Trial Outcomes & Findings for Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL) (NCT NCT00819910)
NCT ID: NCT00819910
Last Updated: 2014-04-24
Results Overview
The reported percent change is the difference between TG levels obtained on initial visit (day 0) and TG levels obtained at final visit (week 12) as per protocol
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
12 weeks from initial visit (day 0) to final visit (12 weeks)
Results posted on
2014-04-24
Participant Flow
Participant milestones
| Measure |
Rosiglitazone + Placebo
Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
Fenofibrate + Placebo
Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
|
Rosiglitazone + Fenofibrate
Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
|
Placebo Therapy Daily
Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
9
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Rosiglitazone + Placebo
Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
Fenofibrate + Placebo
Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
|
Rosiglitazone + Fenofibrate
Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
|
Placebo Therapy Daily
Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)
Baseline characteristics by cohort
| Measure |
Rosiglitazone/Fenofibrate Therapy Daily
n=7 Participants
Rosiglitazone 8mg once daily and Fenofibrate 145mg once daily for 12 weeks
|
Fenofibrate + Placebo
n=9 Participants
Fenofibrate 145mg once daily for 12 weeks and Placebo (Rosiglitazone 8mg once daily)
|
Rosiglitazone + Placebo
n=8 Participants
Rosiglitazone 8mg once daily and Placebo ( Fenofibrate 145mg once daily)
|
Placebo Therapy Daily
n=10 Participants
Placebo (Rosiglitazone 8mg once daily) and placebo (Fenofibrate 145 mg once daily) for 12 weeks
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
56 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
34 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from initial visit (day 0) to final visit (12 weeks)Population: Mean percent change post treatment ( unit %). TG was measured using mg/dL units
The reported percent change is the difference between TG levels obtained on initial visit (day 0) and TG levels obtained at final visit (week 12) as per protocol
Outcome measures
| Measure |
Rosiglitazone + Placebo
n=8 Participants
Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
Fenofibrate + Placebo
n=9 Participants
Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
|
Rosiglitazone +Fenofibrate
n=7 Participants
Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
|
Placebo Therapy Daily
n=10 Participants
Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
|---|---|---|---|---|
|
Percent Change in Triglyceride (TG) Levels Post Treatment
|
7.4 % change
Standard Deviation 48.9
|
-2.2 % change
Standard Deviation 26
|
20 % change
Standard Deviation 36.5
|
7.6 % change
Standard Deviation 51
|
SECONDARY outcome
Timeframe: 12 weeks from initial visit (day 0) to final visit (12 weeks)The reported percent change is the difference between HDL levels obtained on initial visit (day 0) and HDL levels obtained at final visit (week 12) as per protocol
Outcome measures
| Measure |
Rosiglitazone + Placebo
n=8 Participants
Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
Fenofibrate + Placebo
n=9 Participants
Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
|
Rosiglitazone +Fenofibrate
n=7 Participants
Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
|
Placebo Therapy Daily
n=10 Participants
Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
|---|---|---|---|---|
|
Post-treatment Percent Change in High-Density Lipoprotein (HDL) Levels
|
1.9 % change
Standard Deviation 24.6
|
14.5 % change
Standard Deviation 21.6
|
5.8 % change
Standard Deviation 16.4
|
1.7 % change
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 12 weeks from initial visit (day 0) to final visit (12 weeks)The reported percent change is the difference between LDL levels obtained on initial visit (day 0) and LDL levels obtained at final visit (week 12) as per protocol
Outcome measures
| Measure |
Rosiglitazone + Placebo
n=8 Participants
Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
Fenofibrate + Placebo
n=9 Participants
Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
|
Rosiglitazone +Fenofibrate
n=7 Participants
Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
|
Placebo Therapy Daily
n=10 Participants
Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
|---|---|---|---|---|
|
Post-treatment Percent Change in Low-Density Lipoprotein (LDL) Levels
|
-0.5 % change
Standard Deviation 27.4
|
2.6 % change
Standard Deviation 29.3
|
37.3 % change
Standard Deviation 141.6
|
13.7 % change
Standard Deviation 47.8
|
SECONDARY outcome
Timeframe: 12 weeks from initial visit (day 0) to final visit (12 weeks)Post-treatment median change in Apo AI, Apo AII and Apo CIII levels reported in mg/dL with Interquartile ranges provided
Outcome measures
| Measure |
Rosiglitazone + Placebo
n=8 Participants
Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
Fenofibrate + Placebo
n=9 Participants
Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
|
Rosiglitazone +Fenofibrate
n=7 Participants
Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
|
Placebo Therapy Daily
n=10 Participants
Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
|---|---|---|---|---|
|
Post-treatment Percent Change in Apolipoprotein A-I (Apo AI), Apolipoprotein A-II (Apo AII) and Apolipoprotein C-III (Apo CIII) Levels
Apo AII
|
10.25 % Change
Interval 4.9 to 11.5
|
3.4 % Change
Interval 2.7 to 7.4
|
7.2 % Change
Interval -2.3 to 8.0
|
-3.5 % Change
Interval -3.6 to 4.0
|
|
Post-treatment Percent Change in Apolipoprotein A-I (Apo AI), Apolipoprotein A-II (Apo AII) and Apolipoprotein C-III (Apo CIII) Levels
Apo AI
|
-1.00 % Change
Interval -34.0 to 9.0
|
13 % Change
Interval 9.0 to 18.0
|
1 % Change
Interval -4.0 to 12.0
|
5 % Change
Interval -11.0 to 16.0
|
|
Post-treatment Percent Change in Apolipoprotein A-I (Apo AI), Apolipoprotein A-II (Apo AII) and Apolipoprotein C-III (Apo CIII) Levels
Apo CIII
|
0.30 % Change
Interval 0.0 to 1.8
|
-4.35 % Change
Interval -7.4 to -2.2
|
-5.3 % Change
Interval -6.7 to -3.0
|
-2.3 % Change
Interval -3.7 to 0.7
|
SECONDARY outcome
Timeframe: 12 weeks from initial visit (day 0) to final visit (12 weeks)The mean Levels of AST and ALT measured at initial visit (Day 0) and final visit (Week 12) annotated as AST 1, AST 12, and ALT 1 and ALT 12, respectively.
Outcome measures
| Measure |
Rosiglitazone + Placebo
n=8 Participants
Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
Fenofibrate + Placebo
n=9 Participants
Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
|
Rosiglitazone +Fenofibrate
n=7 Participants
Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
|
Placebo Therapy Daily
n=10 Participants
Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
|
|---|---|---|---|---|
|
Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit
AST 1 (aspartate aminotransferase [10-35 U/L])
|
24.00 mg/dl
Standard Deviation 11.091
|
25.25 mg/dl
Standard Deviation 7.517
|
24.30 mg/dl
Standard Deviation 5.870
|
19.88 mg/dl
Standard Deviation 5.249
|
|
Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit
AST 12 (aspartate aminotransferase [15-37 U/L])
|
30.29 mg/dl
Standard Deviation 9.810
|
26.50 mg/dl
Standard Deviation 7.964
|
19.70 mg/dl
Standard Deviation 2.584
|
17.88 mg/dl
Standard Deviation 6.139
|
|
Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit
ALT 1 (alanine aminotransferase [6-60 U/L])
|
28.14 mg/dl
Standard Deviation 13.957
|
25.88 mg/dl
Standard Deviation 15.394
|
24.10 mg/dl
Standard Deviation 10.429
|
20.88 mg/dl
Standard Deviation 6.643
|
|
Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit
ALT 12 (alanine aminotransferase [6-60 U/L])
|
27.43 mg/dl
Standard Deviation 10.358
|
26.38 mg/dl
Standard Deviation 11.916
|
21.10 mg/dl
Standard Deviation 8.647
|
14.88 mg/dl
Standard Deviation 3.523
|
Adverse Events
Rosiglitazone/Fenofibrate Therapy Daily
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Rosiglitazone + Placebo
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Fenofibrate + Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Therapy Daily
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosiglitazone/Fenofibrate Therapy Daily
n=10 participants at risk
Rosiglitazone 8mg po daily + Fenofibrate 145 mg po daily for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out.
|
Rosiglitazone + Placebo
n=10 participants at risk
Rosiglitazone 8mg po daily + Placebo (Fenofibrate 145 mg po daily) for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out.
|
Fenofibrate + Placebo
n=10 participants at risk
Fenofibrate 145 mg po daily for 12 weeks= Placebo (Rosiglitazone 8mg po daily)
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out.
|
Placebo Therapy Daily
n=11 participants at risk
Rosiglitazone (placebo) once daily and Fenofibrate (placebo)once daily for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Renal Failure
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Cardiac disorders
Non-Cardiac Chest Pain
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
Other adverse events
| Measure |
Rosiglitazone/Fenofibrate Therapy Daily
n=10 participants at risk
Rosiglitazone 8mg po daily + Fenofibrate 145 mg po daily for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out.
|
Rosiglitazone + Placebo
n=10 participants at risk
Rosiglitazone 8mg po daily + Placebo (Fenofibrate 145 mg po daily) for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out.
|
Fenofibrate + Placebo
n=10 participants at risk
Fenofibrate 145 mg po daily for 12 weeks= Placebo (Rosiglitazone 8mg po daily)
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out.
|
Placebo Therapy Daily
n=11 participants at risk
Rosiglitazone (placebo) once daily and Fenofibrate (placebo)once daily for 12 weeks
These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
9.1%
1/11 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
9.1%
1/11 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
9.1%
1/11 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
9.1%
1/11 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Eye disorders
Blurred vision
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
9.1%
1/11 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Musculoskeletal and connective tissue disorders
Aching legs
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Infections and infestations
Flu
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Musculoskeletal and connective tissue disorders
Stiff Neck
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
General disorders
Severe Headache
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Infections and infestations
Severe sinusitis
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Musculoskeletal and connective tissue disorders
Tiredness
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Eye disorders
Pressure behind left eye
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Vascular disorders
Swollen Ankles
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
|
General disorders
Lightheadedness
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
10.0%
1/10 • Number of events 1 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/10 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
0.00%
0/11 • 12 weeks
These are the adverse events reported during the monitoring period in 41 initial participants contributing to partially to drop out of 7 participants and the final data reported in the results section of only 34 participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60