ID

37144

Beskrivning

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Nyckelord

Versioner (1)
  1. 2019-07-04 2019-07-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 juli 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

Engelsk

Adverse Experiences (Non-serious)

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Beskrivning

Institution name, Identifier

Datatyp

integer

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

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Person Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Adverse Experiences (Non-serious)
Beskrivning

Adverse Experiences (Non-serious)

Alias
UMLS CUI-1
C1518404
Adverse Experience
Beskrivning

Non-serious Adverse Event

Datatyp

text

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

Non-serious Adverse Event, Start Date, Start Time

Datatyp

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)
Beskrivning

Non-serious Adverse Event, End Date, End Time

Datatyp

datetime

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

Non-serious Adverse Event, Adverse Event Outcome

Datatyp

text

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

Non-serious Adverse Event, Course

Datatyp

text

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

Non-serious Adverse Event. Course, Number of episodes

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C4086638
Common Toxicity Grade
Beskrivning

Non-serious Adverse Event, Toxicity Grade

Datatyp

integer

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

Non-serious Adverse Event, Action Taken with Study Treatment

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Relationship to Investigational Drug
Beskrivning

Non-serious Adverse Event, Relationships, Experiment drug

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Corrective Therapy
Beskrivning

Non-serious Adverse Event, Therapeutic Procedure

Datatyp

boolean

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

Non-serious Adverse Event, Withdraw

Datatyp

boolean

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

Adverse Experiences (Non-serious)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Institution name, Identifier
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (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
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 (3)
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)
Non-serious Adverse Event. Course, Number of episodes
Item
No. of episodes
integer
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Non-serious Adverse Event, Toxicity Grade
Item
Common Toxicity Grade
integer
C1518404 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Item
Action Taken with Respect to Investigational Drug
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious 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 & 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, Action Taken with Study Treatment
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])
Tillbaka till toppen 

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