Description

Subject Identifier

Data type

text

Alias

UMLS CUI [1]

C2348585

Description

If Yes, record details below in the following questions of this itemgroup (fill out the set of questions for each non-serious adverse event). 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. 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 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 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/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. 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. IF THIS EVENT MEETS THE DEFINITION OF SERIOUS, COMPLETE THE SERIOUS ADVERSE EVENT SECTION INSTEAD

Data type

text

Alias

UMLS CUI [1]

C1518404

Description

Ensure that no medical or investigational procedures are captured on Non-Serious Adverse Events pages. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. Non-serious adverse event terms should be reviewed for potential SAEs per protocol. 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.

Data type

text

Alias

UMLS CUI [1]

C1518404

Description

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 [1,1]

C1518404

UMLS CUI [1,2]

C2697888

Description

Start Time Non-Serious Adverse Event

Data type

time

Alias

UMLS CUI [1,1]

C1518404

UMLS CUI [1,2]

C2697889

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 [1,1]

C0518690

UMLS CUI [1,2]

C1518404

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 [1,1]

C1705586

UMLS CUI [1,2]

C1518404

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 [1,1]

C1704758

UMLS CUI [1,2]

C1518404

Description

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]

C2697886

UMLS CUI [1,2]

C1518404

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 the subject was withdrawn from the study due to an adverse event, confirm that the following variables are consistent for the adverse event which resulted in withdrawal: If investigational product was permanently withdrawn due to an adverse event: ‘Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ‘Adverse Event’ If the subject was withdrawn from the study for an adverse event: ‘Withdrawal’ on the Non-Serious Adverse Events page is recorded as ‘Yes’, ‘Action Taken with Investigational Product(s) as a Result of the Non-Serious AE’ on the Non-Serious Adverse Events page is recorded as ‘Investigational Product Withdrawn’.

Data type

text

Alias

UMLS CUI [1,1]

C1710677

UMLS CUI [1,2]

C1518404

Description

End Time Non-Serious Adverse Event

Data type

time

Alias

UMLS CUI [1,1]

C1518404

UMLS CUI [1,2]

C2826658

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]

C0304229

UMLS CUI [1,2]

C0085978

UMLS CUI [1,3]

C1518404

Description

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]

C1518404

UMLS CUI [1,2]

C0439603