ID

41636

Beschrijving

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Trefwoorden

Versies (2)
  1. 04-11-20 04-11-20 -
  2. 29-11-20 29-11-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 november 2020

DOI

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Licentie

Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

Engels

Adverse Events/ Serious Adverse Events; Prior and Concomitant Medications/ Non-drug Therapies

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beschrijving

Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschrijving

Subject

Datatype

text

Alias
UMLS CUI [1]
C2348585
Status
Beschrijving

Status

Datatype

text

Alias
UMLS CUI [1]
C0449438
Doc #
Beschrijving

Doc #

Datatype

text

Alias
UMLS CUI [1]
C1301746
Is Page Blank?
Beschrijving

Is Page Blank?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0750479
Adverse Events
Beschrijving

Adverse Events

Alias
UMLS CUI-1
C0877248
Has the Subject experienced any adverse events?
Beschrijving

If Yes, please add Adverse Event details on next page.

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Events/ Serious Adverse Events - Section 1
Beschrijving

Adverse Events/ Serious Adverse Events - Section 1

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
Adverse Event Number
Beschrijving

Adverse Event Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C0877248
Type of event
Beschrijving

Type of event

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0332307
Adverse Event Start Date
Beschrijving

Adverse Event Start Date

Datatype

date

Alias
UMLS CUI [1]
C2697888
Adverse Event Outcome
Beschrijving

Adverse Event Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Adverse Event End Date
Beschrijving

Adverse Event End Date

Datatype

date

Alias
UMLS CUI [1]
C2697886
Adverse Event Maximum Intensity
Beschrijving

Adverse Event Maximum Intensity

Datatype

integer

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0806909
Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Action Taken with Investigational Product(s) as a Result of the AE

Datatype

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0877248
Withdrawal (Did the subject withdraw from study as a result of this AE?)
Beschrijving

Yes - If subject withdrew from active treatment period, check 'Adverse event' on End of Active Treatment page No - If subject withdrew from follow-up period, check 'Adverse event' on Study Conclusion Page

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C0877248
Relationship to Investigational Product(s)
Beschrijving

Is there a reasonable possibility the AE may have been caused by the investigational product?

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0439849
Was a concomitant medication/non-drug therapy taken for this AE?
Beschrijving

If Yes, please record on Concomitant Medications/Non-Drug Therapies page

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0599938
UMLS CUI [3]
C0877248
Was event serious?
Beschrijving

If Yes, complete sections 2 - 11 below.

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Adverse Events/ Serious Adverse Events - Section 2 (Seriousness)
Beschrijving

Adverse Events/ Serious Adverse Events - Section 2 (Seriousness)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
UMLS CUI-3
C1710056
Specify reason(s) for considering this a SAE, check all that apply
Beschrijving

Specify reason(s) for considering this a SAE, check all that apply

Datatype

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0566251
Specify other reason for considering this a SAE
Beschrijving

(see definition of SAE)

Datatype

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0566251
UMLS CUI [2,2]
C0205394
Adverse Events/ Serious Adverse Events - Section 3 (Demography Data)
Beschrijving

Adverse Events/ Serious Adverse Events - Section 3 (Demography Data)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
UMLS CUI-3
C0011298
Date of Birth
Beschrijving

Date of Birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Adverse Events/ Serious Adverse Events - Section 4
Beschrijving

Adverse Events/ Serious Adverse Events - Section 4

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschrijving

If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?

Datatype

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0034897
UMLS CUI [3]
C0304229
UMLS CUI [4]
C0457454
Adverse Events/ Serious Adverse Events - Section 5
Beschrijving

Adverse Events/ Serious Adverse Events - Section 5

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
Possible Causes of SAE Other Than Investigational Product(s), check all that apply:
Beschrijving

Possible Causes of SAE Other Than Investigational Product(s), check all that apply:

Datatype

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0085978
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0205394
Adverse Events/ Serious Adverse Events - Section 6 (Medical Conditions)
Beschrijving

Adverse Events/ Serious Adverse Events - Section 6 (Medical Conditions)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
UMLS CUI-3
C0012634
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschrijving

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE

Datatype

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
UMLS CUI [4]
C2347946
Serious Adverse Event - Date of Onset
Beschrijving

Serious Adverse Event - Date of Onset

Datatype

date

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C2985916
Condition Present at Time of the SAE?
Beschrijving

Condition Present at Time of the SAE?

Datatype

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1519255
If condition not present at Time of SAE, enter date of Last Occurence
Beschrijving

If condition not present at Time of SAE, enter date of Last Occurence

Datatype

date

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1519255
UMLS CUI [3,1]
C2745955
UMLS CUI [3,2]
C1517741
UMLS CUI [3,3]
C0011008
Adverse Events/ Serious Adverse Events - Section 7 (Other RELEVANT Risk Factors)
Beschrijving

Adverse Events/ Serious Adverse Events - Section 7 (Other RELEVANT Risk Factors)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
UMLS CUI-3
C0035648
UMLS CUI-4
C0205394
UMLS CUI-5
C2347946
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Beschrijving

Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE

Datatype

text

Alias
UMLS CUI [1]
C0241889
UMLS CUI [2]
C3714536
UMLS CUI [3]
C1519384
UMLS CUI [4]
C0001948
UMLS CUI [5]
C0012155
UMLS CUI [6]
C0013146
UMLS CUI [7]
C0337074
UMLS CUI [8]
C1519255
Other RELEVANT Risk Factors
Beschrijving

Other RELEVANT Risk Factors

Datatype

text

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2347946
Adverse Events/ Serious Adverse Events - Section 8 (RELEVANT Concomitant Medications)
Beschrijving

Adverse Events/ Serious Adverse Events - Section 8 (RELEVANT Concomitant Medications)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
UMLS CUI-3
C2347852
UMLS CUI-4
C2347946
Drug Name
Beschrijving

Trade Name preferred

Datatype

text

Alias
UMLS CUI [1]
C2360065
Medication Dose
Beschrijving

Medication Dose

Datatype

float

Alias
UMLS CUI [1]
C3174092
Medication Unit
Beschrijving

Medication Unit

Datatype

text

Alias
UMLS CUI [1]
C2826646
Medication Frequency
Beschrijving

Medication Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschrijving

Medication Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Other Route, specify
Beschrijving

Other Route, specify

Datatype

text

Alias
UMLS CUI [1]
C0013153
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Medication Taken Prior to study
Beschrijving

Medication Taken Prior to study

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Medication Start Date
Beschrijving

Medication Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Medication Stop Date
Beschrijving

Medication Stop Date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Beschrijving

Ongoing Medication?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Alias
UMLS CUI [1]
C2826696
Adverse Events/ Serious Adverse Events - Section 9 (Details of Investigational Product(s))
Beschrijving

Adverse Events/ Serious Adverse Events - Section 9 (Details of Investigational Product(s))

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
UMLS CUI-3
C0304229
UMLS CUI-4
C1522508
Details of Investigational Product(s)
Beschrijving

Details of Investigational Product(s)

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Adverse Events/ Serious Adverse Events - Section 10 (Details of RELEVANT ASSESSMENTS)
Beschrijving

Adverse Events/ Serious Adverse Events - Section 10 (Details of RELEVANT ASSESSMENTS)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
UMLS CUI-3
C0220825
UMLS CUI-4
C2347946
Details of RELEVANT ASSESSMENTS
Beschrijving

Details of RELEVANT ASSESSMENTS

Datatype

text

Alias
UMLS CUI [1]
C0220825
UMLS CUI [2]
C1522508
UMLS CUI [3]
C2347946
Adverse Events/ Serious Adverse Events - Section 11 (Narrative Remarks)
Beschrijving

Adverse Events/ Serious Adverse Events - Section 11 (Narrative Remarks)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1519255
UMLS CUI-3
C0947611
Prior and Concomitant Medications/Non-drug Therapies
Beschrijving

Prior and Concomitant Medications/Non-drug Therapies

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1514463
UMLS CUI-3
C0033082
UMLS CUI-4
C0087111
Did Subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?
Beschrijving

If yes, please add Prior/Concomitant Medication/Non-Drug Therapies details on next page (includes over-the counter and prescription drugs)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0033082
UMLS CUI [2]
C2347852
Prior and Concomitant Medications/Non-drug Therapies
Beschrijving

Prior and Concomitant Medications/Non-drug Therapies

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1514463
UMLS CUI-3
C0033082
UMLS CUI-4
C0087111
Drug Name
Beschrijving

Trade name preferred

Datatype

text

Alias
UMLS CUI [1]
C2360065
Medication Unit Dose
Beschrijving

Medication Unit Dose

Datatype

text

Alias
UMLS CUI [1]
C2826646
Medication Unit
Beschrijving

Medication Unit

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Medication Frequency
Beschrijving

Medication Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschrijving

Medication Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Specify other Medication Route
Beschrijving

Specify other Medication Route

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0205394
Reason for Medication
Beschrijving

Indication (If AE/SAE enter Event Term)

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
AE/SAE #
Beschrijving

If applicable

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0237753
Medication Start Date
Beschrijving

Medication Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Medication Stop Date
Beschrijving

Medication Stop Date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Mark if medication is continuing
Beschrijving

Mark if medication is continuing

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0549178
Medicatino taken prior to study?
Beschrijving

Medicatino taken prior to study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
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Similar models

Adverse Events/ Serious Adverse Events; Prior and Concomitant Medications/ Non-drug Therapies

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc #
Item
Doc #
text
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Has the Subject experienced any adverse events?
Item
Has the Subject experienced any adverse events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Adverse Events/ Serious Adverse Events - Section 1
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Adverse Event Number
Item
Adverse Event Number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Item
Type of event
integer
C0877248 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of event
Code List
Type of event
CL Item
Liver (1)
CL Item
Cardiovascular (2)
CL Item
GI (3)
CL Item
Thyroid (4)
CL Item
Hypoglycemic (5)
CL Item
Injection site reaction (6)
CL Item
Diabetic retinopathy (7)
CL Item
Other (8)
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI [1])
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event Outcome
CL Item
Fatal (1)
CL Item
Recovered/resolved with sequelae (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovering/resolving (4)
CL Item
Recovered/resolved (5)
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Item
Adverse Event Maximum Intensity
integer
C0877248 (UMLS CUI [1])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Adverse Event Maximum Intensity
Code List
Adverse Event Maximum Intensity
CL Item
Not applicable (1)
CL Item
Severe (2)
CL Item
Moderate (3)
CL Item
Mild (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Not applicable (3)
Withdrawal (Did the subject withdraw from study as a result of this AE?)
Item
Withdrawal (Did the subject withdraw from study as a result of this AE?)
boolean
C1710677 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
C0877248 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0439849 (UMLS CUI [3])
Was a concomitant medication/non-drug therapy taken for this AE?
Item
Was a concomitant medication/non-drug therapy taken for this AE?
boolean
C2347852 (UMLS CUI [1])
C0599938 (UMLS CUI [2])
C0877248 (UMLS CUI [3])
Was event serious?
Item
Was event serious?
boolean
C1519255 (UMLS CUI [1])
Item Group
Adverse Events/ Serious Adverse Events - Section 2 (Seriousness)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1710056 (UMLS CUI-3)
Item
Specify reason(s) for considering this a SAE, check all that apply
text
C1519255 (UMLS CUI [1])
C0566251 (UMLS CUI [2])
Specify reason(s) for considering this a SAE, check all that apply
Code List
Specify reason(s) for considering this a SAE, check all that apply
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
Specify other reason for considering this a SAE
Item
Specify other reason for considering this a SAE
text
C1519255 (UMLS CUI [1])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Item Group
Adverse Events/ Serious Adverse Events - Section 3 (Demography Data)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0011298 (UMLS CUI-3)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Sex
Item
Sex
text
C0079399 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Adverse Events/ Serious Adverse Events - Section 4
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1])
C0034897 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
C0457454 (UMLS CUI [4])
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (NA)
Item Group
Adverse Events/ Serious Adverse Events - Section 5
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s), check all that apply:
integer
C1519255 (UMLS CUI [1])
C0085978 (UMLS CUI [2])
C0304229 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Possible Causes of SAE Other Than Investigational Product(s), check all that apply:
Code List
Possible Causes of SAE Other Than Investigational Product(s), check all that apply:
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
CL Item
Other specify (7)
Item Group
Adverse Events/ Serious Adverse Events - Section 6 (Medical Conditions)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C2347946 (UMLS CUI [4])
Serious Adverse Event - Date of Onset
Item
Serious Adverse Event - Date of Onset
date
C1519255 (UMLS CUI [1])
C2985916 (UMLS CUI [2])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
If condition not present at Time of SAE, enter date of Last Occurence
Item
If condition not present at Time of SAE, enter date of Last Occurence
date
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
Item Group
Adverse Events/ Serious Adverse Events - Section 7 (Other RELEVANT Risk Factors)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C2347946 (UMLS CUI-5)
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Item
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
text
C0241889 (UMLS CUI [1])
C3714536 (UMLS CUI [2])
C1519384 (UMLS CUI [3])
C0001948 (UMLS CUI [4])
C0012155 (UMLS CUI [5])
C0013146 (UMLS CUI [6])
C0337074 (UMLS CUI [7])
C1519255 (UMLS CUI [8])
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2347946 (UMLS CUI [3])
Item Group
Adverse Events/ Serious Adverse Events - Section 8 (RELEVANT Concomitant Medications)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C2347852 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Medication Dose
Item
Medication Dose
float
C3174092 (UMLS CUI [1])
Medication Unit
Item
Medication Unit
text
C2826646 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Other Route, specify
Item
Other Route, specify
text
C0013153 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Medication Taken Prior to study
Item
Medication Taken Prior to study
boolean
C2826667 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Item Group
Adverse Events/ Serious Adverse Events - Section 9 (Details of Investigational Product(s))
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Item Group
Adverse Events/ Serious Adverse Events - Section 10 (Details of RELEVANT ASSESSMENTS)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
Details of RELEVANT ASSESSMENTS
Item
Details of RELEVANT ASSESSMENTS
text
C0220825 (UMLS CUI [1])
C1522508 (UMLS CUI [2])
C2347946 (UMLS CUI [3])
Item Group
Adverse Events/ Serious Adverse Events - Section 11 (Narrative Remarks)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0947611 (UMLS CUI-3)
Item Group
Prior and Concomitant Medications/Non-drug Therapies
C2347852 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0033082 (UMLS CUI-3)
C0087111 (UMLS CUI-4)
Did Subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?
Item
Did Subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?
boolean
C0087111 (UMLS CUI [1,1])
C0033082 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Item Group
Prior and Concomitant Medications/Non-drug Therapies
C2347852 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0033082 (UMLS CUI-3)
C0087111 (UMLS CUI-4)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Medication Unit Dose
Item
Medication Unit Dose
text
C2826646 (UMLS CUI [1])
Medication Unit
Item
Medication Unit
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Specify other Medication Route
Item
Specify other Medication Route
text
C0013153 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
AE/SAE #
Item
AE/SAE #
text
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Mark if medication is continuing
Item
Mark if medication is continuing
boolean
C2347852 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medicatino taken prior to study?
Item
Medicatino taken prior to study?
boolean
C2826667 (UMLS CUI [1])
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