ID

41729

Beschrijving

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 documents the concomitant medication taken during the study.

Link

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

Trefwoorden

Versies (1)
  1. 09/01/2021 09/01/2021 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

9 de janeiro de 2021

DOI

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Licentie

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

Engels

Concomitant Medications

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschrijving

hidden

Datatype

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Drug name
Beschrijving

(Trade Name preferred)

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Concomitant Medication Modified Reported Term
Beschrijving

hidden

Datatype

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Beschrijving

hidden

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Beschrijving

hidden

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Beschrijving

hidden

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Unit Dose
Beschrijving

This Item is conditional.

Datatype

text

Alias
UMLS CUI [1]
C2826646
Units of concomitant medication
Beschrijving

Concomitant Medication Units

Datatype

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Beschrijving

Concomitant Medication Frequency

Datatype

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route
Beschrijving

Concomitant Medication Route

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for Medication
Beschrijving

Reason for Concomitant Medication

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2347852
Start Date and Time
Beschrijving

Start Date and Time of Concomitant Medication Intake

Datatype

partialDatetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1301880
Concomitant Medication Taken Prior to Study?
Beschrijving

Concomitant Medication Taken Prior to Study?

Datatype

text

Alias
UMLS CUI [1]
C2826667
Ongoing?
Beschrijving

Ongoing Concomitant Medication

Datatype

text

Alias
UMLS CUI [1]
C2826666
If no, specify End Date and Time
Beschrijving

End date and time of Concomitant Medication Intake

Datatype

partialDatetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1522314
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Similar models

Concomitant Medications

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medication Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant medication name
Item
Drug name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication Modified Reported Term
Item
Concomitant Medication Modified Reported Term
text
C2826819 (UMLS CUI [1])
Concomitant medication synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
Concomitant medication collection code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Concomitant medication failed coding
Item
Failed coding
boolean
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Medication Unit Dose
Item
Unit Dose
text
C2826646 (UMLS CUI [1])
Item
Units of concomitant medication
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units
Code List
Units of concomitant medication
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (APP)
CL Item
Area under curve (AUC)
CL Item
Bottle (BOT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Cup (CUP)
CL Item
Gramma per kilogram per minute (GA/KG/MIN)
CL Item
Gram (G)
CL Item
Drops (GTT)
CL Item
100 International units/ml (100IU/ML)
CL Item
Inhalation (INH)
CL Item
International units (IU)
CL Item
International units per kilogram (IU/KG)
CL Item
International units per kilogram per hour (IU/KG/HR)
CL Item
International units per millilitre (IU/ML)
CL Item
Litre (L)
CL Item
Lozenge (LOZ)
CL Item
Litre per minute (L/MIN)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Microgram (MCG) (MCG)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Microgram per kilogram (MCG/KG)
CL Item
Microgram per kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Micrograms per millilitre (MCG/ML)
CL Item
Microlitre (MCL)
CL Item
Milliequivalent (MEQ)
CL Item
Milliequivalents per 24 hours (MEQ/24HR)
CL Item
Milligram (MG)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour (MG/HR)
CL Item
Milligram per kilogram (MG/KG)
CL Item
Milligram per kilogram per hour (MG/KG/HR)
CL Item
Milligram per kilogram per minute (MG/KG/MIN)
CL Item
Milligrams per metre squared (MG/M2)
CL Item
Milligrams per millilitre (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Million International units (MIU)
CL Item
Millilitre (ML)
CL Item
Millilitres per hour (ML/HR)
CL Item
Millilitres per minute (ML/MIN)
CL Item
Millimole (MMOL)
CL Item
Megaunits (million units) (MU)
CL Item
Nebule (NEB)
CL Item
Ounce (OZ)
CL Item
Patch (PATCH)
CL Item
Percent (%)
CL Item
Puff (PUFF)
CL Item
Sachet (SACH)
CL Item
Spray (SPR)
CL Item
Suppository (SUPP)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Microgram (UG) (UG)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute (U/KG/MIN)
CL Item
Units per minute (U/MIN)
CL Item
Units (U)
CL Item
Unknown (UNK)
CL Item
Vial (VIAL)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
3 times per week (2XWK)
CL Item
3 times per week (3XWK)
CL Item
4 times per week (4XWK)
CL Item
5 times per day (5XD)
CL Item
5 times per week (5XWK)
CL Item
AC (AC)
CL Item
BID (BID)
CL Item
Continuous infusion (CINF)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q12H (Q12H)
CL Item
Q2H (Q2H)
CL Item
every 2 weeks (Q2WK)
CL Item
Q3D (Q3D)
CL Item
Every 3 weeks (Q3WK)
CL Item
Every 3 months (Q3M)
CL Item
Q4D (Q4D)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QH (QH)
CL Item
QID (QID)
CL Item
once a month (QM)
CL Item
every other day (QOD)
CL Item
QPM (QPM)
CL Item
once a week (QWK)
CL Item
TID (TID)
CL Item
Unknown (UNK)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Epidural (EP)
CL Item
Gastrostomy tube (GTT)
CL Item
Intra-arterial (IA)
CL Item
Intra-bursa (IB)
CL Item
intradermal (ID)
CL Item
Inhalation (IH)
CL Item
intralesional (ILES)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Inraocular (IO)
CL Item
Intraosteal (IOS)
CL Item
intraperitoneal (IP)
CL Item
Intrathecal (IT)
CL Item
Intrauterine (IU)
CL Item
Intravenous (IV)
CL Item
nasogastric (NG)
CL Item
Nasal (NS)
CL Item
right eye (OD)
CL Item
opthalmic (OP)
CL Item
left eye (OS)
CL Item
other (OTH)
CL Item
both eyes (OU)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
CL Item
Vaginal (VG)
CL Item
Intra-articular (IART)
CL Item
Otic (OT)
Reason for Concomitant Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Start Date and Time of Concomitant Medication Intake
Item
Start Date and Time
partialDatetime
C2826734 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Item
Concomitant Medication Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
Concomitant Medication Taken Prior to Study?
Code List
Concomitant Medication Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Ongoing Medication
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No, specify End Date and Time (N)
End date and time of Concomitant Medication Intake
Item
If no, specify End Date and Time
partialDatetime
C2826744 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
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