ID
42817
Description
Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage
Keywords
Versions (4)
- 2/22/18 2/22/18 -
- 2/24/18 2/24/18 -
- 2/25/18 2/25/18 -
- 9/17/21 9/17/21 -
Copyright Holder
gsk
Uploaded on
September 17, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013
Serious Adverse Event (SAE)
Description
SECTION 2 Seriousness
Description
Seriousness (specify reason(s) for considering this a SAE, ttl all that apply
Data type
integer
Alias
- UMLS CUI [1]
- C1710056
Description
SECTION 3 Demography Data
Description
SECTION 4
Description
SECTION 5
Description
Possible Causes of SAE
Data type
integer
Alias
- UMLS CUI [1,1]
- C3828190
- UMLS CUI [1,2]
- C1519255
Description
SECTION 6
Description
RELEVANT Medical Conditions
Data type
integer
Alias
- UMLS CUI [1]
- C0012634
Description
Medical history
Data type
text
Alias
- UMLS CUI [1]
- C0262926
Description
Date of Onset
Data type
date
Alias
- UMLS CUI [1]
- C0574845
Description
Condition Present at Time of the SAE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Description
If No, Date of Last Occurrence
Data type
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Description
SECTION 7
Description
SECTION 8 RELEVANT Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Data type
integer
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Taken Prior to Study?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Stop Date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Ongoing Medication?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
SECTION 9: Drug Details
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1522508
Description
Start Date Investigational Product
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013230
Description
Stop Date Investigational Product
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0013230
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Stop Date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
SECTION 10: Details of RELEVANT Assessments
Alias
- UMLS CUI-1
- C0220825
Description
SECTION 11: Narrative Remarks
Description
Investigator's signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Provide a brief narrative description of the SAE and details of treatment given.
Data type
text
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