Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item
Are there any IP diary data to be entered for this subject?
text
C0304229 (UMLS CUI [1,1])
C0376660 (UMLS CUI [1,2])
Code List
Are there any IP diary data to be entered for this subject?
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study?
text
C0347984 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Did the subject experience any serious adverse events during the study?
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Were any concomitant medications taken by the subject during the study?
Item
Were any repeat vital signs recorded?
text
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Code List
Were any repeat vital signs recorded?
Item
Were any repeat ECGs performed?
text
C0205341 (UMLS CUI [1,1])
C2826672 (UMLS CUI [1,2])
Code List
Were any repeat ECGs performed?
Item
Were any repeat ECG measurements abnormal - clinically signifcant?
text
C0205341 (UMLS CUI [1,1])
C1832603 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Code List
Were any repeat ECG measurements abnormal - clinically signifcant?
Item
Were any repeat ECOG assessments performed?
text
C1520224 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Code List
Were any repeat ECOG assessments performed?
Item
Were any repeat echocardiogram or multigated acquisition results recorded?
text
C0013516 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
Code List
Were any repeat echocardiogram or multigated acquisition results recorded?
Item
Were any repeat Chemistry Lab samples taken?
text
C0151339 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
Code List
Were any repeat Chemistry Lab samples taken?
Item
Were any repeat Haematology Lab samples taken?
text
C0475367 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Code List
Were any repeat Haematology Lab samples taken?
Item
Were any repeat PK blood samples taken?
text
C1277698 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Code List
Were any repeat PK blood samples taken?
liver events
Item
Were there any liver events for this subject?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Were any lapatinib doses taken after the Week 3 Date/Date of Decision to Withdraw and prior to the start of dosing in the EGF111767 study?
text
C1506770 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C1548614 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C1506770 (UMLS CUI [2,1])
C1548614 (UMLS CUI [2,2])
C2349954 (UMLS CUI [2,3])
C1506770 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C2347804 (UMLS CUI [3,4])
Code List
Were any lapatinib doses taken after the Week 3 Date/Date of Decision to Withdraw and prior to the start of dosing in the EGF111767 study?