ID

38143

Description

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the concomitant medication form. It has to be filled in if concomitant medication has been taken by subject.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Keywords

Versions (2)
  1. 9/22/19 9/22/19 -
  2. 10/5/19 10/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539

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
Total daily dose
Description

Total daily dose

Data type

integer

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C2347852
Units of concomitant medication
Description

Units of concomitant medication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
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

date

Alias
UMLS CUI [1]
C2826734
Taken Prior to Study?
Description

Concomitant medication prior to study

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1883727
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
Concomitant medication Ongoing?
Description

If you tick No, please specify End date in the following item.

Data type

text

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

day month year

Data type

date

Alias
UMLS CUI [1]
C2826744
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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])
Total daily dose
Item
Total daily dose
integer
C2348070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Units of concomitant medication
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Units of concomitant medication
Code List
Units of concomitant medication
CL Item
ACTU (Actuation)
CL Item
AMP (Ampoule)
CL Item
APP (Application)
CL Item
AUC (Area under curve)
CL Item
BOT (Bottle)
CL Item
CAP (Capsule)
CL Item
CC (Cubic centimeter)
CL Item
CUP (Cup)
CL Item
GA/KG/MIN (Gamma per kilogram per minute)
CL Item
G (Gram)
CL Item
GTT (Drops)
CL Item
100IU/ML (100 International units/ml)
CL Item
INH (Inhalation)
CL Item
IU (International units)
CL Item
IU/KG (International units per kilogram)
CL Item
IU/KG/HR (International units per kilogram per hour)
CL Item
IU/ML (International units per millilitre)
CL Item
L (Litre)
CL Item
LOZ (Lozenge)
CL Item
L/MIN (Litre per minute)
CL Item
MAC (Minimum alveolar concentration)
CL Item
MBQ (Mega becquerels (MBq))
CL Item
MCG (Microgram (MCG))
CL Item
MCG/HR (Micrograms per hour)
CL Item
MCG/KG (Microgram/kilogram)
CL Item
MCG/KG/MIN (Microgram/kilogram per minute)
CL Item
MCG/MIN (Micrograms per minute)
CL Item
MCG/MIN (Micrograms per minute)
CL Item
MCG/ML (Micrograms per millitre)
CL Item
MCL (Microlitre)
CL Item
MEQ (Milliequivalent)
CL Item
MEQ/24HR (Milliequivalent per 24 hours)
CL Item
MG (Milligram)
CL Item
MG/DAY (Milligram per day)
CL Item
MG/HR (Milligram per hour)
CL Item
MG/KG (Milligram/kilogram)
CL Item
MG/KG/HR (Milligram/kilogram per hour)
CL Item
MG/KG/MIN (Milligram/kilogram per minute)
CL Item
MG/M2 (Milligram/metre squared)
CL Item
MG/ML (Milligram/millilitre)
CL Item
MG% (Milligrams percent)
CL Item
MIU (Million international units)
CL Item
ML (Millilitre)
CL Item
ML/HR (Millilitre per hour)
CL Item
ML/MIN (Millilitre per minute)
CL Item
MMOL (Millimole)
CL Item
MU (Megaunits (million units))
CL Item
NEB (Nebule)
CL Item
OZ (Ounce)
CL Item
PATCH (Patch)
CL Item
% (Percent)
CL Item
PUFF (Puff)
CL Item
SACH (Sachet)
CL Item
SPR (Spray)
CL Item
SUPP (Suppository)
CL Item
TAB (Tablet)
CL Item
TBLSP (Tablespoon)
CL Item
TSP (Teaspoon)
CL Item
UG (Microgram (UG))
CL Item
U/HR (Units per hour)
CL Item
U/KG/MIN (Units per kilogram per minute)
CL Item
U/MIN (Units per minute)
CL Item
U (Units)
CL Item
UNK (Unknown)
CL Item
VIAL (Vial)
Item
Route of concomitant medication
text
C2826730 (UMLS CUI [1])
Route of concomitant medication
Code List
Route of concomitant medication
CL Item
EP (Epidural)
CL Item
GTT (Gastrostomy tube)
CL Item
IA (Intra-arterial)
CL Item
IART (Intra-articular)
CL Item
IB (Intra-bursa)
CL Item
ID (Intradermal)
CL Item
IH (Inhalation)
CL Item
ILES (Intralesional)
CL Item
IM (Intramuscular)
CL Item
IN (Intranasal)
CL Item
INJ (Injection)
CL Item
IO (Intraocular)
CL Item
IOS (Intraosteal)
CL Item
IP (Intraperitoneal)
CL Item
IT (Intrathecal)
CL Item
IU (Intrauterine)
CL Item
IV (Intravenous)
CL Item
NG (Nasogastric)
CL Item
NS (Nasal)
CL Item
OD (Right eye)
CL Item
OP (Ophthalmic)
CL Item
OS (Left eye)
CL Item
OT (Otic)
CL Item
OTH (Other)
CL Item
OU (Both eyes)
CL Item
PO (Oral)
CL Item
PR (Rectal)
CL Item
SC (Subcutaneous)
CL Item
SL (Sublingual)
CL Item
TD (Transdermal)
CL Item
TP (Topical)
CL Item
UNK (Unknown)
CL Item
VG (Vaginal)
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date of concomitant medication
Item
Start Date of concomitant medication
date
C2826734 (UMLS CUI [1])
Item
Taken Prior to Study?
text
C2347852 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
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
date
C2826744 (UMLS CUI [1])
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