ID

37643

Description

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

Keywords

Versions (1)
  1. 8/13/19 8/13/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 13, 2019

DOI

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License

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

English

Adverse Events

1 forms  
  1. StudyEvent: ODM
    1. Adverse Events
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Event
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Grade
Description

Adverse Event Grade Code

Data type

text

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

Adverse Event Start Date Time

Data type

datetime

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

Adverse Event End Date Time

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Description

Adverse Event Outcome

Data type

text

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

Adverse Event Ongoing; Adverse Event, Periodic

Data type

text

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

Adverse event, Symptom intensity

Data type

text

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

Adverse Event Action Taken with Study Treatment

Data type

text

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

Adverse event, Relationships, Experimental drug

Data type

text

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

Adverse event, Therapeutic procedure

Data type

boolean

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

Adverse event, Withdraw

Data type

boolean

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

Adverse event, Investigator Signature

Data type

text

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

Adverse event, Investigator Signature, Date in time

Data type

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 forms
  1. StudyEvent: ODM
    1. Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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