ID

37643

Descripción

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

Palabras clave

Versiones (1)
  1. 13/8/19 13/8/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

13 de agosto de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

Inglés

Adverse Events

1 formularios  
  1. StudyEvent: ODM
    1. Adverse Events
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Descripción

Patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Adverse Event
Descripción

Adverse Event

Alias
UMLS CUI-1
C0877248
Event
Descripción

Adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Grade
Descripción

Adverse Event Grade Code

Tipo de datos

text

Alias
UMLS CUI [1]
C2985911
Start Date and Time
Descripción

Adverse Event Start Date Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time (do not complete, if ongoing)
Descripción

Adverse Event End Date Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Descripción

Adverse Event Outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Course of the event - Periodic or Continuous
Descripción

Adverse Event Ongoing; Adverse Event, Periodic

Tipo de datos

text

Alias
UMLS CUI [1]
C2826663
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0332182
Intensity
Descripción

Adverse event, Symptom intensity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Action taken with study drug
Descripción

Adverse Event Action Taken with Study Treatment

Tipo de datos

text

Alias
UMLS CUI [1]
C2826626
Relationship to study drug
Descripción

Adverse event, Relationships, Experimental drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Remedial therapy
Descripción

Adverse event, Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Withdrawal from study to to AE?
Descripción

Adverse event, Withdraw

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2349954
Investigator's Signature
Descripción

Adverse event, Investigator Signature

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2346576
Date
Descripción

Adverse event, Investigator Signature, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2346576
UMLS CUI [1,3]
C0011008
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Similar models

Adverse Events

1 formularios
  1. StudyEvent: ODM
    1. Adverse Events
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Item
Event
text
C0877248 (UMLS CUI [1])
Adverse event
Code List
Event
CL Item
Alopecia (1)
CL Item
Nausea (2)
CL Item
Vomiting (3)
CL Item
Diarrhea (4)
CL Item
Constipation (5)
CL Item
Mucositis (6)
CL Item
Increase in creatinine levels (7)
CL Item
Febrile neutropenia (8)
CL Item
Peripheral sensory neuropathy (9)
CL Item
Motoric neuropathy (10)
CL Item
Impaired hearing (11)
CL Item
Myalgia (12)
CL Item
Athralgia (13)
Item
Grade
text
C2985911 (UMLS CUI [1])
Adverse Event Grade Code
Code List
Grade
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Adverse Event Start Date Time
Item
Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Adverse Event End Date Time
Item
End Date and Time (do not complete, if ongoing)
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Outcome
CL Item
resolved (1)
CL Item
ongoing (2)
CL Item
death (3)
Item
Course of the event - Periodic or Continuous
text
C2826663 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C0332182 (UMLS CUI [2,2])
Adverse Event Ongoing; Adverse Event, Periodic
Code List
Course of the event - Periodic or Continuous
CL Item
Periodic (1)
CL Item
Continuous (2)
Item
Intensity
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Adverse event, Symptom intensity
Code List
Intensity
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Action taken with study drug
text
C2826626 (UMLS CUI [1])
Adverse Event Action Taken with Study Treatment
Code List
Action taken with study drug
CL Item
none (1)
CL Item
dose reduced (2)
CL Item
dose increased (3)
CL Item
4rug permanently discontinued (4rug permanently discontinued)
CL Item
drug temporarily interrupted (5)
CL Item
dose delayed (6)
CL Item
dose delayed & dose reduced (7)
Adverse event, Relationships, Experimental drug
Item
Relationship to study drug
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Adverse event, Therapeutic procedure
Item
Remedial therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Adverse event, Withdraw
Item
Withdrawal from study to to AE?
boolean
C0877248 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Adverse event, Investigator Signature
Item
Investigator's Signature
text
C0877248 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Adverse event, Investigator Signature, Date in time
Item
Date
date
C0877248 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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