ID

42287

Description

Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Keywords

Versions (2)
  1. 5/4/21 5/4/21 -
  2. 5/4/21 5/4/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 4, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

English

Laboratory Reference Ranges; Concomitant Medication; Adverse Experiences (Non-serious)

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Course Number
Description

Course Number

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0750729
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Laboratory Reference Ranges
Description

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Investigator
Description

Investigator

Data type

text

Alias
UMLS CUI [1]
C2826892
Date for which these reference ranges became effective
Description

Date for which these reference ranges became effective

Data type

date

Alias
UMLS CUI [1,1]
C0883335
UMLS CUI [1,2]
C0011008
Laboratory Name
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C3258037
Laboratory Address
Description

Laboratory Address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Reference range gender
Description

Reference range gender

Data type

text

Alias
UMLS CUI [1,1]
C0883335
UMLS CUI [1,2]
C0079399
Age range
Description

Age range

Data type

text

Measurement units
  • Years
Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1514721
Years
Laboratory Reference Ranges
Description

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Test - Haematology
Description

Test - Haematology

Data type

integer

Alias
UMLS CUI [1]
C0018941
Test - Blood Chemistry
Description

Test - Blood Chemistry

Data type

integer

Alias
UMLS CUI [1]
C0525044
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Low Reference Value
Description

Low Reference Value

Data type

float

Alias
UMLS CUI [1]
C1272773
High Reference Value
Description

High Reference Value

Data type

float

Alias
UMLS CUI [1]
C1299400
Concomitant Medication - Continued
Description

Concomitant Medication - Continued

Alias
UMLS CUI-1
C2347852
Drug Name
Description

Trade Name Preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Description

(e.g. 500mg)

Data type

text

Alias
UMLS CUI [1]
C2348070
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Description

Medical Condition

Data type

text

Alias
UMLS CUI [1]
C0012634
Medication Start Date
Description

Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Medication End Date
Description

Medication End Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Medication Continuing
Description

Medication Continuing

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Adverse Experiences (Non-serious)
Description

Adverse Experiences (Non-serious)

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

If no adverse experiences occured during the study, please sign form below and mark this box

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1298908
Adverse Experiences (Non-serious)
Description

Adverse Experiences (Non-serious)

Alias
UMLS CUI-1
C1518404
Adverse Experience
Description

Adverse Experience

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse Experience Onset Date and Time
Description

Adverse Experience Onset Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2985916
UMLS CUI [2]
C2697889
Adverse Experience End Date and Time
Description

If ongoing please leave blank

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Adverse Experience Outcome
Description

If patient died, STOP: go to SAE section and follow instructions given there

Data type

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Description

Experience Course

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If Intermittent Course, record number of episodes
Description

If Intermittent Course, record number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0205267
UMLS CUI [1,3]
C4086638
Common Toxicity Grade
Description

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening

Data type

integer

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

Action Taken with Respect to Investigational Drug

Data type

integer

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

Relationship to Investigational Drug

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Description

If 'Yes' record details in the Concomitant Medication section

Data type

boolean

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

Was patient withdrawn due to this specific AE?

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Investigator's Signature (Adverse Experience)
Description

Investigator's Signature (Adverse Experience)

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C0877248
Investigator's Signature
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Description

Investigator's Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Back to the top of the page

Similar models

Laboratory Reference Ranges; Concomitant Medication; Adverse Experiences (Non-serious)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Course Number
Item
Course Number
integer
C0237753 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Reference Ranges
C0883335 (UMLS CUI-1)
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Date for which these reference ranges became effective
Item
Date for which these reference ranges became effective
date
C0883335 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item
Reference range gender
text
C0883335 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
Reference range male or female
Code List
Reference range gender
CL Item
Male (M)
CL Item
Female (F)
Age range
Item
Age range
text
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
Item Group
Laboratory Reference Ranges
C0883335 (UMLS CUI-1)
Item
Test - Haematology
integer
C0018941 (UMLS CUI [1])
Test - Haematology
Code List
Test - Haematology
CL Item
Haemoglobin (1)
CL Item
Haematokrit (2)
CL Item
RBC (3)
CL Item
WBC (4)
CL Item
Neutrophils - segmented (5)
CL Item
Bands (6)
CL Item
Lymphocytes (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basophils (10)
CL Item
Platelets (11)
Item
Test - Blood Chemistry
integer
C0525044 (UMLS CUI [1])
Test - Blood Chemistry
Code List
Test - Blood Chemistry
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Biocarbonate (4)
CL Item
Magnesium (5)
CL Item
Calcium (6)
CL Item
Phosphorus (7)
CL Item
Uric acid (8)
CL Item
BUN (9)
CL Item
Urea (10)
CL Item
Creatinine (11)
CL Item
Creatinine Clearance (12)
CL Item
Alkaline Phosphatase (13)
CL Item
SGOT/AST (14)
CL Item
SGPT/ALT (15)
CL Item
Total Bilirubin (16)
CL Item
Total Protein (17)
CL Item
Albumin (18)
CL Item
LDH (19)
CL Item
Serum Beta HCG (20)
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Low Reference Value
Item
Low Reference Value
float
C1272773 (UMLS CUI [1])
High Reference Value
Item
High Reference Value
float
C1299400 (UMLS CUI [1])
Item Group
Concomitant Medication - Continued
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
by mouth (PO)
CL Item
intravenous (IV)
CL Item
intramuscular (IM)
CL Item
intra-arterial (IAR)
CL Item
topical (TO)
CL Item
sublingual (SL)
CL Item
intrathecal (IT)
CL Item
vaginal (VA)
CL Item
nasal (NA)
CL Item
intra-articular injection (IA)
CL Item
transdermal (TD)
CL Item
inhaled (IH)
CL Item
subcutaneous (SC)
CL Item
rectal (PR)
CL Item
intradermal (ID)
Medical Condition
Item
Medical Condition
text
C0012634 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C2826744 (UMLS CUI [1])
Item
Medication Continuing
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medication Continuing
Code List
Medication Continuing
CL Item
Medication Continuing (1)
Item Group
Adverse Experiences (Non-serious)
C1518404 (UMLS CUI-1)
Item
If no adverse experiences occured during the study, please sign form below and mark this box
integer
C0877248 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
If no adverse experiences occured during the study, please sign form below and mark this box
Code List
If no adverse experiences occured during the study, please sign form below and mark this box
CL Item
No Adverse Experience (1)
Item Group
Adverse Experiences (Non-serious)
C1518404 (UMLS CUI-1)
Adverse Experience
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
Adverse Experience Onset Date and Time
Item
Adverse Experience Onset Date and Time
datetime
C2985916 (UMLS CUI [1])
C2697889 (UMLS CUI [2])
Adverse Experience End Date and Time
Item
Adverse Experience End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Adverse Experience Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Experience Outcome
Code List
Adverse Experience Outcome
CL Item
Resolved  (1)
CL Item
Ongoing  (2)
CL Item
Died (3)
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Experience Course
CL Item
Intermittent  (1)
CL Item
Constant (2)
If Intermittent Course, record number of episodes
Item
If Intermittent Course, record number of episodes
integer
C0750729 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Common Toxicity Grade
Item
Common Toxicity Grade
integer
C2826262 (UMLS CUI [1])
Item
Action Taken with Respect to Investigational Drug
integer
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 dealyed  (6)
CL Item
Dose delayed and decreased (7)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
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
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was patient 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])
Item Group
Investigator's Signature (Adverse Experience)
C2346576 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial