ID

32152

Beskrivning

This ODM file contains the form to document pregnancy information at the end of the study and the study conclusion and also includes an investigator's comment log. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Nyckelord

Versioner (4)
  1. 2018-10-15 2018-10-15 -
  2. 2018-10-21 2018-10-21 -
  3. 2018-10-28 2018-10-28 -
  4. 2018-10-31 2018-10-31 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 oktober 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

Engelsk

Pregnancy Information, Study Conclusion and Investigator Comment Log

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Pregnancy Information
Beskrivning

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beskrivning

If Yes, complete Pregnancy Notification form.

Datatyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Study Conclusion
Beskrivning

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Beskrivning

Date of subject completion or withdrawal

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0422727
UMLS CUI [2]
C1549507
Time of withdrawal
Beskrivning

Time of withdrawal

Datatyp

time

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0040223
Was the subject withdrawn from the study?
Beskrivning

INVESTIGATOR INSTRUCTIONS • Refer to protocol section(s) 10.1 and 10.2 to evaluate subject completion or withdrawal from the study. • If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. • If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. • If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports. MONITOR DATA VALIDATION CHECKS • If the investigational product was discontinued at the same time as the subject was withdrawn from the study, ensure the reasons for the two discontinuations are consistent.

Datatyp

text

Alias
UMLS CUI [1]
C0422727
If Yes, check the primary reason for withdrawal:
Beskrivning

If primary reason for withdrawal is an adverse event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. • If the subject was withdrawn due to an adverse event, confirm that details recorded correspond with details on the Adverse Event page. • ’Withdrawal’ on the AE/SAE page is recorded as ’Yes’. • ’Action Taken with Investigational Product(s) as a Result of the Non-Serious AE/SAE’ on the AE/SAE page is recorded as ’Investigational Product Withdrawn’. • ’Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’.

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
Other, specify
Beskrivning

Other reason for withdrawal, specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Investigator Comment Log
Beskrivning

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Beskrivning

CRF page number

Datatyp

text

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Pregnancy Information, Study Conclusion and Investigator Comment Log

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy during the study
Code List
Did the subject become pregnant during the study?
CL Item
Yes ([Y])
CL Item
No ([N])
CL Item
Not Applicable (not of childbearing potential or male) ([X])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
Time of withdrawal
Item
Time of withdrawal
time
C0422727 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Was the subject withdrawn from the study?
CL Item
Yes ([Y])
CL Item
No ([N])
Item
If Yes, check the primary reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
The primary reason for withdrawal
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event  ([1])
CL Item
Lost to follow-up ([2])
CL Item
Protocol violation ([3])
CL Item
Subject decided to withdraw from the study ([4])
CL Item
Other ([Z])
Other reason for withdrawal, specification
Item
Other, specify
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number
Item
CRF page number if applicable
text
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
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