ID
37588
Beskrivning
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders
Nyckelord
Versioner (1)
- 2019-08-08 2019-08-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 augusti 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625
Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events
Beskrivning
Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C1708728
- UMLS CUI-2
- C0205341
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C1516048
- UMLS CUI-5
- C2347852
- UMLS CUI-6
- C1516048
Beskrivning
Were any concomitant medications taken by the subject during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Did the subject experience any non-serious adverse events during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Did the subject experience any serious adverse events during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Were any repeat haematology or clinical chemistry samples taken?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
Beskrivning
Were any repeat urinalysis samples taken?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
Beskrivning
Were any repeat vital signs recorded?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beskrivning
Non-serious Adverse Event (AE)
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Modified term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
MedDRA synonym
Datatyp
text
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
MedDRA lower level term code
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
Failed coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Non-serious Adverse Event Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1301880
Beskrivning
Non-serious Adverse Event Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beskrivning
Non-serious Adverse Event End Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1522314
Beskrivning
Non-serious Adverse Event Frequency
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beskrivning
Non-serious Adverse Event Maximum Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Beskrivning
Non-serious Adverse Event Maximum Grade
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beskrivning
Non-serious Adverse Event Maximum Grade or Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0518690
- UMLS CUI [2,3]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Duration of AE if < 24 hours
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beskrivning
Time to Onset Since Last Dose
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beskrivning
Serious Adverse Events (SAE)
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Initial Report
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0205265
Beskrivning
Follow-Up Report
Datatyp
integer
Alias
- UMLS CUI [1]
- C1704685
Beskrivning
Did SAE occur after initiation of study medication?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
Beskrivning
SAE Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Modified term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
MedDRA synonym
Datatyp
text
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
MedDRA lower level term code
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
Failed coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Serious Adverse Events Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beskrivning
Serious Adverse Events Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
Serious Adverse Events End Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1522314
Beskrivning
Serious Adverse Events Maximum Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Serious Adverse Event Maximum Grade
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beskrivning
Serious Adverse Event Maximum Grade or Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0518690
- UMLS CUI [2,3]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Duration of AE if < 24 hours
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beskrivning
Time to Onset Since Last Dose
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beskrivning
Was SAE caused by activities related to study participation (e.g. procedures)?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3641099
- UMLS CUI [1,2]
- C1519255
Beskrivning
Was the event serious?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Check all that apply.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beskrivning
Serious Adverse Event - Concomitant Medication
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beskrivning
CM Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Concomitant Medication Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3174092
Beskrivning
Concomitant Medication Unit
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826646
Beskrivning
Concomitant Medication Frequency
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826654
Beskrivning
Concomitant Medication Route
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826730
Beskrivning
Concomitant Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Concomitant Medication Ongoing?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
If concomitant medication not ongoing, specify end date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826744
Beskrivning
Concomitant medication Primary Indication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
Beskrivning
Drug Type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0457591
Beskrivning
Serious Adverse Event - Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Beskrivning
MHx Sequence Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beskrivning
Specific Condition Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
Medical Conditions - Date of onset
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beskrivning
Medical Conditions/ Risk Factors Continuing?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0549178
Beskrivning
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0011008
- UMLS CUI [2,3]
- C2745955
Beskrivning
Relevant Medical History/ Risk Factors not noted above
Datatyp
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0035648
Beskrivning
Serious Adverse Events - Relevant diagnostic results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beskrivning
Lab Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beskrivning
Test Name
Datatyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Test Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Test Result
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Test Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Normal Low Range
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Beskrivning
Normal High Range
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Beskrivning
Relevant diagnostic results not noted above
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Serious Adverse Events - Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0013230
Beskrivning
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beskrivning
Serious Adverse Events - General narrative comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beskrivning
Serious Adverse Events - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C1298908
Beskrivning
Send incomplete SAE data to GSK Safety
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beskrivning
Receipt by GSK date
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2985846
Beskrivning
Was the event serious?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
SAE Sequence Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Version Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Beskrivning
Case ID
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beskrivning
Randomisation Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
OCEANS Code
Datatyp
text
Alias
- UMLS CUI [1]
- C0805701
Beskrivning
Email Flag
Datatyp
text
Alias
- UMLS CUI [1]
- C0013849
Similar models
Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events
C2985720 (UMLS CUI [1,2])
C0205341 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C1516048 (UMLS CUI-4)
C2347852 (UMLS CUI-5)
C1516048 (UMLS CUI-6)
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2348184 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0035648 (UMLS CUI [2])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
C0013230 (UMLS CUI-2)
C1272691 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0947611 (UMLS CUI-2)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])