ID
37588
Beschreibung
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
Stichworte
Versionen (1)
- 08.08.19 08.08.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. August 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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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
Beschreibung
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
Beschreibung
Were any concomitant medications taken by the subject during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Did the subject experience any non-serious adverse events during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Did the subject experience any serious adverse events during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Were any repeat haematology or clinical chemistry samples taken?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
Beschreibung
Were any repeat urinalysis samples taken?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
Beschreibung
Were any repeat vital signs recorded?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beschreibung
Non-serious Adverse Event (AE)
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Modified term
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
MedDRA synonym
Datentyp
text
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
MedDRA lower level term code
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Non-serious Adverse Event Start Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1301880
Beschreibung
Non-serious Adverse Event Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschreibung
Non-serious Adverse Event End Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1522314
Beschreibung
Non-serious Adverse Event Frequency
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beschreibung
Non-serious Adverse Event Maximum Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Beschreibung
Non-serious Adverse Event Maximum Grade
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschreibung
Non-serious Adverse Event Maximum Grade or Intensity
Datentyp
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
Beschreibung
Action Taken with Investigational Product(s) as a Result of the AE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschreibung
Did the subject withdraw from study as a result of this AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschreibung
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Duration of AE if < 24 hours
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschreibung
Time to Onset Since Last Dose
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beschreibung
Serious Adverse Events (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Initial Report
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0205265
Beschreibung
Follow-Up Report
Datentyp
integer
Alias
- UMLS CUI [1]
- C1704685
Beschreibung
Did SAE occur after initiation of study medication?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
Beschreibung
SAE Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Modified term
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
MedDRA synonym
Datentyp
text
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
MedDRA lower level term code
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Serious Adverse Events Start Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beschreibung
Serious Adverse Events Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Serious Adverse Events End Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1522314
Beschreibung
Serious Adverse Events Maximum Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
Serious Adverse Event Maximum Grade
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschreibung
Serious Adverse Event Maximum Grade or Intensity
Datentyp
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
Beschreibung
Action Taken with Investigational Product(s) as a Result of the AE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Did the subject withdraw from study as a result of this AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschreibung
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Duration of AE if < 24 hours
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschreibung
Time to Onset Since Last Dose
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beschreibung
Was SAE caused by activities related to study participation (e.g. procedures)?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3641099
- UMLS CUI [1,2]
- C1519255
Beschreibung
Was the event serious?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Check all that apply.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beschreibung
Serious Adverse Event - Concomitant Medication
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschreibung
CM Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Concomitant Medication Dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3174092
Beschreibung
Concomitant Medication Unit
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
Concomitant Medication Frequency
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826654
Beschreibung
Concomitant Medication Route
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826730
Beschreibung
Concomitant Medication Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Concomitant Medication Ongoing?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
If concomitant medication not ongoing, specify end date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826744
Beschreibung
Concomitant medication Primary Indication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Drug Type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0457591
Beschreibung
Serious Adverse Event - Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Beschreibung
MHx Sequence Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beschreibung
Specific Condition Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Medical Conditions - Date of onset
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschreibung
Medical Conditions/ Risk Factors Continuing?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0549178
Beschreibung
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
Datentyp
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
Beschreibung
Relevant Medical History/ Risk Factors not noted above
Datentyp
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0035648
Beschreibung
Serious Adverse Events - Relevant diagnostic results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beschreibung
Lab Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beschreibung
Test Name
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Test Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
Test Result
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Test Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Normal Low Range
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Beschreibung
Normal High Range
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Beschreibung
Relevant diagnostic results not noted above
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Serious Adverse Events - Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0013230
Beschreibung
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beschreibung
Serious Adverse Events - General narrative comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschreibung
Serious Adverse Events - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C1298908
Beschreibung
Send incomplete SAE data to GSK Safety
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beschreibung
Receipt by GSK date
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2985846
Beschreibung
Was the event serious?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
SAE Sequence Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Version Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Beschreibung
Case ID
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschreibung
Randomisation Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
OCEANS Code
Datentyp
text
Alias
- UMLS CUI [1]
- C0805701
Beschreibung
Email Flag
Datentyp
text
Alias
- UMLS CUI [1]
- C0013849
Ähnliche Modelle
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])