ID
25643
Beskrivning
Study part: Pregnancy Notification Form. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Phase: phase 1. 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. Study ID: 101468/201. Clinical Study ID: 101468/201
Nyckelord
Versioner (2)
- 2017-09-08 2017-09-08 -
- 2019-05-10 2019-05-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 september 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Pregnancy Notification Form Ropinirole Restless Legs Syndrome 101468/201
Pregnancy Notification Form
- StudyEvent: ODM
Beskrivning
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026591
Beskrivning
(i.e. Include alcohol/tobacco and substance abuse, complications of past pregnancy, labor/delivery, fetus/baby, illness during this pregnancy, assisted conception: specify, other disorders including familial birth defects/genetic/chromosomal disorders, methods of diagnosis consanguinity etc)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0026591
Beskrivning
Number of spontaneous abortion
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Beskrivning
Number of therapeutic abortion
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0032961
Beskrivning
Other
Datatyp
text
Alias
- UMLS CUI [1]
- C0205394
Beskrivning
Full term birth
Datatyp
integer
Alias
- UMLS CUI [1]
- C3814420
Beskrivning
Pre term delivery
Datatyp
integer
Alias
- UMLS CUI [1]
- C4314862
Beskrivning
Stillbirths
Datatyp
integer
Alias
- UMLS CUI [1]
- C0595939
Beskrivning
Deliveries
Datatyp
integer
Alias
- UMLS CUI [1]
- C0011209
Beskrivning
Children born with defects
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beskrivning
Normal Births
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Beskrivning
Outcome Unknown
Datatyp
integer
Alias
- UMLS CUI [1]
- C0810347
Beskrivning
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
Beskrivning
Information provided by
Datatyp
text
Alias
- UMLS CUI [1]
- C0518629
Beskrivning
Other
Datatyp
text
Alias
- UMLS CUI [1]
- C0205394
Beskrivning
(i.e. Include chronic illnesses: specify, familial birth defects/genetic/chromosomal disorders, habitual exposure: specify, alcohol/tobacco, drug exposure: specify, substance abuse and medication use)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
Beskrivning
Father Unknown
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Beskrivning
Number of children
Datatyp
integer
Alias
- UMLS CUI [1]
- C2229974
Beskrivning
Age
Datatyp
integer
Måttenheter
- years
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Concomitant Medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Regimen Dosing
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0178602
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
continuing therapy Concomitant Medication
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2347852
Beskrivning
Indication
Datatyp
text
Alias
- UMLS CUI [1]
- C3146298
Beskrivning
CURRENT PREGNANCY INFORMATION
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
PREGNANCY STATUS
Alias
- UMLS CUI-1
- C0552579
Beskrivning
Pregnancy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0549206
Beskrivning
Delivery Method
Datatyp
text
Alias
- UMLS CUI [1]
- C0565867
Beskrivning
Stillbirth
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0595939
Beskrivning
Fetal death
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015927
Beskrivning
Early Termination
Datatyp
text
Alias
- UMLS CUI [1]
- C0156543
Beskrivning
FETAL/ NEONATAL STATUS
Alias
- UMLS CUI-1
- C3533197
Beskrivning
INFANT INFORMATION
Alias
- UMLS CUI-1
- C3840300
Beskrivning
Gestational weeks
Datatyp
integer
Måttenheter
- Weeks
Alias
- UMLS CUI [1]
- C1954788
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C2348576
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Date of discharge
Datatyp
date
Alias
- UMLS CUI [1]
- C2361123
Beskrivning
Length
Datatyp
float
Alias
- UMLS CUI [1]
- C0221097
Beskrivning
Length
Datatyp
float
Alias
- UMLS CUI [1]
- C0221097
Beskrivning
Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Apgar score
Datatyp
integer
Alias
- UMLS CUI [1]
- C0003533
Beskrivning
multiple births
Datatyp
integer
Alias
- UMLS CUI [1]
- C2015861
Beskrivning
Birth order
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005607
Beskrivning
Discharge summary notes
Datatyp
text
Alias
- UMLS CUI [1]
- C1317307
Beskrivning
Additional details
Datatyp
text
Alias
- UMLS CUI [1]
- C1546922
Beskrivning
RELEVANT LABORATORY TESTS & PROCEDURES
Alias
- UMLS CUI-1
- C0022885
Beskrivning
LABORATORY TESTS
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Causations
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085978
Beskrivning
Investigator Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
Pregnancy Notification Form
- StudyEvent: ODM
C0026591 (UMLS CUI-2)
C0026591 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C2229974 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0015671 (UMLS CUI-2)
C0015671 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
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