ID

37275

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

Non-Serious Adverse Events (NSAE)

1 Formulaires  
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
Non-Serious Adverse Events (NSAE)
Description

Non-Serious Adverse Events (NSAE)

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious Adverse Event, During, Clinical Trials

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Event
Description

Non-serious Adverse Event

Type de données

text

Alias
UMLS CUI [1]
C1518404
Start Date
Description

Non-serious Adverse Event, Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Outcome
Description

Non-serious Adverse Event, Adverse Event Outcome

Type de données

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date
Description

Non-serious Adverse Event, End Date

Type de données

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Maximum Toxicity
Description

Non-serious Adverse Event, Toxicity Grade

Type de données

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826262
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Description

Non-serious Adverse Event, Action Taken with Study Treatment

Type de données

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Description

Non-serious Adverse Event, Withdraw

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Non-serious Adverse Event, Relationships, Experimental drug

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
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Similar models

Non-Serious Adverse Events (NSAE)

1 Formulaires
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])
Item Group
Non-Serious Adverse Events (NSAE)
C1518404 (UMLS CUI-1)
Non-serious Adverse Event, During, Clinical Trials
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Non-serious Adverse Event
Item
Event
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event, Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/ Resolved  (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
Non-serious Adverse Event, End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Toxicity
text
C1518404 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Non-serious Adverse Event, Toxicity Grade
Code List
Maximum Toxicity
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5  (5)
CL Item
Not applicable (6)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action Taken with Study Treatment
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted  (5)
CL Item
Not applicable (6)
Non-serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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