ID
32479
Descripción
This ODM-file contains the form to document the Head impact test (HIT-6) Score, the IHS Headache classification, the migraine history and the previous migraine treatment. To be assessed at screening. 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 (4)
- 2/11/18 2/11/18 -
- 9/11/18 9/11/18 -
- 15/1/19 15/1/19 -
- 20/9/21 20/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
2 de noviembre de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999
Headache Impact Test (HIT-6) Score, IHS Headache Classification, Migraine History, Previous Treatment for Migraine
Descripción
Head Impact Test (HIT-6) Score
Alias
- UMLS CUI-1
- C0018681
- UMLS CUI-2
- C1518965
Descripción
IHS Headache Classification
Alias
- UMLS CUI-1
- C0018681
- UMLS CUI-2
- C0008902
Descripción
Diagnostic criteria: A) At least 5 attacks fulfilling criteria B-D B) Headache attacks, lasting 4-72 hours (untreated or unsuccessfully treated) C) Headache has at least two of the following characteristics: 1. Unilateral location. 2. Pulsating quality. 3. Moderate or severe pain intensity. 4. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs). D) During headache at least one of the following: 1. Nausea and/or vomiting. 2. Photophobia and phonophobia. E) Not attributed to another disorder2. 2 History and physical and neurological examinations do not suggest another disorder3, or history and/or physical and/or neurological examinations do suggest such disorder but it is ruled out by appropriate investigations, or such disorder is present but attacks do not occur for the first time in close temporal relation to the disorder. 3 Disorders include headache attributed to head and/or neck trauma; cranial or cervical vascular disorder; nonvascular intracranial disorder; substance or its withdrawal; infection; disorder of homeostasis; disorder of cranium, neck, eyes, ears, nose, sinuses, teeth, mouth, or other facial or cranial structures; psychiatric disorder; cranial neuralgias and central causes of facial pain.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0008902
- UMLS CUI [1,3]
- C1389175
Descripción
Diagnostic criteria: A) At least 2 attacks fulfilling criteria B-D. B) Aura consisting of at least one of the following, but no motor weakness: 1. Fully reversible visual symptoms including positive features (e.g., flickering light, spots or lines) and/ or negative features (i.e., loss of vision). 2. Fully reversible sensory symptoms including positive features (i.e., pins and needles) and/or negative features (i.e., numbness). 3. Fully reversible dysphasic speech disturbance. C) At least two of the following: 1. Homonymous visual symptoms4 and/or unilateral sensory symptoms. 2. At least one aura symptom develops gradually over ≥5 minutes and/or different aura symptoms occur in succession over ≥5 minutes. 3. Each symptom lasts ≥5 and ≤60 minutes. D) Headache fulfilling criteria B-D for 1.1 Migraine without aura begins during the aura or follows aura within 60 minutes. E) Not attributed to another disorder2. 2 History and physical and neurological examinations do not suggest another disorder3, or history and/or physical and/or neurological examinations do suggest such disorder but it is ruled out by appropriate investigations, or such disorder is present but attacks do not occur for the first time in close temporal relation to the disorder. 3 Disorders include headache attributed to head and/or neck trauma; cranial or cervical vascular disorder; nonvascular intracranial disorder; substance or its withdrawal; infection; disorder of homeostasis; disorder of cranium, neck, eyes, ears, nose, sinuses, teeth, mouth, or other facial or cranial structures; psychiatric disorder; cranial neuralgias and central causes of facial pain. 4 Additional loss or blurring of central vision may occur.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0008902
- UMLS CUI [1,3]
- C0154723
Descripción
Migraine History
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0262926
Descripción
Average number of migraine attacks experienced per 30 day calendar month during the past year?
Tipo de datos
integer
Unidades de medida
- migraines
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0439507
Descripción
Age at onset of migraine attacks
Tipo de datos
integer
Unidades de medida
- years old
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0206132
Descripción
Average number of days with any kind of headache experiences per 30 day calendar month during the past year
Tipo de datos
integer
Unidades de medida
- days
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0556971
Descripción
Average number of days without any kind of headache experiences per 30 day calendar month during the past year
Tipo de datos
integer
Unidades de medida
- days
Alias
- UMLS CUI [1,1]
- C0556971
- UMLS CUI [1,2]
- C0018681
- UMLS CUI [1,3]
- C0332197
Descripción
Previous Treatment for Migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C1514463
Descripción
Previous use of sumatriptan (Imitrex) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0075632
Descripción
Previous use of naratriptan (Amerge) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0540623
Descripción
Previous use of zolmitriptan (Zomig) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0528166
Descripción
Previous use of rizatriptan (Maxalt) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0297635
Descripción
Previous use of almotriptan (Axert) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0914729
Descripción
Previous use of eletriptan (Relpax) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0759933
Descripción
Previous use of frovatriptan (Frova) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0754647
Descripción
Previous use of COX-2 inhibitors (Celebrex, Vioxx, etc.) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C1257954
Descripción
Previous use of OTC naproxen (Aleve, etc.) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0027396
- UMLS CUI [1,4]
- C0013231
Descripción
1 aspirin, ibuprofen, Advil, Motrin, etc.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0003211
- UMLS CUI [1,4]
- C0013231
- UMLS CUI [1,5]
- C0332300
- UMLS CUI [1,6]
- C0027396
Descripción
Previous use of prescription naproxen (Naprosyn, Anaprox, etc.) for the acute treatment of migraine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0027396
- UMLS CUI [1,4]
- C0304227
Descripción
2 Relafen, Feldene, Indocin, Orudis, Voltaren, Daypro, Toradol, etc.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0003211
- UMLS CUI [1,4]
- C0304227
Descripción
1 aspirin, ibuprofen, Advil, Motrin, etc. 2 Relafen, Feldene, Indocin, Orudis, Voltaren, Daypro, Toradol, etc.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0150839
- UMLS CUI [1,2]
- C0149931
Descripción
Satisfaction with sumatriptan during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0075632
- UMLS CUI [1,4]
- C0242428
Descripción
Satisfaction with naratriptan (Amerge) during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0540623
- UMLS CUI [1,4]
- C0242428
Descripción
Satisfaction with rizatriptan during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0297635
- UMLS CUI [1,4]
- C0242428
Descripción
Satisfaction with almotriptan (Axert) during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0914729
- UMLS CUI [1,4]
- C0242428
Descripción
Satisfaction with eletriptan (Relpax) during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0759933
- UMLS CUI [1,4]
- C0242428
Descripción
Satisfaction with frovatriptan (Frova) during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0754647
- UMLS CUI [1,4]
- C0242428
Descripción
Satisfaction with COX-2 inhibitors (Celebrex, Vioxx, etc.) during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C1257954
- UMLS CUI [1,4]
- C0242428
Descripción
Satisfaction with OTC naproxen (Aleve, etc.) during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0027396
- UMLS CUI [1,4]
- C0013231
- UMLS CUI [1,5]
- C0242428
Descripción
1 aspirin, ibuprofen, Advil, Motrin, etc.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0003211
- UMLS CUI [1,4]
- C0013231
- UMLS CUI [1,5]
- C0332300
- UMLS CUI [1,6]
- C0027396
- UMLS CUI [1,7]
- C0242428
Descripción
Satisfaction with prescription naproxen (Naprosyn, Anaprox, etc.) during prior migraine therapy
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0027396
- UMLS CUI [1,4]
- C0304227
- UMLS CUI [1,5]
- C0242428
Descripción
2 Relafen, Feldene, Indocin, Orudis, Voltaren, Daypro, Toradol, etc.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0003211
- UMLS CUI [1,4]
- C0304227
- UMLS CUI [1,5]
- C0242428
Similar models
Headache Impact Test (HIT-6) Score, IHS Headache Classification, Migraine History, Previous Treatment for Migraine
C1518965 (UMLS CUI-2)
C1518965 (UMLS CUI [1,2])
C0008902 (UMLS CUI-2)
C0008902 (UMLS CUI [1,2])
C1389175 (UMLS CUI [1,3])
C0008902 (UMLS CUI [1,2])
C0154723 (UMLS CUI [1,3])
C1304680 (UMLS CUI [1,2])
C0439507 (UMLS CUI [1,3])
C0206132 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1514463 (UMLS CUI-2)
C1514463 (UMLS CUI [1,2])
C0075632 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0540623 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0528166 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0297635 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0914729 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0759933 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0754647 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C1257954 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C0013231 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
C0013231 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0027396 (UMLS CUI [1,6])
C1514463 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C0304227 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
C0304227 (UMLS CUI [1,4])
C0149931 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,2])
C0075632 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0540623 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0297635 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0914729 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0759933 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0754647 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C1257954 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C0013231 (UMLS CUI [1,4])
C0242428 (UMLS CUI [1,5])
C1514463 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
C0013231 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0027396 (UMLS CUI [1,6])
C0242428 (UMLS CUI [1,7])
C1514463 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C0304227 (UMLS CUI [1,4])
C0242428 (UMLS CUI [1,5])
C1514463 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
C0304227 (UMLS CUI [1,4])
C0242428 (UMLS CUI [1,5])