ID

37263

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

Mots-clés

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

GlaxoSmithKline

Téléchargé le

12 juillet 2019

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Cycle 4 Day 8

1 Formulaires  
  1. StudyEvent: ODM
    1. Cycle 4 Day 8
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
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]
C0428883
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
Retour au début de la page

Similar models

Cycle 4 Day 8

1 Formulaires
  1. StudyEvent: ODM
    1. Cycle 4 Day 8
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)
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])
Retour au début de la page 

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