ID

42287

Beschreibung

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

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  1. 04.05.21 04.05.21 -
  2. 04.05.21 04.05.21 -
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GlaxoSmithKline

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4. Mai 2021

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

Englisch

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

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Centre Number
Beschreibung

Centre Number

Datentyp

text

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

Course Number

Datentyp

integer

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

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Laboratory Reference Ranges
Beschreibung

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Investigator
Beschreibung

Investigator

Datentyp

text

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

Date for which these reference ranges became effective

Datentyp

date

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

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Laboratory Address
Beschreibung

Laboratory Address

Datentyp

text

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

Reference range gender

Datentyp

text

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

Age range

Datentyp

text

Maßeinheiten
  • Years
Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1514721
Years
Laboratory Reference Ranges
Beschreibung

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Test - Haematology
Beschreibung

Test - Haematology

Datentyp

integer

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

Test - Blood Chemistry

Datentyp

integer

Alias
UMLS CUI [1]
C0525044
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Low Reference Value
Beschreibung

Low Reference Value

Datentyp

float

Alias
UMLS CUI [1]
C1272773
High Reference Value
Beschreibung

High Reference Value

Datentyp

float

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

Concomitant Medication - Continued

Alias
UMLS CUI-1
C2347852
Drug Name
Beschreibung

Trade Name Preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Beschreibung

(e.g. 500mg)

Datentyp

text

Alias
UMLS CUI [1]
C2348070
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Beschreibung

Medical Condition

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication End Date
Beschreibung

Medication End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Medication Continuing
Beschreibung

Medication Continuing

Datentyp

integer

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

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
Beschreibung

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

Datentyp

integer

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

Adverse Experiences (Non-serious)

Alias
UMLS CUI-1
C1518404
Adverse Experience
Beschreibung

Adverse Experience

Datentyp

text

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

Adverse Experience Onset Date and Time

Datentyp

datetime

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

If ongoing please leave blank

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Adverse Experience Outcome
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Beschreibung

Experience Course

Datentyp

integer

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

If Intermittent Course, record number of episodes

Datentyp

integer

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

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

Datentyp

integer

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

Action Taken with Respect to Investigational Drug

Datentyp

integer

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

Relationship to Investigational Drug

Datentyp

integer

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

If 'Yes' record details in the Concomitant Medication section

Datentyp

boolean

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

Was patient withdrawn due to this specific AE?

Datentyp

boolean

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

Investigator's Signature (Adverse Experience)

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

Investigator's Signature

Datentyp

text

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

Investigator's Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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