ID
42817
Beschrijving
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
Trefwoorden
Versies (4)
- 22-02-18 22-02-18 -
- 24-02-18 24-02-18 -
- 25-02-18 25-02-18 -
- 17-09-21 17-09-21 -
Houder van rechten
gsk
Geüploaded op
17 september 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013
Serious Adverse Event (SAE)
Beschrijving
SECTION 2 Seriousness
Beschrijving
Seriousness (specify reason(s) for considering this a SAE, ttl all that apply
Datatype
integer
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
SECTION 3 Demography Data
Beschrijving
SECTION 4
Beschrijving
SECTION 5
Beschrijving
Possible Causes of SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3828190
- UMLS CUI [1,2]
- C1519255
Beschrijving
SECTION 6
Beschrijving
RELEVANT Medical Conditions
Datatype
integer
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Medical history
Datatype
text
Alias
- UMLS CUI [1]
- C0262926
Beschrijving
Date of Onset
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Condition Present at Time of the SAE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beschrijving
If No, Date of Last Occurrence
Datatype
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Beschrijving
SECTION 7
Beschrijving
SECTION 8 RELEVANT Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Beschrijving
Drug Name
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Dose
Datatype
integer
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Taken Prior to Study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Ongoing Medication?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
SECTION 9: Drug Details
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1522508
Beschrijving
Start Date Investigational Product
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013230
Beschrijving
Stop Date Investigational Product
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0013230
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
SECTION 10: Details of RELEVANT Assessments
Alias
- UMLS CUI-1
- C0220825
Beschrijving
SECTION 11: Narrative Remarks
Beschrijving
Investigator's signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator's name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Provide a brief narrative description of the SAE and details of treatment given.
Datatype
text
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