Informações:
Falhas:
ID
38542
Descrição
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders
Palavras-chave
Versões (2)
- 29/09/2019 29/09/2019 -
- 24/10/2019 24/10/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
24 de outubro de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636
Serious Adverse Events
- StudyEvent: ODM
Similar models
Serious Adverse Events
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
Item Group
Type of Report
C1519255 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
C0332307 (UMLS CUI-3)
C0684224 (UMLS CUI-2)
C0332307 (UMLS CUI-3)
Item
Type of Report
text
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0684224 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
CL Item
Initial Report (1)
CL Item
Follow-Up Report (2)
Item Group
Randomisation
C1519255 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
C0034656 (UMLS CUI-2)
Serious Adverse Event, Experimental drug
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Adverse Event Modified Reported Term
Item
Modified term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Item
MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
Serious Adverse Event, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event, Code, Failed
Item
Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event, Start Date, Start time
Item
Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
CL Item
Fatal, record Date of Death (5)
Serious Adverse Event, End Date; Serious Adverse Event, Date of death
Item
End Date/Date of Death
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1148348 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1148348 (UMLS CUI [2,2])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade at onset of event
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Grade or Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,4])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,4])
Code List
Grade or Intensity at onset of event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Duration
Item
Duration of AE if < 24 hours
time
C1519255 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
C2926735 (UMLS CUI [1,2])
Serious Adverse Event, Time Last Dose
Item
Time to Onset Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
Serious Adverse Event, Relationship, Study Subject Participation Status
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event, Relationship, Experimental drug
Item
Related Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Intensity Changes
C1519255 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/ Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Part, Start Date, Start time
Item
Start Date and Time of event segment
datetime
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Item
Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade or Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Code List
Grade or Intensity of event segment
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710066 (UMLS CUI-2)
C1710066 (UMLS CUI-2)
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
Item Group
Relevant Concomitant/Treatment Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Serous Adverse Event, Concomitant Agent, Sequence Number
Item
CM Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Medication name
Item
Drug name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Adverse Event Modified Reported Term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Medication dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Unit
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Medication Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
C2826734 (UMLS CUI [1,2])
Serous Adverse Event, Concomitant Medication Ongoing
Item
Ongoing?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
Serous Adverse Event, Concomitant Medication Ongoing
Item
No, specify End Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
Serous Adverse Event, Concomitant Agent, Indication
Item
Primary Indication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Adverse Event Modified Reported Term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Type
Item
Drug Type
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Item Group
Relevant Medical Conditions / Risk Factors
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
Serious Adverse Event, Disease, Sequence Number
Item
MHx Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Disease
Item
Specific Condition Name
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Adverse Event Modified Reported Term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Start Date
Item
Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
Continuing?
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Serious Adverse Event, Disease, End Date
Item
No, specify date of last occurrence
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Risk factor
Item
Relevant Medical History / Risk Factors not noted above
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
Item Group
Relevant Diagnostic Results
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
C0430022 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Serious Adverse Event, Laboratory Procedures, Sequence Number
Item
Lab Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure
Item
Test Name
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
Serious Adverse Event, Diagnostic procedure, Date in time
Item
Test Date
date
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Result
Item
Test Result
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Unit of Measure
Item
Test Units
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Normal Range, Low
Item
Normal Low Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedure, Normal Range, High
Item
Normal High Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedure, Result, Other
Item
Relevant diagnostic results not noted above
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Rechallenge
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
C2347900 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C1519255 (UMLS CUI [1,1])
C2347900 (UMLS CUI [1,2])
C2347900 (UMLS CUI [1,2])
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
Serious Adverse Event, Experimental drug
Item
Study Drug
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Dosage
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Cumulative dose
Item
Cumulative Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Therapeutic regimen
Item
Regimen
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1276413 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1276413 (UMLS CUI [1,3])
Item Group
General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item Group
Non Clinical
C1519255 (UMLS CUI-1)
C2698490 (UMLS CUI-2)
C2698490 (UMLS CUI-2)
Item
Send incomplete SAE data to GSK Safety
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
CL Item
Incomplete SAE (1)
Serious Adverse Event, Receipt, Date in time, Time
Item
Receipt by GSK date
datetime
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C2985846 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event, Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event, Version, Numbers
Item
Version Number
integer
C1519255 (UMLS CUI [1,1])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Case Subject, Identifier
Item
Case ID
integer
C1519255 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Serious Adverse Event, Randomization, Numbers
Item
Randomisation Number
integer
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Code
Item
OCEANS Code
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Serious Adverse Event, Email
Item
Email Flag
text
C1519255 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,2])