ID
32672
Descripción
This ODM file contains the form for the subject diary. To be filled out throughout the study. 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)
- 11/11/18 11/11/18 -
- 14/11/18 14/11/18 -
- 15/1/19 15/1/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
11 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
Subject Diary
- StudyEvent: ODM
Descripción
Subject Diary Instructions
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1442085
Descripción
Reminder to Site Personnel
Alias
- UMLS CUI-1
- C1709896
- UMLS CUI-2
- C2985654
Descripción
Migraine Symptoms
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C1457887
Descripción
Enter the date your migraine headache pain started.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0018681
- UMLS CUI [1,3]
- C0332189
- UMLS CUI [1,4]
- C0808070
Descripción
Enter the time your migraine headache pain started.
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0018681
- UMLS CUI [1,3]
- C0332189
- UMLS CUI [1,4]
- C1301880
Descripción
Did you wake up with your migraine headache pain?
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0442696
- UMLS CUI [1,2]
- C0149931
- UMLS CUI [1,3]
- C0018681
Descripción
Aura during migraine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0154723
Descripción
Migraine pain worsened by routine physical activity
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4054844
- UMLS CUI [1,3]
- C0149931
Descripción
Quality of migraine headache pain
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0018681
- UMLS CUI [1,3]
- C1148406
Descripción
Llocation of your migraine headache pain
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0018681
- UMLS CUI [1,3]
- C0030193
- UMLS CUI [1,4]
- C0450429
Descripción
Subject Reminder
Alias
- UMLS CUI-1
- C0681850
- UMLS CUI-2
- C1709896
Descripción
Date and Time Study Medication Taken
Alias
- UMLS CUI-1
- C0011008
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0040223
- UMLS CUI-4
- C0013227
Descripción
Details of Migraine Headache Pain and Symptoms
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0018681
- UMLS CUI-3
- C0030193
- UMLS CUI-4
- C1457887
Descripción
Planned Timepoint of Medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348792
- UMLS CUI [1,3]
- C1301732
Descripción
Severity of migraine headache pain
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0018681
- UMLS CUI [1,3]
- C0439793
Descripción
Tick Yes or No for each symptom at each timepoint:
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0027497
Descripción
Tick Yes or No for each symptom at each timepoint:
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0042963
Descripción
Tick Yes or No for each symptom at each timepoint:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0085636
Descripción
Tick Yes or No for each symptom at each timepoint:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2938899
- UMLS CUI [1,2]
- C0149931
Descripción
Tick Yes or No for each symptom at each timepoint:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0863104
- UMLS CUI [1,2]
- C0149931
- UMLS CUI [2,1]
- C0007859
- UMLS CUI [2,2]
- C0149931
Descripción
Tick Yes or No for each symptom at each timepoint:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0015468
- UMLS CUI [1,2]
- C0149931
- UMLS CUI [2,1]
- C0522251
- UMLS CUI [2,2]
- C0149931
Descripción
ALLODYNIA QUESTIONNAIRE (Complete at time of dosing)
Alias
- UMLS CUI-1
- C0034394
- UMLS CUI-2
- C0458247
- UMLS CUI-3
- C0149931
- UMLS CUI-4
- C0439564
- UMLS CUI-5
- C3469597
Descripción
Details of Work Ability
Alias
- UMLS CUI-1
- C4274891
Descripción
Planned Relative Time
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0439564
Descripción
Tick one appropriate response at each timepoint:
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0441655
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [1,3]
- C0149931
- UMLS CUI [2,1]
- C4274891
- UMLS CUI [2,2]
- C0149931
Descripción
ALLODYNIA QUESTIONNAIRE (Complete 2 hours after dosing)
Alias
- UMLS CUI-1
- C0034394
- UMLS CUI-2
- C0458247
- UMLS CUI-3
- C0149931
- UMLS CUI-4
- C0439564
- UMLS CUI-5
- C1548614
- UMLS CUI-6
- C3469597
Descripción
Recurrence
Alias
- UMLS CUI-1
- C0034897
Descripción
Return of Pain after Treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0149931
Descripción
Date of Migraine Headache Pain Recurrence
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0807712
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C0149931
Descripción
Time of Migraine Headache pain recurrence
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0030193
- UMLS CUI [1,4]
- C0149931
Descripción
Tick one:
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C1507013
- UMLS CUI [1,4]
- C0149931
Descripción
Recurrence of Moderate or Severe Migraine Headache Pain
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2957106
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C1882428
- UMLS CUI [1,4]
- C0149931
- UMLS CUI [2,1]
- C0278139
- UMLS CUI [2,2]
- C0018681
- UMLS CUI [2,3]
- C0034897
- UMLS CUI [2,4]
- C1882428
- UMLS CUI [2,5]
- C0149931
Descripción
Date of Moderate or Severe Migraine Headache Pain Recurrence
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0807712
- UMLS CUI [1,2]
- C2957106
- UMLS CUI [1,3]
- C0149931
- UMLS CUI [2,1]
- C0807712
- UMLS CUI [2,2]
- C0278139
- UMLS CUI [2,3]
- C0018681
- UMLS CUI [2,4]
- C0149931
Descripción
Tick one:
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C1507013
- UMLS CUI [1,4]
- C0149931
Descripción
Medications Taken
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0087111
Descripción
Drug Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
Date Medication Taken
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013227
Descripción
(24 hour clock)
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013227
Descripción
Tick one to indicate migraine headache pain severity ONLY if you took this medication for migraine headache pain:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0018681
- UMLS CUI [1,3]
- C1507013
Descripción
specify reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3840932
Descripción
Productivity
Alias
- UMLS CUI-1
- C0033269
Descripción
Were you scheduled to do paid work during this migraine attack?
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C3846711
- UMLS CUI [1,3]
- C1571999
Descripción
Number of Hours Subject was Scheduled to Do Paid Work
Tipo de datos
float
Unidades de medida
- Hours
Alias
- UMLS CUI [1,1]
- C1265611
- UMLS CUI [1,2]
- C0043227
- UMLS CUI [1,3]
- C1571999
Descripción
Productivity: Affect of Migraine Attack on work and non-work related activities
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0026516
- UMLS CUI-3
- C0441655
Descripción
Activity
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0441655
Descripción
Zero = 00.0
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0441655
- UMLS CUI [1,2]
- C0443288
- UMLS CUI [1,3]
- C1265611
- UMLS CUI [1,4]
- C0149931
Descripción
Number of hours continued to do activity with migraine symptoms
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0441655
- UMLS CUI [1,2]
- C1314677
- UMLS CUI [1,3]
- C1265611
- UMLS CUI [1,4]
- C0149931
Descripción
If number of hours doing activity is 00.0, DO NOT COMPLETE. 100% = effective as usual
Tipo de datos
integer
Unidades de medida
- %
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1280519
Descripción
PATIENT PERCEPTION OF MIGRAINE QUESTIONNAIRE - REVISED (PPMQ-R)
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0030971
- UMLS CUI-3
- C0034394
Similar models
Subject Diary
- StudyEvent: ODM
C1442085 (UMLS CUI-2)
C2985654 (UMLS CUI-2)
C0018681 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
C0018681 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
C0149931 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,3])
C4054844 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,2])
C1148406 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,4])
C0013227 (UMLS CUI-2)
C0040223 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0018681 (UMLS CUI-2)
C0030193 (UMLS CUI-3)
C1457887 (UMLS CUI-4)
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,3])
C0085636 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,2])
C0007859 (UMLS CUI [2,1])
C0149931 (UMLS CUI [2,2])
C0149931 (UMLS CUI [1,2])
C0522251 (UMLS CUI [2,1])
C0149931 (UMLS CUI [2,2])
C0458247 (UMLS CUI-2)
C0149931 (UMLS CUI-3)
C0439564 (UMLS CUI-4)
C3469597 (UMLS CUI-5)
C0085732 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C4274891 (UMLS CUI [2,1])
C0149931 (UMLS CUI [2,2])
C0458247 (UMLS CUI-2)
C0149931 (UMLS CUI-3)
C0439564 (UMLS CUI-4)
C1548614 (UMLS CUI-5)
C3469597 (UMLS CUI-6)
C0034897 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,4])
C0030193 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,4])
C0030193 (UMLS CUI [1,2])
C1507013 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,4])
C0034897 (UMLS CUI [1,2])
C1882428 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,4])
C0278139 (UMLS CUI [2,1])
C0018681 (UMLS CUI [2,2])
C0034897 (UMLS CUI [2,3])
C1882428 (UMLS CUI [2,4])
C0149931 (UMLS CUI [2,5])
C2957106 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0807712 (UMLS CUI [2,1])
C0278139 (UMLS CUI [2,2])
C0018681 (UMLS CUI [2,3])
C0149931 (UMLS CUI [2,4])
C0030193 (UMLS CUI [1,2])
C1507013 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,2])
C1507013 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,2])
C3846711 (UMLS CUI [1,2])
C1571999 (UMLS CUI [1,3])
C0043227 (UMLS CUI [1,2])
C1571999 (UMLS CUI [1,3])
C0026516 (UMLS CUI-2)
C0441655 (UMLS CUI-3)
C0443288 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,4])
C1314677 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0149931 (UMLS CUI [1,4])
C1280519 (UMLS CUI [1,2])
C0030971 (UMLS CUI-2)
C0034394 (UMLS CUI-3)
C0850287 (UMLS CUI [1,2])
Sin comentarios