ID

29868

Descripción

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Link

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Palabras clave

Versiones (1)
  1. 24/4/18 24/4/18 - Halim Ugurlu
Titular de derechos de autor

GSK

Subido en

24 de abril de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Serious Adverse Experience

Inglés

Serious Adverse Experience (SAE)

1 formularios  
Identification Numbers
Descripción

Identification Numbers

Alias
UMLS CUI-1
C1300638
Center Number
Descripción

Center Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Serious Adverse Experience (SAE)
Descripción

Serious Adverse Experience (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE (Please print clearly)
Descripción

Person Reporting SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0335038
UMLS CUI [1,2]
C1519255
Serious Adverse Experience
Descripción

Serious Adverse Experience

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Specify reason(s) for considering this a serious AE. Mark all that apply.
Descripción

Reason(s) for considering this a serious AE

Tipo de datos

text

Alias
UMLS CUI [1]
C3828190
Onset Data and Time
Descripción

Onset Data and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
End Date and Time (if ongoing please leave blank)
Descripción

End Date and Time (if ongoing please leave blank)

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2981425
Outcome- If patient died, please complete Form D
Descripción

Outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Experience Course
Descripción

Experience Course

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Common Toxicity Grade: 1-4
Descripción

Common Toxicity Grade

Tipo de datos

text

Alias
UMLS CUI [1]
C2826262
Action Taken with Respect to Investigational Drug
Descripción

Action Taken with Respect to Investigational Drug

Tipo de datos

text

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

SAE Abate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)
Descripción

Study medication reintroduced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0580673
If Yes to study medication reintroduced (or dose increased), did SAE recur?
Descripción

If Yes to study medication reintroduced (or dose increased)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
Relationship to Investigational Drug
Descripción

Relationship to Investigational Drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C3854006
What is the SAE probably associated with ?
Descripción

Assessment of SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1710056
If ´Yes´ record details in the Concomitant Medication section
Descripción

Corrective Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific SAE?
Descripción

Withdrawn due to this specific SAE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Relevant Laboratory Data-Test name
Descripción

Relevant Laboratory Data - Please provide relevant abnormal laboratory data below

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0027365
Relevant Laboratory Data - Date
Descripción

Relevant Laboratory Data-Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Relevant Laboratory Data-Value
Descripción

Relevant Laboratory Data-Value

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0587081
Relevant Laboratory Data-Units
Descripción

Relevant Laboratory Data-Units

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1519795
Relevant Laboratory Data-Normal Range
Descripción

Relevant Laboratory Data-Normal Range

Tipo de datos

text

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

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

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0947611
Additional Informations
Descripción

Additional Informations

Alias
UMLS CUI-1
C1546922
If applicable, was randomisation code broken at investigational site ?
Descripción

Randomisation code broken at investigational site

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1272691
UMLS CUI [1,3]
C2825164
Randomisation/Study Medication Number
Descripción

Randomisation/Study Medication Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigators Signature
Descripción

Investigators Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Investigators Signature Date
Descripción

Investigators Signature Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0807937
Please PRINT name
Descripción

Please PRINT name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Serious Adverse Experience (SAE)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Serious Adverse Experience (SAE)
C1519255 (UMLS CUI-1)
Person Reporting SAE
Item
Person Reporting SAE (Please print clearly)
text
C0335038 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Experience
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
text
C3828190 (UMLS CUI [1])
Specify reason(s) for considering this a serious AE. Mark all that apply.
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
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)
Onset Data and Time
Item
Onset Data and Time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
End Date and Time (if ongoing please leave blank)
Item
End Date and Time (if ongoing please leave blank)
datetime
C2981425 (UMLS CUI [1])
Item
Outcome- If patient died, please complete Form D
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome- If patient died, please complete Form D
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Experience Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Experience Course
CL Item
Intermittent (number of episodes:..............) (1)
CL Item
Constant (2)
Common Toxicity Grade
Item
Common Toxicity Grade: 1-4
text
C2826262 (UMLS CUI [1])
Item
Action Taken with Respect to Investigational Drug
text
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug stopped (4)
CL Item
Drug interrupted/restarted (5)
CL Item
Dose delayed (6)
CL Item
Dose delayed and decreased (7)
SAE Abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Study medication reintroduced
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)
boolean
C3854006 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
If Yes to study medication reintroduced (or dose increased)
Item
If Yes to study medication reintroduced (or dose increased), did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Item
Relationship to Investigational Drug
text
C0439849 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
CL Item
Not related (4)
CL Item
Unlikely (3)
CL Item
Suspected (reasonable possibility) (2)
CL Item
Probable (1)
Item
What is the SAE probably associated with ?
text
C0085978 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Assessment of SAE
Code List
What is the SAE 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 -Please specify:....................... (3)
Corrective Therapy
Item
If ´Yes´ record details in the Concomitant Medication section
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawn due to this specific SAE
Item
Was patient withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relevant Laboratory Data-Test name
Item
Relevant Laboratory Data-Test name
text
C0022885 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Relevant Laboratory Data-Date
Item
Relevant Laboratory Data - Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Relevant Laboratory Data-Value
Item
Relevant Laboratory Data-Value
text
C0022885 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Relevant Laboratory Data-Units
Item
Relevant Laboratory Data-Units
text
C0022885 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Relevant Laboratory Data-Normal Range
Item
Relevant Laboratory Data-Normal Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Relevant Laboratory Data-Remarks
Item
Relevant Laboratory Data-Remarks
text
C0587081 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Additional Informations
C1546922 (UMLS CUI-1)
Randomisation code broken at investigational site
Item
If applicable, was randomisation code broken at investigational site ?
boolean
C0034656 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
Randomisation/Study Medication Number
Item
Randomisation/Study Medication Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigators Signature
Item
Investigators Signature
text
C2346576 (UMLS CUI [1])
Investigators Signature Date
Item
Investigators Signature Date
date
C0807937 (UMLS CUI [1])
Please PRINT name
Item
Please PRINT name
text
C2826892 (UMLS CUI [1])
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