ID

33290

Beskrivning

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the Non-Serious Adverse Events form. It has to be filled in if a Non-Serious Adverse Events occurs during study. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form. Any untoward medical occurrence in a patient or clinical investigation subject, temporally associated withthe use of a medicinal product, whether or not considered related to the medicinal product. 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. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. Examples of an AE include: Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. New condition(s) detected or diagnosedafter investigationalproduct 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 asuspected overdose of either investigational product or a concomitant medication (overdose per se should not be reported as an AE/SAE). Examples of an AE do NOT include a/an: 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. The disease/disorderbeingstudied, or expected progression, signs, or symptoms of the disease/disorder being studied, unless more severe than expected for the subject's condition.

Länk

https://clinicaltrials.gov/ct2/show/NCT00599612

Nyckelord

Versioner (1)
  1. 2018-12-04 2018-12-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 december 2018

DOI

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Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

Engelsk

Non-Serious Adverse Events (AE)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beskrivning

Subject identifier

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 following items.

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
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 anddated by the investigator. If this non-serious event progresses to serious, put a line through the Non-Serious AE record and transcribe the details onto the SAE form

Datatyp

text

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

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

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start time of AE
Beskrivning

00:00-23:59. Record the start time of the AE.

Datatyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1518404
AE outcome
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/Notresolved' 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. Record the end date. This is the date the AE Recovered/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject's medical condition resolved or stablised. 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. Record the end time of the AE.

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 discomfortingto 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 [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action taken with investigational product(s) as a result of the non-serious AE
Beskrivning

Investigational product(s) withdrawn = Administrat ion 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'. If you tick yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.

Datatyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a 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]
C0085978
UMLS CUI [1,3]
C1518404
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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 identifier
Item
Subject identifier
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 [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Non-serious adverse events 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
Item
Event
text
C0877248 (UMLS CUI [1])
Start date of AE
Item
Start date of AE
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start time of AE
Item
Start time of AE
time
C1301880 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
AE outcome
integer
C1705586 (UMLS CUI [1])
AE outcome
Code List
AE outcome
CL Item
Recovered/Reolved (1)
CL Item
not recovered/not resolved (2)
CL Item
Recovered/Recovered with squelae (3)
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
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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 applicable (X)
Item
Action taken with investigational product(s) as a result of the non-serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with investigational product(s) as a result of the non-serious AE
Code List
Action taken with investigational product(s) as a result of the non-serious 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
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
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 possibility that the AE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relationship to investigational product(s)
Code List
Is there a possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
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