ID

29421

Descrizione

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

Keywords

  1. 22/03/18 22/03/18 -
Titolare del copyright

GlaxoSmithKline

Caricato su

22 marzo 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Investigational Product Discontinuation

Investigational Product Discontinuation
Descrizione

Investigational Product Discontinuation

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

Subject Identifier

Tipo di dati

text

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

Investigational Product Discontinuation

Tipo di dati

boolean

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

primary reason the investigational product was stopped

Tipo di dati

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
Descrizione

reason the investigational product was stopped

Tipo di dati

text

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

Similar models

Investigational Product Discontinuation

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
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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