Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease

An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study drug or withdrawal were reported.

Time frame: From start of study medication (Wk 0) to Wk 50

Population: All subject population, is defined as all the participants who received at least one dose of study drug.

The MMSE, is a score scale which consists of 11 tests of orientation (to time and place), memory (recent and immediate), concentration, language and praxis. The scoring ranged from 0 to 30, with lower scores indicative of greater cognitive impairment (more severe disease) and higher scores indicative less cognitive impairment (less severe disease). The total score was calculated by summing the scores from each of the tests. The investigator questioned the participants individually with set of questions and scored the participant, based on his performance. The baseline was defined as Wk 0. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.

Time frame: From baseline to Wk 48

Population: Intent to treat (ITT). The ITT population consisted of all participants in the safety population who also had at least one post-dose efficacy assessment within this study.

The HR for the participant's, were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The HR was measured in beats per minute (bpm).

Time frame: Baseline (Wk 0) to Wk 50

Population: All subject population. 'n' is participants available at the particular time of assessment which were included in analysis.

Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.

Time frame: Baseline (Wk 0) to Wk 50

Population: All subject population. 'n' is participants available at the particular time of assessment which were included in analysis.

The weight for the participant, was measured without wearing shoes and with light clothing. There was no particular RR, reported for weight; however, the increase from baseline was reported to be \>=7 % and the decrease also reported as \>=7 %. The values as of potential clinical concern were 'both' outside of RR, or met a change from baseline criterion.

Time frame: Baseline (Wk 0) to Wk 50

Population: All subject population. 'n' is participants available at the particular time of assessment which were included in analysis.

Participants with AE of peripheral edema were evaluated. The test was performed by firmly pressing the thumb anterior to the participants ankle until further pressure produced no greater indentation. The depth of the pit was estimated and it was graded using below 5 point scale; where estimated depth of indentation corresponded to a particular grade (G). G 0 as depth of \<1 millimeter (mm); G1 as depth of 1-2 mm; G2 as depth of 3-5 mm; G3 as depth of 6-10 mm; and G4 as depth of \> 10 mm. The data for only the participants who had peripheral edema on more than one visit, then their most severe G were presented.

Time frame: Up to Wk 50

Population: All subject population

The data for participants for clinical parameters, with values only of potential clinical concern (PCI) were reported for creatine, creatinine kinase(CK), urea and glucose. Creatinine(unit: micromoles per litre) : low concern and high concern values were considered as 22 absolute value (AB) (\<50% lower limit of RR ) and 155 (AB) (\>125% upper limit of RR) respectively. CK (unit: international unit per litre ): low concern value and high concern values was none and 1.25 respectively. Glucose (unit: millimole per litre): low concern and high concern values were considered as 3.6 (AB) and 7.8 (AB) respectively.

Time frame: Up to Wk 50

Population: All subjects population. 'n' is participants available at the particular time of assessment which were included in analysis.

Participant data for clinical concern lipid parameters for Total cholesterol, high density lipoprotein, low density lipoprotein, triglycerides was to be collected. However this data was not collected.

Time frame: Up to Wk 50

Population: All subject population. The data for 'The number of participants with clinical chemistry parameters of clinical concern- Lipids' was not collected.

Participant data for clinical concern hematology parameters, were reported for hematocrit (Hct) (unit:1): low concern (LC) and high concern (HC) values as 0.8 and 1.2 respectively, hemoglobin (Hb) (unit: gram per deciliter): LC and HC values as value for female (F) 10 (AB) , value for male (M) 11; and value for F 16.5 (AB), value for M 18 respectively; lymphocytes absolute(LA) (unit: giga cells per litre \[GI/L\]) : LC and HC value as 0.75 and 1.5 respectively; monocytes absolute (MA) (unit: GI/L) LC and HC value as 0.75 and 2 respectively, platelet count (PC) (unit: x103/mm3): LC and HC value as 100 (AB) and 500(AB) respectively, red blood cell count (RBC) (unit: x106 micro litre): LC and HC value as 0.8 and 1.2 respectively, segmented neutrophils absolute (SNA) (unit: GI/L) LC and HC value as 0.75 and 1.3 respectively, total neutrophils absolute (TNA) (unit : GI/L) LC and HC value as 0.75 and 1.5 respectively; White blood cell (WBC) (unit: GI/L) LC and HC value as 3 and 15.

Time frame: Up to Wk 50

Population: All subjects population. 'n' is participants available at the particular time of assessment which were included in analysis.

An SAE, is any untoward medical occurrence, that at any dose may result in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, is congenital anomaly or birth defect, and medically important events. The number of participants with any SAE, were reported.

Time frame: From start of study medication (Wk 0) to Wk 50

Population: All subject population

The data for number of participants with vital sign data, outside the range of potential clinical concern for SBP, DBP, HR and body weight were reported. The values as of potential clinical concern were 'both' outside of reference range or met a change from baseline criterion. The RR, for SBP was 90-140 mmHg for which the increase from baseline was reported to be \>= 40 mmHg and decrease from baseline reported as \>=30 mmHg; the RR for DBP was 50-90 mmHg for which the increase from baseline was reported to be \>= 30 mmHg and decrease from baseline reported as \>=20 mmHg; and the RR, for HR was 50-100 bpm for which the increase from baseline was reported to be \>= 30 bpm and the decrease from baseline reported as \>=30 bpm. The data of number of participants with \> clinical concern range (CCR) or \< CCR were reported.

Time frame: Up to Wk 50

Population: All subject population. 'n' is participants available at the particular time of assessment which were included in analysis.