ID
36395
Description
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.
Keywords
Versions (2)
- 9/8/17 9/8/17 -
- 5/10/19 5/10/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 10, 2019
DOI
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License
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
Description
REPORTER INFORMATION
Alias
- UMLS CUI-1
- C3840395
Description
Reporter name
Data type
text
Alias
- UMLS CUI [1]
- C1709908
Description
Title of reporter
Data type
text
Alias
- UMLS CUI [1]
- C3888414
Description
Address
Data type
text
Alias
- UMLS CUI [1]
- C1442065
Description
Telephone No
Data type
integer
Alias
- UMLS CUI [1]
- C1515258
Description
Fax No
Data type
integer
Alias
- UMLS CUI [1]
- C1549619
Description
City
Data type
text
Alias
- UMLS CUI [1]
- C2316883
Description
Postal Code
Data type
integer
Alias
- UMLS CUI [1]
- C1514254
Description
Country
Data type
text
Alias
- UMLS CUI [1]
- C1562954
Description
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026591
Description
(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)
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0026591
Description
Number of spontaneous abortion
Data type
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Description
Number of therapeutic abortion
Data type
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0032961
Description
Number of previous Pregnancies Terminations- Other
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0205394
Description
Full term birth
Data type
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C3814420
Description
Pre term delivery
Data type
integer
Alias
- UMLS CUI [1]
- C4314862
Description
Stillbirths
Data type
integer
Alias
- UMLS CUI [1]
- C0595939
Description
Deliveries
Data type
integer
Alias
- UMLS CUI [1]
- C0011209
Description
provide details under mother’s history
Data type
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Description
Normal Births
Data type
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Description
Birth, Outcome Unknown
Data type
integer
Alias
- UMLS CUI [1]
- C0810347
Description
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
Description
Information provided by
Data type
integer
Alias
- UMLS CUI [1]
- C0518629
Description
Information provided by Other
Data type
text
Alias
- UMLS CUI [1]
- C0518629
Description
(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)
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
Description
Father Unknown
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Description
Number of children
Data type
integer
Alias
- UMLS CUI [1]
- C2229974
Description
Age of father
Data type
integer
Measurement units
- years
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0001779
Description
Race of father
Data type
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0034510
Description
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant Medication
Data type
text
Alias
- UMLS CUI [1]
- C2347852
Description
Regimen Dosing
Data type
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0178602
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Continuing therapy Concomitant Medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2347852
Description
Indication
Data type
text
Alias
- UMLS CUI [1]
- C3146298
Description
CURRENT PREGNANCY INFORMATION
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0425932
Description
Last menstruation Unknown
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C1287845
Description
Pregnancy status
Data type
integer
Alias
- UMLS CUI [1]
- C0552579
Description
Delivery Method
Data type
text
Alias
- UMLS CUI [1]
- C0565867
Description
If you tick other, please note details in "Additional details" section below.
Data type
integer
Alias
- UMLS CUI [1]
- C0156543
Description
If you tick Birth defect, please note details in "Additional details" below.
Data type
integer
Alias
- UMLS CUI [1]
- C3533197
Description
INFANT INFORMATION
Alias
- UMLS CUI-1
- C3840300
Description
Gestational weeks
Data type
integer
Measurement units
- Weeks
Alias
- UMLS CUI [1]
- C1954788
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2348576
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2361123
Description
Length of infant, cm
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0221097
Description
Length of infant, inches
Data type
float
Measurement units
- inches
Alias
- UMLS CUI [1]
- C0221097
Description
Weight of infant, kg
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Weight of infant, lb
Data type
float
Measurement units
- lb
Alias
- UMLS CUI [1]
- C0005910
Description
Apgar score
Data type
integer
Alias
- UMLS CUI [1]
- C0003533
Description
Multiple births
Data type
integer
Alias
- UMLS CUI [1]
- C2015861
Description
(1,2,3,etc) send separate form for each child.
Data type
integer
Alias
- UMLS CUI [1]
- C0005607
Description
Discharge summary notes
Data type
text
Alias
- UMLS CUI [1]
- C1317307
Description
Additional details
Data type
text
Alias
- UMLS CUI [1]
- C1546922
Description
RELEVANT LABORATORY TESTS & PROCEDURES
Alias
- UMLS CUI-1
- C0022885
Description
(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.
Data type
text
Alias
- UMLS CUI [1]
- C0022885
Description
Causations
Data type
text
Alias
- UMLS CUI [1]
- C0085978
Description
(if not the same as reporter)
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Reporter’s signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
day month year
Data type
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])