Non-Serious Adverse Event (AE) GSK Rosiglitazone Alzheimer's disease 100468

Subject Identifier

Did the subject experience any non-serious adverse events during the study?

Event (e.g. Headache) Diagnosis Only (if known) otherwise Sign/Symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initiated and dated by the investigator.

Start Date (e.g. 25 Jan 02) Record the start date of the first occurence of the AE.

Outcome (e.g. 1) 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.

End Date (e.g. 27 Jan 02) 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'.

Maximum Intesity (e.g. 1) Record the maximum intesity that occured over the duration of the event. Amend the intesity 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 discomforting to interfere with normal everyday activities. Severe = An event that prevents normal everday activities. Not applicable = those event(s) where intensity is meaningless or impossible to determine (i.e. blindness and coma)

Action Taken with Investigational Product(s) as a Result of the Non-Serious AE (e.g. 4) Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued.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 occured. 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 occured (e.g. pre- or post-dosing).

Withdrawal (e.g. Y) Did the subject withdrawal from study as a result of this AE? Indicate 'YES' if the event(s) were directly responsible for the subject's withdrawal as a indicated on the Study Conclusion page, otherwise indicate 'NO'.

Relationship to Investigational Product(s) (e.g. Y) Is there a reasonable possibility that the AE may have been caused by the investigational product? 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.