ID

33053

Description

This form contains a form to document the study conclusion and pregnancy information. To be assessed at the follow-up visit. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 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

Link

https://clinicaltrials.gov/ct2/show/NCT00875784

Keywords

Versions (2)
  1. 11/25/18 11/25/18 -
  2. 11/25/18 11/25/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 25, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

English

Study Conclusion and Pregnancy Information

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
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

Data type

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Description

If yes, complete primary reason for witltdrawal

Data type

text

Alias
UMLS CUI [1]
C0422727
If the subject was withdrawn from the study, complete the primary reason:
Description

In case you tick Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. In case you tick Investigator discretion, specify in the next item. Select this reason if none of the other primary reasons are appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If you ticked 'Investigator discretion' as primary reason for withdrawal, specify
Description

Withdrawal from the study at the investigator's discretion, specification

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1710220
UMLS CUI [1,3]
C0679006
UMLS CUI [1,4]
C2348235
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Description

if Yes, complete the paper Pregnancy Notification form Check Not Applicable iffemale partner not of childbearing potential or no female partner

Data type

text

Alias
UMLS CUI [1]
C0919624
Did the subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form

Data type

text

Alias
UMLS CUI [1]
C0032961
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Similar models

Study Conclusion and Pregnancy Information

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
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
C2983670 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Subject withdrawn from the study
Code List
Was the subject withdrawn from the study?
CL Item
No (No)
CL Item
Yes (Yes)
Item
If the subject was withdrawn from the study, complete the primary reason:
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
If the subject was withdrawn from the study, complete the primary reason:
CL Item
Adverse Event (Adverse Event)
CL Item
Protocol deviation (Protocol deviation)
CL Item
Subject reached protocol defined stopping criteria (Subject reached protocol defined stopping criteria)
CL Item
Study closed/terminated (Study closed/terminated)
CL Item
Lost to Follow-up (Lost to Follow-up)
CL Item
Investigator discretion, specify (Investigator discretion, specify)
CL Item
Withdrew consent (Withdrew consent)
Withdrawal from the study at the investigator's discretion, specification
Item
If you ticked 'Investigator discretion' as primary reason for withdrawal, specify
text
C2349954 (UMLS CUI [1,1])
C1710220 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Pregnancy of a female partner of the male subject
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Not applicable (Not applicable)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Pregnancy of the subject
Code List
Did the subject become pregnant during the study?
CL Item
No (No)
CL Item
Yes (Yes)
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