ID
44553
Descripción
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
Palabras clave
Versiones (3)
- 31/10/18 31/10/18 -
- 9/11/18 9/11/18 -
- 27/9/21 27/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
27 de septiembre de 2021
DOI
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Licencia
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
Descripción
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Descripción
Date of subject completion or withdrawal
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [2]
- C1549507
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0422727
Descripción
• 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’.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Descripción
Other reason for withdrawal, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Descripción
If "Did not meet treatment eligibility criteria" ticked, ensure ’Clinically significant screening lab values’ and/or ’Clinically significant screening ECG abnormalities’ are ticked
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2826633
- UMLS CUI [1,2]
- C1516637
Descripción
If "Did not meet treatment eligibility criteria" ticked, ensure ’Clinically significant screening lab values’ and/or ’Clinically significant screening ECG abnormalities’ are ticked
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [1,3]
- C1516637
Descripción
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Descripción
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Descripción
Investigator's Signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator's name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Investigator's signature: Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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