ID
32430
Beskrivning
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
Nyckelord
Versioner (2)
- 2018-10-31 2018-10-31 -
- 2018-11-09 2018-11-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
31 oktober 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999
Childbearing Potential, Birth Control Methods and Medical Conditions
Beskrivning
Child-bearing Potential (Complete for Female Subjects Only)
Alias
- UMLS CUI-1
- C3831118
- UMLS CUI-2
- C0086287
Beskrivning
Birth Control Methods
Alias
- UMLS CUI-1
- C0700589
Beskrivning
If female is potentially able to bear children, ✔Yes or No
Datatyp
text
Alias
- UMLS CUI [1]
- C0009905
Beskrivning
If female is potentially able to bear children, ✔Yes or No
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0021900
- UMLS CUI [1,2]
- C0700589
Beskrivning
If female is potentially able to bear children, ✔Yes or No
Datatyp
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
Beskrivning
If female is potentially able to bear children, ✔Yes or No
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037862
- UMLS CUI [1,2]
- C0004764
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004764
- UMLS CUI [1,2]
- C0677582
- UMLS CUI [2,1]
- C0004764
- UMLS CUI [2,2]
- C0042241
Beskrivning
If female is potentially able to bear children, ✔Yes or No
Datatyp
text
Alias
- UMLS CUI [1]
- C0036899
Beskrivning
If female is potentially able to bear children, ✔Yes or No
Datatyp
text
Alias
- UMLS CUI [1]
- C0024559
Beskrivning
If female is potentially able to bear children, ✔Yes or No
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other Contraceptive Method, Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0851353
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018799
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0851354
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0014130
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015397
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0017178
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0267792
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021053
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0851358
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0263660
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027765
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0004936
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042075
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0851366
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0851355
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0178301
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042373
Similar models
Childbearing Potential, Birth Control Methods and Medical Conditions
C0086287 (UMLS CUI-2)
C0700589 (UMLS CUI [1,2])
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])
C0004764 (UMLS CUI [1,2])
C0677582 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C0042241 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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