Information:
Fel:
ID
35667
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-03-14 2019-03-14 -
Rättsinnehavare
GSK group of companies
Uppladdad den
14 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369
Similar models
Treatment Completion Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Last Name
Item
Last Name
text
First Name
Item
First Name
text
Section
Item
Section
text
Gynecologic Oncology Group Number
Item
GOG #
integer
Total number of courses
Item
Total number of courses of protocol therapy administered
integer
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
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
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
Lost to follow-up
Item
Was the patient contacted for current scheduled follow-up
boolean
CL Item
Alive (1)
CL Item
Dead (2)
Date of last contact
Item
Date patient last known alive or date of death
date
CL Item
cancer under study (1)
CL Item
protocol treatment (2)
CL Item
no information on cause (3)
CL Item
other, specify (4)
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
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
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
AE
Item
Has patient experienced any adverse events that have not been previously reported or have persisted for 3 months or more?
boolean
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
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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