ID

40786

Beschrijving

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Trefwoorden

Versies (1)
  1. 13-05-20 13-05-20 -
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GlaxoSmithKline

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13 mei 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

Engels

Concomitant Medication; Adverse Event; Serious Adverse Event

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschrijving

Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Concomitant Medication
Beschrijving

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Are there any concomitant medication CHANGES since the start of the study?
Beschrijving

If ’YES’, please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0443172
Concomitant Medication
Beschrijving

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Drug Name
Beschrijving

(Trade Name Preferred)

Datatype

text

Alias
UMLS CUI [1]
C2360065
SINGLE Dose/Unit
Beschrijving

(eg.500mg)

Datatype

text

Alias
UMLS CUI [1,1]
C1960417
UMLS CUI [1,2]
C0869039
Frequency of this Dose
Beschrijving

(e.g.BID,PRN)

Datatype

text

Alias
UMLS CUI [1]
C3476109
Concomitant Medication Route
Beschrijving

Concomitant Medication Route

Datatype

text

Alias
UMLS CUI [1]
C2826730
Concomitant Medication Indication
Beschrijving

Concomitant Medication Indication

Datatype

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication Start Date/Time
Beschrijving

Concomitant Medication Start Date/Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826825
Concomitant Medication End Date/Time
Beschrijving

Concomitant Medication End Date/Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826815
Concomitant Medication continuing at end of Study?
Beschrijving

Concomitant Medication continuing at end of Study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Adverse Event
Beschrijving

Adverse Event

Alias
UMLS CUI-1
C0877248
If no adverse events, please mark box
Beschrijving

If no adverse events, please mark box

Datatype

integer

Alias
UMLS CUI [1]
C0877248
Adverse Event
Beschrijving

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Beschrijving

Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Adverse Event - Onset Date/Time
Beschrijving

Adverse Event - Onset Date/Time

Datatype

datetime

Alias
UMLS CUI [1]
C2985916
UMLS CUI [2]
C2697889
Adverse Event - End Date/Time
Beschrijving

(If ongoing, please leave blank)

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Adverse Event - Outcome
Beschrijving

Adverse Event - Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Adverse Event - Event Course
Beschrijving

Adverse Event - Event Course

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If intermittent course, enter number of episodes
Beschrijving

If intermittent course, enter number of episodes

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0205267
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C4086638
Adverse Event - Intensity (maximum)
Beschrijving

Adverse Event - Intensity (maximum)

Datatype

integer

Alias
UMLS CUI [1]
C1710066
Adverse Event - Action Taken with Respect to Investigational Drug
Beschrijving

Adverse Event - Action Taken with Respect to Investigational Drug

Datatype

integer

Alias
UMLS CUI [1]
C2826626
Adverse Event - Relationship to Investigational Drug
Beschrijving

Adverse Event - Relationship to Investigational Drug

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Adverse Event - Corrective Therapy
Beschrijving

If "Yes", Please record on Concomitant Medication form

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this AE?
Beschrijving

Was subject withdrawn due to this AE?

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Advrese Event - Investigator’s Signature
Beschrijving

Advrese Event - Investigator’s Signature

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2346576
Investigator’s Signature
Beschrijving

Investigator’s Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator’s Signature Date
Beschrijving

Investigator’s Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Serious Adverse Event
Beschrijving

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Beschrijving

Person Reporting SAE

Datatype

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0335038
Serious Adverse Event
Beschrijving

Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Onset Date and Time
Beschrijving

Serious Adverse Event - Onset Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Serious Adverse Event - End Date and Time
Beschrijving

Serious Adverse Event - End Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Serious Adverse Event - Outcome
Beschrijving

Serious Adverse Event - Outcome

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event - Event Course
Beschrijving

Serious Adverse Event - Event Course

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
Serious Adverse Event - If intermittent course, enter number of episodes
Beschrijving

Serious Adverse Event - If intermittent course, enter number of episodes

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205267
UMLS CUI [2]
C4086638
Serious Adverse Event - Intensity
Beschrijving

(maximum)

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Serious Advrese Event - Action Taken with Respect to Investigational Drug
Beschrijving

Serious Advrese Event - Action Taken with Respect to Investigational Drug

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826626
Serious Adverse Event - Relationship to Investigational Drug
Beschrijving

Serious Adverse Event - Relationship to Investigational Drug

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013230
Did the SAE abate?
Beschrijving

Did the SAE abate?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?
Beschrijving

Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1512900
UMLS CUI [3]
C0850893
UMLS CUI [4,1]
C0304229
UMLS CUI [4,2]
C1707814
UMLS CUI [5,1]
C0013230
UMLS CUI [5,2]
C0580673
Serious Adverse Event - If study medication was reintroduced, did SAE recur?
Beschrijving

Serious Adverse Event - If study medication was reintroduced, did SAE recur?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0580673
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0034897
The SAE is probably associated with
Beschrijving

The SAE is probably associated with

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
If SAE is associated with protocol design or procedures, please specify
Beschrijving

If SAE is associated with protocol design or procedures, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
UMLS CUI [2,1]
C1507394
UMLS CUI [2,2]
C1507083
UMLS CUI [3]
C2700391
UMLS CUI [4]
C2348235
If SAE is associated with other condition, specify
Beschrijving

If SAE is associated with other condition, specify

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
UMLS CUI [2]
C2348235
Serious Adverse Event - Corrective Therapy
Beschrijving

If ’Yes’,Please record on Concomitant Medication form

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this AE ?
Beschrijving

Was subject withdrawn due to this AE ?

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Specify reason(s) for considering this a serious AE.
Beschrijving

Mark all that apply.

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0566251
Specify other reason(s) for considering this a serious AE.
Beschrijving

Specify other reason(s) for considering this a serious AE.

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205394
Serious Adverse Event - Relevant Laboratory Data
Beschrijving

Serious Adverse Event - Relevant Laboratory Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0022885
Laboratory Test
Beschrijving

Laboratory Test

Datatype

text

Alias
UMLS CUI [1]
C0022885
Laboratory Test Date
Beschrijving

Laboratory Test Date

Datatype

date

Alias
UMLS CUI [1]
C2826641
Laboratory Test Value
Beschrijving

Laboratory Test Value

Datatype

float

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1522609
Laboratory Test - Units
Beschrijving

Laboratory Test - Units

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1519795
Laboratory Test - Normal Range
Beschrijving

Laboratory Test - Normal Range

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Relevant Laboratory Data - Remarks
Beschrijving

(Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0947611
If applicable, was randomisation code broken at investigational site?
Beschrijving

If applicable, was randomisation code broken at investigational site?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C3899531
Randomisation/Study Medication Number:
Beschrijving

Randomisation/Study Medication Number:

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Serious Adverse Event - Investigator's Signature
Beschrijving

Serious Adverse Event - Investigator's Signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
Investigator’s Signature:
Beschrijving

(confirming that the above data are accurate and complete)

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator's Name
Beschrijving

Investigator's Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Investigator’s Signature Date
Beschrijving

Investigator’s Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Concomitant Medication; Adverse Event; Serious Adverse Event

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Are there any concomitant medication CHANGES since the start of the study?
Item
Are there any concomitant medication CHANGES since the start of the study?
boolean
C2347852 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
SINGLE Dose/Unit
Item
SINGLE Dose/Unit
text
C1960417 (UMLS CUI [1,1])
C0869039 (UMLS CUI [1,2])
Frequency of this Dose
Item
Frequency of this Dose
text
C3476109 (UMLS CUI [1])
Concomitant Medication Route
Item
Concomitant Medication Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Indication
Item
Concomitant Medication Indication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Start Date/Time
Item
Concomitant Medication Start Date/Time
datetime
C2826825 (UMLS CUI [1])
Concomitant Medication End Date/Time
Item
Concomitant Medication End Date/Time
datetime
C2826815 (UMLS CUI [1])
Concomitant Medication continuing at end of Study?
Item
Concomitant Medication continuing at end of Study?
boolean
C2826666 (UMLS CUI [1])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Item
If no adverse events, please mark box
integer
C0877248 (UMLS CUI [1])
If no adverse events, please mark box
Code List
If no adverse events, please mark box
CL Item
No adverse events (1)
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Adverse Event - Onset Date/Time
Item
Adverse Event - Onset Date/Time
datetime
C2985916 (UMLS CUI [1])
C2697889 (UMLS CUI [2])
Adverse Event - End Date/Time
Item
Adverse Event - End Date/Time
datetime
C2826793 (UMLS CUI [1])
Item
Adverse Event - Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Event - Outcome
Code List
Adverse Event - Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
Item
Adverse Event - Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Adverse Event - Event Course
Code List
Adverse Event - Event Course
CL Item
Intermittent (1)
CL Item
Constant (2)
If intermittent course, enter number of episodes
Item
If intermittent course, enter number of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C4086638 (UMLS CUI [2,2])
Item
Adverse Event - Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Adverse Event - Intensity (maximum)
Code List
Adverse Event - Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Adverse Event - Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Adverse Event - Action Taken with Respect to Investigational Drug
Code List
Adverse Event - Action Taken with Respect to Investigational Drug
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
Adverse Event - Relationship to Investigational Drug
integer
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Adverse Event - Relationship to Investigational Drug
Code List
Adverse Event - Relationship to Investigational Drug
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
Adverse Event - Corrective Therapy
Item
Adverse Event - Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was subject withdrawn due to this AE?
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Advrese Event - Investigator’s Signature
C0877248 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Investigator’s Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Investigator’s Signature Date
Item
Investigator’s Signature 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
C1519255 (UMLS CUI [1])
C0335038 (UMLS CUI [2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event - Onset Date and Time
Item
Serious Adverse Event - Onset Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Serious Adverse Event - End Date and Time
Item
Serious Adverse Event - End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Serious Adverse Event - Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event - Outcome
Code List
Serious Adverse Event - Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Serious Adverse Event - Event Course
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Serious Adverse Event - Event Course
Code List
Serious Adverse Event - Event Course
CL Item
Intermittent (1)
CL Item
Constant (2)
Serious Adverse Event - If intermittent course, enter number of episodes
Item
Serious Adverse Event - If intermittent course, enter number of episodes
integer
C1519255 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [2])
Item
Serious Adverse Event - Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Serious Adverse Event - Intensity
Code List
Serious Adverse Event - Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Serious Advrese Event - Action Taken with Respect to Investigational Drug
integer
C1519255 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Serious Advrese Event - Action Taken with Respect to Investigational Drug
Code List
Serious Advrese Event - Action Taken with Respect to Investigational Drug
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
Serious Adverse Event - Relationship to Investigational Drug
integer
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Serious Adverse Event - Relationship to Investigational Drug
Code List
Serious Adverse Event - Relationship to Investigational Drug
CL Item
Related (1)
CL Item
Possible Related (2)
CL Item
Probable unrelated (3)
CL Item
Unrelated (4)
Did the SAE abate?
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?
Item
Serious Adverse Event - If study medication was interrupted, stopped or dose reduced, was study medication reintroduced (or dose increased)?
boolean
C1519255 (UMLS CUI [1])
C0304229 (UMLS CUI [2,1])
C1512900 (UMLS CUI [2,2])
C0850893 (UMLS CUI [3])
C0304229 (UMLS CUI [4,1])
C1707814 (UMLS CUI [4,2])
C0013230 (UMLS CUI [5,1])
C0580673 (UMLS CUI [5,2])
Serious Adverse Event - If study medication was reintroduced, did SAE recur?
Item
Serious Adverse Event - If study medication was reintroduced, did SAE recur?
boolean
C0013230 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
Item
The SAE is probably associated with
integer
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
The SAE is probably associated with
Code List
The SAE is probably associated with
CL Item
Protocol design or procedures (but not to study drug), please specify (1)
CL Item
Another condition (eg, condition under study, intercurrent illness), please specify (2)
CL Item
Another drug (3)
If SAE is associated with protocol design or procedures, please specify
Item
If SAE is associated with protocol design or procedures, please specify
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1507394 (UMLS CUI [2,1])
C1507083 (UMLS CUI [2,2])
C2700391 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
If SAE is associated with other condition, specify
Item
If SAE is associated with other condition, specify
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Serious Adverse Event - Corrective Therapy
Item
Serious Adverse Event - Corrective Therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was subject withdrawn due to this AE ?
Item
Was subject withdrawn due to this AE ?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE.
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Specify reason(s) for considering this a serious AE.
Code List
Specify reason(s) for considering this a serious AE.
CL Item
results in Death (A)
CL Item
life threatening (B)
CL Item
requires hospitalisation or prolongationof existing hospitalization (C)
CL Item
results in disability/incapacity (D)
CL Item
congenital anomaly/birth defect (E)
CL Item
other (see definition) (F)
Specify other reason(s) for considering this a serious AE.
Item
Specify other reason(s) for considering this a serious AE.
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Laboratory Test
Item
Laboratory Test
text
C0022885 (UMLS CUI [1])
Laboratory Test Date
Item
Laboratory Test Date
date
C2826641 (UMLS CUI [1])
Laboratory Test Value
Item
Laboratory Test Value
float
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Laboratory Test - Units
Item
Laboratory Test - Units
text
C0022885 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Laboratory Test - Normal Range
Item
Laboratory Test - Normal Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Relevant Laboratory Data - Remarks
Item
Relevant Laboratory Data - Remarks
text
C0022885 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
If applicable, was randomisation code broken at investigational site?
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C3899531 (UMLS CUI [1,2])
Randomisation/Study Medication Number:
Item
Randomisation/Study Medication Number:
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Investigator's Signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Investigator’s Signature:
Item
Investigator’s Signature:
text
C2346576 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
Investigator’s Signature Date
Item
Investigator’s Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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