ID
42817
Beskrivning
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
Nyckelord
Versioner (4)
- 2018-02-22 2018-02-22 -
- 2018-02-24 2018-02-24 -
- 2018-02-25 2018-02-25 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
gsk
Uppladdad den
17 september 2021
DOI
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Licens
Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013
Serious Adverse Event (SAE)
Beskrivning
SECTION 2 Seriousness
Beskrivning
Seriousness (specify reason(s) for considering this a SAE, ttl all that apply
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
SECTION 3 Demography Data
Beskrivning
SECTION 4
Beskrivning
SECTION 5
Beskrivning
Possible Causes of SAE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3828190
- UMLS CUI [1,2]
- C1519255
Beskrivning
SECTION 6
Beskrivning
RELEVANT Medical Conditions
Datatyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beskrivning
Medical history
Datatyp
text
Alias
- UMLS CUI [1]
- C0262926
Beskrivning
Date of Onset
Datatyp
date
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
Condition Present at Time of the SAE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beskrivning
If No, Date of Last Occurrence
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Beskrivning
SECTION 7
Beskrivning
SECTION 8 RELEVANT Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Beskrivning
Drug Name
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Dose
Datatyp
integer
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Taken Prior to Study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
Stop Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Ongoing Medication?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
SECTION 9: Drug Details
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1522508
Beskrivning
Start Date Investigational Product
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013230
Beskrivning
Stop Date Investigational Product
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0013230
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
Stop Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
SECTION 10: Details of RELEVANT Assessments
Alias
- UMLS CUI-1
- C0220825
Beskrivning
SECTION 11: Narrative Remarks
Beskrivning
Investigator's signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator's name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Provide a brief narrative description of the SAE and details of treatment given.
Datatyp
text
Similar models
Serious Adverse Event (SAE)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0008976 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)
C0443172 (UMLS CUI-2)
(Comment:en)
C0178602 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C3840932 (UMLS CUI-2)
(Comment:en)
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C1521902 (UMLS CUI-2)
(Comment:en)
C0013227 (UMLS CUI-2)
(Comment:en)
C1519255 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])