ID

22295

Beschreibung

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Serious Adverse Events Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Stichworte

Versionen (2)
  1. 18.05.17 18.05.17 -
  2. 29.05.17 29.05.17 -
Hochgeladen am

29. Mai 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Serious Adverse Events NCT00078572

Englisch

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Serious Adverse Events NCT00078572

1 Formulare  
Serious Adverse Events
Beschreibung

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse events during the study?
Beschreibung

If YES, indicate below:

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
Beschreibung

Serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Date of onset
Beschreibung

Date of onset

Datentyp

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
NCI-CTCAE toxicity
Beschreibung

NCI-CTCAE toxicity

Datentyp

integer

Alias
UMLS CUI [1,1]
C3887242
UMLS CUI [1,2]
C1519255
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Date of resolution or death
Beschreibung

Date of resolution or death

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Action taken with investigational product(s) as a result of the non-serious AE
Beschreibung

Action taken with investigational product

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did subject withdraw from study as a result of this serious AE?
Beschreibung

Withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
Beschreibung

Relationship to investigational product(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Does the AE meet the definition of serious?
Beschreibung

Seriousness

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Possible Causes of SAE other than Investigational Product(s), check all that apply:
Beschreibung

Cause of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Please specify cause of SAE
Beschreibung

Cause of SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Seriousness, check all that apply
Beschreibung

Seriousness

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Seriousness, if other please specify
Beschreibung

Seriousness

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
If fatal, was an autopsy done/to be performed?
Beschreibung

autopsy

Datentyp

text

Alias
UMLS CUI [1]
C0004398
UMLS CUI [2]
C1519255
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Beschreibung

Relevant Medical Conditions

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Date of onset
Beschreibung

Date of onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C1519255
Condition present at time of the SAE
Beschreibung

Condition present at time of the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If NO, date of last occurrence
Beschreibung

date of last occurrence

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [2]
C1519255
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Beschreibung

Other relevant risk factors

Datentyp

text

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Daily Dose
Beschreibung

Daily Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
mg
Details of Investigational Product(s): Cumulative Dose
Beschreibung

Cumulative Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
mg
Details of Investigational Product(s): Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Drug, Trade name preferred
Beschreibung

Include any concomitant medications that may contribute to the occurrence of the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Started Pre-study
Beschreibung

Started Pre-study

Datentyp

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Stop date
Beschreibung

Stop date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Continued Post-SAE
Beschreibung

Continued

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3494713
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Conditions treated / indication
Beschreibung

indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Narrative / Comments
Beschreibung

Provide a textual description of the serious adverse event (including treatment of the event).

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Details of Relevant Assessments
Beschreibung

Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.

Datentyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
Additional or follow-up information
Beschreibung

Use this page to provide any additional details on the serious adverse event not already captured on the previous pages.

Datentyp

text

Alias
UMLS CUI [1,1]
C1533716
UMLS CUI [1,2]
C1519255
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Ähnliche Modelle

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Serious Adverse Events NCT00078572

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Withdrawal
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
American Hispanic (4)
CL Item
Other (5)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Serious adverse event
Item
Serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1519255 (UMLS CUI [1])
Date of onset
Item
Date of onset
text
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
NCI-CTCAE toxicity
integer
C3887242 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
NCI-CTCAE toxicity
Code List
NCI-CTCAE toxicity
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 (6)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved  (R)
CL Item
Resolved with sequelae  (S)
CL Item
Not resolved (N)
CL Item
Fatal (F)
Date of resolution or death
Item
Date of resolution or death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with investigational product
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (4)
Item
Did subject withdraw from study as a result of this serious AE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Did subject withdraw from study as a result of this serious AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Withdrawal
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
Item
Possible Causes of SAE other than Investigational Product(s), check all that apply:
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Cause of SAE
Code List
Possible Causes of SAE other than Investigational Product(s), check all that apply:
CL Item
Disease under study (1)
CL Item
Treatment failure (2)
CL Item
Activity related to study participation (e.g., procedures) (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant disorder (5)
CL Item
Concomitant medication (6)
CL Item
Other (7)
Cause of SAE
Item
Please specify cause of SAE
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Seriousness, check all that apply
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness, check all that apply
CL Item
Death (A)
CL Item
Life threatening (B)
CL Item
Hospitalization required or prolonged (C)
CL Item
Disabling or incapacitating (D)
CL Item
Congenital anomaly (E)
CL Item
Other (see definition) (F)
Seriousness
Item
Seriousness, if other please specify
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
If fatal, was an autopsy done/to be performed?
text
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Withdrawal
Code List
If fatal, was an autopsy done/to be performed?
CL Item
Yes (Y)
CL Item
No (N)
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Condition present at time of the SAE
text
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Condition present at time of the SAE
CL Item
Yes (Y)
CL Item
No (N)
date of last occurrence
Item
If NO, date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Other relevant risk factors
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Start Date
Item
Details of Investigational Product(s): Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Daily Dose
Item
Details of Investigational Product(s): Daily Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Cumulative Dose
Item
Details of Investigational Product(s): Cumulative Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Stop Date
Item
Details of Investigational Product(s): Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Drug
Item
Relevant Concomitant Medications: Drug, Trade name preferred
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Dose
Item
Relevant Concomitant Medications: Dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Unit
Item
Relevant Concomitant Medications: Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Frequency
Item
Relevant Concomitant Medications: Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Start Date
Item
Relevant Concomitant Medications: Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Relevant Concomitant Medications: Started Pre-study
text
C2347852 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Withdrawal
Code List
Relevant Concomitant Medications: Started Pre-study
CL Item
Yes (Y)
CL Item
No (N)
Stop date
Item
Relevant Concomitant Medications: Stop date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Relevant Concomitant Medications: Continued Post-SAE
text
C2347852 (UMLS CUI [1,1])
C3494713 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Withdrawal
Code List
Relevant Concomitant Medications: Continued Post-SAE
CL Item
Yes (Y)
CL Item
No (N)
indication
Item
Relevant Concomitant Medications: Conditions treated / indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Narrative
Item
Narrative / Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Additional or follow-up information
Item
Additional or follow-up information
text
C1533716 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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