ID

32015

Beschreibung

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Stichworte

Versionen (1)
  1. 12.10.18 12.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. Oktober 2018

DOI

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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

Englisch

Serious Adverse Events

1 Formulare  
  1. StudyEvent: ODM
    1. Serious Adverse Events
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any serious adverse events during the study?
Beschreibung

Serious Adverse Event; During; Clinical Trial Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
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

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date
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; Adverse Event End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826658
Maximum Intensity
Beschreibung

Serious Adverse Event; Symptom Intensity

Datentyp

integer

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

Serious Adverse Event; Action taken with investigational product

Datentyp

integer

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; Patient withdrawn from trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0422727
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschreibung

Serious Adverse Event; Investigational New Drugs; Relationships

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
If fatal, was a post-mortem/autopsy performed?
Beschreibung

Serious Adverse Event; Autopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0004398
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness
Beschreibung

Serious Adverse Event; Seriousness of Adverse Event

Datentyp

text

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

Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1704791
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

integer

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

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
C0034897
UMLS CUI-3
C0013230
UMLS CUI-4
C0205394
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

Serious Adverse Event; Recurrence; Investigational New Drugs; Other

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C0205394
Possible Causes of SAE Other Than Investigational Product(s)
Beschreibung

Possible Causes of SAE Other Than Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible Causes of SAE Other Than Investigational Product(s)
Beschreibung

Serious Adverse Event; Cause

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Relevant Medical Conditions
Beschreibung

Relevant Medical Conditions

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0262926
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschreibung

Serious Adverse Event; Disease; Hypersensitivity; Operative Surgical Procedures

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0020517
UMLS CUI [1,4]
C0543467
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschreibung

Serious Adverse Event, Disease, Date of onset; Serious Adverse Event, Hypersensitivity, Date of onset; Serious Adverse Event, Operative Surgical Procedures, Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0574845
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0574845
UMLS CUI [3,1]
C1519255
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0574845
Condition Present at Time of the 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
C0150312
Beschreibung

Serious Adverse Event, Disease, ; Serious Adverse Event, Hypersensitivity, Occurrence, Date in Time; Serious Adverse Event, Operative Surgical Procedures, Occurrence, Date in Time

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C2745955
UMLS CUI [2,4]
C0011008
UMLS CUI [3,1]
C1519255
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C2745955
UMLS CUI [3,4]
C0011008
Other relevant Risk Factors
Beschreibung

Other relevant Risk Factors

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

Serious Adverse Events; Risk Factors

Datentyp

text

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

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; Medication Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
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; Medication frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3476109
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 Agent; Concomitant Medication Previous Occurrence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826667
Start Date
Beschreibung

Serious Adverse Event; Concomitant Agent; Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Stop Date
Beschreibung

Serious Adverse Event; Concomitant Agent; End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Ongoing Medication?
Beschreibung

Serious Adverse Event; Concomitant Agent; Concomitant Medication ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826666
Reason for Medication
Beschreibung

Serious Adverse Event; Concomitant Agent; Concomitant Medication Use Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826696
Details of Investigational Product(s)
Beschreibung

Details of Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Planned Timepoint
Beschreibung

Serious Adverse Events; Experimental Drugs; Timepoint; Planned

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2348792
UMLS CUI [1,4]
C1301732
Date of Injection
Beschreibung

Serious Adverse Events; Experimental Drugs; Injection of therapeutic agent; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0021485
UMLS CUI [1,4]
C0011008
Time of Injection
Beschreibung

Serious Adverse Events; Experimental Drugs; Injection of therapeutic agent; Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0021485
UMLS CUI [1,4]
C0040223
Dose
Beschreibung

Serious Adverse Events; Experimental Drugs; Medication Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3174092
Details of relevant Assessments
Beschreibung

Details of relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
Details of relevant Assessments
Beschreibung

Serious Adverse Events; Evaluation

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
Narrative Remarks
Beschreibung

Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Narrative Remarks
Beschreibung

Serious Adverse Event; Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
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Ähnliche Modelle

Serious Adverse Events

1 Formulare
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Serious Adverse Event; During; Clinical Trial Period
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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
integer
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)
Serious Adverse Event; End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event; Adverse Event End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Non-Serious Adverse Event; Frequencies
Code List
Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of SAE
integer
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-Serious Adverse Event; Frequencies
Code List
Action Taken with Investigational Product(s) as a Result of 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; Patient withdrawn from trial
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Serious Adverse Event; Investigational New Drugs; Relationships
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Serious Adverse Event; Autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C1519255 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event; Seriousness of Adverse Event
Code List
Seriousness
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)
Item Group
Demography Data
C1519255 (UMLS CUI-1)
C1704791 (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
integer
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
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
C1519255 (UMLS CUI-1)
C0034897 (UMLS CUI-2)
C0013230 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
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])
C0034897 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Serious Adverse Event; Recurrence;
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
Possible Causes of SAE Other Than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Serious Adverse Event; Cause
Code List
Possible Causes of SAE Other Than Investigational Product(s)
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)
Item Group
Relevant Medical Conditions
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Serious Adverse Event; Disease; Hypersensitivity; 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])
C0020517 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Serious Adverse Event, Disease, Date of onset; Serious Adverse Event, Hypersensitivity, Date of onset; Serious Adverse Event, Operative Surgical Procedures, Date of onset
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0574845 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0574845 (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 the 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, ; Serious Adverse Event, Hypersensitivity, Occurrence, Date in Time; Serious Adverse Event, Operative Surgical Procedures, Occurrence, Date in Time
Item
C0150312
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,4])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C2745955 (UMLS CUI [3,3])
C0011008 (UMLS CUI [3,4])
Item Group
Other relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Serious Adverse Events; Risk Factors
Item
Other relevant Risk Factors (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
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; Medication Dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (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; Medication frequency
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3476109 (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 Agent; Concomitant Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826667 (UMLS CUI [1,3])
Serious Adverse Event; Concomitant Agent; Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event; Concomitant Agent; End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event; Concomitant Agent; Concomitant Medication ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,3])
Serious Adverse Event; Concomitant Agent; Concomitant Medication Use Indication
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826696 (UMLS CUI [1,3])
Item Group
Details of Investigational Product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Serious Adverse Events; Experimental Drugs; Timepoint; Planned
Item
Planned Timepoint
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Serious Adverse Events; Experimental Drugs; Injection of therapeutic agent; Date in time
Item
Date of Injection
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0021485 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Serious Adverse Events; Experimental Drugs; Injection of therapeutic agent; Time
Item
Time of Injection
time
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0021485 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Serious Adverse Events; Experimental Drugs; Medication Dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Item Group
Details of relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Serious Adverse Events; Evaluation
Item
Details of relevant Assessments
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event; Comment
Item
Narrative Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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