ID

37649

Beskrivning

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Nyckelord

Versioner (1)
  1. 2019-08-13 2019-08-13 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

13 augusti 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

Engelsk

Study End

1 Formulär  
  1. StudyEvent: ODM
    1. Study End
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Beskrivning

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Study End
Beskrivning

Study End

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C0444930
Did the patient prematurely terminate the study or was she prematurely withdrawn?
Beskrivning

Clinical Trials, Withdraw

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
If "yes", please document the date
Beskrivning

Clinical Trials, Withdraw, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0011008
If "yes", please provide the primary reason for withdrawal
Beskrivning

Clinical Trials, Withdraw, Reason and justification

Datatyp

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
Please specify
Beskrivning

Clinical Trials, Withdraw, Reason and justification

Datatyp

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
Confirmation of the investigator
Beskrivning

Confirmation of the investigator

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C0750484
Signature of the responsible investigator I hereby declare that the data documented in his case report form are an exact and correct repetition of the patient's findings, that the trial was conducted according to protocol, and that the patient's consent for the study participation has been obtained.
Beskrivning

Investigator Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

Investigator Signature, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name in printed letters or practice stamp
Beskrivning

Investigator Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Tillbaka till toppen

Similar models

Study End

1 Formulär
  1. StudyEvent: ODM
    1. Study End
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Study End
C0008972 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Clinical Trials, Withdraw
Item
Did the patient prematurely terminate the study or was she prematurely withdrawn?
boolean
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Clinical Trials, Withdraw, Date in time
Item
If "yes", please document the date
date
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If "yes", please provide the primary reason for withdrawal
text
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Clinical Trials, Withdraw, Reason and justification
Code List
If "yes", please provide the primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol violation (incl. non-compliance) (3)
CL Item
Patient is lost to follow-up (4)
CL Item
Other, please specify (5)
Clinical Trials, Withdraw, Reason and justification
Item
Please specify
text
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Confirmation of the investigator
C2346576 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Investigator Signature
Item
Signature of the responsible investigator I hereby declare that the data documented in his case report form are an exact and correct repetition of the patient's findings, that the trial was conducted according to protocol, and that the patient's consent for the study participation has been obtained.
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Name in printed letters or practice stamp
text
C2826892 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial