ID

39785

Description

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Non-serious adverse event form. It has to be filled in if a non-serious AE occurs during the study.

Lien

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Mots-clés

Versions (1)
  1. 19/02/2020 19/02/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

19 février 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

Anglais

Non-Serious Adverse Events (AE)

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

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.

Type de données

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.

Type de données

text

Alias
UMLS CUI [1]
C1518404
Modified term
Description

In the original form this item is hidden.

Type de données

text

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

In the original form this item is hidden.

Type de données

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.

Type de données

boolean

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

In the original form this item is hidden.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0877248
Start Date of AE
Description

day month year

Type de données

partialDate

Alias
UMLS CUI [1]
C2697888
Start Time of AE
Description

00:00-23:59

Type de données

time

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

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

Type de données

integer

Alias
UMLS CUI [1]
C1705586
End Date of AE
Description

day month year

Type de données

partialDate

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

00:00-23:59

Type de données

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1518404
Frequency of AE
Description

Frequency of AE

Type de données

integer

Alias
UMLS CUI [1]
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. An AE that is assessed as severe will not be confused with an SAE. Severity is a category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed as severe.

Type de données

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

Type de données

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

Type de données

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

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Start Date of AE
Item
Start Date of AE
partialDate
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
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
partialDate
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Time of AE
Item
End Time of AE
time
C1522314 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Frequency of AE
integer
C1518404 (UMLS CUI [1])
Frequency of AE
Code List
Frequency of AE
CL Item
Single Episode (1)
CL Item
Intermittent (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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