ID

37719

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

Adverse Experiences (Non-serious)

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
Adverse Experiences (Non-serious)
Description

Adverse Experiences (Non-serious)

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

Non-serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Adverse Experience
Description

Non-serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1518404
Onset Date and Time
Description

Non-serious Adverse Event, Start Date, Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
End Date and Time (if ongoing please leave blank)
Description

Non-serious Adverse Event, End Date, End time

Data type

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Outcome
Description

Non-serious Adverse Event, Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Experience Course
Description

Non-serious Adverse Event, Course

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0750729
No. of episodes
Description

Non-Serious Adverse Event, Episode, Numbers

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0237753
Common Toxicity Grade
Description

Non-Serious Adverse Event, Toxicity Grade

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826262
Action Taken with Respect to investigational Drug
Description

Non-Serious Adverse Event, Adverse Event Action Taken with Study Treatment

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826626
Relationship to Investigational Drug
Description

Non-serious Adverse Event, Relationships, Experimental drug

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Corrective therapy
Description

Non-serious Adverse Event, Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Description

Non-serious Adverse Event, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
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Similar models

Adverse Experiences (Non-serious)

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
Adverse Experiences (Non-serious)
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
If no adverse experiences occurred during the study, please mark this box.
boolean
C1518404 (UMLS CUI [1])
Non-serious Adverse Event
Item
Adverse Experience
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event, Start Date, Start time
Item
Onset Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Non-serious Adverse Event, End Date, End time
Item
End Date and Time (if ongoing please leave blank)
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (2)
Item
Experience Course
text
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Experience Course
CL Item
Intermittent (1)
CL Item
Constant (2)
CL Item
Constant (2)
Non-Serious Adverse Event, Episode, Numbers
Item
No. of episodes
text
C1518404 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
Common Toxicity Grade
text
C1518404 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Non-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
C1518404 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Non-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
Dose interrupted/restarted (4)
CL Item
Dose stopped (5)
CL Item
Dose delayed (6)
CL Item
Dose delayed & decreased (7)
Item
Relationship to Investigational Drug
text
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Non-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)
Non-serious Adverse Event, Therapeutic procedure
Item
Corrective therapy
boolean
C1518404 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Non-serious Adverse Event, Withdraw
Item
Was patient withdrawn due to this specific AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
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