ID

37259

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 8

1 formularios  
  1. StudyEvent: ODM
    1. Cycle 3 Day 8
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Visit Date
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766 (Vital signs)
LOINC
LP30605-7
Blood pressure - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470 (Systolic Pressure)
SNOMED
271649006
mmHg
Blood pressure - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883 (Diastolic blood pressure)
SNOMED
271650006
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810 (heart rate)
SNOMED
364075005
LOINC
LP29713-2
bpm
Temperature
Descripción

Body Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903 (Body Temperature)
SNOMED
722490005
LOINC
LP36617-6
°C
Treatment Confirmation
Descripción

Treatment Confirmation

Alias
UMLS CUI-1
C0087111 (Therapeutic procedure)
SNOMED
277132007
LOINC
LP21090-3
UMLS CUI-2
C0750484 (Confirmation)
LOINC
LA15290-2
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 (Therapeutic procedure)
SNOMED
277132007
LOINC
LP21090-3
UMLS CUI [1,2]
C0750484 (Confirmation)
LOINC
LA15290-2
If No, record reason(s)
Descripción

Therapeutic procedure, Wrong, Reason and Justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111 (Therapeutic procedure)
SNOMED
277132007
LOINC
LP21090-3
UMLS CUI [1,2]
C3827420 (Wrong)
LOINC
LA7342-4
UMLS CUI [1,3]
C0566251 (Reason and justification)
SNOMED
288830005
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Similar models

Cycle 3 Day 8

1 formularios
  1. StudyEvent: ODM
    1. Cycle 3 Day 8
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)
Systolic Pressure
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure - Diastolic
integer
C0428883 (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])
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