ID

38914

Beschreibung

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form should be filled in in case of a serious adverse event.

Link

https://clinicaltrials.gov/ct2/show/NCT00992160

Stichworte

Versionen (1)
  1. 12.11.19 12.11.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. November 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Englisch

Serious Adverse Event

1 Formulare  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Beschreibung

Study site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Beschreibung

Subject No.

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Type of Report
Beschreibung

Type of Report

Alias
UMLS CUI-1
C0585733
Initial Report
Beschreibung

Initial Report

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0205265
Follow-Up Report
Beschreibung

Follow-Up Report

Datentyp

boolean

Alias
UMLS CUI [1]
C1704685
Randomisation
Beschreibung

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Beschreibung

SAE after initiation of study medication

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C1704686
UMLS CUI [1,4]
C0304229
Serious adverse event Entry
Beschreibung

Serious adverse event Entry

Alias
UMLS CUI-1
C1519255
Sequence Number
Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

SAE Diagnosis or Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3540840
Adverse Event Modified Reported Term
Datentyp

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Datentyp

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Datentyp

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start Date and Time
Beschreibung

Adverse Event Start Date/Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826806
Outcome
Beschreibung

if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death

Datentyp

text

Alias
UMLS CUI [1]
C1705586
End Date and Time
Beschreibung

if applicable

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Maximum Intensity
Beschreibung

SAE Maximum Intensity

Datentyp

text

Alias
UMLS CUI [1]
C1710066
Maximum Grade
Beschreibung

SAE Maximum Grade

Datentyp

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Maximum Grade or Intensity
Beschreibung

SAE Maximum Grade or Intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action regarding Investigational Product

Datentyp

text

Alias
UMLS CUI [1]
C1704758
Did the subject withdraw from study as a result of this AE?
Beschreibung

Subject withdrawal because of AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
Beschreibung

AE possibly caused by investigational product

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332149
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C0877248
Duration of AE if < 24 hours
Beschreibung

Duration of AE

Datentyp

time

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
Time to Onset Since Last Dose
Datentyp

time

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0439659
UMLS CUI [1,5]
C1519255
Was SAE caused by activities related to study participation (e.g. procedures)?
Beschreibung

SAE caused by activities related to study participation

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C2348568
Was the event serious?
Datentyp

text

Alias
UMLS CUI [1]
C1547644
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C0566251
UMLS CUI-2
C1547644
Results in death
Beschreibung

Adverse Event Results in death

Datentyp

boolean

Alias
UMLS CUI [1]
C1320832
Is life-threatening
Beschreibung

Adverse event is life-threatening

Datentyp

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalisation or prolongation of existing hospitalisation
Beschreibung

adverse event requires hospitalisation or prolongation of hospitalisation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826664
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0745041
UMLS CUI [2,2]
C1519255
Results in disability/incapacity
Beschreibung

Serious adverse event results in disability/incapacity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3176592
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C1519255
Congenital anomaly/birth defect
Beschreibung

Serious adverse event: Congenital anomaly/birth defect

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other, specify within general narrative comment
Beschreibung

Other reason for event seriousness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1519255
Relevant concomitant/treatment medications
Beschreibung

Relevant concomitant/treatment medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2347946
UMLS CUI-3
C0304229
CM Sequence Number
Datentyp

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Drug name
Beschreibung

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Dose
Beschreibung

Concomitant medication dose

Datentyp

float

Alias
UMLS CUI [1]
C2826811
Unit
Beschreibung

Concomitant medication unit

Datentyp

text

Alias
UMLS CUI [1]
C2826646
Frequency
Beschreibung

Concomitant medication frequency

Datentyp

text

Alias
UMLS CUI [1]
C2826654
Route
Beschreibung

Concomitant medication route

Datentyp

text

Alias
UMLS CUI [1]
C2826730
Start Date
Beschreibung

Concomitant Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Ongoing?
Beschreibung

if no, specify End Date

Datentyp

text

Alias
UMLS CUI [1]
C2826666
Medication not ongoing, specify end date
Beschreibung

Concomitant medication end date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Primary Indication
Beschreibung

Concomitant Medication Primary Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C2826696
UMLS CUI [1,2]
C0205225
Drug Type
Beschreibung

Drug Type

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Relevant Medical Conditions/Risk Factors
Beschreibung

Relevant Medical Conditions/Risk Factors

Alias
UMLS CUI-1
C2347946
UMLS CUI-2
C0012634
UMLS CUI-3
C0035648
MHx Sequence Number
Datentyp

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
Specific Condition Name
Beschreibung

Specific Condition

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Date of onset
Beschreibung

Date of onset

Datentyp

date

Alias
UMLS CUI [1]
C0574845
Continuing?
Beschreibung

If no, specify date of last occurrence

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
If no, specify date of last occurrence
Beschreibung

Date of last disease occurence

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
Relevant Medical History / Risk Factors not noted above
Beschreibung

Relevant Other Medical History / Risk Factors

Datentyp

text

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0035648
Relevant Diagnostic Results
Beschreibung

Relevant Diagnostic Results

Alias
UMLS CUI-1
C2347946
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
Lab Sequence Number
Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Test Name
Beschreibung

Lab Test Name

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
Laboratory Test Result
Beschreibung

Laboratory Test Result

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Laboratory Test Units
Beschreibung

Laboratory Test Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Beschreibung

Normal Low Range

Datentyp

text

Alias
UMLS CUI [1]
C1272773
Normal High Range
Beschreibung

Normal High Range

Datentyp

text

Alias
UMLS CUI [1]
C1299400
Relevant diagnostic results not noted above
Beschreibung

Relevant other diagnostic laboratory results

Datentyp

text

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0205394
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Beschreibung

Event recurrence after investigational product administered again

Datentyp

text

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1517331
UMLS CUI [1,4]
C0304229
General narrative comments
Beschreibung

General narrative comments

Alias
UMLS CUI-1
C0947611
General narrative comment
Beschreibung

General comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Non clinical
Beschreibung

Non clinical

Alias
UMLS CUI-1
C1320722
Send incomplete SAE data to GSK Safety
Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519246
UMLS CUI [1,2]
C0205257
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1511726
UMLS CUI [1,5]
C2347796
Receipt by GSK date
Beschreibung

Receipt date by sponsoring company

Datentyp

datetime

Alias
UMLS CUI [1,1]
C2985846
UMLS CUI [1,2]
C2347796
Was the event serious?
Datentyp

text

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Datentyp

text

Alias
UMLS CUI [1]
C2985700
Case ID
Datentyp

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C1516728
Email Flag
Datentyp

text

Alias
UMLS CUI [1]
C0013849
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Ähnliche Modelle

Serious Adverse Event

1 Formulare
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item Group
Type of Report
C0585733 (UMLS CUI-1)
Initial Report
Item
Initial Report
boolean
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Follow-Up Report
Item
Follow-Up Report
boolean
C1704685 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Item
Did SAE occur after initiation of study medication?
text
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
SAE after initiation of study medication
Code List
Did SAE occur after initiation of study medication?
CL Item
No (No)
CL Item
Yes (Yes)
Item Group
Serious adverse event Entry
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
SAE Diagnosis or Sign/Symptom
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
Adverse Event Modified Reported Term
Item
Adverse Event Modified Reported Term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Adverse Event Start Date/Time
Item
Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date and Time (Recovered/Resolved, provide End Date and Time)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (Recovered/Resolved with sequelae, provide End Date and Time)
CL Item
Fatal, record Date and Time of Death (Fatal, record Date and Time of Death)
Adverse Event End Date/Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
Maximum Grade
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade
Code List
Maximum Grade
CL Item
Grade 1 (Grade 1)
CL Item
Grade 2 (Grade 2)
CL Item
Grade 3 (Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Maximum Grade
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1 (Mild or Grade 1)
CL Item
Moderate or Grade 2 (Moderate or Grade 2)
CL Item
Severe or Grade 3 (Severe or Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1])
Action regarding Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Subject withdrawal because of AE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
Subject withdrawal because of AE
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
CL Item
Yes (Yes)
CL Item
No (No)
Duration of AE
Item
Duration of AE if < 24 hours
time
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Interval between Last Dose and AE Onset
Item
Time to Onset Since Last Dose
time
C1272706 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,5])
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Subject withdrawal because of AE
Code List
Was SAE caused by activities related to study participation (e.g. procedures)?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was the event serious?
text
C1547644 (UMLS CUI [1])
Subject withdrawal because of AE
Code List
Was the event serious?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Seriousness
C0566251 (UMLS CUI-1)
C1547644 (UMLS CUI-2)
Adverse Event Results in death
Item
Results in death
boolean
C1320832 (UMLS CUI [1])
Adverse event is life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
adverse event requires hospitalisation or prolongation of hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C2826664 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Serious adverse event results in disability/incapacity
Item
Results in disability/incapacity
boolean
C3176592 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Serious adverse event: Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other reason for event seriousness
Item
Other, specify within general narrative comment
boolean
C3840932 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Relevant concomitant/treatment medications
C2347852 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Concomitant Medication Sequence Number
Item
CM Sequence Number
text
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Concomitant medication dose
Item
Dose
float
C2826811 (UMLS CUI [1])
Concomitant medication unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Concomitant medication frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant medication route
Item
Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Subject withdrawal because of AE
Code List
Ongoing?
CL Item
Yes (Yes)
CL Item
No (No)
Concomitant medication end date
Item
Medication not ongoing, specify end date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Primary Indication
Item
Primary Indication
text
C2826696 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Drug Type
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Item Group
Relevant Medical Conditions/Risk Factors
C2347946 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
MHx Sequence Number
Item
MHx Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Specific Condition
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing?
Code List
Continuing?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Date of last disease occurence
Item
If no, specify date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Relevant Other Medical History / Risk Factors
Item
Relevant Medical History / Risk Factors not noted above
text
C2347946 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
Item Group
Relevant Diagnostic Results
C2347946 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Lab Test Name
Item
Test Name
text
C0022885 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Laboratory Test Result
Item
Laboratory Test Result
text
C0587081 (UMLS CUI [1])
Laboratory Test Units
Item
Laboratory Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C1272773 (UMLS CUI [1])
Normal High Range
Item
Normal High Range
text
C1299400 (UMLS CUI [1])
Relevant other diagnostic laboratory results
Item
Relevant diagnostic results not noted above
text
C2347946 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0034897 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
event recurence after investigational product administered again
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
General narrative comments
C0947611 (UMLS CUI-1)
General comment
Item
General narrative comment
text
C0947611 (UMLS CUI [1])
Item Group
Non clinical
C1320722 (UMLS CUI-1)
send incomplete SAE data to sponsoring company
Item
Send incomplete SAE data to GSK Safety
boolean
C1519246 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
Receipt date by sponsoring company
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
Item
Was the event serious?
text
C1519255 (UMLS CUI [1])
Subject withdrawal because of AE
Code List
Was the event serious?
CL Item
Yes (Yes)
CL Item
No (No)
SAE Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
text
C2985700 (UMLS CUI [1])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Email
Item
Email Flag
text
C0013849 (UMLS CUI [1])
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