ID

37646

Description

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian 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: HycamtinTM Study Indication: Ovarian Cancer

Keywords

Versions (1)
  1. 8/13/19 8/13/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 13, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

English

Prior to Second Cycle

1 forms  
  1. StudyEvent: ODM
    1. Prior to Second Cycle
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Computed tomography
Description

Computed tomography

Alias
UMLS CUI-1
C0040405
CT performed?
Description

X-Ray Computed Tomography, Performed

Data type

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0884358
Are there any changes compared to the baseline?
Description

X-Ray Computed Tomography, Changed status

Data type

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0443172
Findings in CT - Please specify
Description

X-Ray Computed Tomography, Finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0243095
Date of examination
Description

X-Ray Computed Tomography, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0011008
Assessment of response
Description

Assessment of response

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0220825
Assessment of response performed?
Description

Response to treatment, Evaluation, Performed

Data type

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0884358
Please mark one of the following
Description

Response to treatment, Evaluation

Data type

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0884358
Which method was applied for the assessment of response? Please mark the applicable one
Description

Response to treatment, Evaluation Method

Data type

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C2911685
Date of examination
Description

Response to treatment, Evaluation, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0011008
Presence of an evaluable/measurable tumor?
Description

Response to treatment, Evaluation, Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0006826
Serious adverse events
Description

Serious adverse events

Alias
UMLS CUI-1
C1519255
Has a serious adverse event occurred during the course of the previous cycle?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Status of the study
Description

Status of the study

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0449438
Will the next treatment cycle be performed in the patient?
Description

Continuation status, Clinical Trials

Data type

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
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Similar models

Prior to Second Cycle

1 forms
  1. StudyEvent: ODM
    1. Prior to Second Cycle
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Computed tomography
C0040405 (UMLS CUI-1)
X-Ray Computed Tomography, Performed
Item
CT performed?
boolean
C0040405 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
X-Ray Computed Tomography, Changed status
Item
Are there any changes compared to the baseline?
boolean
C0040405 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
X-Ray Computed Tomography, Finding
Item
Findings in CT - Please specify
boolean
C0040405 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
X-Ray Computed Tomography, Date in time
Item
Date of examination
date
C0040405 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Assessment of response
C0521982 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Response to treatment, Evaluation, Performed
Item
Assessment of response performed?
boolean
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
Item
Please mark one of the following
text
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
Response to treatment, Evaluation
Code List
Please mark one of the following
CL Item
complete response (1)
CL Item
partial response (2)
CL Item
stable disease (3)
CL Item
no evidence of disease (4)
CL Item
progression of disease (5)
CL Item
not evaluable (6)
Item
Which method was applied for the assessment of response? Please mark the applicable one
text
C0521982 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Response to treatment, Evaluation
Code List
Which method was applied for the assessment of response? Please mark the applicable one
CL Item
CA 125 (1)
CL Item
X-ray (2)
CL Item
Sonography (3)
CL Item
CT (4)
CL Item
NMR (5)
CL Item
Other (6)
Response to treatment, Evaluation, Date in time
Item
Date of examination
date
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Response to treatment, Evaluation, Malignant Neoplasms
Item
Presence of an evaluable/measurable tumor?
boolean
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Item Group
Serious adverse events
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Has a serious adverse event occurred during the course of the previous cycle?
boolean
C1519255 (UMLS CUI [1])
Item Group
Status of the study
C0008976 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Continuation status, Clinical Trials
Item
Will the next treatment cycle be performed in the patient?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
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