ID

33743

Description

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the concomitant medication form. It has to be filled in if subject has taken a concomitant medication during study.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

English

Concomitant medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant medication
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Concomitant medication
Description

Concomitant medication

Alias
UMLS CUI-1
C2347852
Sequence Number
Description

Sequence Number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Modified reported term [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Unit Dose
Description

This item is conditional

Data type

float

Alias
UMLS CUI [1]
C0869039
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

text

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

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
Start time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013227
Taken prior to study?
Description

Taken prior to study

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Ongoing?
Description

Ongoing

Data type

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0013227
If not ongoing, specify end date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
If not ongoing, specify end time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0013227
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Similar models

Concomitant medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term [hidden]
text
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym [hidden]
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code [hidden]
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding [hidden]
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (AP)
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
Gamma per kilogram per minute (GA/KG/MIN)
CL Item
Gram (G)
CL Item
Drops (GTT)
CL Item
100 International units/ml (100 IU/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
Microgram per hour (MCG/HR)
CL Item
Microgramm/kilogram (MCG/KG)
CL Item
Microgramm/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Micrograms per millilitre (MCG/ML)
CL Item
Microlltre (MCL)
CL Item
Milliequivalent (MEQ)
CL Item
Milliequivalent 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/kilogram (MG/KG)
CL Item
Milligram/kilogram per hour (MG/KG/HR)
CL Item
Milligram/kilogram per minute (MG/KG/MIN)
CL Item
Milligram/metre squared (MG/M2)
CL Item
Milligram/ millilitre (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Million International units (MIU)
CL Item
Millilitre (ML)
CL Item
Millilitre per hour (ML/HR)
CL Item
Millilitre 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
2 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 months (Q3M)
CL Item
Every 3 weeks (Q3WK)
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 (U)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (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-articular (IART)
CL Item
Intra-bursa (IB)
CL Item
Intra-dermal (ID)
CL Item
Inhalation (IH)
CL Item
Intralesional (ILES)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Intraocular (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
Ophthalmic (OP)
CL Item
Left eye (OS)
CL Item
Otic (OT)
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)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C0013227 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Taken prior to study
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Ongoing?
text
C0549178 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Ongoing
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End date
Item
If not ongoing, specify end date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
End time
Item
If not ongoing, specify end time
time
C1522314 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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