Inglese

GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

1 moduli  
Vital signs
Descrizione

Vital signs

Alias
UMLS CUI-1
C0518766
Pulse
Descrizione

after 5 minutes sitting

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting systolic Blood Pressure
Descrizione

after 5 minutes sitting

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting diastolic blood pressure
Descrizione

after 5 min sitting

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Laboratory Evaluation
Descrizione

Laboratory Evaluation

Alias
UMLS CUI-1
C0022877
Date of blood sample
Descrizione

Date of blood sample

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Descrizione

(Affix label only if sample was sent to Quest)

Tipo di dati

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Descrizione

If "Yes", please record the diagnosis on the Baseline Signs and Symptoms page in this module and/or SAE page in separate pad and exclude the patient from the study.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
Urine Dipstick
Descrizione

Urine Dipstick

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Descrizione

If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptom/SAE pages and send a sample to Quest Diagnostics for further evaluation.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Pregnancy dipstick
Descrizione

Pregnancy dipstick

Alias
UMLS CUI-1
C0430056
Is the patient a female of child-bearing potential?
Descrizione

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Tipo di dati

integer

Alias
UMLS CUI [1]
C1960468
Pregnancy dipstick result
Descrizione

If previous question was answered "yes", please perform a pregnancy dipstick test and record result below. If ’Positive’, please record details on the pregnancy form and exclude the patient.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
Medical Procedures
Descrizione

Medical Procedures

Alias
UMLS CUI-1
C0199171
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
Descrizione

If 'Yes', please record details below using standard medical terminology

Tipo di dati

integer

Alias
UMLS CUI [1]
C0199171
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0430022
UMLS CUI [4]
C0543467
Medical Procedures
Descrizione

Medical Procedures

Alias
UMLS CUI-1
C0199171
Procedure
Descrizione

Procedure

Tipo di dati

text

Alias
UMLS CUI [1]
C0199171
Indication
Descrizione

Indication of medical procedure

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C3146298
Procedure Start Date
Descrizione

Procedure Start Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0808070
End Date Procedure
Descrizione

End Date Procedure

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0806020
Prior and concomitant medication
Descrizione

Prior and concomitant medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
Descrizione

If ‘Yes’, please record details below (Please print clearly)

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2347852
prior and concomitant medication
Descrizione

prior and concomitant medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Drug Name (Trade name preferred)
Descrizione

Drug name

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0919189
Total daily dose
Descrizione

eg. 500 mg

Tipo di dati

text

Alias
UMLS CUI [1]
C2348070
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
Descrizione

or symptom in absence of diagnosis

Tipo di dati

text

Alias
UMLS CUI [1]
C0011900
Start Date (be as precise as possible)
Descrizione

start date of medication

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Descrizione

End Date of medication

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Does the medication still continue?
Descrizione

medication is current

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521116
Baseline signs and symptoms
Descrizione

Baseline signs and symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Please mark this box if no baseline events occurred prior to randomisation into study.
Descrizione

Baseline adverse reaction

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
Baseline event
Descrizione

Record any baseline events (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way in the last 7 days?” Provide the diagnosis, not symptoms where possible. One baseline event per column.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1442488
Onset Date and Time
Descrizione

Adverse Reaction Start Date Time

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C2981441
UMLS CUI [1,2]
C1442488
End Date and Time
Descrizione

(If ongoing please leave blank)

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C2981425
UMLS CUI [1,2]
C1442488
Outcome
Descrizione

If patient died, STOP: go to SAE section and follow instructions given there

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1624730
Event Course
Descrizione

adverse reaction course

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0750729
Number of episodes
Descrizione

only answer if previous answer was 'intermittent'

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Descrizione

Intensity concerning the maximum

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0518690
Relationship to study procedures performed prior to enrolment
Descrizione

Relationship to study procedures

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1510821
Corrective Therapy
Descrizione

If ‘Yes’, record details in Prior and Concomitant Medication section and/or Resource Utilisation section if appropriate

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific event prior to randomisation?
Descrizione

Study subject participation status due to adverse reaction

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0559546
UMLS CUI [1,3]
C0424092
Significant medical/surgical history and physical examination
Descrizione

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0489540
UMLS CUI-5
C0031809
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
Descrizione

If 'Yes' , please list below one diagnosis per line.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0008976
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0008976
Significant medical/surgical history and physical examination
Descrizione

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Diagnosis
Descrizione

Diagnosis

Tipo di dati

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis (if know)
Descrizione

Year of diagnosis

Tipo di dati

partialDate

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0439234
Past and/or ongoing (diagnosis)
Descrizione

Past and/or ongoing medical history

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0455458
UMLS CUI [2]
C2826680
Patient continuation/ withdrawal
Descrizione

Patient continuation/ withdrawal

Alias
UMLS CUI-1
C2348568
Is the patient continuing in the study?
Descrizione

If ’Yes’, please place this Module in the CRF (Book 1) If ’No’, please mark the primary cause of withdrawal. (Mark one box only).

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0549178
Cause of withdrawal from study
Descrizione

Cause of withdrawal from study

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0085978
Please specify 'other' cause of withdrawal from study.
Descrizione

Other cause of withdrawal from study

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205394
Investigator signature
Descrizione

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
Descrizione

I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Baseline Signs and Symptoms and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.

Tipo di dati

text

Alias
UMLS CUI [1]
C2346576
Date
Descrizione

Investigator Signature Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Repeated Laboratory Evaluation
Descrizione

Repeated Laboratory Evaluation

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0205341
Date of blood sample
Descrizione

Date of blood sample

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Descrizione

Affix label only if sample was sent to Quest

Tipo di dati

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Descrizione

If "Yes", please record the diagnosis on the Baseline Signs and Symptoms page in this module and/or SAE page in separate pad and exclude the patient from the study.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
Repeated Urine dipstick
Descrizione

Repeated Urine dipstick

Alias
UMLS CUI-1
C0430370
UMLS CUI-2
C0205341
What was the result of the urine dipstick performed at this visit?
Descrizione

If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptom/SAE pages and send a sample to Quest Diagnostics for further evaluation.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
systolic blood pressure sitting
Item
Sitting systolic Blood Pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
diastolic blood pressure sitting
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Laboratory Evaluation
C0022877 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
abnormalities in blood sample
Code List
Were any clinically significant abnormalities detected?
CL Item
yes (1)
CL Item
no (2)
Item Group
Urine Dipstick
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine dipstick result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Positive (2)
CL Item
Negative (1)
Item Group
Pregnancy dipstick
C0430056 (UMLS CUI-1)
Item
Is the patient a female of child-bearing potential?
integer
C1960468 (UMLS CUI [1])
female of child-bearing potential
Code List
Is the patient a female of child-bearing potential?
CL Item
no (1 )
CL Item
yes (2 )
Item
Pregnancy dipstick result
integer
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Pregnancy dipstick result
Code List
Pregnancy dipstick result
CL Item
negative (1)
CL Item
positive (2)
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Item
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
integer
C0199171 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0430022 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
medical procedures
Code List
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
CL Item
No (1 )
CL Item
Yes (2)
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Procedure
Item
Procedure
text
C0199171 (UMLS CUI [1])
Indication of medical procedure
Item
Indication
text
C0199171 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Procedure Start Date
Item
Procedure Start Date
date
C0199171 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Procedure
Item
End Date Procedure
date
C0199171 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Prior and concomitant medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
integer
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Prior and concomitant medication
Code List
Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
CL Item
no (1 )
CL Item
yes (2 )
Item Group
prior and concomitant medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug name
Item
Drug Name (Trade name preferred)
text
C0013227 (UMLS CUI [1,1])
C0919189 (UMLS CUI [1,2])
Total Daily Dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1])
start date of medication
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
medication is current
Item
Does the medication still continue?
boolean
C0013227 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Item Group
Baseline signs and symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Baseline adverse reaction
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Baseline adverse reaction
Item
Baseline event
text
C0559546 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Adverse Reaction Start Date Time
Item
Onset Date and Time
datetime
C2981441 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Adverse Reaction End Date Time
Item
End Date and Time
datetime
C2981425 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Outcome
integer
C0559546 (UMLS CUI [1,1])
C1624730 (UMLS CUI [1,2])
Adverse Event Outcome
Code List
Outcome
CL Item
resolved (1)
CL Item
ongoing (2)
CL Item
died (3)
Item
Event Course
integer
C0559546 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
adverse event course
Code List
Event Course
CL Item
intermittent (1)
CL Item
constant (2)
Number of episodes of adverse reaction
Item
Number of episodes
integer
C0559546 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C0559546 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of the adverse event
Code List
Intensity (maximum)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Relationship to study procedures performed prior to enrolment
integer
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
Relationship to study procedures
Code List
Relationship to study procedures performed prior to enrolment
CL Item
Related (5)
CL Item
Possibly related (6)
CL Item
Probably unrelated (7)
CL Item
Unrelated (1)
Item
Corrective Therapy
integer
C0559546 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective therapy to adverse event
Code List
Corrective Therapy
CL Item
yes (1)
CL Item
no (2)
Item
Was patient withdrawn due to this specific event prior to randomisation?
integer
C2348568 (UMLS CUI [1,1])
C0559546 (UMLS CUI [1,2])
C0424092 (UMLS CUI [1,3])
withdrawn due to this specific event prior to randomisation
Code List
Was patient withdrawn due to this specific event prior to randomisation?
CL Item
yes (1)
CL Item
no (2)
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-3)
C0031809 (UMLS CUI-5)
Item
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
integer
C0012634 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Medical condition or Surgery since previous study
Code List
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
CL Item
No (1)
CL Item
Yes (2)
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Diagnosis
Item
text
C0011900 (UMLS CUI [1])
Year of diagnosis
Item
Year of first diagnosis (if know)
partialDate
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item
Past and/or ongoing (diagnosis)
integer
C0011900 (UMLS CUI [1,1])
C0455458 (UMLS CUI [1,2])
C2826680 (UMLS CUI [2])
Past and/or ongoing medical history
Code List
Past and/or ongoing (diagnosis)
CL Item
Past (1)
CL Item
ongoing (2)
CL Item
past+ongoing (3)
Item Group
Patient continuation/ withdrawal
C2348568 (UMLS CUI-1)
Item
Is the patient continuing in the study?
integer
C2348568 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing study
Code List
Is the patient continuing in the study?
CL Item
Yes (1)
CL Item
No (2)
Item
Cause of withdrawal from study
text
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
undefined item
Code List
Cause of withdrawal from study
CL Item
Baseline sign and symptom (please complete Baseline Signs and Symptoms page)  (1)
CL Item
Does not meet inclusion/exclusion criteria (10)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify: (7)
Other cause of withdrawal from study
Item
Please specify 'other' cause of withdrawal from study.
text
C0422727 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Repeated Laboratory Evaluation
C0022877 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
abnormalities in blood sample
Code List
Were any clinically significant abnormalities detected?
CL Item
yes (1)
CL Item
no (2)
Item Group
Repeated Urine dipstick
C0430370 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine dipstick result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Positive (2)
CL Item
Negative (1)
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