ID

30368

Beschreibung

https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Link

https://clinicaltrials.gov/ct2/show/NCT00486954

Stichworte

Versionen (1)
  1. 30.05.18 30.05.18 - Halim Ugurlu
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

30. Mai 2018

DOI

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NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

Englisch

NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS

1 Formulare  
NON-SERIOUS ADVERSE EVENTS
Beschreibung

NON-SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1518404
Event
Beschreibung

Diagnosis only (if known) otherwise sign/symptom

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Outcome/End date
Beschreibung

Outcome/End date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Maximum Grade
Beschreibung

Maximum Grade

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C0877248
Action taken with Investigational Product(s) as a result of the AE
Beschreibung

Action taken

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this AE?
Beschreibung

Withdraw from study

Datentyp

boolean

Alias
UMLS CUI [1]
C2348571
Is there a reasonable possibility that the AE may have been caused by investigational product?
Beschreibung

AE may have been caused by investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
SERIOUS ADVERSE EVENTS
Beschreibung

SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1519255
Type of Report: Initial/Follow-Up Report
Beschreibung

Type of Report

Datentyp

integer

Alias
UMLS CUI [1]
C0684224
Did SAE occur after initiation of study medication?
Beschreibung

Randomisation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event, Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0011900
Serious Adverse Event Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697888
Serious Adverse Event Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event Outcome/End Date
Beschreibung

Outcome/End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697886
Serious Adverse Event- Fatal
Beschreibung

Fatal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1302234
Serious Adverse Event-Fatal, record Date of Death
Beschreibung

Fatal-SAE, Death Date

Datentyp

date

Alias
UMLS CUI [1]
C1705232
Maximum Grade
Beschreibung

Maximum Grade

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action taken with Investigational Product(s) as a Result of AE
Beschreibung

Action taken

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this AE?
Beschreibung

Withdraw from study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348571
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by investigational product?
Beschreibung

possibility that the AE may have been caused by investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Was SAE caused by activities related to study participation (e.g. procedures)?
Beschreibung

SAE caused by activities related to study participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
Seriousness
Beschreibung

Seriousness

Datentyp

integer

Alias
UMLS CUI [1]
C1710056
Relevant Concominant/Treatment Medications
Beschreibung

Relevant Concominant/Treatment Medications

Alias
UMLS CUI-1
C3476109
UMLS CUI-2
C2347852
UMLS CUI-3
C1519255
Drug name
Beschreibung

Trade name preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Dose
Beschreibung

Dose

Datentyp

text

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C0439148
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Ongoing?
Beschreibung

Ongoing?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Primary Indication
Beschreibung

Primary Indication

Datentyp

text

Alias
UMLS CUI [1]
C3146298
Drug Type
Beschreibung

Drug Type

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Relevant Medical Conditions/Risk Factors
Beschreibung

Relevant Medical Conditions/Risk Factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
Specific Condition Name
Beschreibung

Specific Condition Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Alias
UMLS CUI [1]
C0574845
Continuing
Beschreibung

Continuing

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
If no continuation, date of last occurance
Beschreibung

If no continuation, date of last occurance

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
Relevant Medical History /Risk Factors not noted above
Beschreibung

Relevant Medical History /Risk Factors not noted above

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
Relevant Diagnostic Results
Beschreibung

Relevant Diagnostic Results

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
UMLS CUI-3
C1519255
Test name
Beschreibung

Test name

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0027365
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
Test Result
Beschreibung

Please enter units additional to results

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Test Ranges
Beschreibung

Test Ranges

Datentyp

text

Alias
UMLS CUI [1]
C0883335
Relevant diagnostic results not noted above
Beschreibung

Relevant diagnostic results not noted above

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Investigational Products
Beschreibung

Investigational Products

Alias
UMLS CUI-1
C0013230
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administred?
Beschreibung

Investigational Products

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
General Narrative Comments
Beschreibung

General Narrative Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
General Narrative Comments
Beschreibung

General Narrative Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
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Ähnliche Modelle

NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
NON-SERIOUS ADVERSE EVENTS
C1518404 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovering/resolving (1)
CL Item
Not recovered/Not resolved (2)
Outcome/End date
Item
Outcome/End date
date
C2697886 (UMLS CUI [1])
Item
Maximum Grade
integer
C0441799 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Grade
Code List
Maximum Grade
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 (0)
Item
Action taken with Investigational Product(s) as a result of the AE
integer
C2826626 (UMLS CUI [1])
Action taken
Code List
Action taken with Investigational Product(s) as a result of the 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 (0)
Withdraw from study
Item
Did the subject withdraw from study as a result of this AE?
boolean
C2348571 (UMLS CUI [1])
AE may have been caused by investigational product
Item
Is there a reasonable possibility that the AE may have been caused by investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item Group
SERIOUS ADVERSE EVENTS
C1519255 (UMLS CUI-1)
Item
Type of Report: Initial/Follow-Up Report
integer
C0684224 (UMLS CUI [1])
Type of Report
Code List
Type of Report: Initial/Follow-Up Report
CL Item
Initial Report (1)
CL Item
Follow-Up Report (2)
Randomisation
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event, Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome
Code List
Serious Adverse Event Outcome
CL Item
Recovering/Resolving (1)
CL Item
Not Recovered/Resolved (2)
Outcome/End Date
Item
Serious Adverse Event Outcome/End Date
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Fatal
Item
Serious Adverse Event- Fatal
boolean
C1705586 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
Fatal-SAE, Death Date
Item
Serious Adverse Event-Fatal, record Date of Death
date
C1705232 (UMLS CUI [1])
Item
Maximum Grade
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Grade
Code List
Maximum Grade
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 (0)
Item
Action taken with Investigational Product(s) as a Result of AE
integer
C2826626 (UMLS CUI [1])
Action taken
Code List
Action taken with Investigational Product(s) as a Result of 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 (0)
Withdraw from study
Item
Did the subject withdraw from study as a result of this AE?
boolean
C2348571 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
possibility that the AE may have been caused by investigational product
Item
Is there a reasonable possibility that the AE may have been caused by investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
SAE caused by activities related to study participation
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Seriousness
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
Seriousness
CL Item
Results in Death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
CL Item
Cardiac dysfunction/Any signs or symptoms of pneumonitis (7)
Item Group
Relevant Concominant/Treatment Medications
C3476109 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C0439148 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Ongoing?
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Primary Indication
Item
Primary Indication
text
C3146298 (UMLS CUI [1])
Drug Type
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Item Group
Relevant Medical Conditions/Risk Factors
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Item
Continuing
integer
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing
Code List
Continuing
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
If no continuation, date of last occurance
Item
If no continuation, date of last occurance
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Relevant Medical History /Risk Factors not noted above
Item
Relevant Medical History /Risk Factors not noted above
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Item Group
Relevant Diagnostic Results
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Test name
Item
Test name
text
C0022885 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Ranges
Item
Test Ranges
text
C0883335 (UMLS CUI [1])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])
Item Group
Investigational Products
C0013230 (UMLS CUI-1)
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administred?
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Investigational Products
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administred?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
General Narrative Comments
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
General Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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