ID

39305

Beschreibung

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Stichworte

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  1. 18.12.19 18.12.19 -
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GlaxoSmithKline

Hochgeladen am

18. Dezember 2019

DOI

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Brain Penetration by [Carbonyl-11C] GSK1034702; 110771

Englisch

Serious Adverse Event (SAE)

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Study Coordinating Center, Identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Randomisation Number
Beschreibung

Randomization, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Section 1
Beschreibung

Section 1

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Event - Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

Serious Adverse Event, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Start Time
Beschreibung

Serious Adverse Event, Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Outcome
Beschreibung

Serious Adverse Event, Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date (If fatal, record date of death)
Beschreibung

Serious Adverse Event, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
End Time
Beschreibung

Serious Adverse Event, End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Maximum Grade or Intensity
Beschreibung

Serious Adverse Event, Grade, Maximum; Serious Adverse Event, Symptom Intensity, Maximum

Datentyp

text

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

Serious Adverse Event, Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this SAE?
Beschreibung

Serious Adverse Event, Withdraw

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschreibung

Serious Adverse Event, Relationships, Experimental drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
If fatal, was a post-mortem/autopsy performed
Beschreibung

Serious Adverse Event, Fatal, Autopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Section 2: Seriousness
Beschreibung

Section 2: Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Specify reason(s) for considering this a SAE
Beschreibung

Serious Adverse Event, Seriousness of Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Specify
Beschreibung

Serious Adverse Event, Seriousness of Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Serious 3: Demography Data
Beschreibung

Serious 3: Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0011298
Date of birth
Beschreibung

Serious Adverse Event, Patient date of birth

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0421451
Sex
Beschreibung

Serious Adverse Event, Gender

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0079399
Weight
Beschreibung

Serious Adverse Event, Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0005910
kg
Section 4: If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

Section 4: If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0439849
UMLS CUI-3
C0304229
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

Serious Adverse Event, Relationships, Experimental drug

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Section 5: Possible Causes of SAE Other Than Investigational Product(s)
Beschreibung

Section 5: Possible Causes of SAE Other Than Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0015127
Possible Causes of SAE Other Than Investigational Product(s), check all that apply
Beschreibung

Serious Adverse Event, Etiology aspects

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
Specify
Beschreibung

Serious Adverse Event, Etiology aspects

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
Section 6: Relevant Medical Conditions
Beschreibung

Section 6: Relevant Medical Conditions

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

Serious Adverse Event, Disease; Serious Adverse Event, Hypersensitivity; Serious Adverse Event, Operative Surgical Procedures

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C1519255
UMLS CUI [3,2]
C0543467
Date of Onset
Beschreibung

Serious Adverse Event, Disease, Start Date; Serious Adverse Event, Hypersensitivity, Start Date; Serious Adverse Event, Operative Surgical Procedures, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0808070
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0808070
UMLS CUI [3,1]
C1519255
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0808070
Condition Present at Time of SAE
Beschreibung

Serious Adverse Event, Disease, Present; Serious Adverse Event, Hypersensitivity, Present; Serious Adverse Event, Operative Surgical Procedures, Present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0150312
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0150312
UMLS CUI [3,1]
C1519255
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0150312
If No, Date of Last Occurrence
Beschreibung

Serious Adverse Event, Disease, End Date; Serious Adverse Event, Hypersensitivity, End Date; Serious Adverse Event, Operative Surgical Procedures, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0806020
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0806020
UMLS CUI [3,1]
C1519255
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0806020
Section 7: Other Relevant Risk Factors
Beschreibung

Section 7: Other Relevant Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Beschreibung

Serious Adverse Event, Risk factors

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0035648
Section 8: Relevant Concomitant Medications
Beschreibung

Section 8: Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug Name
Beschreibung

Serious Adverse Event, Concomitant Agent, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Beschreibung

Serious Adverse Event, Concomitant Agent, Dosage

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0178602
Unit
Beschreibung

Serious Adverse Event, Concomitant Agent, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519795
Frequency
Beschreibung

Serious Adverse Event, Concomitant Agent, Frequencies

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Beschreibung

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Taken Prior to Study?
Beschreibung

Serious Adverse Event, Concomitant Medication Previous Occurrence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826667
Start Date
Beschreibung

Serious Adverse Event, Concomitant Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826734
Stop Date
Beschreibung

Serious Adverse Event, Concomitant Medication End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826744
Ongoing Medication?
Beschreibung

Serious Adverse Event, Concomitant Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
Reason for Medication
Beschreibung

Serious Adverse Event, Concomitant Agent, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0566251
Section 9: Details of Investigational Product(s)
Beschreibung

Section 9: Details of Investigational Product(s)

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

Serious Adverse Event, Experimental drug, Details

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1522508
Section 10: Details of Relevant Assessments
Beschreibung

Section 10: Details of Relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0430022
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range
Beschreibung

Serious Adverse Event, Diagnostic Procedure

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
Section 11: Narrative Remarks
Beschreibung

Section 11: Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Provide a brief narrative description of the SAE and details of treatment given
Beschreibung

Serious Adverse Event, Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator's Signature
Beschreibung

Investigator's Signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
Investigator’s signature (confirming that the data on the SAE pages are accurate and complete)
Beschreibung

Serious Adverse Event, Investigator Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
Date
Beschreibung

Serious Adverse Event, Investigator Signature, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
UMLS CUI [1,3]
C0011008
Investigator’s name
Beschreibung

Serious Adverse Event, Investigator Name

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826892
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Ähnliche Modelle

Serious Adverse Event (SAE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Randomization, Numbers
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Section 1
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Event - Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, Start Time
Item
Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/ Resolved  (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
CL Item
Fatal (5)
Serious Adverse Event, End Date
Item
End Date (If fatal, record date of death)
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
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])
Non-serious Adverse Event, Symptom Intensity, Maximum
Code List
Maximum Grade or Intensity
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 SAE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action Taken with Study Treatment
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
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 SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Fatal, Autopsy
Item
If fatal, was a post-mortem/autopsy performed
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item Group
Section 2: Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Specify reason(s) for considering this a SAE
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Specify reason(s) for considering this a SAE
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 (6)
Serious Adverse Event, Seriousness of Adverse Event
Item
Specify
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item Group
Serious 3: Demography Data
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Serious Adverse Event, Patient date of birth
Item
Date of birth
date
C1519255 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
Item
Sex
text
C1519255 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
Serious Adverse Event, Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Serious Adverse Event, Body Weight
Item
Weight
float
C1519255 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
Item Group
Section 4: If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
C1519255 (UMLS CUI-1)
C0439849 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Experimental drug
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Unknown at this time  (3)
CL Item
Not applicable (4)
Item Group
Section 5: Possible Causes of SAE Other Than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0015127 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s), check all that apply
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Serious Adverse Event, Etiology aspects
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), specify (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s), specify (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Serious Adverse Event, Etiology aspects
Item
Specify
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item Group
Section 6: Relevant Medical Conditions
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Serious Adverse Event, Disease; Serious Adverse Event, Hypersensitivity; Serious Adverse Event, Operative Surgical Procedures
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Serious Adverse Event, Disease, Start Date; Serious Adverse Event, Hypersensitivity, Start Date; Serious Adverse Event, Operative Surgical Procedures, Start Date
Item
Date of Onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0808070 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0808070 (UMLS CUI [3,3])
Serious Adverse Event, Disease, Present; Serious Adverse Event, Hypersensitivity, Present; Serious Adverse Event, Operative Surgical Procedures, Present
Item
Condition Present at Time of SAE
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0150312 (UMLS CUI [3,3])
Serious Adverse Event, Disease, End Date; Serious Adverse Event, Hypersensitivity, End Date; Serious Adverse Event, Operative Surgical Procedures, End Date
Item
If No, Date of Last Occurrence
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0806020 (UMLS CUI [3,3])
Item Group
Section 7: Other Relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Serious Adverse Event, Risk factors
Item
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
text
C1519255 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Item Group
Section 8: Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Serious 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])
Serious Adverse Event, Concomitant Agent, Dosage
Item
Dose
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit of Measure
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious 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])
Serious Adverse Event, Concomitant Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2826667 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Reason and justification
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Section 9: Details of Investigational Product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Item
Details of Investigational Product(s)
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug
Code List
Details of Investigational Product(s)
Item Group
Section 10: Details of Relevant Assessments
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
Serious Adverse Event, Diagnostic Procedure
Item
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Item Group
Section 11: Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Provide a brief narrative description of the SAE and details of treatment given
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator's Signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Serious Adverse Event, Investigator Signature
Item
Investigator’s signature (confirming that the data on the SAE pages are accurate and complete)
text
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Serious Adverse Event, Investigator Signature, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Investigator Name
Item
Investigator’s name
text
C1519255 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
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