS CUI [1,4]
C0392360
If other Reason for informed consent for PGx-Pharmacogenetic research not obtained, specify
Description

Other reason for informed consent for PGx-Pharmacogenetic research not obtained

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C1882120
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C2348235
PGx - Blood Sample Collection (DNA)
Description

PGx - Blood Sample Collection (DNA)

Alias
UMLS CUI-1
C0031325
UMLS CUI-2
C0005834
UMLS CUI-3
C0012854
Has a blood sample been collected for PGx-pharmacogenetic research?
Description

If Yes, record the date sample taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0005834
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
PGx - Withdrawal of Consent
Description

PGx - Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Description

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
PGx - Blood Sample Destruction
Description

PGx - Blood Sample Destruction

Alias
UMLS CUI-1
C0031325
UMLS CUI-2
C0370003
UMLS CUI-3
C1948029
Has a request been made for sample destruction?
Description

If Yes, check one reason

Data type

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
Reason for sample destruction
Description

Reason for sample destruction

Data type

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
If other Reason for sample destruction, specify
Description

If other Reason for sample destruction, specify

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Description

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

(Trade Name preferred) e.g., Aspirin

Data type

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Description

Total Daily Dose

Data type

integer

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Medication Taken Prior to Study?
Description

Medication Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant Medication Stop Date
Description

Concomitant Medication Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Description

Ongoing Medication?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Description

If Yes, record details below.

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Event
Description

Diagnosis Only (if known), Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C0877248
Non-Serious Adverse Event Start Date
Description

Non-Serious Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697888
Non-Serious Adverse Event Start Time
Description

Non-Serious Adverse Event Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Non-Serious Adverse Event Outcome
Description

Non-Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-Serious Adverse Event End Date
Description

Non-Serious Adverse Event End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event End Time
Description

Non-Serious Adverse Event End Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Non-Serious Adverse Event Frequency
Description

Non-Serious Adverse Event Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non-Serious Adverse Event Maximum Intensity
Description

Non-Serious Adverse Event Maximum Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Description

Action Taken with Investigational Product(s) as a Result of the Non-Serious AE

Data type

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigat ional product?
Description

Relationship to Investigational Product(s)

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Time to Onset Since Last Dose
Description

Time to Onset Since Last Dose

Data type

time

Measurement units
  • Hr(s):Min(s)
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
Hr(s):Min(s)
Serious Adverse Events
Description

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Description

If Yes, record details below.

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Serious Adverse Events - Section 1
Description

Serious Adverse Events - Section 1

Alias
UMLS CUI-1
C1519255
Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C0877248
Serious Adverse Event Start Date
Description

Serious Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Serious Adverse Event Start Time
Description

Serious Adverse Event Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Serious Adverse Event Outcome
Description

Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Evnet End date
Description

If fatal, record date of death.

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Serious Adverse Event End Time
Description

Serious Adverse Event End Time

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Serious Adverse Event Maximum Intensity
Description

Serious Adverse Event Maximum Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the SAE
Description

Action Taken with Investigational Product(s) as a Result of the SAE

Data type

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Description

If yes, Complete Study Conclusion page and check Adverse event as reason for withdrawal.

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Description

Relationship to Investigational Product(s)

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Time to Onset Since Last Dose
Description

Time to Onset Since Last Dose

Data type

time

Measurement units
  • Hr(s):Min(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0449244
Hr(s):Min(s)
If fatal, was a post-mortem/autopsy performed
Description

If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Serious Adverse Events - Section 2 (Seriousness)
Description

Serious Adverse Events - Section 2 (Seriousness)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness
Description

Seriousness

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
If other Reason for considering this a SAE, please specify.
Description

If other Reason for considering this a SAE, please specify.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Serious Adverse Events - Section 3 (Demography Data)
Description

Serious Adverse Events - Section 3 (Demography Data)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Serious Adverse Events - Section 4
Description

Serious Adverse Events - Section 4

Alias
UMLS CUI-1
C1519255
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Description

If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0034897
Serious Adverse Events - Section 5 (Possible Cause of SAE)
Description

Serious Adverse Events - Section 5 (Possible Cause of SAE)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible Causes of SAE Other Than Investigational Product(s)
Description

Check all that apply:

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0205394
If other cause, specify
Description

If other cause, specify

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Serious Adverse Events - Medical Conditions
Description

Serious Adverse Events - Medical Conditions

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Description

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C2347946
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
Medical Condition Date of Onset
Description

Medical Condition Date of Onset

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition Present at Time of the SAE?
Description

Condition Present at Time of the SAE?

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Description

If No, Date of Last Occurrence

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C2745955
Serious Adverse Events - Section 7 (Other relevant Risk Factors)
Description

Serious Adverse Events - Section 7 (Other relevant Risk Factors)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
UMLS CUI-3
C2347946
Other relevant Risk Factors
Description

(provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C2347946
Serious Adverse Events - Section 8 (Relevant Concomitant Medication)
Description

Serious Adverse Events - Section 8 (Relevant Concomitant Medication)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug Name
Description

Trade Name preferred

Data type

text

Alias
UMLS CUI [1]
C0013227
Medication Dose
Description

Medication Dose

Data type

integer

Alias
UMLS CUI [1]
C3174092
Medication Unit
Description

Medication Unit

Data type

text

Alias
UMLS CUI [1]
C2826646
Medication Frequency
Description

Medication Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Medication Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Description

Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Medication Start Date
Description

Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Medication Stop Date
Description

Medication Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Description

Ongoing Medication?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Serious Adverse Events - Section 9 (Details of Investigational Product(s))
Description

Serious Adverse Events - Section 9 (Details of Investigational Product(s))

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Investigational Product Start Date
Description

Investigational Product Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Investigational Product Start Time
Description

Investigational Product Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1301880
Start Date of Most Recent Titration to SAE
Description

Start Date of Most Recent Titration to SAE

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0162621
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1513491
Start Time of Most Recent Titration to SAE
Description

Start Time of Most Recent Titration to SAE

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0162621
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1513491
Dose of Most Recent Titration
Description

Dose of Most Recent Titration

Data type

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0162621
UMLS CUI [1,3]
C1513491
Was treatment blind broken at investigational site?
Description

Was treatment blind broken at investigational site?

Data type

integer

Alias
UMLS CUI [1]
C3897431
Serious Adverse Events - Section 10 ( Details of relevant Assessments)
Description

Serious Adverse Events - Section 10 ( Details of relevant Assessments)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
UMLS CUI-3
C2347946
Details of relevant Assessments
Description

Details of relevant Assessments

Data type

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C2347946
Serious Adverse Events - Section 11 (Narrative Remarks)
Description

Serious Adverse Events - Section 11 (Narrative Remarks)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Serious Adverse Events - Investigator's signature
Description

Serious Adverse Events - Investigator's signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
Investigator's signature
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C234657
Investigator’s name (print)
Description

Investigator’s name (print)

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Investigational Product; Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medication; Non-Serious Adverse Events; Serious Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Blinded Dose Level
Item
Blinded Dose Level
text
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational Product Start Date
Item
Investigational Product Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product Stop Date
Item
Investigational Product Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Has the subject missed investigational product for >2 consecutive days?
Item
Has the subject missed investigational product for >2 consecutive days?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C1707491 (UMLS CUI [1,4])
Investigational Product Container Number
Item
Investigational Product Container Number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Investigational Product Container Number
Item
Investigational Product Container Number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken, check one:
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken, check one:
Code List
Reason blind broken, check one:
CL Item
Medical emergency requiring identification of investigational product for further treatment  (1)
CL Item
Other, specify (2)
If other reason for blind broken, specify.
Item
If other reason for blind broken, specify.
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Consent for Pharmacogenetic Research
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Has informed consent been obtained for PGx-Pharmacogenetic research?
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained for PGx-Pharmacogenetic research
Item
Date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Reason for informed consent for PGx-Pharmacogenetic research not obtained
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Reason for informed consent for PGx-Pharmacogenetic research not obtained
Code List
Reason for informed consent for PGx-Pharmacogenetic research not obtained
CL Item
Subject declined  (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Other reason for informed consent for PGx-Pharmacogenetic research not obtained
Item
If other Reason for informed consent for PGx-Pharmacogenetic research not obtained, specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
Item Group
PGx - Blood Sample Collection (DNA)
C0031325 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0012854 (UMLS CUI-3)
Has a blood sample been collected for PGx-pharmacogenetic research?
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C0031325 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item Group
PGx - Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Item Group
PGx - Blood Sample Destruction
C0031325 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C1948029 (UMLS CUI-3)
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C0031325 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Reason for sample destruction
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for sample destruction
Code List
Reason for sample destruction
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
If other Reason for sample destruction, specify
Item
If other Reason for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
integer
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Item
Units
text
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Medication Taken Prior to Study?
Item
Medication Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication Stop Date
Item
Concomitant Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Non-Serious Adverse Event Start Date
Item
Non-Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Non-Serious Adverse Event Start Time
Item
Non-Serious Adverse Event Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event Outcome
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
Non-Serious Adverse Event End Date
Item
Non-Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event End Time
Item
Non-Serious Adverse Event End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-Serious Adverse Event Frequency
Code List
Non-Serious Adverse Event Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Non-Serious Adverse Event Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event Maximum Intensity
Code List
Non-Serious Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility that the AE may have been caused by the investigat ional product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
time
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 1
C1519255 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event Start Time
Item
Serious Adverse Event Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event Outcome
Code List
Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
CL Item
Fatal (5)
Serious Adverse Evnet End date
Item
Serious Adverse Evnet End date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
text
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Serious Adverse Event Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event Maximum Intensity
Code List
Serious Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the SAE
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
If fatal, was a post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 2 (Seriousness)
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness
CL Item
Results in death  (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
If other Reason for considering this a SAE, please specify.
Item
If other Reason for considering this a SAE, please specify.
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Events - Section 3 (Demography Data)
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious Adverse Events - Section 4
C1519255 (UMLS CUI-1)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
integer
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Serious Adverse Events - Section 5 (Possible Cause of SAE)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Possible Causes of SAE Other Than Investigational Product(s)
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study  (1)
CL Item
Medical condition(s) (record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (record in Section 8) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
If other cause, specify
Item
If other cause, specify
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Events - Medical Conditions
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Medical Condition Date of Onset
Item
Medical Condition Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
If No, Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Item Group
Serious Adverse Events - Section 7 (Other relevant Risk Factors)
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
Other relevant Risk Factors
Item
Other relevant Risk Factors
text
C1519255 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
Item Group
Serious Adverse Events - Section 8 (Relevant Concomitant Medication)
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Medication Dose
Item
Medication Dose
integer
C3174092 (UMLS CUI [1])
Medication Unit
Item
Medication Unit
text
C2826646 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Item Group
Serious Adverse Events - Section 9 (Details of Investigational Product(s))
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Investigational Product Start Date
Item
Investigational Product Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product Start Time
Item
Investigational Product Start Time
time
C0304229 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Start Date of Most Recent Titration to SAE
Item
Start Date of Most Recent Titration to SAE
date
C0808070 (UMLS CUI [1,1])
C0162621 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
Start Time of Most Recent Titration to SAE
Item
Start Time of Most Recent Titration to SAE
time
C1301880 (UMLS CUI [1,1])
C0162621 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
Dose of Most Recent Titration
Item
Dose of Most Recent Titration
text
C3174092 (UMLS CUI [1,1])
C0162621 (UMLS CUI [1,2])
C1513491 (UMLS CUI [1,3])
Item
Was treatment blind broken at investigational site?
integer
C3897431 (UMLS CUI [1])
Was treatment blind broken at investigational site?
Code List
Was treatment blind broken at investigational site?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item Group
Serious Adverse Events - Section 10 ( Details of relevant Assessments)
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
Details of relevant Assessments
Item
Details of relevant Assessments
text
C0220825 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
Item Group
Serious Adverse Events - Section 11 (Narrative Remarks)
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Item Group
Serious Adverse Events - Investigator's signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Investigator's signature
Item
Investigator's signature
text
C234657 (UMLS CUI [1])
Investigator’s name (print)
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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