ID

34797

Beskrivning

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the Non-Serious Adverse Events (AE)form. It has to be filled in if a non-serious AE occurs during study.

Nyckelord

Versioner (1)
  1. 2019-01-29 2019-01-29 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

29 januari 2019

DOI

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Creative Commons BY-NC 3.0
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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Engelsk

Non-Serious Adverse Events (AE)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beskrivning

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Beskrivning

If Yes, record details below.

Datatyp

text

Alias
UMLS CUI [1]
C1518404
Event
Beskrivning

Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator.

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
Start date of AE
Beskrivning

day month year Record the start date of the first occurrence of the AE.

Datatyp

date

Alias
UMLS CUI [1]
C2697888
Start time of AE
Beskrivning

00:00-23:59. Start time is optional

Datatyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1518404
Outcome of AE
Beskrivning

All AEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up . Indicate if the event was 'Recovered/Resolved' or Recovered/Resolved with sequelae'. If the AE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as 'Not recovered/Not resolved' or 'Recovering/Resolving' Also enter 'Not recovered/Not resolved' if the AE was ongoing at the time of death, but was not the cause of death.

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
End date of AE
Beskrivning

day month year. This is the date the AE Recovered/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject's medical End Time condition resolved or stabilised. Leave blank if the AE is 'Not recovered/Not resolved' or 'Recovering/Resolving'.

Datatyp

date

Alias
UMLS CUI [1]
C2697886
End time of AE
Beskrivning

00:00-23:59. End Time is optional. Please fill in if the AE is 1) recovered/resolvedor 2) recovered/resolved with sequelae

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
Frequency of AE
Beskrivning

Select either single episode or intermittent Intermittent should be used if the subject experiences the same AE on multiple occasions over a period of time (e.g., dizziness). In these circumstances, the start date will be the start date of the first episode and the end date will be the date of resolution.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Maximum Intensity of AE
Beskrivning

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with normal everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

Datatyp

text

Alias
UMLS CUI [1]
C1710056
Action Taken with investigational Product(s) as a Result of the AE
Beskrivning

lnvestigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = lnvestigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing).

Datatyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beskrivning

Indicate 'Yes' if the event(s) were directly responsible for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate 'No'.

Datatyp

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?
Beskrivning

It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. 'A reasonable possibility' is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support 'a reasonable possibility' include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0877248
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Similar models

Non-Serious Adverse Events (AE)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Non-serious AE during study
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Event Diagnosis
Item
Event
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start date of AE
Item
Start date of AE
date
C2697888 (UMLS CUI [1])
Start time of AE
Item
Start time of AE
time
C1301880 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome of AE
integer
C1705586 (UMLS CUI [1])
Outcome of AE
Code List
Outcome of AE
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 of AE
date
C2697886 (UMLS CUI [1])
End time of AE
Item
End time of AE
time
C1522314 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Frequency of AE
integer
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency of AE
Code List
Frequency of AE
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity of AE
text
C1710056 (UMLS CUI [1])
Maximum Intensity of AE
Code List
Maximum Intensity of AE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not aplicable (X)
Item
Action Taken with investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with investigational Product(s)
Code List
Action Taken with investigational Product(s) as a Result of the AE
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose 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])
Withdrawing as result of 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
C0304229 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Investigational product causing 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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