ID

34419

Description

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders This document asks if the subject is of child-bearing potential and which birth control methods the subject is using to prevent pregnancy during the study. This form should be filled out for female subjects at the screening visit.

Keywords

Versions (3)
  1. 1/11/19 1/11/19 -
  2. 1/13/19 1/13/19 -
  3. 1/17/19 1/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

English

Child Bearing Potential and Birth Control

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Child-Bearing Potential
Description

Child-Bearing Potential

Alias
UMLS CUI-1
C3831118
Tick one
Description

Complete for female subjects only - Pre-menarcheal: Females who have not begun to menstruate. - Post-menopausal: Women who have completed menopause at least one year ago. - Sterile: Pre-menopausal women who cannot conceive children. (This category includes women who have become sterile through surgical procedures such as tubal ligation. Do not include post-menopausal women in this category.) - Potentially able to bear children: Women of child-bearing age who are not sterile. Note: If the subject is sterile and is not of child-bearing age, then ‘post-menopausal’ will be the best choice and should be ticked. If the subject is sterile and does not know if she is post-menopausal and is less than 62 years of age, then she is of child-bearing age and ‘sterile’ should be ticked.

Data type

integer

Alias
UMLS CUI [1]
C3831118
Birth Control Methods
Description

Birth Control Methods

Alias
UMLS CUI-1
C0700589
Oral contraceptive
Description

Oral contraceptive

Data type

boolean

Alias
UMLS CUI [1]
C0009905
Intrauterine contraceptive device
Description

Intrauterine contraceptive device

Data type

boolean

Alias
UMLS CUI [1]
C0021900
Depot contraceptive (implants, injectables)
Description

Depot contraceptive (implants, injectables)

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0086129
Spermicide plus physical barrier
Description

Spermicide plus physical barrier

Data type

boolean

Alias
UMLS CUI [1,1]
C0037862
UMLS CUI [1,2]
C0004764
Physical Barrier (condom, diaphragm)
Description

Barrier method only if used in combination with any of the other acceptable contraception methods.

Data type

boolean

Alias
UMLS CUI [1]
C0004764
UMLS CUI [2]
C0042241
UMLS CUI [3]
C3873750
Abstinence
Description

Abstinence

Data type

boolean

Alias
UMLS CUI [1]
C3843422
Sterilization of male partner
Description

Sterilization of male partner

Data type

boolean

Alias
UMLS CUI [1]
C0024559
Other
Description

Other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
Other, specify
Description

Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
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Similar models

Child Bearing Potential and Birth Control

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Child-Bearing Potential
C3831118 (UMLS CUI-1)
Item
Tick one
integer
C3831118 (UMLS CUI [1])
Child-Bearig Potential
Code List
Tick one
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item Group
Birth Control Methods
C0700589 (UMLS CUI-1)
Oral contraceptive
Item
Oral contraceptive
boolean
C0009905 (UMLS CUI [1])
Intrauterine contraceptive device
Item
Intrauterine contraceptive device
boolean
C0021900 (UMLS CUI [1])
Depot contraceptive (implants, injectables)
Item
Depot contraceptive (implants, injectables)
boolean
C0700589 (UMLS CUI [1,1])
C0086129 (UMLS CUI [1,2])
Spermicide plus physical barrier
Item
Spermicide plus physical barrier
boolean
C0037862 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Physical Barrier (condom, diaphragm)
Item
Physical Barrier (condom, diaphragm)
boolean
C0004764 (UMLS CUI [1])
C0042241 (UMLS CUI [2])
C3873750 (UMLS CUI [3])
Abstinence
Item
Abstinence
boolean
C3843422 (UMLS CUI [1])
Sterilization of male partner
Item
Sterilization of male partner
boolean
C0024559 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1])
Other Specification
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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