ID

36395

Beschreibung

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.

Stichworte

Versionen (2)
  1. 08.09.17 08.09.17 -
  2. 10.05.19 10.05.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Mai 2019

DOI

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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

Englisch

Pregnancy Notification Form

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
REPORTER INFORMATION
Beschreibung

REPORTER INFORMATION

Alias
UMLS CUI-1
C3840395
Reporter name
Beschreibung

Reporter name

Datentyp

text

Alias
UMLS CUI [1]
C1709908
Title of reporter
Beschreibung

Title of reporter

Datentyp

text

Alias
UMLS CUI [1]
C3888414
Address
Beschreibung

Address

Datentyp

text

Alias
UMLS CUI [1]
C1442065
Telephone No
Beschreibung

Telephone No

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Fax No
Beschreibung

Fax No

Datentyp

integer

Alias
UMLS CUI [1]
C1549619
City, State/Province
Beschreibung

City

Datentyp

text

Alias
UMLS CUI [1]
C2316883
Postal Code
Beschreibung

Postal Code

Datentyp

integer

Alias
UMLS CUI [1]
C1514254
Country
Beschreibung

Country

Datentyp

text

Alias
UMLS CUI [1]
C1562954
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Beschreibung

MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0026591
Family or Medical History
Beschreibung

(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)

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0026591
Number of spontaneous abortion
Beschreibung

Number of spontaneous abortion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0000786
UMLS CUI [1,2]
C0449788
Number of therapeutic abortion
Beschreibung

Number of therapeutic abortion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0032961
Number of previous Pregnancies Terminations- Other
Beschreibung

Number of previous Pregnancies Terminations- Other

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C0205394
Number of Full term birth
Beschreibung

Full term birth

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C3814420
Number of Pre term
Beschreibung

Pre term delivery

Datentyp

integer

Alias
UMLS CUI [1]
C4314862
Number of stillbirths
Beschreibung

Stillbirths

Datentyp

integer

Alias
UMLS CUI [1]
C0595939
Number of Deliveries
Beschreibung

Deliveries

Datentyp

integer

Alias
UMLS CUI [1]
C0011209
Number of Children born with defects
Beschreibung

provide details under mother’s history

Datentyp

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2229974
Number of normal Births
Beschreibung

Normal Births

Datentyp

integer

Alias
UMLS CUI [1,1]
C3665337
UMLS CUI [1,2]
C0449788
Outcome Unknown
Beschreibung

Birth, Outcome Unknown

Datentyp

integer

Alias
UMLS CUI [1]
C0810347
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Beschreibung

FATHER’S RELEVANT MEDICAL/FAMILY HISTORY

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0015671
Information provided by:
Beschreibung

Information provided by

Datentyp

integer

Alias
UMLS CUI [1]
C0518629
If information provided by Other, please specify
Beschreibung

Information provided by Other

Datentyp

text

Alias
UMLS CUI [1]
C0518629
Medical Or Family History
Beschreibung

(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)

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0015671
Check the box If father is unknown
Beschreibung

Father Unknown

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0439673
Number of children
Beschreibung

Number of children

Datentyp

integer

Alias
UMLS CUI [1]
C2229974
Age of father
Beschreibung

Age of father

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0001779
years
Race of father
Beschreibung

Race of father

Datentyp

text

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0034510
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Beschreibung

GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
Reported Drug/ Vaccine/OTC name (generic or trade name)
Beschreibung

Concomitant Medication

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Dosing Regimen and Frequency of Dosing
Beschreibung

Regimen Dosing

Datentyp

text

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0178602
Start Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End Date or Check Box if Continuing
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Continuing therapy Concomitant Medication
Beschreibung

Continuing therapy Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2347852
Indication
Beschreibung

Indication

Datentyp

text

Alias
UMLS CUI [1]
C3146298
CURRENT PREGNANCY INFORMATION
Beschreibung

CURRENT PREGNANCY INFORMATION

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Date of last menstrual period or check box below if unknown.
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0425932
Last menstruation Unknown
Beschreibung

Last menstruation Unknown

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0425932
UMLS CUI [1,2]
C0439673
Estimated date of delivery
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1287845
Pregnancy status
Beschreibung

Pregnancy status

Datentyp

integer

Alias
UMLS CUI [1]
C0552579
If Delivery, please specify method
Beschreibung

Delivery Method

Datentyp

text

Alias
UMLS CUI [1]
C0565867
If Early Termination, please specify
Beschreibung

If you tick other, please note details in "Additional details" section below.

Datentyp

integer

Alias
UMLS CUI [1]
C0156543
Fetal/Neonatal Status
Beschreibung

If you tick Birth defect, please note details in "Additional details" below.

Datentyp

integer

Alias
UMLS CUI [1]
C3533197
INFANT INFORMATION
Beschreibung

INFANT INFORMATION

Alias
UMLS CUI-1
C3840300
Gestational weeks at birth/miscarriage/ termination
Beschreibung

Gestational weeks

Datentyp

integer

Maßeinheiten
  • Weeks
Alias
UMLS CUI [1]
C1954788
Weeks
Date of birth/miscarriage/termination
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2348576
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Date of discharge
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2361123
Length in cm
Beschreibung

Length of infant, cm

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0221097
cm
Length in inches
Beschreibung

Length of infant, inches

Datentyp

float

Maßeinheiten
  • inches
Alias
UMLS CUI [1]
C0221097
inches
Weight in kg
Beschreibung

Weight of infant, kg

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight in lb
Beschreibung

Weight of infant, lb

Datentyp

float

Maßeinheiten
  • lb
Alias
UMLS CUI [1]
C0005910
lb
Apgar score (0-10)
Beschreibung

Apgar score

Datentyp

integer

Alias
UMLS CUI [1]
C0003533
If multiple births (e.g., twins), indicate number
Beschreibung

Multiple births

Datentyp

integer

Alias
UMLS CUI [1]
C2015861
Birth order
Beschreibung

(1,2,3,etc) send separate form for each child.

Datentyp

integer

Alias
UMLS CUI [1]
C0005607
Discharge summary notes
Beschreibung

Discharge summary notes

Datentyp

text

Alias
UMLS CUI [1]
C1317307
Additional details on current pregnancy, labor/delivery, fetus and/or infant
Beschreibung

Additional details

Datentyp

text

Alias
UMLS CUI [1]
C1546922
RELEVANT LABORATORY TESTS & PROCEDURES
Beschreibung

RELEVANT LABORATORY TESTS & PROCEDURES

Alias
UMLS CUI-1
C0022885
RELEVANT LABORATORY TESTS and PROCEDURES
Beschreibung

(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.

Datentyp

text

Alias
UMLS CUI [1]
C0022885
If any problems occurred, do you believe they may be drug ( or vaccine) related?
Beschreibung

Causations

Datentyp

text

Alias
UMLS CUI [1]
C0085978
Investigator Name
Beschreibung

(if not the same as reporter)

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Reporter’s signature
Beschreibung

Reporter’s signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Pregnancy Notification Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
REPORTER INFORMATION
C3840395 (UMLS CUI-1)
Reporter name
Item
Reporter name
text
C1709908 (UMLS CUI [1])
Title of reporter
Item
Title of reporter
text
C3888414 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1])
Telephone No
Item
Telephone No
integer
C1515258 (UMLS CUI [1])
Fax No
Item
Fax No
integer
C1549619 (UMLS CUI [1])
City
Item
City, State/Province
text
C2316883 (UMLS CUI [1])
Postal Code
Item
Postal Code
integer
C1514254 (UMLS CUI [1])
Country
Item
Country
text
C1562954 (UMLS CUI [1])
Item Group
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
C0262926 (UMLS CUI-1)
C0026591 (UMLS CUI-2)
Medical history mother
Item
Family or Medical History
text
C0262926 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
Number of spontaneous abortion
Item
Number of spontaneous abortion
integer
C0000786 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of therapeutic abortion
Item
Number of therapeutic abortion
integer
C0030705 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Number of previous Pregnancies Terminations- Other
Item
Number of previous Pregnancies Terminations- Other
integer
C0422807 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Full term birth
Item
Number of Full term birth
integer
C0030705 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C3814420 (UMLS CUI [1,3])
Pre term delivery
Item
Number of Pre term
integer
C4314862 (UMLS CUI [1])
Stillbirths
Item
Number of stillbirths
integer
C0595939 (UMLS CUI [1])
Deliveries
Item
Number of Deliveries
integer
C0011209 (UMLS CUI [1])
Children born with defects
Item
Number of Children born with defects
integer
C0000768 (UMLS CUI [1,1])
C2229974 (UMLS CUI [1,2])
Normal Births
Item
Number of normal Births
integer
C3665337 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Birth, Outcome Unknown
Item
Outcome Unknown
integer
C0810347 (UMLS CUI [1])
Item Group
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
C0262926 (UMLS CUI-1)
C0015671 (UMLS CUI-2)
Item
Information provided by:
integer
C0518629 (UMLS CUI [1])
Information provided by
Code List
Information provided by:
CL Item
Father (1)
CL Item
Other (2)
Information provided by Other
Item
If information provided by Other, please specify
text
C0518629 (UMLS CUI [1])
Medical history father
Item
Medical Or Family History
text
C0262926 (UMLS CUI [1,1])
C0015671 (UMLS CUI [1,2])
Father Unknown
Item
Check the box If father is unknown
boolean
C0015671 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Number of children
Item
Number of children
integer
C2229974 (UMLS CUI [1])
Age of father
Item
Age of father
integer
C0015671 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Race of father
Item
Race of father
text
C0015671 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Item Group
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Reported Drug/ Vaccine/OTC name (generic or trade name)
text
C2347852 (UMLS CUI [1])
Regimen Dosing
Item
Dosing Regimen and Frequency of Dosing
text
C1276413 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date or Check Box if Continuing
date
C0806020 (UMLS CUI [1])
Continuing therapy Concomitant Medication
Item
Continuing therapy Concomitant Medication
boolean
C1553904 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Item Group
CURRENT PREGNANCY INFORMATION
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Date of last menstrual period
Item
Date of last menstrual period or check box below if unknown.
date
C0425932 (UMLS CUI [1])
Last menstruation Unknown
Item
Last menstruation Unknown
boolean
C0425932 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
Item
Pregnancy status
integer
C0552579 (UMLS CUI [1])
Pregnancy status
Code List
Pregnancy status
CL Item
Pregnancy Ongoing (1)
CL Item
Stillbirth (2)
CL Item
Delivery  (3)
CL Item
Fetal death (4)
CL Item
Early Termination (5)
Delivery Method
Item
If Delivery, please specify method
text
C0565867 (UMLS CUI [1])
Item
If Early Termination, please specify
integer
C0156543 (UMLS CUI [1])
Early Termination
Code List
If Early Termination, please specify
CL Item
Spontaneous abortion (1)
CL Item
Therapeutic abortion (2)
CL Item
Other (3)
Item
Fetal/Neonatal Status
integer
C3533197 (UMLS CUI [1])
Neonatal status
Code List
Fetal/Neonatal Status
CL Item
Normal  (1)
CL Item
Birth defect (structural/chromosomal disorder) (2)
CL Item
Other disorder (non-structural, premature birth,intrauterine death/stillbirth) (3)
Item Group
INFANT INFORMATION
C3840300 (UMLS CUI-1)
Gestational weeks
Item
Gestational weeks at birth/miscarriage/ termination
integer
C1954788 (UMLS CUI [1])
Date of birth
Item
Date of birth/miscarriage/termination
date
C2348576 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
CL Item
Unknown (U)
Date of discharge
Item
Date of discharge
date
C2361123 (UMLS CUI [1])
Length of infant, cm
Item
Length in cm
float
C0221097 (UMLS CUI [1])
Length of infant, inches
Item
Length in inches
float
C0221097 (UMLS CUI [1])
Weight of infant, kg
Item
Weight in kg
float
C0005910 (UMLS CUI [1])
Weight of infant, lb
Item
Weight in lb
float
C0005910 (UMLS CUI [1])
Apgar score
Item
Apgar score (0-10)
integer
C0003533 (UMLS CUI [1])
Multiple births
Item
If multiple births (e.g., twins), indicate number
integer
C2015861 (UMLS CUI [1])
Birth order
Item
Birth order
integer
C0005607 (UMLS CUI [1])
Discharge summary notes
Item
Discharge summary notes
text
C1317307 (UMLS CUI [1])
Additional details
Item
Additional details on current pregnancy, labor/delivery, fetus and/or infant
text
C1546922 (UMLS CUI [1])
Item Group
RELEVANT LABORATORY TESTS & PROCEDURES
C0022885 (UMLS CUI-1)
LABORATORY TESTS
Item
RELEVANT LABORATORY TESTS and PROCEDURES
text
C0022885 (UMLS CUI [1])
Item
If any problems occurred, do you believe they may be drug ( or vaccine) related?
text
C0085978 (UMLS CUI [1])
Causations
Code List
If any problems occurred, do you believe they may be drug ( or vaccine) related?
CL Item
Yes (Y)
CL Item
No (N)
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Reporter’s signature
Item
Reporter’s signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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