ID
32652
Descripción
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
Palabras clave
Versiones (2)
- 31/10/18 31/10/18 -
- 9/11/18 9/11/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
9 de noviembre de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Child-bearing Potential (Complete for Female Subjects Only)
Alias
- UMLS CUI-1
- C3831118
- UMLS CUI-2
- C0086287
Descripción
Birth Control Methods
Alias
- UMLS CUI-1
- C0700589
Descripción
If female is potentially able to bear children, tick Yes or No
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0009905
Descripción
If female is potentially able to bear children, tick Yes or No
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0021900
- UMLS CUI [1,2]
- C0700589
Descripción
If female is potentially able to bear children, tick Yes or No
Tipo de datos
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
Descripción
If female is potentially able to bear children, tick Yes or No
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0037862
- UMLS CUI [1,2]
- C0004764
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004764
- UMLS CUI [1,2]
- C0677582
- UMLS CUI [2,1]
- C0004764
- UMLS CUI [2,2]
- C0042241
Descripción
If female is potentially able to bear children, tick Yes or No
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0036899
Descripción
If female is potentially able to bear children, tick Yes or No
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0024559
Descripción
If female is potentially able to bear children, tick Yes or No
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Descripción
Other Contraceptive Method, Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Descripción
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0851353
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0018799
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0851354
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0014130
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0015397
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0017178
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0267792
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0021053
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0851358
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0263660
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0027765
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0004936
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0042075
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0851366
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0851355
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0178301
Descripción
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.
Tipo de datos
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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