Lapatinib diary

  1. StudyEvent: ODM
    1. Lapatinib diary
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Week number and study day
Description

Week number and study day

Alias
UMLS CUI-1
C0439230
UMLS CUI-2
C0449788
UMLS CUI-3
C2826182
Week Number
Description

Week number

Data type

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0449788
Study Day
Description

Study day

Data type

text

Alias
UMLS CUI [1]
C2826182
Predose Overnight Fast
Description

Predose Overnight Fast

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C0015663
UMLS CUI-3
C0439583
Date and Time of Last Meal
Description

Date and Time of Last Meal

Data type

datetime

Alias
UMLS CUI [1,1]
C0578574
UMLS CUI [1,2]
C0011008
Study Medication - 1250 mg of lapatinib
Description

Study Medication - 1250 mg of lapatinib

Alias
UMLS CUI-1
C1506770
UMLS CUI-2
C0178602
UMLS CUI-3
C0449788
Date and Time of Dose
Description

Date and Time of Dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Number of Tablets taken
Description

Tablet dosage form, taken, count of entities

Data type

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C1883727
UMLS CUI [1,3]
C0449788
Postdose Fast
Description

Postdose Fast

Alias
UMLS CUI-1
C0439568
UMLS CUI-2
C0015663
Date and Time of next Meal
Description

Start Date and Time of next Meal

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1998602
UMLS CUI [1,3]
C0439568
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C1998602
UMLS CUI [2,3]
C0439568
Postdose Vomiting
Description

Postdose Vomiting

Alias
UMLS CUI-1
C0042963
UMLS CUI-2
C0439568
Did you vomit within the four hours after you took the study drug?
Description

Post-dose vomiting

Data type

text

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0439568
Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
If entire dose was missed, or less than 5 tablets were taken, enter reason:
Description

missed dose, tablet dosage form, reason

Data type

text

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0566251
UMLS CUI [2,1]
C0039225
UMLS CUI [2,2]
C0449788
UMLS CUI [2,3]
C1709043
UMLS CUI [2,4]
C0566251

Similar models

Lapatinib diary

  1. StudyEvent: ODM
    1. Lapatinib diary
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Week number and study day
C0439230 (UMLS CUI-1)
C0449788 (UMLS CUI-2)
C2826182 (UMLS CUI-3)
Item
Week Number
integer
C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Code List
Week Number
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
Item
Study Day
text
C2826182 (UMLS CUI [1])
Code List
Study Day
CL Item
Day1 (DAY 1 DOSE)
CL Item
Day2 (DAY 2 DOSE)
CL Item
Day3 (DAY 3 DOSE)
CL Item
Day4 (DAY 4 DOSE)
CL Item
Day5 (DAY 5 DOSE)
CL Item
Day6 (DAY 6 DOSE)
CL Item
Day7 (DAY 7 DOSE)
CL Item
Day8 (DAY 8 DOSE)
Item Group
Predose Overnight Fast
C0439565 (UMLS CUI-1)
C0015663 (UMLS CUI-2)
C0439583 (UMLS CUI-3)
Date and Time of Last Meal
Item
Date and Time of Last Meal
datetime
C0578574 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Study Medication - 1250 mg of lapatinib
C1506770 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0449788 (UMLS CUI-3)
Date and Time of Dose
Item
Date and Time of Dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Tablet dosage form, taken, count of entities
Item
Number of Tablets taken
text
C0039225 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item Group
Postdose Fast
C0439568 (UMLS CUI-1)
C0015663 (UMLS CUI-2)
Start Date and Time of next Meal
Item
Date and Time of next Meal
datetime
C0808070 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C1301880 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
Item Group
Postdose Vomiting
C0042963 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Did you vomit within the four hours after you took the study drug?
text
C0042963 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Code List
Did you vomit within the four hours after you took the study drug?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
missed dose, tablet dosage form, reason
Item
If entire dose was missed, or less than 5 tablets were taken, enter reason:
text
C1709043 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0039225 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
C1709043 (UMLS CUI [2,3])
C0566251 (UMLS CUI [2,4])