ID

40863

Description

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline 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

Keywords

Versions (2)
  1. 5/27/20 5/27/20 -
  2. 5/27/20 5/27/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 27, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

English

Adverse Event, Serious Adverse Event

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Any Adverse Events?
Description

Any Adverse Events?

Alias
UMLS CUI-1
C0877248
Adverse Event Time Point
Description

Adverse Event Time Point

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348792
Any Adverse Events?
Description

Any Adverse Events?

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Any Adverse Events?
Description

Any Adverse Events?

Alias
UMLS CUI-1
C0877248
Adverse Event Time Point
Description

Adverse Event Time Point

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348792
Any Adverse Events?
Description

Any Adverse Events?

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Any Adverse Events?
Description

Any Adverse Events?

Alias
UMLS CUI-1
C0877248
Adverse Event Time Point
Description

Adverse Event Time Point

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348792
Any Adverse Events?
Description

Any Adverse Events?

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Any Adverse Events? (Follow-up)
Description

Any Adverse Events? (Follow-up)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1522577
Have any Adverse events occured since the last visit?
Description

Have any Adverse events occured since the last visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1711239
Adverse Event
Description

Adverse Event

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

If no adverse events, please mark box

Data type

integer

Alias
UMLS CUI [1]
C0877248
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

Adverse Event

Data type

text

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

Adverse Event - Onset Date/Time

Data type

datetime

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

(If ongoing, please leave blank)

Data type

datetime

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

Adverse Event - Outcome

Data type

integer

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

Adverse Event - Event Course

Data type

integer

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

If intermittent course, enter number of episodes

Data type

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)
Description

Adverse Event - Intensity (maximum)

Data type

integer

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

Adverse Event - Action Taken with Respect to Investigational Drug

Data type

integer

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

Adverse Event - Relationship to Investigational Drug

Data type

integer

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

If "Yes", Please record on Concomitant Medication form

Data type

boolean

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

Was subject withdrawn due to this AE?

Data type

boolean

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

Adverse Event - Investigator’s Signature

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

Investigator’s Signature

Data type

text

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

Investigator’s Signature Date

Data type

date

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

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Description

Person Reporting SAE

Data type

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0335038
AEGIS Number
Description

AEGIS Number

Data type

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
Serious Adverse Event
Description

Serious Adverse Event

Data type

text

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

Serious Adverse Event - Onset Date and Time

Data type

datetime

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

Serious Adverse Event - End Date and Time

Data type

datetime

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

Serious Adverse Event - Outcome

Data type

integer

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

Serious Adverse Event - Event Course

Data type

integer

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

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

Data type

integer

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

(maximum)

Data type

integer

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

Serious Advrese Event - Action Taken with Respect to Investigational Drug

Data type

integer

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

Serious Adverse Event - Relationship to Investigational Drug

Data type

integer

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

Did the SAE abate?

Data type

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)?
Description

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

Data type

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?
Description

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

Data type

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
Description

The SAE is probably associated with

Data type

integer

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

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

Data type

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
Description

If SAE is associated with other condition, specify

Data type

text

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

If ’Yes’,Please record on Concomitant Medication form

Data type

boolean

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

Was subject withdrawn due to this AE ?

Data type

boolean

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

Mark all that apply.

Data type

text

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

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

Data type

text

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

Serious Adverse Event - Relevant Laboratory Data

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

Laboratory Test

Data type

text

Alias
UMLS CUI [1]
C0022885
Laboratory Test Date
Description

Laboratory Test Date

Data type

date

Alias
UMLS CUI [1]
C2826641
Laboratory Test Value
Description

Laboratory Test Value

Data type

float

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

Laboratory Test - Units

Data type

text

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

Laboratory Test - Normal Range

Data type

text

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

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

Data type

text

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

If applicable, was randomisation code broken at investigational site?

Data type

boolean

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

Randomisation/Study Medication Number:

Data type

text

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

Serious Adverse Event - Investigator's Signature

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

(confirming that the above data are accurate and complete)

Data type

text

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

Investigator's Name

Data type

text

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

Investigator’s Signature Date

Data type

date

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

Adverse Event, Serious Adverse Event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Any Adverse Events?
C0877248 (UMLS CUI-1)
Item
Adverse Event Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Adverse Event Time Point
Code List
Adverse Event Time Point
CL Item
Post-dose (1)
CL Item
+ 2 hrs (2)
CL Item
+ 8 hrs (3)
CL Item
+ 18 hrs (4)
Any Adverse Events?
Item
Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Any Adverse Events?
C0877248 (UMLS CUI-1)
Item
Adverse Event Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Adverse Event Time Point
Code List
Adverse Event Time Point
CL Item
Pre-dose  (1)
CL Item
+ 4 hrs  (2)
Any Adverse Events?
Item
Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Any Adverse Events?
C0877248 (UMLS CUI-1)
Item
Adverse Event Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Adverse Event Time Point
Code List
Adverse Event Time Point
CL Item
Pre-dose (1)
Any Adverse Events?
Item
Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Any Adverse Events? (Follow-up)
C0877248 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Have any Adverse events occured since the last visit?
Item
Have any Adverse events occured since the last visit?
boolean
C0877248 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
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
Adverse 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])
AEGIS Number
Item
AEGIS Number
text
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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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