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32652

Description

This ODM-file contains the form to document the childbearing potential, birth control methods and medical conditions of the subject. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

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Versions (2)
  1. 10/31/18 10/31/18 -
  2. 11/9/18 11/9/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 9, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

    English

    Childbearing Potential, Birth Control Methods and Medical Conditions

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Child-bearing Potential (Complete for Female Subjects Only)
    Description

    Child-bearing Potential (Complete for Female Subjects Only)

    Alias
    UMLS CUI-1
    C3831118
    UMLS CUI-2
    C0086287
    Tick one:
    Description

    Childbearing Potential

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3831118
    Birth Control Methods
    Description

    Birth Control Methods

    Alias
    UMLS CUI-1
    C0700589
    Oral contraceptive
    Description

    If female is potentially able to bear children, tick Yes or No

    Data type

    text

    Alias
    UMLS CUI [1]
    C0009905
    Intrauterine contraceptive device
    Description

    If female is potentially able to bear children, tick Yes or No

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021900
    UMLS CUI [1,2]
    C0700589
    Depot contraceptive (implants, injectables)
    Description

    If female is potentially able to bear children, tick Yes or No

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0086466
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C0086129
    UMLS CUI [2,1]
    C0021102
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [2,3]
    C0086129
    Spermicide plus physical barrier
    Description

    If female is potentially able to bear children, tick Yes or No

    Data type

    text

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

    If female is potentially able to bear children, tick Yes or No Barrier method only if used in combination with any of the other acceptable contraception methods.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004764
    UMLS CUI [1,2]
    C0677582
    UMLS CUI [2,1]
    C0004764
    UMLS CUI [2,2]
    C0042241
    Abstinence
    Description

    If female is potentially able to bear children, tick Yes or No

    Data type

    text

    Alias
    UMLS CUI [1]
    C0036899
    Sterilization of male partner
    Description

    If female is potentially able to bear children, tick Yes or No

    Data type

    text

    Alias
    UMLS CUI [1]
    C0024559
    Other
    Description

    If female is potentially able to bear children, tick Yes or No

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0205394
    If another contraceptive method is used: specify
    Description

    Other Contraceptive Method, Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Medical Conditions
    Description

    Medical Conditions

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0009488
    Blood and lymphatic system disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0851353
    Cardiac disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018799
    Ear and labyrinth disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0851354
    Endocrine disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0014130
    Eye disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015397
    Gastrointestinal disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0017178
    Hepatobiliary disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0267792
    Immune system disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0021053
    Metabolism and nutrition disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0851358
    Musculoskeletal and connective tissue disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0263660
    Nervous system disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0027765
    Psychiatric disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0004936
    Renal and urinary disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042075
    Reproductive system and breast disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0851366
    Respiratory, thoracic and mediastinal disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0851355
    Skin and subcutaneous tissue disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178301
    Vascular disorders
    Description

    DEFINITIONS CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. NO MEDICAL CONDITION Condition not present. NOT ASSESSED Procedure not performed, unable to diagnose. INVESTIGATOR INSTRUCTIONS Do not include the condition being treated in the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042373
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    Similar models

    Childbearing Potential, Birth Control Methods and Medical Conditions

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Child-bearing Potential (Complete for Female Subjects Only)
    C3831118 (UMLS CUI-1)
    C0086287 (UMLS CUI-2)
    Item
    Tick one:
    integer
    C3831118 (UMLS CUI [1])
    Childbearing 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)
    Item
    Oral contraceptive
    text
    C0009905 (UMLS CUI [1])
    Oral contraceptive
    Code List
    Oral contraceptive
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Intrauterine contraceptive device
    text
    C0021900 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Intrauterine contraceptive device
    Code List
    Intrauterine contraceptive device
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Depot contraceptive (implants, injectables)
    text
    C0086466 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0086129 (UMLS CUI [1,3])
    C0021102 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C0086129 (UMLS CUI [2,3])
    Depot contraceptive (implants, injectables)
    Code List
    Depot contraceptive (implants, injectables)
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Spermicide plus physical barrier
    text
    C0037862 (UMLS CUI [1,1])
    C0004764 (UMLS CUI [1,2])
    Spermicide plus physical barrier
    Code List
    Spermicide plus physical barrier
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Physical Barrier (condom, diaphragm)
    text
    C0004764 (UMLS CUI [1,1])
    C0677582 (UMLS CUI [1,2])
    C0004764 (UMLS CUI [2,1])
    C0042241 (UMLS CUI [2,2])
    Physical Barrier (condom, diaphragm)
    Code List
    Physical Barrier (condom, diaphragm)
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Abstinence
    text
    C0036899 (UMLS CUI [1])
    Sexual Abstinence
    Code List
    Abstinence
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Sterilization of male partner
    text
    C0024559 (UMLS CUI [1])
    Sterilization of male partner
    Code List
    Sterilization of male partner
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Other
    text
    C0700589 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other Contraceptive Method
    Code List
    Other
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Other Contraceptive Method, Specification
    Item
    If another contraceptive method is used: specify
    text
    C0700589 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Medical Conditions
    C0262926 (UMLS CUI-1)
    C0009488 (UMLS CUI-2)
    Item
    Blood and lymphatic system disorders
    integer
    C0851353 (UMLS CUI [1])
    Blood and lymphatic system disorders
    Code List
    Blood and lymphatic system disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Cardiac disorders
    integer
    C0018799 (UMLS CUI [1])
    Cardiac disorders
    Code List
    Cardiac disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Ear and labyrinth disorders
    integer
    C0851354 (UMLS CUI [1])
    Ear and labyrinth disorders
    Code List
    Ear and labyrinth disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Endocrine disorders
    integer
    C0014130 (UMLS CUI [1])
    Endocrine disorders
    Code List
    Endocrine disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Eye disorders
    integer
    C0015397 (UMLS CUI [1])
    Eye disorders
    Code List
    Eye disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Gastrointestinal disorders
    integer
    C0017178 (UMLS CUI [1])
    Gastrointestinal disorders
    Code List
    Gastrointestinal disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Hepatobiliary disorders
    integer
    C0267792 (UMLS CUI [1])
    Hepatobiliary disorders
    Code List
    Hepatobiliary disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Immune system disorders
    integer
    C0021053 (UMLS CUI [1])
    Immune system disorders
    Code List
    Immune system disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Metabolism and nutrition disorders
    integer
    C0851358 (UMLS CUI [1])
    Metabolism and nutrition disorders
    Code List
    Metabolism and nutrition disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Musculoskeletal and connective tissue disorders
    integer
    C0263660 (UMLS CUI [1])
    Musculoskeletal and connective tissue disorders
    Code List
    Musculoskeletal and connective tissue disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Nervous system disorders
    integer
    C0027765 (UMLS CUI [1])
    Nervous system disorders
    Code List
    Nervous system disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Psychiatric disorders
    integer
    C0004936 (UMLS CUI [1])
    Psychiatric disorders
    Code List
    Psychiatric disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Renal and urinary disorders
    integer
    C0042075 (UMLS CUI [1])
    Renal and urinary disorders
    Code List
    Renal and urinary disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Reproductive system and breast disorders
    integer
    C0851366 (UMLS CUI [1])
    Reproductive system and breast disorders
    Code List
    Reproductive system and breast disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Respiratory, thoracic and mediastinal disorders
    integer
    C0851355 (UMLS CUI [1])
    Respiratory, thoracic and mediastinal disorders
    Code List
    Respiratory, thoracic and mediastinal disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Skin and subcutaneous tissue disorders
    integer
    C0178301 (UMLS CUI [1])
    Skin and subcutaneous tissue disorders
    Code List
    Skin and subcutaneous tissue disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
    Item
    Vascular disorders
    integer
    C0042373 (UMLS CUI [1])
    Vascular disorders
    Code List
    Vascular disorders
    CL Item
    Current (1)
    CL Item
    No Medical Condition (5)
    CL Item
    Not Assessed (4)
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