Lapatinib diary

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Subject number

Datatyp

integer

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

Week number and study day

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

Week number

Datatyp

integer

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

Study day

Datatyp

text

Alias
UMLS CUI [1]
C2826182
Predose Overnight Fast
Beskrivning

Predose Overnight Fast

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

Date and Time of Last Meal

Datatyp

datetime

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

Study Medication - 1250 mg of lapatinib

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

Date and Time of Dose

Datatyp

datetime

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

Tablet dosage form, taken, count of entities

Datatyp

text

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

Postdose Fast

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

Start Date and Time of next Meal

Datatyp

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
Beskrivning

Postdose Vomiting

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

Post-dose vomiting

Datatyp

text

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

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:
Beskrivning

missed dose, tablet dosage form, reason

Datatyp

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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])