ID

39018

Beschreibung

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

Stichworte

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  1. 20.11.19 20.11.19 -
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GlaxoSmithKline

Hochgeladen am

20. November 2019

DOI

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Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

Englisch

Follow-Up

1 Formulare  
  1. StudyEvent: ODM
    1. Follow-Up
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Follow-up month
Beschreibung

Follow-up month

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C0439231
Please mark the number of months that have passed since the last performed cycle up to this follow-up report.
Beschreibung

Follow-up, Month

Datentyp

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0439231
Please specify
Beschreibung

Follow-up, Month

Datentyp

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0439231
Result
Beschreibung

Result

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C1274040
Is the patient "lost to follow-up"?
Beschreibung

Clinical Trials, Result, Lost to Follow-Up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1302313
If "no", please record date of follow-up
Beschreibung

Clinical Trials, Result, Follow-Up visit Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C3694716
Has the patient died?
Beschreibung

Clinical Trials, Result, Cessation of life

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0011065
If "no", please record the date of the last contact with the patient (e.g. visit, phone call)
Beschreibung

Clinical Trials, Result, Date last contact

Datentyp

date

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0805839
Computed tomography
Beschreibung

Computed tomography

Alias
UMLS CUI-1
C0040405
CT performed?
Beschreibung

X-Ray Computed Tomography, Performed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0884358
Finding in CT
Beschreibung

X-Ray Computed Tomography, Finding

Datentyp

text

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0243095
Findings in CT - Please specify
Beschreibung

X-Ray Computed Tomography, Finding

Datentyp

text

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

X-Ray Computed Tomography, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0011008
Tumor markers
Beschreibung

Tumor markers

Alias
UMLS CUI-1
C0041365
Tumor marker
Beschreibung

Tumor Markers

Datentyp

text

Alias
UMLS CUI [1]
C0041365
Date
Beschreibung

Tumor Markers, Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C2985720
Value
Beschreibung

Tumor Markers, Numerical value

Datentyp

integer

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C1522609
Unit
Beschreibung

Tumor Markers, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C1519795
if applicable, please comment
Beschreibung

Tumor Markers, Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0041365
UMLS CUI [1,2]
C0947611
Date of follow-up
Beschreibung

Date of follow-up

Alias
UMLS CUI-1
C3694716
Date of follow-up
Beschreibung

follow-up visit date

Datentyp

date

Alias
UMLS CUI [1]
C3694716
Assessment of response
Beschreibung

Assessment of response

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

Response to treatment, Evaluation, Performed

Datentyp

boolean

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

Response to treatment, Evaluation

Datentyp

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
Beschreibung

Response to treatment, Evaluation Method

Datentyp

text

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

Response to treatment, Evaluation, Date in time

Datentyp

date

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

Response to treatment, Evaluation, Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0006826
Further Therapy
Beschreibung

Further Therapy

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0205394
Did the patient receive a further therapy?
Beschreibung

Therapeutic procedure, Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
If "yes", please specify
Beschreibung

Therapeutic procedure, Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
Date of treatment start
Beschreibung

Therapeutic procedure, Other, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0808070
Please specify
Beschreibung

Therapeutic procedure, Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0808070
Investigator's Signature
Beschreibung

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Confirmation of the correctness and completeness of the data of the follow-up visit
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Name
Beschreibung

Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Investigator Signature, Date in time

Datentyp

date

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

Follow-Up

1 Formulare
  1. StudyEvent: ODM
    1. Follow-Up
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Follow-up month
C1522577 (UMLS CUI-1)
C0439231 (UMLS CUI-2)
Item
Please mark the number of months that have passed since the last performed cycle up to this follow-up report.
text
C1522577 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
Follow-up, Month
Code List
Please mark the number of months that have passed since the last performed cycle up to this follow-up report.
CL Item
3 (1)
CL Item
6 (2)
CL Item
9 (3)
CL Item
12 (4)
CL Item
15 (5)
CL Item
18 (6)
CL Item
21 (7)
CL Item
24 (8)
CL Item
Other, please specify (9)
Follow-up, Month
Item
Please specify
text
C1522577 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
Item Group
Result
C0008976 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Clinical Trials, Result, Lost to Follow-Up
Item
Is the patient "lost to follow-up"?
boolean
C0008976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1302313 (UMLS CUI [1,3])
Clinical Trials, Result, Follow-Up visit Date
Item
If "no", please record date of follow-up
date
C0008976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C3694716 (UMLS CUI [1,3])
Clinical Trials, Result, Cessation of life
Item
Has the patient died?
boolean
C0008976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,3])
Clinical Trials, Result, Date last contact
Item
If "no", please record the date of the last contact with the patient (e.g. visit, phone call)
date
C0008976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
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])
Item
Finding in CT
text
C0040405 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
X-Ray Computed Tomography, Finding
Code List
Finding in CT
CL Item
normal (1)
CL Item
abnormal (2)
X-Ray Computed Tomography, Finding
Item
Findings in CT - Please specify
text
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
Tumor markers
C0041365 (UMLS CUI-1)
Item
Tumor marker
text
C0041365 (UMLS CUI [1])
Tumor Markers
Code List
Tumor marker
CL Item
CA 125 (1)
CL Item
CA 125 (2)
Tumor Markers, Assessment Date
Item
Date
date
C0041365 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Tumor Markers, Numerical value
Item
Value
integer
C0041365 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Tumor Markers, Unit of Measure
Item
Unit
text
C0041365 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Tumor Markers, Comment
Item
if applicable, please comment
text
C0041365 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Date of follow-up
C3694716 (UMLS CUI-1)
follow-up visit date
Item
Date of follow-up
date
C3694716 (UMLS CUI [1])
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 Method
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
Further Therapy
C0087111 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Therapeutic procedure, Other
Item
Did the patient receive a further therapy?
boolean
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
If "yes", please specify
text
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Therapeutic procedure, Other
Code List
If "yes", please specify
CL Item
Surgery (1)
CL Item
Radiotherapy (2)
CL Item
Chemotherapy (3)
CL Item
Hormonal therapy (4)
CL Item
Immunotherapy (5)
Therapeutic procedure, Other, Start Date
Item
Date of treatment start
date
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Therapeutic procedure, Other
Item
Please specify
text
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Confirmation of the correctness and completeness of the data of the follow-up visit
text
C2346576 (UMLS CUI [1])
Investigator Name
Item
Name
text
C2826892 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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