ID

40786

Descrizione

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

Keywords

versioni (1)
  1. 13/05/20 13/05/20 -
Titolare del copyright

GlaxoSmithKline

Caricato su

13 maggio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

Inglese

Concomitant Medication; Adverse Event; Serious Adverse Event

1 moduli  
Administrative
Descrizione

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descrizione

Patient Number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrizione

Centre Number

Tipo di dati

text

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

Concomitant Medication

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

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.

Tipo di dati

boolean

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

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Drug Name
Descrizione

(Trade Name Preferred)

Tipo di dati

text

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

(eg.500mg)

Tipo di dati

text

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

(e.g.BID,PRN)

Tipo di dati

text

Alias
UMLS CUI [1]
C3476109
Concomitant Medication Route
Descrizione

Concomitant Medication Route

Tipo di dati

text

Alias
UMLS CUI [1]
C2826730
Concomitant Medication Indication
Descrizione

Concomitant Medication Indication

Tipo di dati

text

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

Concomitant Medication Start Date/Time

Tipo di dati

datetime

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

Concomitant Medication End Date/Time

Tipo di dati

datetime

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

Concomitant Medication continuing at end of Study?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2826666
Adverse Event
Descrizione

Adverse Event

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

If no adverse events, please mark box

Tipo di dati

integer

Alias
UMLS CUI [1]
C0877248
Adverse Event
Descrizione

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Descrizione

Adverse Event

Tipo di dati

text

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

Adverse Event - Onset Date/Time

Tipo di dati

datetime

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

(If ongoing, please leave blank)

Tipo di dati

datetime

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

Adverse Event - Outcome

Tipo di dati

integer

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

Adverse Event - Event Course

Tipo di dati

integer

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

If intermittent course, enter number of episodes

Tipo di dati

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)
Descrizione

Adverse Event - Intensity (maximum)

Tipo di dati

integer

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

Adverse Event - Action Taken with Respect to Investigational Drug

Tipo di dati

integer

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

Adverse Event - Relationship to Investigational Drug

Tipo di dati

integer

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

If "Yes", Please record on Concomitant Medication form

Tipo di dati

boolean

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

Was subject withdrawn due to this AE?

Tipo di dati

boolean

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

Advrese Event - Investigator’s Signature

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

Investigator’s Signature

Tipo di dati

text

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

Investigator’s Signature Date

Tipo di dati

date

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

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Descrizione

Person Reporting SAE

Tipo di dati

text

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

Serious Adverse Event

Tipo di dati

text

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

Serious Adverse Event - Onset Date and Time

Tipo di dati

datetime

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

Serious Adverse Event - End Date and Time

Tipo di dati

datetime

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

Serious Adverse Event - Outcome

Tipo di dati

integer

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

Serious Adverse Event - Event Course

Tipo di dati

integer

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

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

Tipo di dati

integer

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

(maximum)

Tipo di dati

integer

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

Serious Advrese Event - Action Taken with Respect to Investigational Drug

Tipo di dati

integer

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

Serious Adverse Event - Relationship to Investigational Drug

Tipo di dati

integer

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

Did the SAE abate?

Tipo di dati

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)?
Descrizione

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

Tipo di dati

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?
Descrizione

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

Tipo di dati

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
Descrizione

The SAE is probably associated with

Tipo di dati

integer

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

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

Tipo di dati

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
Descrizione

If SAE is associated with other condition, specify

Tipo di dati

text

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

If ’Yes’,Please record on Concomitant Medication form

Tipo di dati

boolean

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

Was subject withdrawn due to this AE ?

Tipo di dati

boolean

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

Mark all that apply.

Tipo di dati

text

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

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

Tipo di dati

text

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

Serious Adverse Event - Relevant Laboratory Data

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

Laboratory Test

Tipo di dati

text

Alias
UMLS CUI [1]
C0022885
Laboratory Test Date
Descrizione

Laboratory Test Date

Tipo di dati

date

Alias
UMLS CUI [1]
C2826641
Laboratory Test Value
Descrizione

Laboratory Test Value

Tipo di dati

float

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

Laboratory Test - Units

Tipo di dati

text

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

Laboratory Test - Normal Range

Tipo di dati

text

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

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

Tipo di dati

text

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

If applicable, was randomisation code broken at investigational site?

Tipo di dati

boolean

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

Randomisation/Study Medication Number:

Tipo di dati

text

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

Serious Adverse Event - Investigator's Signature

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

(confirming that the above data are accurate and complete)

Tipo di dati

text

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

Investigator's Name

Tipo di dati

text

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

Investigator’s Signature Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Ritorna all'inizio della pagina

Similar models

Concomitant Medication; Adverse Event; Serious Adverse Event

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial