ID

37272

Beschreibung

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

Stichworte

Versionen (1)
  1. 12.07.19 12.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. Juli 2019

DOI

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

Englisch

End of Treatment

1 Formulare  
  1. StudyEvent: ODM
    1. End of Treatment
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure - Systolic
Beschreibung

Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure - Diastolic
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature
Beschreibung

Body Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Lesion Assessment Using WHO Criteria - Indicator Lesions
Beschreibung

Lesion Assessment Using WHO Criteria - Indicator Lesions

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

Lesion, Indicator, Numbers

Datentyp

integer

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

Lesion, Indicator, Organ, Code

Datentyp

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
Beschreibung

Lesion, Indicator, Location

Datentyp

text

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

Lesion, Indicator, Date in time

Datentyp

date

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

Lesion, Indicator, Measurement method

Datentyp

boolean

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

Lesion, Indicator, Diameter

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C1301886
mm
Product
Beschreibung

Lesion, Indicator, Lesion size

Datentyp

integer

Maßeinheiten
  • mm2
Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0449453
mm2
Method
Beschreibung

Lesion, Indicator, Measurement method

Datentyp

text

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

Lesion, Indicator, Lesion Code

Datentyp

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
Beschreibung

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

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

Non-Measurable Lesion, Numbers

Datentyp

integer

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

Non-Measurable Lesion, Location

Datentyp

text

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

Non-Measurable Lesion, Date in time

Datentyp

date

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

Non-Measurable Lesion, Present

Datentyp

text

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

Non-Measurable Lesion, Absent

Datentyp

text

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

Non-Measurable Lesion, Not Done

Datentyp

text

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

Response Assessment Using WHO Criteria

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

Response to treatment, Evaluation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
Was this a confirmatory scan?
Beschreibung

Response to treatment, Evaluation, Confirmation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0750484
Date of Lesion Assessment
Beschreibung

Lesion, Assessment Date

Datentyp

date

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

Malignant Neoplasms, Evaluation, Disease Response

Datentyp

text

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

Response to treatment, Evaluation method

Datentyp

text

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

Response to treatment, Assessment Date, Clinical

Datentyp

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:
Beschreibung

Response to treatment, Evaluation, Clinical

Datentyp

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0205210
Local Laboratory - Haematology
Beschreibung

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Lab ID
Beschreibung

Laboratory Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Beschreibung

Performing laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Address
Beschreibung

Performing Laboratory, Street Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1882331
UMLS CUI [1,2]
C1301826
Date sample taken
Beschreibung

Laboratory Procedures, Hematology finding, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Haematology Test
Beschreibung

Laboratory Procedures, Hematology finding

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Result
Beschreibung

Laboratory Procedures, Hematology finding, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1274040
Local Laboratory - Clinical Chemistry
Beschreibung

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Lab ID
Beschreibung

Laboratory Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Beschreibung

Performing laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Address
Beschreibung

Performing Laboratory, Street Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1882331
UMLS CUI [1,2]
C1301826
Date sample taken
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Clinical Chemistry Test
Beschreibung

Laboratory Procedures, Chemistry, Clinical

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
Result
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1274040
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Ähnliche Modelle

End of Treatment

1 Formulare
  1. StudyEvent: ODM
    1. End of Treatment
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Weight
Item
Weight
float
C0005910 (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
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])
Response to treatment, Evaluation, Confirmation
Item
Was this a confirmatory scan?
boolean
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
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])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory Identifier
Item
Lab ID
text
C2986056 (UMLS CUI [1])
Performing laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Performing Laboratory, Street Address
Item
Address
text
C1882331 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Haematology Test
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding
Code List
Haematology Test
CL Item
Haemoglobin (1)
CL Item
Haematocrit (2)
CL Item
Red Blood Cell (3)
CL Item
White Blood Cell (4)
CL Item
Platelet (5)
CL Item
Neutrophils (6)
CL Item
Bands (7)
CL Item
Lymphocytes (8)
CL Item
Monocytes (9)
CL Item
Eosinophils (10)
CL Item
Basophils (11)
Laboratory Procedures, Hematology finding, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Laboratory Identifier
Item
Lab ID
text
C2986056 (UMLS CUI [1])
Performing laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Performing Laboratory, Street Address
Item
Address
text
C1882331 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Clinical Chemistry Test
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Laboratory Procedures, Chemistry, Clinical
Code List
Clinical Chemistry Test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Calcium (5)
CL Item
Phosphorus (6)
CL Item
Magnesium (7)
CL Item
Blood Urea Nitrogen (BUN) (8)
CL Item
Urea (9)
CL Item
Uric acid (10)
CL Item
Creatinine (11)
CL Item
LDH (12)
CL Item
Aspartate Aminotransferase (AST) (13)
CL Item
Alanine Transaminase (ALT) (14)
CL Item
Bilirubin (total) (15)
CL Item
Protein (total) (16)
CL Item
Albumin (17)
CL Item
Creatinine Clearance (calculated) (18)
CL Item
CA125 (19)
Laboratory Procedures, Chemistry, Clinical, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
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