ID
38264
Descrição
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
Palavras-chave
Versões (3)
- 18/09/2019 18/09/2019 -
- 18/09/2019 18/09/2019 -
- 05/10/2019 05/10/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
5 de outubro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
Descrição
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0877248
Descrição
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.
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1518404
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C0877248
Descrição
In the original form this item is hidden.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0877248
Descrição
In the original form this item is hidden.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C0877248
Descrição
In the original form this item is hidden.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C0877248
Descrição
day month year
Tipo de dados
partialDate
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1518404
Descrição
If you tick "Recovered/Resolved" or "Recovered/Resolved with sequelae". provide End Date and Time
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1705586
Descrição
day month year
Tipo de dados
partialDate
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1518404
Descrição
00:00-23:59
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1518404
Descrição
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
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1710066
Descrição
Action Taken with Investigational Product(s) as a Result of the AE
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2826626
Descrição
Patient withdrawn due to this AE
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Descrição
Relationship to Investigational Drug
Tipo de dados
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
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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])