ID

29573

Description

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Adverse Events: Non-Serious Adverse Events (Part of "End of Study").

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Keywords

Versions (1)
  1. 4/6/18 4/6/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 6, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

English

Adverse Events: Non-Serious Adverse Events

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
UMLS CUI-2
C0877248
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Non-Serious adverse Events
Description

Non-Serious adverse Events

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

Non-serious adverse event terms should be reviewed for potential SAEs per protocol. If it qualifies as Serious Adverse Event (SAE), do not complete this itemgroup, go to the SAE section and complete the SAE itemgroup. If yes, record details in the other items of this itemgroup. DEFINITION 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. 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. For GSK clinical studies, AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e., invasive procedures, modification of subject’s previous therapeutic regimen). See protocol for clarification.

Data type

text

Alias
UMLS CUI [1]
C1518404
Diagnosis only if known, otherwise sign/symptom
Description

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. Ensure that no medical or investigational procedures are captured.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0037088
Start Date
Description

Record the start date of the first occurrence of the AE. Start dates must be provided for the reporting of adverse event data. If the exact date is not known, liaise with the investigator to ensure that a best estimate is provided.

Data type

date

Alias
UMLS CUI [1]
C2697888
Start Time
Description

Record the start time of the AE.

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0877248
Outcome
Description

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.

Data type

integer

Alias
UMLS CUI [1]
C1705586
End date
Description

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 stabilised. Leave blank if the AE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Record the end time of the AE.
Description

End Time

Data type

time

Alias
UMLS CUI [1]
C2826658
Frequency
Description

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.

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439603
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
Description

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).

Data type

text

Alias
UMLS CUI [1]
C1710066
Action taken with investigational products as a result of the non-serious AE
Description

Investigational 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 = Investigational 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).

Data type

text

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this AE?
Description

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 yes, complete Study Conclusion form and pick Adverse event as reason for withdrawal.

Data type

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
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Similar models

Adverse Events: Non-Serious Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
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])
Non-Serious Adverse Event
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
yes (Y)
CL Item
no (N)
Event: Diagnosis, Signs, Symptoms
Item
Diagnosis only if known, otherwise sign/symptom
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Start Date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
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
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Time
Item
Record the end time of the AE.
time
C2826658 (UMLS CUI [1])
Item
Frequency
integer
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
single episode (1)
CL Item
intermittent (2)
Item
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
text
C1710066 (UMLS CUI [1])
Maximum intensity
Code List
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
not applicable (X)
Item
Action taken with investigational products as a result of the non-serious AE
text
C2826626 (UMLS CUI [1])
Action taken with investigational products
Code List
Action taken with investigational products as a result of the non-serious AE
CL Item
investigational products 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
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Non-Serious Adverse Event
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])
Non-Serious Adverse Event
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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