ID

37258

Descripción

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Palabras clave

Versiones (1)
  1. 12/7/19 12/7/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de julio de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

Inglés

Cycle 3 Day 1

1 formularios  
  1. StudyEvent: ODM
    1. Cycle 3 Day 1
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Blood pressure - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature
Descripción

Body Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Treatment Confirmation
Descripción

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descripción

Therapeutic procedure, Confirmation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
If No, record reason(s)
Descripción

Therapeutic procedure, Wrong, Reason and Justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Lesion Assessment Using WHO Criteria - Indicator Lesions
Descripción

Lesion Assessment Using WHO Criteria - Indicator Lesions

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1522602
UMLS CUI-3
C0220825
Lesion No.
Descripción

Lesion, Indicator, Numbers

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0237753
Anatomic Description - Organ Code
Descripción

Lesion, Indicator, Organ, Code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0805701
Anatomic Description - Lesion Location
Descripción

Lesion, Indicator, Location

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0450429
Date
Descripción

Lesion, Indicator, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0011008
Can lesion be measured?
Descripción

Lesion, Indicator, Measurement method

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C1299991
Diameter
Descripción

Lesion, Indicator, Diameter

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C1301886
mm
Product
Descripción

Lesion, Indicator, Lesion size

Tipo de datos

integer

Unidades de medida
  • mm2
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0449453
mm2
Method
Descripción

Lesion, Indicator, Measurement method

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C1299991
Lesion Code
Descripción

Lesion, Indicator, Lesion Code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0805701
Lesion Assessment Using WHO Criteria - Non-Measurable, Non-Evaluable Lesions
Descripción

Lesion Assessment Using WHO Criteria - Non-Measurable, Non-Evaluable Lesions

Alias
UMLS CUI-1
C1334988
UMLS CUI-2
C0220825
Lesion No.
Descripción

Non-Measurable Lesion, Numbers

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0237753
Anatomic Description - Lesion Location
Descripción

Non-Measurable Lesion, Location

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0450429
Date
Descripción

Non-Measurable Lesion, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0011008
Present
Descripción

Non-Measurable Lesion, Present

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0150312
Absent
Descripción

Non-Measurable Lesion, Absent

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0332197
Not Done
Descripción

Non-Measurable Lesion, Not Done

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C1272696
Response Assessment Using WHO Criteria
Descripción

Response Assessment Using WHO Criteria

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0220825
Was a response assessment performed?
Descripción

Response to treatment, Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
Date of Lesion Assessment
Descripción

Lesion, Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C2985720
Indicate the subject’s response for this tumor assessment, check only one
Descripción

Malignant Neoplasms, Evaluation, Disease Response

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1704632
Method of Assessment
Descripción

Response to treatment, Evaluation method

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C2911685
Date of Clinical Assessment
Descripción

Response to treatment, Assessment Date, Clinical

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C2985720
UMLS CUI [1,3]
C0205210
If ’Clinical Assessment’ is done, specify clinical symptoms of progression and method of assessment:
Descripción

Response to treatment, Evaluation, Clinical

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0205210
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Similar models

Cycle 3 Day 1

1 formularios
  1. StudyEvent: ODM
    1. Cycle 3 Day 1
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body surface area
float
C0005902 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure - Diastolic
integer
C0871470 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic procedure, Wrong, Reason and Justification
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Lesion Assessment Using WHO Criteria - Indicator Lesions
C0221198 (UMLS CUI-1)
C1522602 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Lesion, Indicator, Numbers
Item
Lesion No.
integer
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Lesion, Indicator, Organ, Code
Item
Anatomic Description - Organ Code
text
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Lesion, Indicator, Location
Item
Anatomic Description - Lesion Location
text
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
Lesion, Indicator, Date in time
Item
Date
date
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Lesion, Indicator, Measurement method
Item
Can lesion be measured?
boolean
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
Lesion, Indicator, Diameter
Item
Diameter
integer
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Lesion, Indicator, Lesion size
Item
Product
integer
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0449453 (UMLS CUI [1,3])
Lesion, Indicator, Measurement method
Item
Method
text
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
Lesion, Indicator, Lesion Code
Item
Lesion Code
text
C0221198 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
Lesion Assessment Using WHO Criteria - Non-Measurable, Non-Evaluable Lesions
C1334988 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Non-Measurable Lesion, Numbers
Item
Lesion No.
integer
C1334988 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Anatomic Description - Lesion Location
text
C1334988 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Non-Measurable Lesion, Location
Code List
Anatomic Description - Lesion Location
CL Item
Pericardial Effusion (1)
CL Item
Pleural Effusion (2)
CL Item
Ascites (3)
CL Item
Lymphangetic Metastases (4)
CL Item
Bone or Bone Marrow Metastases (5)
CL Item
Leptomeningeal Metastases (6)
Non-Measurable Lesion, Date in time
Item
Date
date
C1334988 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Non-Measurable Lesion, Present
Item
Present
text
C1334988 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Non-Measurable Lesion, Absent
Item
Absent
text
C1334988 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Non-Measurable Lesion, Not Done
Item
Not Done
text
C1334988 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Response Assessment Using WHO Criteria
C0521982 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Response to treatment, Evaluation
Item
Was a response assessment performed?
boolean
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Lesion, Assessment Date
Item
Date of Lesion Assessment
date
C0221198 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Indicate the subject’s response for this tumor assessment, check only one
text
C0006826 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
Malignant Neoplasms, Evaluation, Disease Response
Code List
Indicate the subject’s response for this tumor assessment, check only one
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Not Evaluable (5)
Item
Method of Assessment
text
C0521982 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Response to treatment, Evaluation method
Code List
Method of Assessment
CL Item
Lesion Assessment (1)
CL Item
Clinical Assessment (2)
Response to treatment, Assessment Date, Clinical
Item
Date of Clinical Assessment
date
C0521982 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Response to treatment, Evaluation, Clinical
Item
If ’Clinical Assessment’ is done, specify clinical symptoms of progression and method of assessment:
text
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
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