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37258

Description

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

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Versions (1)
  1. 12/07/2019 12/07/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

12 juillet 2019

DOI

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Licence

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

    Anglais

    Cycle 3 Day 1

    1 Formulaires  
    1. StudyEvent: ODM
      1. Cycle 3 Day 1
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Date of visit

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Weight
    Description

    Body Weight

    Type de données

    float

    Unités de mesure
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body surface area
    Description

    Body Surface Area

    Type de données

    float

    Unités de mesure
    • m2
    Alias
    UMLS CUI [1]
    C0005902
    m2
    Blood pressure - Systolic
    Description

    Systolic Pressure

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure - Diastolic
    Description

    Diastolic blood pressure

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Heart rate
    Description

    Heart rate

    Type de données

    integer

    Unités de mesure
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Temperature
    Description

    Body Temperature

    Type de données

    float

    Unités de mesure
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Treatment Confirmation
    Description

    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?
    Description

    Therapeutic procedure, Confirmation

    Type de données

    boolean

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

    Therapeutic procedure, Wrong, Reason and Justification

    Type de données

    text

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

    Lesion Assessment Using WHO Criteria - Indicator Lesions

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

    Lesion, Indicator, Numbers

    Type de données

    integer

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

    Lesion, Indicator, Organ, Code

    Type de données

    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
    Description

    Lesion, Indicator, Location

    Type de données

    text

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

    Lesion, Indicator, Date in time

    Type de données

    date

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

    Lesion, Indicator, Measurement method

    Type de données

    boolean

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

    Lesion, Indicator, Diameter

    Type de données

    integer

    Unités de mesure
    • mm
    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1522602
    UMLS CUI [1,3]
    C1301886
    mm
    Product
    Description

    Lesion, Indicator, Lesion size

    Type de données

    integer

    Unités de mesure
    • mm2
    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1522602
    UMLS CUI [1,3]
    C0449453
    mm2
    Method
    Description

    Lesion, Indicator, Measurement method

    Type de données

    text

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

    Lesion, Indicator, Lesion Code

    Type de données

    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
    Description

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

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

    Non-Measurable Lesion, Numbers

    Type de données

    integer

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

    Non-Measurable Lesion, Location

    Type de données

    text

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

    Non-Measurable Lesion, Date in time

    Type de données

    date

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

    Non-Measurable Lesion, Present

    Type de données

    text

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

    Non-Measurable Lesion, Absent

    Type de données

    text

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

    Non-Measurable Lesion, Not Done

    Type de données

    text

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

    Response Assessment Using WHO Criteria

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

    Response to treatment, Evaluation

    Type de données

    boolean

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

    Lesion, Assessment Date

    Type de données

    date

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

    Malignant Neoplasms, Evaluation, Disease Response

    Type de données

    text

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

    Response to treatment, Evaluation method

    Type de données

    text

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

    Response to treatment, Assessment Date, Clinical

    Type de données

    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:
    Description

    Response to treatment, Evaluation, Clinical

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0205210
    Retour au début de la page

    Similar models

    Cycle 3 Day 1

    1 Formulaires
    1. StudyEvent: ODM
      1. Cycle 3 Day 1
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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