ID
44553
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. 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
Keywords
Versions (3)
- 10/31/18 10/31/18 -
- 11/9/18 11/9/18 -
- 9/27/21 9/27/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 27, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999
Study Conclusion, Pregnancy Information and Investigator Comment Log
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Description
Date of subject completion or withdrawal
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [2]
- C1549507
Description
INVESTIGATOR INSTRUCTIONS • Refer to protocol section(s) (9.1 and 9.2) 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.
Data type
text
Alias
- UMLS CUI [1]
- C0422727
Description
• If the subject was withdrawn due to an adverse event, confirm that details recorded correspond with details on the Adverse Event: • ’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’.
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Description
Other reason for withdrawal, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Description
If "Did not meet treatment eligibility criteria" ticked, ensure ’Clinically significant screening lab values’ and/or ’Clinically significant screening ECG abnormalities’ are ticked
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826633
- UMLS CUI [1,2]
- C1516637
Description
If "Did not meet treatment eligibility criteria" ticked, ensure ’Clinically significant screening lab values’ and/or ’Clinically significant screening ECG abnormalities’ are ticked
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [1,3]
- C1516637
Description
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator's Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator's signature: Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Study Conclusion, Pregnancy Information and Investigator Comment Log
C0008976 (UMLS CUI [1,2])
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
C1549995 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1516637 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,3])
C0947611 (UMLS CUI-2)
C1516308 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])