ID

30661

Beskrivning

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Nyckelord

Versioner (2)
  1. 2018-06-19 2018-06-19 -
  2. 2018-06-19 2018-06-19 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

19 juni 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024

Engelsk

End of Study

1 Formulär  
  1. StudyEvent: ODM
    1. End of Study
Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
Date of Visit/Assessment
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Status of Treatment Blind
Beskrivning

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beskrivning

treatment blind broken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
If Yes, complete the date
Beskrivning

Was the treatment blind broken during the study?

Datatyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If Yes, tick one reason below:
Beskrivning

Was the treatment blind broken during the study?

Datatyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Reason treatment blind broken. If other, specify:
Beskrivning

reason treatment blind broken

Datatyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Pregnancy information
Beskrivning

Pregnancy information

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant during the study?
Beskrivning

If yes, please complete the Pregnancy Notification form.

Datatyp

integer

Alias
UMLS CUI [1]
C0032961
Withdrawal of Consent for PGx (DNA)/Sample Destruction
Beskrivning

Withdrawal of Consent for PGx (DNA)/Sample Destruction

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C1948029
UMLS CUI-3
C0178913
Has subject withdrawn consent for PGx research?
Beskrivning

withdrawn consent

Datatyp

boolean

Alias
UMLS CUI [1]
C1707492
Yes, date informed consent withdrawn
Beskrivning

Date informed consent withdrawn

Datatyp

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0011008
Ha a request been made for sample destruction?
Beskrivning

Sample destruction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
Yes, check reason for sample destruction
Beskrivning

Reason for sample destruction

Datatyp

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
If Other Reason for sample destruction, specify
Beskrivning

Reason for sample destruction

Datatyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Study conclusion
Beskrivning

Study conclusion

1. Date of subject completion or withdrawal
Beskrivning

Date of subject completion or withdrawal

Datatyp

date

Alias
UMLS CUI [1]
C2983670
2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
Beskrivning

subject withdrawal

Datatyp

text

Alias
UMLS CUI [1]
C0422727
3. Primary reason for withdrawal
Beskrivning

Primary reason for withdrawal

Datatyp

integer

If subject withdrew consent, provide comment
Beskrivning

Pre-defined sub-reasons are optional. The following primary reasons are optional : 2, 4 and 7. Pre-defined sub-reasons may/should be moved under appropriate primary reasons. See specific note for Group DSRS8.

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1707492
If investigator site closed, provide comment
Beskrivning

Pre-defined sub-reasons are optional. The following primary reasons are optional : 2, 4 and 7. Pre-defined sub-reasons may/should be moved under appropriate primary reasons. See specific note for Group DSRS8.

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1710101
If subject reached stopping criteria: Subject did not have opportunity to treat migraine?
Beskrivning

no opportunity to treat migraine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0332155
5. Q1
Beskrivning

[hidden] Item is not required

Datatyp

boolean

6. Q2
Beskrivning

[hidden] Item is not required

Datatyp

text

Investigators signature
Beskrivning

Investigators signature

Alias
UMLS CUI-1
C2346576
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
Beskrivning

By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances. [hidden]. Item is not required.

Datatyp

boolean

Alias
UMLS CUI [1]
C1706256
Is this casebook ready to sign? Investigator Signature
Beskrivning

Investigator Signature

Datatyp

boolean

Alias
UMLS CUI [1]
C2346576
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Similar models

End of Study

1 Formulär
  1. StudyEvent: ODM
    1. End of Study
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
treatment blind broken
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
date treatment blind broken
Item
If Yes, complete the date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If Yes, tick one reason below:
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason treatment blind broken
Code List
If Yes, tick one reason below:
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
reason treatment blind broken
Item
Reason treatment blind broken. If other, specify:
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Did the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Withdrawal of Consent for PGx (DNA)/Sample Destruction
C1707492 (UMLS CUI-1)
C1948029 (UMLS CUI-2)
C0178913 (UMLS CUI-3)
withdrawn consent
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1])
Date informed consent withdrawn
Item
Yes, date informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sample destruction
Item
Ha a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
Yes, check reason for sample destruction
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for sample destruction
Code List
Yes, check reason for sample destruction
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Reason for sample destruction
Item
If Other Reason for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Study conclusion
Date of subject completion or withdrawal
Item
1. Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Item
2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
text
C0422727 (UMLS CUI [1])
subject withdrawal
Code List
2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
CL Item
No (N)
CL Item
Yes, complete primary reason for withdrawal (Y)
Item
3. Primary reason for withdrawal
integer
Primary reason for withdrawal
Code List
3. Primary reason for withdrawal
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Withdrew consent, specify! (8)
CL Item
Adverse Event (1)
CL Item
Subject reached protocol defined stopping criteria (2)
CL Item
Lack of efficacy (3)
CL Item
Protocol deviation (4)
CL Item
Investigator discretion, specify! (7)
withdrawal of consent comment
Item
If subject withdrew consent, provide comment
text
C0947611 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
investigator site closed comment
Item
If investigator site closed, provide comment
text
C0947611 (UMLS CUI [1,1])
C1710101 (UMLS CUI [1,2])
no opportunity to treat migraine
Item
If subject reached stopping criteria: Subject did not have opportunity to treat migraine?
boolean
C0149931 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Q1
Item
5. Q1
boolean
Item
6. Q2
text
Q2
Code List
6. Q2
CL Item
PF_SC_LOST (PF_SC_LOST)
CL Item
[?] PF_SC_DEATH ([?] PF_SC_DEATH)
CL Item
[?] PF_SC_SPONSORDECISION ([?] PF_SC_SPONSORDECISION)
CL Item
PF_SC_PHYSICIANDECISION (PF_SC_PHYSICIANDECISION)
CL Item
PF_SC_PATIENTDECISION (PF_SC_PATIENTDECISION)
CL Item
PF_SC_AE (PF_SC_AE)
CL Item
PF_SC_ALE (PF_SC_ALE)
CL Item
PF_SC_CRITERIA (PF_SC_CRITERIA)
CL Item
PF_SC_OTHER (PF_SC_OTHER)
Item Group
Investigators signature
C2346576 (UMLS CUI-1)
re-sign case book
Item
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
boolean
C1706256 (UMLS CUI [1])
Investigator Signature
Item
Is this casebook ready to sign? Investigator Signature
boolean
C2346576 (UMLS CUI [1])
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