ID
38116
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00833989
Nyckelord
Versioner (3)
- 2019-09-18 2019-09-18 -
- 2019-09-18 2019-09-18 -
- 2019-10-05 2019-10-05 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
18 september 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
Beskrivning
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1518404
Beskrivning
If you tick "Recovered/Resolved" or "Recovered/Resolved with sequelae". provide End Date and Time
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1518404
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1518404
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
text
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
Patient withdrawn due to this AE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beskrivning
Relationship to Investigational Drug
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Similar models
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])