ID
25643
Beschrijving
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
Trefwoorden
Versies (2)
- 08-09-17 08-09-17 -
- 10-05-19 10-05-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 september 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Pregnancy Notification Form Ropinirole Restless Legs Syndrome 101468/201
Pregnancy Notification Form
- StudyEvent: ODM
Beschrijving
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026591
Beschrijving
(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)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0026591
Beschrijving
Number of spontaneous abortion
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Beschrijving
Number of therapeutic abortion
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0032961
Beschrijving
Other
Datatype
text
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
Full term birth
Datatype
integer
Alias
- UMLS CUI [1]
- C3814420
Beschrijving
Pre term delivery
Datatype
integer
Alias
- UMLS CUI [1]
- C4314862
Beschrijving
Stillbirths
Datatype
integer
Alias
- UMLS CUI [1]
- C0595939
Beschrijving
Deliveries
Datatype
integer
Alias
- UMLS CUI [1]
- C0011209
Beschrijving
Children born with defects
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beschrijving
Normal Births
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Beschrijving
Outcome Unknown
Datatype
integer
Alias
- UMLS CUI [1]
- C0810347
Beschrijving
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
Beschrijving
Information provided by
Datatype
text
Alias
- UMLS CUI [1]
- C0518629
Beschrijving
Other
Datatype
text
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
(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)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
Beschrijving
Father Unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Beschrijving
Number of children
Datatype
integer
Alias
- UMLS CUI [1]
- C2229974
Beschrijving
Age
Datatype
integer
Maateenheden
- years
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Regimen Dosing
Datatype
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0178602
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
continuing therapy Concomitant Medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2347852
Beschrijving
Indication
Datatype
text
Alias
- UMLS CUI [1]
- C3146298
Beschrijving
CURRENT PREGNANCY INFORMATION
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
PREGNANCY STATUS
Alias
- UMLS CUI-1
- C0552579
Beschrijving
Pregnancy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0549206
Beschrijving
Delivery Method
Datatype
text
Alias
- UMLS CUI [1]
- C0565867
Beschrijving
Stillbirth
Datatype
boolean
Alias
- UMLS CUI [1]
- C0595939
Beschrijving
Fetal death
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015927
Beschrijving
Early Termination
Datatype
text
Alias
- UMLS CUI [1]
- C0156543
Beschrijving
FETAL/ NEONATAL STATUS
Alias
- UMLS CUI-1
- C3533197
Beschrijving
INFANT INFORMATION
Alias
- UMLS CUI-1
- C3840300
Beschrijving
Gestational weeks
Datatype
integer
Maateenheden
- Weeks
Alias
- UMLS CUI [1]
- C1954788
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C2348576
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Date of discharge
Datatype
date
Alias
- UMLS CUI [1]
- C2361123
Beschrijving
Length
Datatype
float
Alias
- UMLS CUI [1]
- C0221097
Beschrijving
Length
Datatype
float
Alias
- UMLS CUI [1]
- C0221097
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Apgar score
Datatype
integer
Alias
- UMLS CUI [1]
- C0003533
Beschrijving
multiple births
Datatype
integer
Alias
- UMLS CUI [1]
- C2015861
Beschrijving
Birth order
Datatype
integer
Alias
- UMLS CUI [1]
- C0005607
Beschrijving
Discharge summary notes
Datatype
text
Alias
- UMLS CUI [1]
- C1317307
Beschrijving
Additional details
Datatype
text
Alias
- UMLS CUI [1]
- C1546922
Beschrijving
RELEVANT LABORATORY TESTS & PROCEDURES
Alias
- UMLS CUI-1
- C0022885
Beschrijving
LABORATORY TESTS
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Causations
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085978
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Date
Datatype
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)
(Comment:en)
(Comment:en)
(Comment:en)