ID

29859

Description

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

Keywords

Versions (1)
  1. 4/24/18 4/24/18 - Halim Ugurlu
Copyright Holder

GSK

Uploaded on

April 24, 2018

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License

Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Adverse Experiences (non-serious)

English

Adverse Experiences (non-Serious)

1 forms  
Identification Numbers
Description

Identification Numbers

Alias
UMLS CUI-1
C1300638
Center Number
Description

Center Number

Data type

text

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

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Adverse Experiences (non-Serious)
Description

Adverse Experiences (non-Serious)

Alias
UMLS CUI-1
C1518404
If no adverse experiences occurred during the study, please sign form below and mark this box
Description

No Advers Experiences

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1298908
Serious adverse experience
Description

If you consider this to be a serious adverse experience (SAE), please do not enter on this page but enter in the SAE section in the back of this binder (See tab for definitions of an SAE).

Data type

text

Alias
UMLS CUI [1]
C1519255
Adverse Experiences (non-Serious)
Description

Adverse Experiences (non-Serious)

Alias
UMLS CUI-1
C1518404
Adverse Experience
Description

Record any adverse experiences (using standard medical terminology ) observed or elicited by the following direct question to patient: "Do you feel different in any way since starting the treatment or since the last visit ?" Provide the diagnosis not symptoms where possible. Enter one adverse experience per column

Data type

text

Alias
UMLS CUI [1]
C0877248
Onset Data and Time
Description

Onset Data and Time

Data type

datetime

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

End Date and Time (if ongoing please leave blank)

Data type

datetime

Alias
UMLS CUI [1]
C2981425
Outcome- If patient died, STOP: go to SAE section and follow instructions given here
Description

Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Experience Course
Description

Experience Course

Data type

text

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

Common Toxicity Grade

Data type

text

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

Action Taken with Respect to Investigational Drug

Data type

text

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

Relationship to Investigational Drug

Data type

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C3854006
If ´Yes´ record details in the Concomitant Medication section
Description

Corrective Therapy

Data type

boolean

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

Withdrawn due to this specific AE

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Investigators Signature
Description

Investigators Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigators Signature Date
Description

Investigators Signature Date

Data type

date

Alias
UMLS CUI [1]
C0807937
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Similar models

Adverse Experiences (non-Serious)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Adverse Experiences (non-Serious)
C1518404 (UMLS CUI-1)
No Advers Experiences
Item
If no adverse experiences occurred during the study, please sign form below and mark this box
boolean
C0877248 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Serious adverse experience
Item
Serious adverse experience
text
C1519255 (UMLS CUI [1])
Item Group
Adverse Experiences (non-Serious)
C1518404 (UMLS CUI-1)
Adverse Experience
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
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, STOP: go to SAE section and follow instructions given here
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome- If patient died, STOP: go to SAE section and follow instructions given here
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)
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)
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 AE
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (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])
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