ID

32432

Description

This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log as well as the investigator's signature. 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

Mots-clés

Versions (4)
  1. 15/10/2018 15/10/2018 -
  2. 21/10/2018 21/10/2018 -
  3. 28/10/2018 28/10/2018 -
  4. 31/10/2018 31/10/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

31 octobre 2018

DOI

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Licence

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

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Study Conclusion, Pregnancy Information, Investigator Comment Log and Investigator's Signature

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date
Description

Date

Type de données

date

Alias
UMLS CUI [1]
C0011008
Pregnancy Information
Description

Pregnancy Information

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

If Yes, complete Pregnancy Notification form.

Type de données

text

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

Study Conclusion

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

Date of subject completion or withdrawal

Type de données

date

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

Time of withdrawal

Type de données

time

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Was the subject withdrawn from the study?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

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.

Type de données

text

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

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’.

Type de données

text

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

Other reason for withdrawal, specification

Type de données

text

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

Investigator Comment Log

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

CRF page number

Type de données

text

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

Comment

Type de données

text

Alias
UMLS CUI [1]
C0947611
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator’s signature
Description

Investigator's Signature

Type de données

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Description

Investigator's name

Type de données

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Investigator's signature: Date

Type de données

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Conclusion, Pregnancy Information, Investigator Comment Log and Investigator's Signature

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
Investigator's signature: Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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