ID

29421

Descrição

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Investigational Product Discontinuation

Palavras-chave

Versões (1)
  1. 22/03/2018 22/03/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

22 de março de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587

Inglês

Investigational Product Discontinuation

1 Formulários  
Investigational Product Discontinuation
Descrição

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Descrição

Investigational Product Discontinuation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
If Yes, check the primary reason the investigational product was stopped
Descrição

primary reason the investigational product was stopped

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0392360
If other reason the investigational product was stopped, specify
Descrição

reason the investigational product was stopped

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0392360
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Similar models

Investigational Product Discontinuation

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Investigational Product Discontinuation
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Item
If Yes, check the primary reason the investigational product was stopped
integer
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
primary reason the investigational product was stopped
Code List
If Yes, check the primary reason the investigational product was stopped
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
Sponsor terminated study (5)
CL Item
Non-compliance (6)
CL Item
Other, specify (7)
reason the investigational product was stopped
Item
If other reason the investigational product was stopped, specify
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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