ID

37273

Beschrijving

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

Trefwoorden

  1. 12-07-19 12-07-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 juli 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

Investigational Product Discontinuation

Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product Discontinuation
Beschrijving

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Give primary reason Investigational Products were discontinued permanently. Check only one item
Beschrijving

Experimental drug, Discontinued, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0566251
Specify
Beschrijving

Experimental drug, Discontinued, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0566251

Similar models

Investigational Product Discontinuation

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Give primary reason Investigational Products were discontinued permanently. Check only one item
text
C0304229 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
Give primary reason Investigational Products were discontinued permanently. Check only one item
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Subject decided to withdraw from Investigational Product but is continuing to be followed per protocol (5)
CL Item
Disease progression (6)
CL Item
Completed specified protocol dosing schedule  (7)
CL Item
Other, specify (8)
Item
Specify
text
C0304229 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])

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