ID

29869

Beschrijving

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: Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

Trefwoorden

Versies (1)
  1. 24-04-18 24-04-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

24 april 2018

DOI

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Licentie

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

Engels

Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

1 Formulieren  
Relevant concomitant / treatment medications
Beschrijving

Relevant concomitant / treatment medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0087111
UMLS CUI-3
C1519255
CM Sequence Number
Beschrijving

CM Sequence Number

Datatype

integer

Alias
UMLS CUI [1]
C2348184
Drug name
Beschrijving

(Trade Name preferred)

Datatype

text

Alias
UMLS CUI [1]
C2360065
Dose
Beschrijving

Dose

Datatype

text

Alias
UMLS CUI [1]
C3174092
Unit
Beschrijving

units of medication

Datatype

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route
Beschrijving

Route of medication

Datatype

text

Alias
UMLS CUI [1]
C0013153
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Ongoing?
Beschrijving

Ongoing medication

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
If no ongoing medication, specify end date
Beschrijving

End date medication

Datatype

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
Primary Indication
Beschrijving

Primary Indication

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Drug Type
Beschrijving

Drug Type

Datatype

text

Alias
UMLS CUI [1,1]
C0457591
UMLS CUI [1,2]
C2347852
Relevant medical conditions/Risk factors
Beschrijving

Relevant medical conditions/Risk factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
MHx Sequence Number
Beschrijving

MHx Sequence Number

Datatype

integer

Alias
UMLS CUI [1]
C2348184
Specific Condition Name
Beschrijving

Specific Condition Name

Datatype

text

Alias
UMLS CUI [1]
C0012634
Date of onset
Beschrijving

Date of onset

Datatype

date

Alias
UMLS CUI [1]
C0574845
Specific Condition Continuing?
Beschrijving

Specific Condition Continuing

Datatype

integer

Alias
UMLS CUI [1]
C0012634
Specific Condition Continuing? If No, specify date of last occurrence
Beschrijving

Date of last occurrence

Datatype

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
Relevant medical conditions/Risk factors not noted above
Beschrijving

Relevant medical conditions/Risk factors

Datatype

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0035648
Relevant diagnostic results
Beschrijving

Relevant diagnostic results

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
UMLS CUI-3
C1519255
Lab Sequence Number
Beschrijving

Lab Sequence Number

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Test Name
Beschrijving

Test Name

Datatype

text

Alias
UMLS CUI [1]
C0022885
Test Date
Beschrijving

Test Date

Datatype

date

Alias
UMLS CUI [1]
C2826641
Test Result
Beschrijving

Test Result

Datatype

text

Alias
UMLS CUI [1]
C0587081
Test Units
Beschrijving

Test Units

Datatype

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Beschrijving

Normal Low Range

Datatype

text

Alias
UMLS CUI [1]
C0086715
Normal High Range
Beschrijving

Normal High Range

Datatype

text

Alias
UMLS CUI [1]
C0086715
Relevant diagnostic results not noted above
Beschrijving

Relevant diagnostic results not noted above

Datatype

text

Alias
UMLS CUI [1]
C0587081
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Beschrijving

event recurrence

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0034897
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Similar models

Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Relevant concomitant / treatment medications
C2347852 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
units of medication
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route of medication
Item
Route
text
C0013153 (UMLS CUI [1])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Ongoing medication
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
End date medication
Item
If no ongoing medication, specify end date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Primary Indication
Item
Primary Indication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Drug Type
Item
Drug Type
text
C0457591 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Relevant medical conditions/Risk factors
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
MHx Sequence Number
Item
MHx Sequence Number
integer
C2348184 (UMLS CUI [1])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Specific Condition Continuing?
integer
C0012634 (UMLS CUI [1])
Specific Condition Continuing
Code List
Specific Condition Continuing?
CL Item
Yes (1)
CL Item
No, specify date of last occurrence  (2)
CL Item
Unknown (3)
Date of last occurrence
Item
Specific Condition Continuing? If No, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Relevant medical conditions/Risk factors
Item
Relevant medical conditions/Risk factors not noted above
text
C0262926 (UMLS CUI [1])
C0035648 (UMLS CUI [2])
Item Group
Relevant diagnostic results
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Test Name
Item
Test Name
text
C0022885 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826641 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C0086715 (UMLS CUI [1])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
integer
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
Rechallenge
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
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