Trial Outcomes & Findings for Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease (NCT NCT00381238)
NCT ID: NCT00381238
Last Updated: 2017-05-23
Results Overview
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.
COMPLETED
PHASE2
33 participants
From start of study medication (Wk 0) to Wk 50
2017-05-23
Participant Flow
The study was conducted from 20 June 2006 to 03 February 2009, at seven centers in Canada and United States. This was an extension study, with a total of 33 participants with mild to moderate Alzheimer's disease, recruited in the study, who had completed 12-months of treatment in 49653/461 study.
Participant milestones
| Measure |
RSG XR, 8 mg
The study duration was of 50-week (Wk), which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received Rosiglitazone (RSG) extended release (XR), 4 milligram (mg) tablets once daily (od), orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
RSG XR, 8 mg
The study duration was of 50-week (Wk), which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received Rosiglitazone (RSG) extended release (XR), 4 milligram (mg) tablets once daily (od), orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrew by physician
|
1
|
|
Overall Study
Disease progression
|
1
|
Baseline Characteristics
Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Age, Continuous
|
71.9 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study medication (Wk 0) to Wk 50Population: All subject population, is defined as all the participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
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|---|---|
|
Number of Participants With Adverse Events (AE's)
All AEs
|
25 participants
|
|
Number of Participants With Adverse Events (AE's)
SAEs
|
2 participants
|
|
Number of Participants With Adverse Events (AE's)
Drug related AEs
|
8 participants
|
|
Number of Participants With Adverse Events (AE's)
AE leading to prm disc of study drug or withdrawal
|
3 participants
|
SECONDARY outcome
Timeframe: From baseline to Wk 48Population: 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 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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=21 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score
|
-4.5 score on scale
Standard Deviation 4.07
|
SECONDARY outcome
Timeframe: From start of study medication (Wk 0) to Wk 50Population: All subject population
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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Number of Participants With SAEs
|
2 participants
|
SECONDARY outcome
Timeframe: Up to Wk 50Population: All subject population
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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
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|---|---|
|
Number of Participants With AE of Peripheral Edema by Grade
Participants with G0 peripheral edema
|
28 participants
|
|
Number of Participants With AE of Peripheral Edema by Grade
Participants with G1 peripheral edema
|
3 participants
|
|
Number of Participants With AE of Peripheral Edema by Grade
Participants with G2 peripheral edema
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) to Wk 50Population: 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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
DBP, Wk 2
|
-1.1 mmHg
Standard Deviation 8.31
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
SBP, Wk 2
|
1.7 mmHg
Standard Deviation 14.56
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
DBP, Wk 4
|
-1.8 mmHg
Standard Deviation 9.25
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
SBP, Wk 4
|
-1.3 mmHg
Standard Deviation 12.91
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
DBP, Wk 8
|
0.3 mmHg
Standard Deviation 8.19
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
SBP, Wk 8
|
3.2 mmHg
Standard Deviation 12.96
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
DBP, Wk 16
|
-2.0 mmHg
Standard Deviation 9.69
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
SBP, Wk 16
|
-1.4 mmHg
Standard Deviation 13.94
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
DBP, Wk 24
|
-2.6 mmHg
Standard Deviation 10.22
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
SBP, Wk 24
|
3.2 mmHg
Standard Deviation 17.96
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
DBP, Wk 32
|
-0.9 mmHg
Standard Deviation 7.96
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
SBP, Wk 32
|
4.7 mmHg
Standard Deviation 12.59
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
DBP, Wk 40
|
-2.7 mmHg
Standard Deviation 10.10
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
SBP, Wk 40
|
1.6 mmHg
Standard Deviation 13.96
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
DBP, Wk 48
|
-3.7 mmHg
Standard Deviation 10.13
|
|
Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
SBP, Wk 48
|
1.0 mmHg
Standard Deviation 13.72
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) to Wk 50Population: All subject population. 'n' is participants available at the particular time of assessment which were included in analysis.
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).
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Mean Change From Baseline in Vital Signs-heart Rate (HR)
HR, Wk 2
|
1.8 bpm
Standard Deviation 5.70
|
|
Mean Change From Baseline in Vital Signs-heart Rate (HR)
HR, Wk 4
|
1.2 bpm
Standard Deviation 10.20
|
|
Mean Change From Baseline in Vital Signs-heart Rate (HR)
HR, Wk 8
|
1.0 bpm
Standard Deviation 12.72
|
|
Mean Change From Baseline in Vital Signs-heart Rate (HR)
HR, Wk 16
|
0.3 bpm
Standard Deviation 12.53
|
|
Mean Change From Baseline in Vital Signs-heart Rate (HR)
HR, Wk 24
|
1.5 bpm
Standard Deviation 13.24
|
|
Mean Change From Baseline in Vital Signs-heart Rate (HR)
HR, Wk 32
|
-0.2 bpm
Standard Deviation 12.34
|
|
Mean Change From Baseline in Vital Signs-heart Rate (HR)
HR, Wk 40
|
1.9 bpm
Standard Deviation 15.29
|
|
Mean Change From Baseline in Vital Signs-heart Rate (HR)
HR, Wk 48
|
0.1 bpm
Standard Deviation 7.57
|
SECONDARY outcome
Timeframe: Up to Wk 50Population: All subject population. 'n' is participants available at the particular time of assessment which were included in analysis.
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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
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|---|---|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 16
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 32
|
5 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 40
|
7 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 48
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
HR >CCR, Wk 0
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
HR <CCR, Wk 4
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
HR <CCR, Wk 8
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
HR <CCR, Wk 16
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
HR >CCR, Wk 40
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
HR <CCR, Wk 40
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
DBP >CCR, Wk 0
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
DBP <CCR, Wk 4
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
DBP >CCR, Wk 24
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
DBP <CCR, Wk 48
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 0
|
4 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP <CCR, Wk 0
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 2
|
5 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 4
|
4 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP <CCR, Wk 4
|
1 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 8
|
5 participants
|
|
Number of Participants With Vital Signs of Clinical Concern.
SBP >CCR, Wk 24
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline (Wk 0) to Wk 50Population: 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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Mean Change From Baseline in Vital Signs- Weight
Weight, Wk 2
|
-0.4 kilograms
Standard Deviation 1.42
|
|
Mean Change From Baseline in Vital Signs- Weight
Weight, Wk 4
|
-0.0 kilograms
Standard Deviation 1.93
|
|
Mean Change From Baseline in Vital Signs- Weight
Weight, Wk 8
|
0.3 kilograms
Standard Deviation 2.12
|
|
Mean Change From Baseline in Vital Signs- Weight
Weight, Wk 16
|
0.2 kilograms
Standard Deviation 3.18
|
|
Mean Change From Baseline in Vital Signs- Weight
Weight, Wk 24
|
0.3 kilograms
Standard Deviation 3.21
|
|
Mean Change From Baseline in Vital Signs- Weight
Weight, Wk 32
|
0.3 kilograms
Standard Deviation 3.97
|
|
Mean Change From Baseline in Vital Signs- Weight
Weight, Wk 40
|
0.4 kilograms
Standard Deviation 3.25
|
|
Mean Change From Baseline in Vital Signs- Weight
Weight, Wk 48
|
0.0 kilograms
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Up to Wk 50Population: All subjects population. 'n' is participants available at the particular time of assessment which were included in analysis.
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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 8, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 8, high
|
1 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 16, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 16, high
|
1 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 24, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 24, high
|
1 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 32, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 32, high
|
1 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 40, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
CK, Wk 40, high
|
2 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 8, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 8, high
|
1 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 8, low
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 16, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 16, high
|
2 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 16, low
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 24, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine,Wk 24, high
|
1 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 24, low
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 32, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine,Wk 32, high
|
1 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Creatinine, Wk 32, low
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Glucose, Wk 0, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Glucose, Wk 0, high
|
1 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Glucose, Wk 0, low
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Urea, Wk 0, normal
|
0 participants
|
|
Number of Participants With Clinical Chemistry Parameters of Clinical Concern
Urea, Wk 0, high
|
1 participants
|
SECONDARY outcome
Timeframe: Up to Wk 50Population: 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 lipid parameters for Total cholesterol, high density lipoprotein, low density lipoprotein, triglycerides was to be collected. However this data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Wk 50Population: All subjects population. 'n' is participants available at the particular time of assessment which were included in analysis.
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.
Outcome measures
| Measure |
RSG XR, 8 mg
n=33 Participants
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hct, Wk 32, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hct, Wk 32, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hct, Wk 32, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 8, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 8, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 8, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 24, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 24, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 32, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 32, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 32, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 40, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 40, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb,Wk 48, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 48, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb,Wk 48, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
LA, Wk 8, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
LA, Wk 8, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
LA, Wk 8, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
LA, Wk 24, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
LA, Wk 24, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 0, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 0, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 24, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 24, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 24, low
|
2 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 40, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 40, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 40, low
|
2 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 8, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 8, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 8, low
|
2 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 32, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 32, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 32, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 40, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 40, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 40, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 48, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 48, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
RBC, Wk 32, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
RBC, Wk 32, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
SNP, Wk 8, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
SNP, Wk 8, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
SNP, Wk 24, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
SNP, Wk 24, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
TNA, Wk 8, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
TNA, Wk 24, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
LA, Wk 24, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
MA, Wk 0, normal,
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
PC, Wk 48, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
RBC, Wk 32, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
SNP, Wk 8, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
SNP, Wk 24, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
TNA, Wk 8, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
TNA, Wk 8, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
TNA, Wk 24, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
TNA, Wk 24, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
WBC, Wk 8, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
WBC, Wk 8, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
WBC, Wk 8, low
|
2 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
WBC, Wk 16, normal
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
WBC, Wk 16, high
|
0 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
WBC, Wk 16, low
|
2 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 24, low
|
1 participant
|
|
Number of Participant's With Hematology Parameters of Clinical Concern
Hb, Wk 40, low
|
1 participant
|
Adverse Events
RSG XR, 8 MG
Serious adverse events
| Measure |
RSG XR, 8 MG
n=33 participants at risk
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
1/33 • From start of study medication (Wk 0) to Wk 50
All subject population was used
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
3.0%
1/33 • From start of study medication (Wk 0) to Wk 50
All subject population was used
|
|
Nervous system disorders
Convulsion
|
3.0%
1/33 • From start of study medication (Wk 0) to Wk 50
All subject population was used
|
Other adverse events
| Measure |
RSG XR, 8 MG
n=33 participants at risk
The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
|
|---|---|
|
General disorders
Oedema peripheral
|
9.1%
3/33 • From start of study medication (Wk 0) to Wk 50
All subject population was used
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
6.1%
2/33 • From start of study medication (Wk 0) to Wk 50
All subject population was used
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
2/33 • From start of study medication (Wk 0) to Wk 50
All subject population was used
|
|
Vascular disorders
Haematoma
|
6.1%
2/33 • From start of study medication (Wk 0) to Wk 50
All subject population was used
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33 • From start of study medication (Wk 0) to Wk 50
All subject population was used
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER