ID

38263

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

October 5, 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, NCT00833989

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
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

partialDate

Alias
UMLS CUI [1]
C2826734
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 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])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
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
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
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])
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
date
C2826744 (UMLS CUI [1])
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