ID

37733

Beschrijving

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

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  1. 20-08-19 20-08-19 -
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GlaxoSmithKline

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20 augustus 2019

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Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

Engels

Serious Adverse Experiences (SAE)

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Beschrijving

Study Coordinating Center, Identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschrijving

Patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschrijving

Person Initials

Datatype

text

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

Serious Adverse Experience (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Beschrijving

Serious Adverse Event, Reporter

Datatype

text

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

Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1519255
Onset Date and Time
Beschrijving

Serious Adverse Event, Start Date, Start time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
End Date and Time (if ongoing please leave blank)
Beschrijving

Serious Adverse Event, End Date, End time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Outcome
Beschrijving

Serious Adverse Event, Adverse Event Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Experience Course
Beschrijving

Serious Adverse Event, Course

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
Common Toxicity Grade
Beschrijving

Serious Adverse Event, Toxicity Grade

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826262
Action Taken with Respect to Investigational Drug
Beschrijving

Serious Adverse Event, Adverse Event Action Taken with Study Treatment

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826626
Relationship to Investigational Drug
Beschrijving

Serious Adverse Event, Relationships, Experimental drug

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Corrective therapy
Beschrijving

Serious Adverse Event, Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific SAE?
Beschrijving

Serious Adverse Event, Withdraw

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Specify reason(s) for considering this a serious AE.
Beschrijving

Serious Adverse Event,Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0566251
Did the SAE abate?
Beschrijving

Serious Adverse Event, Abate

Datatype

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)?
Beschrijving

Serious Adverse Event, Experimental drug, Drug dosage altered

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0420247
If yes, did SAE recur?
Beschrijving

Serious Adverse Event, Experimental drug, Drug dosage altered, Recurrence

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0420247
UMLS CUI [1,4]
C0034897
Assessment: SAE is probably associated with
Beschrijving

Serious Adverse Event, Causations

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Please specify
Beschrijving

Serious Adverse Event, Causations

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Relevant Laboratory Data
Beschrijving

Relevant Laboratory Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0587081
Test
Beschrijving

Serious Adverse Event, Laboratory Procedures

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
Date
Beschrijving

Serious Adverse Event, Laboratory Procedures, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0011008
Value
Beschrijving

Serious Adverse Event, Laboratory Procedures, Numerical value

Datatype

float

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1522609
Units
Beschrijving

Serious Adverse Event, Laboratory Procedures, Unit of Measure

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1519795
Normal Range
Beschrijving

Serious Adverse Event, Laboratory Procedures, Normal Range

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0086715
Remarks
Beschrijving

Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Please provide a brief narrative description of the AE, attaching extra pages e.g. hospital discharge summary if necessary
Beschrijving

Serious Adverse Event, Comment

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Randomization
Beschrijving

Randomization

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0034656
If applicable, was randomization code broken at investigational site?
Beschrijving

Serious Adverse Event, Randomization, Revealed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0443289
Randomization / Study Medication Number
Beschrijving

Serious Adverse Event, Randomization, Numbers

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0237753
Investigator's Signature
Beschrijving

Investigator's Signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
Investigator's Signature (confirming that the above data are accurate and complete)
Beschrijving

Serious Adverse Event, Investigator Signature

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
Date
Beschrijving

Serious Adverse Event, Investigator Signature, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
UMLS CUI [1,3]
C0011008
Name
Beschrijving

Serious Adverse Event, Investigator Name

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826892
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Similar models

Serious Adverse Experiences (SAE)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Serious Adverse Experience (SAE)
C1519255 (UMLS CUI-1)
Serious Adverse Event, Reporter
Item
Person Reporting SAE
text
C1519255 (UMLS CUI [1,1])
C0335038 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date, Start time
Item
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, End time
Item
End Date and Time (if ongoing please leave blank)
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Resolved  (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Experience Course
text
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Serious Adverse Event, Course
Code List
Experience Course
CL Item
Intermittent (1)
CL Item
Constant (2)
Item
Common Toxicity Grade
text
C1519255 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Serious Adverse Event, Toxicity Grade
Code List
Common Toxicity Grade
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
Action Taken with Respect to Investigational Drug
text
C1519255 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Action Taken with Study Treatment
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 interrupted/restarted (4)
CL Item
Drug stopped (5)
CL Item
Dose delayed (6)
CL Item
Dose delayed & reduced (7)
Item
Relationship to Investigational Drug
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Experimental drug
Code List
Relationship to Investigational Drug
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (reasonable possibility) (3)
CL Item
Probable (4)
Serious Adverse Event, Therapeutic procedure
Item
Corrective therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Serious Adverse Event, Withdraw
Item
Was patient withdrawn due to this specific SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (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])
Serious Adverse Event,Reason and justification
Code List
Specify reason(s) for considering this a serious AE.
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)
Serious Adverse Event, Abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug, Drug dosage altered
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Drug dosage altered, Recurrence
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,4])
Item
Assessment: SAE is probably associated with
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Serious Adverse Event, Causations
Code List
Assessment: SAE is probably associated with
CL Item
Protocol design or procedures (but not to study drug); Please specify (1)
CL Item
Another condition (e.g. condition under study, intercurrent illness); Please specify (2)
CL Item
Another drug; Please specify (3)
Serious Adverse Event, Causations
Item
Please specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Item Group
Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
Serious Adverse Event, Laboratory Procedures
Item
Test
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Serious Adverse Event, Laboratory Procedures, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Numerical value
Item
Value
float
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Unit of Measure
Item
Units
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Normal Range
Item
Normal Range
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
Item Group
Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Please provide a brief narrative description of the AE, attaching extra pages e.g. hospital discharge summary if necessary
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Randomization
C1519255 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Serious Adverse Event, Randomization, Revealed
Item
If applicable, was randomization code broken at investigational site?
boolean
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,3])
Serious Adverse Event, Randomization, Numbers
Item
Randomization / Study Medication Number
boolean
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item Group
Investigator's Signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Serious Adverse Event, Investigator Signature
Item
Investigator's Signature (confirming that the above data are accurate and complete)
text
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Serious Adverse Event, Investigator Signature, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Investigator Name
Item
Name
text
C1519255 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
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