ID

42283

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 (1)
  1. 5/3/21 5/3/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 3, 2021

DOI

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License

Creative Commons BY 4.0
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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

English

Serious Adverse Experience (SAE)

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
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
Course Number
Description

Course Number

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0750729
Serious Adverse Experience (SAE)
Description

Serious Adverse Experience (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Description

Person Reporting SAE

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1519255
Specify reason(s) for considering this a serious AE
Description

Mark all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0566251
SAE Onset Date and Time
Description

SAE Onset Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
SAE End Date and Time
Description

SAE End Date and Time

Data type

datetime

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

If patient died, please complete Form D

Data type

integer

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

Experience Course

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
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

Common Toxicity Grade

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
Did the SAE abate?
Description

Did the SAE 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

If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?

Data type

boolean

Alias
UMLS CUI [1,1]
C0420247
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1611744
UMLS CUI [3]
C0580673
If medication was reintroduced dose increased, did SAE recur?
Description

If medication was reintroduced dose increased, did SAE recur?

Data type

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C1611744
UMLS CUI [3]
C0580673
UMLS CUI [4,1]
C1519255
UMLS CUI [4,2]
C0034897
Relationship to Investigational Drug
Description

Relationship to Investigational Drug

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
If Relationship to Investigational Drug is "Not related" or "Unlikely", the SAE is probably associated with
Description

If Relationship to Investigational Drug is "Not related" or "Unlikely", the SAE is probably associated with

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Specify protocol designs or prodcedures
Description

Specify protocol designs or prodcedures

Data type

text

Alias
UMLS CUI [1]
C1507083
UMLS CUI [2]
C2700391
UMLS CUI [3]
C2348235
Specify Another Condition
Description

Specify Another Condition

Data type

text

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Specify Another drug
Description

Specify Another drug

Data type

text

Alias
UMLS CUI [1]
C1115771
UMLS CUI [2]
C2348235
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 SAE?
Description

Was patient withdrawn due to this specific SAE?

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Remarks
Description

Please provide a brief narrative description of the SAE, attaching extra pages eg. hopsital discharge summary if necessary.

Data type

text

Alias
UMLS CUI [1]
C0947611
If applicable, was randomisation code broken at investigational site?
Description

Confirming that the above data are accurate and complete.

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C3899531
Please print name
Description

Please print name

Data type

text

Alias
UMLS CUI [1]
C0027365
SB Medical Monitor's Signature
Description

SB Medical Monitor's Signature

Data type

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1708968
UMLS CUI [1,3]
C0008961
Signature Date
Description

Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Serious Adverse Experience - Relevant Laboratory Data
Description

Serious Adverse Experience - Relevant Laboratory Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0022885
Test
Description

Test

Data type

text

Alias
UMLS CUI [1]
C0022885
Test Date
Description

Test Date

Data type

date

Alias
UMLS CUI [1]
C2826247
Test Value
Description

Test Value

Data type

float

Alias
UMLS CUI [1]
C0587081
Test Units
Description

Test Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Range
Description

Normal Range

Data type

text

Alias
UMLS CUI [1]
C0086715
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Similar models

Serious Adverse Experience (SAE)

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])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Course Number
Item
Course Number
integer
C0237753 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item Group
Serious Adverse Experience (SAE)
C1519255 (UMLS CUI-1)
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE
integer
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Specify reason(s) for considering this a serious AE
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 hospitalisation (excluding elective surgery or routine clinical procedures) (4)
CL Item
hospitalisation 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)
SAE Onset Date and Time
Item
SAE Onset Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
SAE End Date and Time
Item
SAE End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
SAE Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE Outcome
Code List
SAE Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Experience Course
integer
C1519255 (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
Drug stopped (4)
CL Item
Dose increased (3)
CL Item
Dose reduced (2)
CL Item
None (1)
CL Item
Drug interrupted/restarted (5)
CL Item
Dose delayed (6)
CL Item
Dose delayed & decreased (7)
Did the SAE abate?
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0420247 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1611744 (UMLS CUI [2])
C0580673 (UMLS CUI [3])
If medication was reintroduced dose increased, did SAE recur?
Item
If medication was reintroduced dose increased, did SAE recur?
boolean
C0304229 (UMLS CUI [1])
C1611744 (UMLS CUI [2])
C0580673 (UMLS CUI [3])
C1519255 (UMLS CUI [4,1])
C0034897 (UMLS CUI [4,2])
Item
Relationship to Investigational Drug
integer
C1519255 (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)
Item
If Relationship to Investigational Drug is "Not related" or "Unlikely", the SAE is probably associated with
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
If Relationship to Investigational Drug is "Not related" or "Unlikely", the SAE is probably associated with
Code List
If Relationship to Investigational Drug is "Not related" or "Unlikely", the SAE is probably associated with
CL Item
Protocol design or procedures (but not to study drug), please specify (1)
CL Item
Another condition (eg, condition under study, intercurrent illness), please specify (2)
CL Item
Another drug, please specify (3)
Specify protocol designs or prodcedures
Item
Specify protocol designs or prodcedures
text
C1507083 (UMLS CUI [1])
C2700391 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Specify Another Condition
Item
Specify Another Condition
text
C0348080 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Specify Another drug
Item
Specify Another drug
text
C1115771 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
Corrective therapy
Item
Corrective therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was patient withdrawn due to this specific SAE?
Item
Was patient withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
If applicable, was randomisation code broken at investigational site?
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C3899531 (UMLS CUI [1,2])
Please print name
Item
Please print name
text
C0027365 (UMLS CUI [1])
SB Medical Monitor's Signature
Item
SB Medical Monitor's Signature
text
C1519316 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
Signature Date
Item
Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Serious Adverse Experience - Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Test
Item
Test
text
C0022885 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Value
Item
Test Value
float
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
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