ID

41229

Beschreibung

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the end of study document within the Study conclusion, death and pregnancy information. It has to be filled in for the Follow-up visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Stichworte

Versionen (1)
  1. 20.07.20 20.07.20 - Christian Arras
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Juli 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

Englisch

End of Study

1 Formulare  
  1. StudyEvent: ODM
    1. End of Study
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Beschreibung

Study End Date

Datentyp

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Beschreibung

Patient withdrawn from trial

Datentyp

text

Alias
UMLS CUI [1]
C0422727
If withdrawn from the study, please complete the primary reason:
Beschreibung

If Adverse Event, please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Select Investigator discretion as reason if none of the other primary reasons are appropriate.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If investigator discretion, please specify:
Beschreibung

Clinical Investigators Judgment, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
Will the subject enter the extension study?
Beschreibung

Study subject participation status, extension study

Datentyp

text

Alias
UMLS CUI [1,1]
C0231448
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C2348568
Case book ready for signature
Beschreibung

hidden/not required. Data owner should check the box when data cleaning is complete.

Datentyp

text

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316
Office use 1
Beschreibung

hidden

Datentyp

text

Alias
UMLS CUI [1]
C0442603
Office use 2
Beschreibung

hidden

Datentyp

integer

Alias
UMLS CUI [1]
C0442603
Death
Beschreibung

Death

Alias
UMLS CUI-1
C0011065
Is the subject alive?
Beschreibung

Alive

Datentyp

text

Alias
UMLS CUI [1]
C2584946
If the subject is dead, enter date of death:
Beschreibung

date of death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
If the subject is dead, indicate the primary cause of death:
Beschreibung

cause of death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
If other cause of death, please specify
Beschreibung

other cause of death, to specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Pregnancy information (Preg)
Beschreibung

Pregnancy information (Preg)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschreibung

If Yes, complete the paper Pregnancy Notification form.

Datentyp

text

Alias
UMLS CUI [1]
C3828490
Pregnancy Information (Preg M)
Beschreibung

Pregnancy Information (Preg M)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C0086582
Did a female partner of the male subject become pregnant during the study?
Beschreibung

If Yes, complete the paper Pregnancy Notification form. Check Not Applicable if female partner not of childbearing potential or no female partner.

Datentyp

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008972
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Ähnliche Modelle

End of Study

1 Formulare
  1. StudyEvent: ODM
    1. End of Study
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study End Date
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Patient withdrawn from trial
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes, complete primary reason for withdrawal (Y)
Item
If withdrawn from the study, please complete the primary reason:
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason, withdrawn from study
Code List
If withdrawn from the study, please complete the primary reason:
CL Item
Adverse Event (1)
CL Item
Protocol deviation (3)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent (8)
Clinical Investigators Judgment, specify
Item
If investigator discretion, please specify:
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Item
Will the subject enter the extension study?
text
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Will the subject enter the extension study?
Code List
Will the subject enter the extension study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Case book ready for signature
text
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Clinical study case, signature
Code List
Case book ready for signature
CL Item
Yes (Y)
Item
Office use 1
text
C0442603 (UMLS CUI [1])
Office use
Code List
Office use 1
CL Item
No (N)
CL Item
Yes (Y)
Item
Office use 2
integer
C0442603 (UMLS CUI [1])
Office use
Code List
Office use 2
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
Item Group
Death
C0011065 (UMLS CUI-1)
Item
Is the subject alive?
text
C2584946 (UMLS CUI [1])
Alive
Code List
Is the subject alive?
CL Item
Yes (Y)
CL Item
No, enter date of death and indicate the primary cause of death: (N)
date of death
Item
If the subject is dead, enter date of death:
date
C1148348 (UMLS CUI [1])
Item
If the subject is dead, indicate the primary cause of death:
text
C0007465 (UMLS CUI [1])
cause of death
Code List
If the subject is dead, indicate the primary cause of death:
CL Item
Disease under study (1)
CL Item
Haematologic toxicity (2)
CL Item
Non-haematologic toxicity (3)
CL Item
Other, specify (OT)
other cause of death, to specify
Item
If other cause of death, please specify
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Pregnancy information (Preg)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Pregnant during the study
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Pregnancy Information (Preg M)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0086582 (UMLS CUI-3)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Pregnancy of partner, during clinical research
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (X)
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