ID

37733

Description

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

Keywords

Versions (1)
  1. 8/20/19 8/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 20, 2019

DOI

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License

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

English

Serious Adverse Experiences (SAE)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Description

Study Coordinating Center, Identification number

Data type

integer

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

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Person Initials

Data type

text

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

Serious Adverse Experience (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Description

Serious Adverse Event, Reporter

Data type

text

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

Serious Adverse Event

Data type

text

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

Serious Adverse Event, Start Date, Start time

Data type

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)
Description

Serious Adverse Event, End Date, End time

Data type

datetime

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

Serious Adverse Event, Adverse Event Outcome

Data type

text

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

Serious Adverse Event, Course

Data type

text

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

Serious Adverse Event, Toxicity Grade

Data type

text

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

Serious Adverse Event, Adverse Event Action Taken with Study Treatment

Data type

text

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

Serious Adverse Event, Relationships, Experimental drug

Data type

text

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

Serious Adverse Event, Therapeutic procedure

Data type

boolean

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

Serious Adverse Event, Withdraw

Data type

boolean

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

Serious Adverse Event,Reason and justification

Data type

text

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

Serious Adverse Event, Abate

Data type

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)?
Description

Serious Adverse Event, Experimental drug, Drug dosage altered

Data type

boolean

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

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

Data type

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
Description

Serious Adverse Event, Causations

Data type

text

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

Serious Adverse Event, Causations

Data type

text

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

Relevant Laboratory Data

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

Serious Adverse Event, Laboratory Procedures

Data type

text

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

Serious Adverse Event, Laboratory Procedures, Date in time

Data type

date

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

Serious Adverse Event, Laboratory Procedures, Numerical value

Data type

float

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

Serious Adverse Event, Laboratory Procedures, Unit of Measure

Data type

text

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

Serious Adverse Event, Laboratory Procedures, Normal Range

Data type

text

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

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
Description

Serious Adverse Event, Comment

Data type

text

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

Randomization

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

Serious Adverse Event, Randomization, Revealed

Data type

boolean

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

Serious Adverse Event, Randomization, Numbers

Data type

boolean

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

Investigator's Signature

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

Serious Adverse Event, Investigator Signature

Data type

text

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

Serious Adverse Event, Investigator Signature, Date in time

Data type

date

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

Serious Adverse Event, Investigator Name

Data type

text

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

Serious Adverse Experiences (SAE)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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