ID

38264

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 Non-serious adverse event form. It has to be filled in if a non-serious AE occurs during the study.

Link

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

Keywords

Versions (3)
  1. 9/18/19 9/18/19 -
  2. 9/18/19 9/18/19 -
  3. 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

Non-Serious Adverse Events (AE)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Non-serious Adverse Event
Description

Non-serious Adverse Event

Alias
UMLS CUI-1
C1518404
Sequence Number
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0877248
Non-serious Adverse Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom. Definition of AE: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Events meeting the definition of an AE include: -Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., ECGs, radiological scans, vital signs measurements), including those that worsen from baseline, and felt to be clinically significant in the medical and scientific judgement of the investigator. -Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. -New conditions detected or diagnosed after investigational product administration even though it may have been present prior to the start of the study. -Signs, symptoms, or the clinical sequelae of a suspected interaction. -Signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concomitant medication (overdose per se will not be reported as an AE/SAE). Events that do not meet the definition of an AE include: -Any clinically significant abnormal laboratory findings or other abnormal safety assessments that are associated with the underlying disease, unless judged by the investigator to be more severe than expected for the subject’s condition. -The disease/disorder being studied, or expected progression, signs, or symptoms of the disease/disorder being studied, unless more severe than expected for the subject’s condition. -Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to the procedure is an AE. -Situations where an untoward medical occurrence did not occur (social and/or convenience admission to a hospital). -Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen.

Data type

text

Alias
UMLS CUI [1]
C1518404
Modified term
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C0877248
MedDRA synonym
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C0877248
MedDRA lower level term code
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C0877248
Failed coding
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0877248
Onset Date
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1518404
Outcome
Description

If you tick "Recovered/Resolved" or "Recovered/Resolved with sequelae". provide End Date and Time

Data type

integer

Alias
UMLS CUI [1]
C1705586
End Date
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
End Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1518404
Intensity (maximum)
Description

MILD: Adverse experience which is easily tolerated MODERATE: Adverse experience sufficiently discomforting to interfere with daily activities SEVERE: Adverse experience which prevents normal everyday activities

Data type

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Investigational Product(s) as a Result of the AE
Description

Action Taken with Investigational Product(s) as a Result of the AE

Data type

text

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this AE?
Description

Patient withdrawn due to this AE

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to Investigational Drug

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
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Similar models

Non-Serious Adverse Events (AE)

1 forms
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
Non-serious Adverse Event
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Non-serious Adverse Event
Item
Non-serious Adverse Event
text
C1518404 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
MedDRA synonym
Item
MedDRA synonym
boolean
C1140263 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
boolean
C3898442 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Onset Date of AE
Item
Onset Date
partialDate
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date of AE
Item
End Date
partialDate
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Time of AE
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Drug interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Patient withdrawn due to this AE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Patient withdrawn due to this AE
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
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