ID

35667

Descripción

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Palabras clave

  1. 14/3/19 14/3/19 -
Titular de derechos de autor

GSK group of companies

Subido en

14 de marzo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0

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Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369

Treatment Completion Form

Administrative data
Descripción

Administrative data

Last Name
Descripción

Last Name

Tipo de datos

text

First Name
Descripción

First Name

Tipo de datos

text

Section
Descripción

Section

Tipo de datos

text

GOG #
Descripción

Inst.,Prot.,Seq.

Tipo de datos

integer

Treatment Completion
Descripción

Treatment Completion

Total number of courses of protocol therapy administered
Descripción

Total number of courses

Tipo de datos

integer

Reasons for discontinuing protocol treatment
Descripción

check only one

Tipo de datos

text

Specify Other
Descripción

Specify Other

Tipo de datos

text

Summarize plans for further anti-cancer therapy:
Descripción

plans for further therapy

Tipo de datos

text

Tumor Measurements
Descripción

Tumor Measurements

Tipo de datos

integer

Unidades de medida
  • cm
cm
Tumor Measurements
Descripción

Tumor Measurements

Location
Descripción

Location

Tipo de datos

integer

Method of Tumor Measurement
Descripción

Method

Tipo de datos

text

Date of assessment
Descripción

Date of assessment

Tipo de datos

date

Tumor measurements
Descripción

Tumor measurements

Tipo de datos

text

Unidades de medida
  • cm
cm
Best Tumor Response
Descripción

Best Tumor Response

Best Tumor Response
Descripción

Best Tumor Response

Tipo de datos

text

Date of Progression
Descripción

Date of Progression

Tipo de datos

date

Date of Best Response
Descripción

Date of Best Response

Tipo de datos

date

Follow-Up Form
Descripción

Follow-Up Form

Was the patient contacted for current scheduled follow-up
Descripción

Lost to follow-up

Tipo de datos

boolean

Vital Status
Descripción

Vital Status

Tipo de datos

text

Date patient last known alive or date of death
Descripción

Date of last contact

Tipo de datos

date

If dead, indicate contributing factor(s)
Descripción

Death reason

Tipo de datos

text

Disease Follow-Up Status
Descripción

Disease Follow-Up Status

Has the patient been assessed by a physician for progression/recurrence of this cancer since previous information submission?
Descripción

Disease Follow-Up Status

Tipo de datos

text

If Yes, date of assessment
Descripción

date of assessment

Tipo de datos

date

Has the patient been diagnosed with a progression/recurrence?
Descripción

disease progression/recurrence

Tipo de datos

boolean

Date of Progression/recurrence
Descripción

Progression/recurrence date

Tipo de datos

date

Determination method
Descripción

Determination method

Tipo de datos

integer

Site / Marker
Descripción

Site / Marker

Tipo de datos

text

If protocol therapy included radiation, is location of progression within the radiation port?
Descripción

location of progression

Tipo de datos

boolean

Notice of New Primary
Descripción

Notice of New Primary

Has a new malignant neoplasm or myelodysplastic syndrome (MDS) been diagnosed that was not previously reported?
Descripción

Notice of New Primary

Tipo de datos

boolean

Date diagnosed
Descripción

Date diagnosed

Tipo de datos

date

Long Term Adverse Events
Descripción

Long Term Adverse Events

Has patient experienced any adverse events that have not been previously reported or have persisted for 3 months or more?
Descripción

AE

Tipo de datos

boolean

Adverse Events details
Descripción

Adverse Events details

Sequence Number
Descripción

Sequence Number

Tipo de datos

integer

Description
Descripción

CTC Terminology

Tipo de datos

text

Grade
Descripción

Grade

Tipo de datos

text

Onset Date
Descripción

Onset Date

Tipo de datos

date

Is event related to protocol therapy?
Descripción

Causality

Tipo de datos

boolean

Additional Cancer Therapy
Descripción

Additional Cancer Therapy

Specify therapy
Descripción

Therapy type

Tipo de datos

text

Date therapy started
Descripción

Start Date

Tipo de datos

date

Specify reason
Descripción

reason

Tipo de datos

text

Comments
Descripción

Comments

Tipo de datos

text

Similar models

Treatment Completion Form

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Last Name
Item
Last Name
text
First Name
Item
First Name
text
Section
Item
Section
text
Gynecologic Oncology Group Number
Item
GOG #
integer
Item Group
Treatment Completion
Total number of courses
Item
Total number of courses of protocol therapy administered
integer
Item
Reasons for discontinuing protocol treatment
text
Code List
Reasons for discontinuing protocol treatment
CL Item
routine, completed planned study treatment (1)
CL Item
disease progression, as defined in the protocol (2)
CL Item
toxicity as permitted in protocol (3)
CL Item
patient refused further study treatment for reasons other than toxicity (4)
CL Item
death (5)
CL Item
patient off study treatment for other medical condition  (6)
CL Item
other (7)
Specify Other
Item
Specify Other
text
plans for further therapy
Item
Summarize plans for further anti-cancer therapy:
text
Tumor Measurements
Item
Tumor Measurements
integer
Item Group
Tumor Measurements
Item
Location
integer
Code List
Location
CL Item
Location #1 (1)
CL Item
Location #2 (2)
CL Item
Location #3 (3)
Method
Item
Method of Tumor Measurement
text
Date of assessment
Item
Date of assessment
date
Tumor measurements
Item
Tumor measurements
text
Item Group
Best Tumor Response
Item
Best Tumor Response
text
Code List
Best Tumor Response
CL Item
Complete Response (NED) (1)
CL Item
Partial (>50% decrease each lesion followed) (2)
CL Item
Stable (3)
CL Item
Increasing Disease (>50% increase in any tumor) (4)
CL Item
Not evaluated this course (5)
Date of Progression
Item
Date of Progression
date
Date of Best Response
Item
Date of Best Response
date
Item Group
Follow-Up Form
Lost to follow-up
Item
Was the patient contacted for current scheduled follow-up
boolean
Item
Vital Status
text
Code List
Vital Status
CL Item
Alive (1)
CL Item
Dead (2)
Date of last contact
Item
Date patient last known alive or date of death
date
Item
If dead, indicate contributing factor(s)
text
Code List
If dead, indicate contributing factor(s)
CL Item
cancer under study (1)
CL Item
protocol treatment (2)
CL Item
no information on cause (3)
CL Item
other, specify (4)
Item Group
Disease Follow-Up Status
Item
Has the patient been assessed by a physician for progression/recurrence of this cancer since previous information submission?
text
Code List
Has the patient been assessed by a physician for progression/recurrence of this cancer since previous information submission?
CL Item
Yes (1)
CL Item
no (2)
CL Item
Not applicable (3)
date of assessment
Item
If Yes, date of assessment
date
disease progression/recurrence
Item
Has the patient been diagnosed with a progression/recurrence?
boolean
Progression/recurrence date
Item
Date of Progression/recurrence
date
Item
Determination method
integer
Code List
Determination method
CL Item
histologically (1)
CL Item
radiologically (2)
CL Item
physically (3)
CL Item
marker (4)
Site / Marker
Item
Site / Marker
text
location of progression
Item
If protocol therapy included radiation, is location of progression within the radiation port?
boolean
Item Group
Notice of New Primary
Notice of New Primary
Item
Has a new malignant neoplasm or myelodysplastic syndrome (MDS) been diagnosed that was not previously reported?
boolean
Date diagnosed
Item
Date diagnosed
date
Item Group
Long Term Adverse Events
AE
Item
Has patient experienced any adverse events that have not been previously reported or have persisted for 3 months or more?
boolean
Item Group
Adverse Events details
Sequence Number
Item
Sequence Number
integer
Description
Item
Description
text
Grade
Item
Grade
text
Onset Date
Item
Onset Date
date
Causality
Item
Is event related to protocol therapy?
boolean
Item Group
Additional Cancer Therapy
Therapy type
Item
Specify therapy
text
Start Date
Item
Date therapy started
date
reason
Item
Specify reason
text
Comments
Item
Comments
text

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