ID

32430

Beschreibung

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

Stichworte

Versionen (2)
  1. 31.10.18 31.10.18 -
  2. 09.11.18 09.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

31. Oktober 2018

DOI

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

Englisch

Childbearing Potential, Birth Control Methods and Medical Conditions

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

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

Child-bearing Potential (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C3831118
UMLS CUI-2
C0086287
✔ one:
Beschreibung

Childbearing Potential

Datentyp

integer

Birth Control Methods
Beschreibung

Birth Control Methods

Alias
UMLS CUI-1
C0700589
Oral contraceptive
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0009905
Intrauterine contraceptive device
Beschreibung

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

Datentyp

text

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

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

Datentyp

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
Beschreibung

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

Alias
UMLS CUI [1]
C0024559
Other
Beschreibung

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

Datentyp

text

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

Other Contraceptive Method, Specification

Datentyp

text

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

Medical Conditions

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

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0851353
Cardiac disorders
Beschreibung

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.

Datentyp

integer

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

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0851354
Endocrine disorders
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0014130
Eye disorders
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0015397
Gastrointestinal disorders
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0017178
Hepatobiliary disorders
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0267792
Immune system disorders
Beschreibung

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.

Datentyp

integer

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

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.

Datentyp

integer

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

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0263660
Nervous system disorders
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0027765
Psychiatric disorders
Beschreibung

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.

Datentyp

integer

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

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.

Datentyp

integer

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

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.

Datentyp

integer

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

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.

Datentyp

integer

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

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0178301
Vascular disorders
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1]
C0042373
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Ähnliche Modelle

Childbearing Potential, Birth Control Methods and Medical Conditions

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
✔ one:
integer
Childbearing Potential
Code List
✔ 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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