ID

39922

Description

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the concomitant medication form. It has to be filled in if concomitant medication has been taken by subject during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Keywords

Versions (2)
  1. 2/25/20 2/25/20 -
  2. 3/4/20 3/4/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

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

integer

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 [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Modified reported term
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Description

In the original form this item is hidden.

Data type

text

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

In the original form this item is hidden.

Data type

text

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

In the original form this item is hidden.

Data type

text

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

Unit Dose

Data type

text

Alias
UMLS CUI [1,1]
C0869039
UMLS CUI [1,2]
C2347852
Units of concomitant medication
Description

Units of concomitant medication

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency of concomitant medication
Description

Frequency of concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2826654
Route of concomitant medication
Description

Route of concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2826730
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date of concomitant medication
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1]
C2826734
Start Time of concomitant medication
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Taken Prior to Study?
Description

Concomitant medication prior to study

Data type

text

Alias
UMLS CUI [1]
C2826667
Concomitant medication Ongoing?
Description

If you tick No, please specify End date and time in the appropriate items.

Data type

text

Alias
UMLS CUI [1]
C2826666
End Date of concomitant medication
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1]
C2826744
End Time of concomitant medication
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C2347852
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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
integer
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
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
text
C0869039 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Units of concomitant medication
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units of concomitant medication
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
Gamma 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/kilogram  (MCG/KG)
CL Item
Microgram/kilogram per minute  (MCG/KG/MIN)
CL Item
Micrograms per minute  (MCG/MIN)
CL Item
Micrograms per minute  (MCG/MIN)
CL Item
Micrograms per millitre  (MCG/ML)
CL Item
Microlitre  (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 of concomitant medication
text
C2826654 (UMLS CUI [1])
Units of concomitant medication
Code List
Frequency of concomitant medication
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 (UNK)
CL Item
With meals (Meals)
CL Item
With snacks (Snacks)
Item
Route of concomitant medication
text
C2826730 (UMLS CUI [1])
Route of concomitant medication
Code List
Route of concomitant medication
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
Intradermal  (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
C2826696 (UMLS CUI [1])
Start Date of concomitant medication
Item
Start Date of concomitant medication
partialDate
C2826734 (UMLS CUI [1])
Start Time of concomitant medication
Item
Start Time of concomitant medication
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
Concomitant medication prior to study
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Concomitant medication Ongoing?
text
C2826666 (UMLS CUI [1])
Concomitant medication Ongoing
Code List
Concomitant medication Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End Date of concomitant medication
Item
End Date of concomitant medication
partialDate
C2826744 (UMLS CUI [1])
End Time of concomitant medication
Item
End Time of concomitant medication
time
C1522314 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
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