ID

26285

Beschreibung

Concomitant Medication, Adverse Event, SAE - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Stichworte

Versionen (1)
  1. 15.10.17 15.10.17 -
Rechteinhaber

glaxoSmithKline

Hochgeladen am

15. Oktober 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Concomitant Medication, Adverse Event, SAE - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Englisch

Concomitant Medication, Adverse Event, SAE - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulare  
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Has the patient taken any concomitant medication(s) (other than study drug and medications for the treatment of Parkinson ́s Disease) from 30 days prior to screening through the end of the Treatment Period?
Beschreibung

Record all medication(s) taken by the patient from 30 days prior to screening through the end of the Treatment Period.

Datentyp

integer

Alias
UMLS CUI [1]
C2347852
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Medication
Beschreibung

Use Generic Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0592502
Date started
Beschreibung

Date medication started

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Date stopped
Beschreibung

Date medication stopped

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing
Beschreibung

Medication continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Dose and frequency
Beschreibung

eg. 10mg tid

Datentyp

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C3476109
Route
Beschreibung

medication administration route

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Specify other route of administration
Beschreibung

Specify other route of administration

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0013153
indication
Beschreibung

Indication of medication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Adverse event
Beschreibung

Adverse event

Alias
UMLS CUI-1
C0877248
Has the patient experienced any new and/or worsening adverse events from the time of screening through the end of the Treatment Period?
Beschreibung

If yes indicate below.

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Adverse event
Beschreibung

Adverse event

Alias
UMLS CUI-1
C0877248
Adverse event
Beschreibung

Adverse event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Serious
Beschreibung

A Serious Adverse Event is any AE that is fatal, life-threatening, disabling/incapacitating, results in inpatient hospitalization or prolongation of existing hospitalization, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgement, they may jeopardise the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Cancer, overdose and pregnancy must also be reported on SAE form. Record any Serious Adverse Events on the Serious Adverse Event form and notify the PAREXEL Clinical Trial Safety Center within 24 hours of learning of its occurence.

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Start date
Beschreibung

Start date adverse event

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Start time
Beschreibung

Start time adverse event

Datentyp

time

Alias
UMLS CUI [1]
C2697889
Stop date
Beschreibung

Stop date adverse event

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Stop time
Beschreibung

Stop time adverse event

Datentyp

time

Alias
UMLS CUI [1]
C2826658
Intensity
Beschreibung

Intensity adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Relationship to drug
Beschreibung

adverse event Relationship to drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Action taken
Beschreibung

Adverse event action taken

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Corrective therapy
Beschreibung

If Yes, record on Other (non-study) Medications Form

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Event course
Beschreibung

If Intermittent, record number of episodes in box

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Number of episodes
Beschreibung

Adverse event number of episodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Outcome
Beschreibung

Adverse event outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Subject death
Beschreibung

Subject death

Alias
UMLS CUI-1
C0011065
Date of death
Beschreibung

Date of death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Was an autopsy performed?
Beschreibung

If YES, attach a copy of the autopsy report

Datentyp

integer

Alias
UMLS CUI [1]
C0004398
Primary cause of death
Beschreibung

Primary cause of death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Underlying cause(s) of death
Beschreibung

Underlying causes of death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Was death related to study drug?
Beschreibung

death related to study drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0304229
Signature of investigator
Beschreibung

Signature of investigator

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date of investigator's signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Serious adverse event
Beschreibung

Serious adverse event

Alias
UMLS CUI-1
C1519255
Person reporting SAE
Beschreibung

Person reporting SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1519255
Serious adverse event
Beschreibung

Serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Specify reason(s) for considering this a serious AE.
Beschreibung

reason for SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0679228
UMLS CUI [1,2]
C1519255
Onset date
Beschreibung

Onset date serious adverse event

Datentyp

date

Alias
UMLS CUI [1]
C2985916
Onset time
Beschreibung

Onset time serious adverse event

Datentyp

time

Alias
UMLS CUI [1]
C2697889
End date
Beschreibung

If ongoing please leave blank

Datentyp

date

Alias
UMLS CUI [1]
C2697886
End time
Beschreibung

End time serious adverse event

Datentyp

time

Alias
UMLS CUI [1]
C2826658
Outcome
Beschreibung

If patient died, please complete Patient Death form

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Course of event
Beschreibung

Course of serious adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
Number of episodes
Beschreibung

Number of episodes serious adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4086638
Intensity
Beschreibung

Intensity serious adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Action Taken with Respect to Study Drug
Beschreibung

Action Taken with Respect to Study Drug

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Did the SAE abate?
Beschreibung

SAE abate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
Was study drug reintroduced (or dose increased)?
Beschreibung

drug reintroduced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0580673
If yes, did SAE recur?
Beschreibung

SAE reoccurence

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Relationship to Study Drug
Beschreibung

Relationship to Study Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
The SAE is probably associated with Protocol design or procedures (but not to study drug).
Beschreibung

Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
The SAE is probably associated with another condition (eg, condition under study, concurrent illness).
Beschreibung

Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
The SAE is probably associated with another drug.
Beschreibung

Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
Corrective therapy
Beschreibung

If Yes, record details in the Concomitant Medication section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0087111
Was patient withdrawn from the study due to this specific AE?
Beschreibung

withdrawn due to adverse event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Laboratory Test 1
Beschreibung

(Please provide relevant abnormal laboratory data below)

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Date 1
Beschreibung

Date of laboratory test 1

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Value 1
Beschreibung

Value of laboratory test 1

Datentyp

float

Alias
UMLS CUI [1]
C0587081
Units 1
Beschreibung

Unit of laboratory test 1

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Normal range 1
Beschreibung

Normal range of laboratory test 1

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Laboratory test 2
Beschreibung

Laboratory test 2

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Date 2
Beschreibung

Date of laboratory test 2

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Value 2
Beschreibung

laboratory test result 2

Datentyp

float

Alias
UMLS CUI [1]
C0587081
Unit 2
Beschreibung

Unit of laboratory test 2

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Normal range 2
Beschreibung

Normal range of laboratory test 2

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Laboratory test 3
Beschreibung

Laboratory test 3

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Date 3
Beschreibung

Date of laboratory test 3

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Value 3
Beschreibung

laboratory test result 3

Datentyp

float

Alias
UMLS CUI [1]
C0587081
Unit 3
Beschreibung

Unit of laboratory test 3

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Normal range 3
Beschreibung

Normal range of laboratory test 3

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Laboratory test 4
Beschreibung

Laboratory test 4

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Value 4
Beschreibung

Value of laboratory test 4

Datentyp

float

Alias
UMLS CUI [1]
C0587081
Date 4
Beschreibung

Date of laboratory test 4

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Unit 4
Beschreibung

Unit of laboratory test 4

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Normal range 4
Beschreibung

Normal range of laboratory test 4

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Remarks
Beschreibung

Please provide a brief narrative description of the SAE, attaching extra pages, e g hospital discharge summary, if necessary

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
If applicable, was the randomisation code broken at the investigational site?
Beschreibung

randomization broken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C3897431
Randomisation number
Beschreibung

Please do NOT enter the blister package number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigator´s signature
Beschreibung

onfirming that the above data are accurate and complete

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's print name
Beschreibung

Investigator's print name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date of Investigator Signature
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Concomitant Medication, Adverse Event, SAE - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Has the patient taken any concomitant medication(s) (other than study drug and medications for the treatment of Parkinson ́s Disease) from 30 days prior to screening through the end of the Treatment Period?
integer
C2347852 (UMLS CUI [1])
concomitant medication
Code List
Has the patient taken any concomitant medication(s) (other than study drug and medications for the treatment of Parkinson ́s Disease) from 30 days prior to screening through the end of the Treatment Period?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Medication name
Item
Medication
text
C2360065 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Date medication started
Item
Date started
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date medication stopped
Item
Date stopped
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuous
Item
Continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medication dose and frequency
Item
Dose and frequency
text
C3174092 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
Item
Route
integer
C0013153 (UMLS CUI [1])
medication administration route
Code List
Route
CL Item
IV  (1)
CL Item
PR (2)
CL Item
IM  (3)
CL Item
Sublingual  (4)
CL Item
PO  (5)
CL Item
Inhaled  (6)
CL Item
SC  (7)
CL Item
Topical (8)
CL Item
Other, Specify (9)
Specify other route of administration
Item
Specify other route of administration
text
C0205394 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Indication of medication
Item
indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Has the patient experienced any new and/or worsening adverse events from the time of screening through the end of the Treatment Period?
integer
C0877248 (UMLS CUI [1])
Adverse event
Code List
Has the patient experienced any new and/or worsening adverse events from the time of screening through the end of the Treatment Period?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Serious adverse event
Item
Serious
boolean
C1519255 (UMLS CUI [1])
Start date adverse event
Item
Start date
date
C2697888 (UMLS CUI [1])
Start time adverse event
Item
Start time
time
C2697889 (UMLS CUI [1])
Stop date adverse event
Item
Stop date
date
C2697886 (UMLS CUI [1])
Stop time adverse event
Item
Stop time
time
C2826658 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Intensity adverse event
Code List
Intensity
CL Item
MILD (1)
CL Item
MODERATE  (2)
CL Item
SEVERE (3)
Item
Relationship to drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
adverse event Relationship to drug
Code List
Relationship to drug
CL Item
NOT RELATED  (1)
CL Item
UNLIKELY (2)
CL Item
SUSPECTED (reasonable possibility) (3)
CL Item
PROBABLE (4)
Item
Action taken
integer
C2826626 (UMLS CUI [1])
Adverse event action taken
Code List
Action taken
CL Item
NONE (1)
CL Item
DOSE REDUCED (2)
CL Item
DOSE INCREASED (3)
CL Item
DRUG INTERRUPTED/RESTARTED (4)
CL Item
DRUG STOPPED (5)
Item
Corrective therapy
integer
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective therapy
Code List
Corrective therapy
CL Item
YES (1)
CL Item
NO (2)
Item
Event course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event course
Code List
Event course
CL Item
INTERMITTENT (1)
CL Item
CONSTANT (2)
Adverse event number of episodes
Item
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Adverse event outcome
Code List
Outcome
CL Item
RESOLVED  (1)
CL Item
ONGOING  (2)
CL Item
‚RESOLVED WITH SEQUELAE  (3)
CL Item
DIED (4)
Item Group
Subject death
C0011065 (UMLS CUI-1)
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Was an autopsy performed?
integer
C0004398 (UMLS CUI [1])
Autopsy
Code List
Was an autopsy performed?
CL Item
Yes (1)
CL Item
No (2)
Primary cause of death
Item
Primary cause of death
text
C0007465 (UMLS CUI [1])
Underlying causes of death
Item
Underlying cause(s) of death
text
C0007465 (UMLS CUI [1])
Item
Was death related to study drug?
integer
C0011065 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
death related to study drug
Code List
Was death related to study drug?
CL Item
Yes (1)
CL Item
No (2)
Signature of investigator
Item
Signature of investigator
text
C2346576 (UMLS CUI [1])
Date of investigator's signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Serious adverse event
C1519255 (UMLS CUI-1)
Person reporting SAE
Item
Person reporting SAE
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious adverse event
Item
Serious adverse event
text
C1519255 (UMLS CUI [1])
Item
Specify reason(s) for considering this a serious AE.
integer
C0679228 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
reason for SAE
Code List
Specify reason(s) for considering this a serious AE.
CL Item
fatal (1)
CL Item
life threatening (2)
CL Item
disabling/incapacitating (3)
CL Item
results in hospitalization (excluding elective surgery or routine clinical procedures) (4)
CL Item
hospitalization prolonged  (5)
CL Item
congenital abnormality (6)
CL Item
cancer (7)
CL Item
overdose (8)
CL Item
Investigator considers serious or a significant hazard, contraindication, side effect or precaution (9)
CL Item
pregnancy (10)
Onset date serious adverse event
Item
Onset date
date
C2985916 (UMLS CUI [1])
Onset time serious adverse event
Item
Onset time
time
C2697889 (UMLS CUI [1])
End date serious adverse event
Item
End date
date
C2697886 (UMLS CUI [1])
End time serious adverse event
Item
End time
time
C2826658 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome serious adverse event
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Course of event
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Course of serious adverse event
Code List
Course of event
CL Item
intermittent (1)
CL Item
constant (2)
Number of episodes serious adverse event
Item
Number of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity serious adverse event
Code List
Intensity
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Action Taken with Respect to Study Drug
integer
C2826626 (UMLS CUI [1])
Action Taken with Respect to Study Drug
Code List
Action Taken with Respect to Study Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose interrupted/restarted (4)
CL Item
Drug stopped (5)
SAE abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
drug reintroduced
Item
Was study drug reintroduced (or dose increased)?
boolean
C0013230 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
SAE reoccurence
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1])
Item
Relationship to Study Drug
integer
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Relationship to Study Drug
Code List
Relationship to Study Drug
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (reasonable possibility) (3)
CL Item
Probable (4)
Assessment
Item
The SAE is probably associated with Protocol design or procedures (but not to study drug).
boolean
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Assessment
Item
The SAE is probably associated with another condition (eg, condition under study, concurrent illness).
boolean
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Assessment
Item
The SAE is probably associated with another drug.
boolean
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
withdrawn due to adverse event
Item
Was patient withdrawn from the study due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Laboratory test 1
Item
Laboratory Test 1
text
C0022885 (UMLS CUI [1])
Date of laboratory test 1
Item
Date 1
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Value of laboratory test 1
Item
Value 1
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 1
Item
Units 1
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 1
Item
Normal range 1
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Laboratory test 2
Item
Laboratory test 2
text
C0022885 (UMLS CUI [1])
Date of laboratory test 2
Item
Date 2
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 2
Item
Value 2
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 2
Item
Unit 2
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 2
Item
Normal range 2
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Laboratory test 3
Item
Laboratory test 3
text
C0022885 (UMLS CUI [1])
Date of laboratory test 3
Item
Date 3
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 3
Item
Value 3
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 3
Item
Unit 3
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 3
Item
Normal range 3
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Laboratory test 4
Item
Laboratory test 4
text
C0022885 (UMLS CUI [1])
Value of laboratory test 4
Item
Value 4
float
C0587081 (UMLS CUI [1])
Date of laboratory test 4
Item
Date 4
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Unit of laboratory test 4
Item
Unit 4
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 4
Item
Normal range 4
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
SAE remarks
Item
Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
randomization broken
Item
If applicable, was the randomisation code broken at the investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Investigator's print name
Item
Investigator's print name
text
C2826892 (UMLS CUI [1])
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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