ID
36395
Descripción
Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: 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 Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pregnancy Notification Form. It has to be filled in for each patient who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. After delivery complete the remaining sections and fax the form to GSK. Original pages should remain with the subject’s Case Report Form.
Palabras clave
Versiones (2)
- 8/9/17 8/9/17 -
- 10/5/19 10/5/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
10 de mayo de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Pregnancy Notification Form
- StudyEvent: ODM
Descripción
REPORTER INFORMATION
Alias
- UMLS CUI-1
- C3840395
Descripción
Reporter name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1709908
Descripción
Title of reporter
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3888414
Descripción
Address
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1442065
Descripción
Telephone No
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1515258
Descripción
Fax No
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1549619
Descripción
City
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2316883
Descripción
Postal Code
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1514254
Descripción
Country
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1562954
Descripción
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026591
Descripción
(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)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0026591
Descripción
Number of spontaneous abortion
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Descripción
Number of therapeutic abortion
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0032961
Descripción
Number of previous Pregnancies Terminations- Other
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0205394
Descripción
Full term birth
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C3814420
Descripción
Pre term delivery
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C4314862
Descripción
Stillbirths
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0595939
Descripción
Deliveries
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0011209
Descripción
provide details under mother’s history
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Descripción
Normal Births
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Descripción
Birth, Outcome Unknown
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0810347
Descripción
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
Descripción
Information provided by
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0518629
Descripción
Information provided by Other
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0518629
Descripción
(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)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
Descripción
Father Unknown
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Descripción
Number of children
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2229974
Descripción
Age of father
Tipo de datos
integer
Unidades de medida
- years
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0001779
Descripción
Race of father
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0034510
Descripción
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Descripción
Concomitant Medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2347852
Descripción
Regimen Dosing
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0178602
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0808070
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0806020
Descripción
Continuing therapy Concomitant Medication
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2347852
Descripción
Indication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3146298
Descripción
CURRENT PREGNANCY INFORMATION
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0425932
Descripción
Last menstruation Unknown
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1287845
Descripción
Pregnancy status
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0552579
Descripción
Delivery Method
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0565867
Descripción
If you tick other, please note details in "Additional details" section below.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0156543
Descripción
If you tick Birth defect, please note details in "Additional details" below.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3533197
Descripción
INFANT INFORMATION
Alias
- UMLS CUI-1
- C3840300
Descripción
Gestational weeks
Tipo de datos
integer
Unidades de medida
- Weeks
Alias
- UMLS CUI [1]
- C1954788
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2348576
Descripción
Sex
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2361123
Descripción
Length of infant, cm
Tipo de datos
float
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0221097
Descripción
Length of infant, inches
Tipo de datos
float
Unidades de medida
- inches
Alias
- UMLS CUI [1]
- C0221097
Descripción
Weight of infant, kg
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Weight of infant, lb
Tipo de datos
float
Unidades de medida
- lb
Alias
- UMLS CUI [1]
- C0005910
Descripción
Apgar score
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0003533
Descripción
Multiple births
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2015861
Descripción
(1,2,3,etc) send separate form for each child.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0005607
Descripción
Discharge summary notes
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1317307
Descripción
Additional details
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1546922
Descripción
RELEVANT LABORATORY TESTS & PROCEDURES
Alias
- UMLS CUI-1
- C0022885
Descripción
(e.g., ultrasound, amniocentesis, chorionic villi sampling, autopsy on products of gestation) In case of an abnormal evolution or outcome, please send a copy of all relevant laboratory tests and procedures and complete the AE or SAE form as appropriate.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0022885
Descripción
Causations
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0085978
Descripción
(if not the same as reporter)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Reporter’s signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- 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])
C0205394 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C3814420 (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])
C0001779 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C0439673 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])