ID

42249

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. 4/17/21 4/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 17, 2021

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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

Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
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
Toxicities related to previous Radiotherapy for SCLC
Description

Toxicities related to previous Radiotherapy for SCLC

Alias
UMLS CUI-1
C0013221
UMLS CUI-2
C1522449
UMLS CUI-3
C0205156
UMLS CUI-4
C0149925
Does the patient have any residual toxicities related to previous radiotherapy for small cell lung cancer?
Description

If "Yes" please record the toxicity below with NCI Common Toxicity Grade.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1609982
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205156
UMLS CUI [3]
C0149925
Toxicities related to previous Radiotherapy for SCLC
Description

Toxicities related to previous Radiotherapy for SCLC

Alias
UMLS CUI-1
C0013221
UMLS CUI-2
C1522449
UMLS CUI-3
C0205156
UMLS CUI-4
C0149925
Toxicity
Description

Toxicity

Data type

text

Alias
UMLS CUI [1]
C0013221
NCI Toxicity Grade
Description

NCI Toxicity Grade

Data type

text

Alias
UMLS CUI [1]
C2826262
12-Lead Electrocardiogram
Description

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date ECG Performed
Description

Date ECG Performed

Data type

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
ECG Result
Description

ECG Result

Data type

integer

Alias
UMLS CUI [1]
C0438154
Diagnostic Studies for Tumor Assessment
Description

Diagnostic Studies for Tumor Assessment

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0008976
UMLS CUI-3
C0027651
UMLS CUI-4
C0220825
Tumor Assessment
Description

Tumor Assessment

Data type

integer

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0220825
Tumor Assessment Not Done
Description

Tumor Assessment Not Done

Data type

integer

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1272696
Date Assessment Performed
Description

Date Assessment Performed

Data type

date

Alias
UMLS CUI [1]
C2985720
Assessment Result
Description

Assessment Result

Data type

integer

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1274040
Ongoing Medical Conditions Associated with SCLC
Description

Ongoing Medical Conditions Associated with SCLC

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0549178
UMLS CUI-3
C0149925
Does the patient have any ongoing medical condition(s) that is associated or possibly associated with SCLC?
Description

If "Yes", list condition below with NCI Common Toxicity Grade.

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0149925
Ongoing Medical Conditions Associated with SCLC
Description

Ongoing Medical Conditions Associated with SCLC

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0549178
UMLS CUI-3
C0149925
Condition
Description

Condition

Data type

text

Alias
UMLS CUI [1]
C0012634
NCL Toxicity Grade
Description

NCL Toxicity Grade

Data type

text

Alias
UMLS CUI [1]
C2826262
Year of first diagnosis
Description

Year of first diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Significant Medical/ Surgical History and Physical Examination
Description

Significant Medical/ Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0455610
UMLS CUI-3
C0031809
Is the patient suffering from or has he/ she ever suffered from any significant medical or surgical condition (other than small cell lung cancer or conditions related to small cell lung cancer)?
Description

If "Yes" please provide diagnosis below, listing no more than one diagnosis per line. All signs and symptoms referring to a single diagnosis must be recorded on the same line with the diagnosis. Signs and symptoms without an associated diagnosis must be recorded on separate lines. Please record the associated NCI CTC toxicity grade. For events not covered by the NCI scale, record the maximum intensity based on the SB criteria (grade 1 - 4) presented in the Assessment of Intensity section of the protocol. If a diagnosis does not warrant a toxicity, please populate the box with "NA"

Data type

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0012634
UMLS CUI [3]
C0149925
Significant Medical/ Surgical History and Physical Examination
Description

Significant Medical/ Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0455610
UMLS CUI-3
C0031809
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
NCI Grade
Description

NCI Grade

Data type

text

Alias
UMLS CUI [1]
C2826262
Year of first diagnosis
Description

Year of first diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Condition Status
Description

Condition Status

Data type

integer

Alias
UMLS CUI [1]
C3176928
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Similar models

Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Toxicities related to previous Radiotherapy for SCLC
C0013221 (UMLS CUI-1)
C1522449 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
C0149925 (UMLS CUI-4)
Does the patient have any residual toxicities related to previous radiotherapy for small cell lung cancer?
Item
Does the patient have any residual toxicities related to previous radiotherapy for small cell lung cancer?
boolean
C0013221 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0149925 (UMLS CUI [3])
Item Group
Toxicities related to previous Radiotherapy for SCLC
C0013221 (UMLS CUI-1)
C1522449 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
C0149925 (UMLS CUI-4)
Toxicity
Item
Toxicity
text
C0013221 (UMLS CUI [1])
NCI Toxicity Grade
Item
NCI Toxicity Grade
text
C2826262 (UMLS CUI [1])
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
Date ECG Performed
Item
Date ECG Performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
ECG Result
integer
C0438154 (UMLS CUI [1])
ECG Result
Code List
ECG Result
CL Item
Normal/ no clinically significant abnormalities (1)
CL Item
Clinically significant abnormalities (Record details on the Significanr Medical/ Surgical History and Physical Examination page (2)
Item Group
Diagnostic Studies for Tumor Assessment
C0430022 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0027651 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
Item
Tumor Assessment
integer
C0027651 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Tumor Assessment
Code List
Tumor Assessment
CL Item
Chest X-Ray (1)
CL Item
Chest CT or MRI Scan (2)
CL Item
Abdominal CT or MRI Scan (3)
CL Item
Radionuclide Bone Scan (4)
CL Item
Head CT or MRI Scan (5)
CL Item
Neurologic Assessment (6)
Item
Tumor Assessment Not Done
integer
C0027651 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Tumor Assessment Not Done
Code List
Tumor Assessment Not Done
CL Item
Not Done (1)
Date Assessment Performed
Item
Date Assessment Performed
date
C2985720 (UMLS CUI [1])
Item
Assessment Result
integer
C0220825 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Assessment Result
Code List
Assessment Result
CL Item
Normal/ no clinically significant abnormality (1)
CL Item
Clinically significant abnormality (2)
Item Group
Ongoing Medical Conditions Associated with SCLC
C0012634 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
C0149925 (UMLS CUI-3)
Does the patient have any ongoing medical condition(s) that is associated or possibly associated with SCLC?
Item
Does the patient have any ongoing medical condition(s) that is associated or possibly associated with SCLC?
boolean
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0149925 (UMLS CUI [1,3])
Item Group
Ongoing Medical Conditions Associated with SCLC
C0012634 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
C0149925 (UMLS CUI-3)
Condition
Item
Condition
text
C0012634 (UMLS CUI [1])
NCL Toxicity Grade
Item
NCL Toxicity Grade
text
C2826262 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item Group
Significant Medical/ Surgical History and Physical Examination
C0262926 (UMLS CUI-1)
C0455610 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Is the patient suffering from or has he/ she ever suffered from any significant medical or surgical condition (other than small cell lung cancer or conditions related to small cell lung cancer)?
Item
Is the patient suffering from or has he/ she ever suffered from any significant medical or surgical condition (other than small cell lung cancer or conditions related to small cell lung cancer)?
boolean
C0012634 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0149925 (UMLS CUI [3])
Item Group
Significant Medical/ Surgical History and Physical Examination
C0262926 (UMLS CUI-1)
C0455610 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
NCI Grade
Item
NCI Grade
text
C2826262 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
CL Item
Past (1)
CL Item
Current Active (2)
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