GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Beschreibung

Subject identifier

Datentyp

text

Alias

UMLS CUI [1]

C2348585

Beschreibung

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.

Datentyp

text

Alias

UMLS CUI [1]

C1518404

Beschreibung

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.

Datentyp

text

Alias

UMLS CUI [1,1]

C0877248

UMLS CUI [1,2]

C0011900

UMLS CUI [2,1]

C0877248

UMLS CUI [2,2]

C0037088

Beschreibung

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.

Datentyp

date

Alias

UMLS CUI [1]

C2697888

Beschreibung

Record the start time of the AE.

Datentyp

time

Alias

UMLS CUI [1,1]

C1301880

UMLS CUI [1,2]

C0877248

Beschreibung

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.

Datentyp

integer

Alias

UMLS CUI [1]

C1705586

Beschreibung

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’.

Datentyp

date

Alias

UMLS CUI [1,1]

C0806020

UMLS CUI [1,2]

C1518404

Beschreibung

End Time

Datentyp

time

Alias

UMLS CUI [1]

C2826658

Beschreibung

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.

Datentyp

integer

Alias

UMLS CUI [1,1]

C0877248

UMLS CUI [1,2]

C0439603

Beschreibung

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).

Datentyp

text

Alias

UMLS CUI [1]

C1710066

Beschreibung

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).

Datentyp

text

Alias

UMLS CUI [1]

C2826626

Beschreibung

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.

Datentyp

text

Alias

UMLS CUI [1,1]

C1710677

UMLS CUI [1,2]

C1518404

Beschreibung

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.

Datentyp

text

Alias

UMLS CUI [1,1]

C1518404

UMLS CUI [1,2]

C0013230

UMLS CUI [1,3]

C0439849