Trial Outcomes & Findings for Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia (NCT NCT00246376)
NCT ID: NCT00246376
Last Updated: 2016-03-21
Results Overview
Triglycerides (mg/dL): Fasting lipid levels
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
221 participants
Primary outcome timeframe
Measured at 24 weeks
Results posted on
2016-03-21
Participant Flow
Subjects were recruited mainly from the Legacy Community Health Center and Thomas Street Clinic of the Harris County Hospital District and from Houston Area Community Services and private clinics. Recruitment period: January 2004 to September 2009.
If potential subjects were taking nutritional supplements or lipid-lowering drugs, these were discontinued for washout for 6 weeks - baseline fasting lipid levels were then measured to determine eligibility prior to randomization.
Participant milestones
| Measure |
Group 1: Usual Care
Subjects receive lifestyle advice and placebos for Niaspan and Tricor
|
Group 2: Diet / Exercise
Diet, exercise, and two placebos
|
Group 3: Diet / Exercise + Fenofibrate
Diet, exercise, Fenofibrate, and Niaspan placebo
|
Group 4: Diet / Exercise + Niacin
Diet, exercise, Fenofibrate placebo, and Niaspan
|
Group 5: Diet / Exercise + Niacin + Fenofibrate
Diet, exercise, Fenofibrate and Niaspan
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
45
|
47
|
45
|
|
Overall Study
After Dietary run-in at Two Weeks
|
30
|
38
|
41
|
40
|
42
|
|
Overall Study
COMPLETED
|
26
|
24
|
29
|
21
|
28
|
|
Overall Study
NOT COMPLETED
|
15
|
19
|
16
|
26
|
17
|
Reasons for withdrawal
| Measure |
Group 1: Usual Care
Subjects receive lifestyle advice and placebos for Niaspan and Tricor
|
Group 2: Diet / Exercise
Diet, exercise, and two placebos
|
Group 3: Diet / Exercise + Fenofibrate
Diet, exercise, Fenofibrate, and Niaspan placebo
|
Group 4: Diet / Exercise + Niacin
Diet, exercise, Fenofibrate placebo, and Niaspan
|
Group 5: Diet / Exercise + Niacin + Fenofibrate
Diet, exercise, Fenofibrate and Niaspan
|
|---|---|---|---|---|---|
|
Overall Study
Dropped/withdrew during dietary run-in
|
11
|
5
|
4
|
7
|
3
|
|
Overall Study
Adverse Event
|
2
|
3
|
1
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
11
|
11
|
16
|
13
|
Baseline Characteristics
Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia
Baseline characteristics by cohort
| Measure |
Group 1: Usual Care
n=41 Participants
Subjects receive lifestyle advice and placebos for Niaspan and Tricor
|
Group 2: Diet / Exercise
n=43 Participants
Diet, exercise, and two placebos
|
Group 3: Diet / Exercise + Fenofibrate
n=45 Participants
Diet, exercise, Fenofibrate, and Niaspan placebo
|
Group 4: Diet / Exercise + Niacin
n=47 Participants
Diet, exercise, Fenofibrate placebo, and Niaspan
|
Group 5: Diet / Exercise + Niacin + Fenofibrate
n=45 Participants
Diet, exercise, Fenofibrate and Niaspan
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=39 Participants
|
43 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
47 Participants
n=31 Participants
|
45 Participants
n=146 Participants
|
220 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
29 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
42 Participants
n=31 Participants
|
38 Participants
n=146 Participants
|
192 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=39 Participants
|
43 participants
n=41 Participants
|
45 participants
n=35 Participants
|
47 participants
n=31 Participants
|
45 participants
n=146 Participants
|
221 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Measured at 24 weeksPopulation: All those who underwent the 2-week (first follow-up) measurement and continued in the study.
Triglycerides (mg/dL): Fasting lipid levels
Outcome measures
| Measure |
Group 1 - Usual Care
n=30 Participants
These subjects did not participate in the diet/exercise program and took placebos.
|
Group 2 - Diet/Exercise Only
n=38 Participants
These subjects participated in the diet/exercise program and took placebos.
|
Group 3 - Diet/Exercise + Fenofibrate
n=41 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
|
Group 4 - Diet/Exercise + Niacin
n=40 Participants
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
|
Group 5 - Diet/Exercise + Fenofibrate + Niacin
n=42 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
|
|---|---|---|---|---|---|
|
Triglycerides
|
199 mg/dL
Standard Error 24.9
|
216.9 mg/dL
Standard Error 28.6
|
155.1 mg/dL
Standard Error 18.5
|
177.6 mg/dL
Standard Error 24.2
|
135.6 mg/dL
Standard Error 16.9
|
PRIMARY outcome
Timeframe: Measured at 24 weeksPopulation: All those who underwent the 2-week (first follow-up) measurement and continued in the study.
non-HDL-C (mg/dL): Fasting lipid levels
Outcome measures
| Measure |
Group 1 - Usual Care
n=30 Participants
These subjects did not participate in the diet/exercise program and took placebos.
|
Group 2 - Diet/Exercise Only
n=38 Participants
These subjects participated in the diet/exercise program and took placebos.
|
Group 3 - Diet/Exercise + Fenofibrate
n=41 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
|
Group 4 - Diet/Exercise + Niacin
n=40 Participants
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
|
Group 5 - Diet/Exercise + Fenofibrate + Niacin
n=42 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
|
|---|---|---|---|---|---|
|
Non-HDL-C
|
162.2 mg/dl
Standard Error 7.8
|
165.4 mg/dl
Standard Error 8.1
|
145.8 mg/dl
Standard Error 7.4
|
154 mg/dl
Standard Error 8.3
|
137.1 mg/dl
Standard Error 7.7
|
PRIMARY outcome
Timeframe: Measured at 24 weeksPopulation: All those who underwent the 2-week (first follow-up) measurement and continued in the study.
HDL-C (mg/dL): Fasting lipid levels
Outcome measures
| Measure |
Group 1 - Usual Care
n=30 Participants
These subjects did not participate in the diet/exercise program and took placebos.
|
Group 2 - Diet/Exercise Only
n=38 Participants
These subjects participated in the diet/exercise program and took placebos.
|
Group 3 - Diet/Exercise + Fenofibrate
n=41 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
|
Group 4 - Diet/Exercise + Niacin
n=40 Participants
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
|
Group 5 - Diet/Exercise + Fenofibrate + Niacin
n=42 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
|
|---|---|---|---|---|---|
|
HDL-C
|
37.1 mg/dl
Standard Error 1.8
|
38.7 mg/dl
Standard Error 1.9
|
40.7 mg/dl
Standard Error 1.8
|
41.8 mg/dl
Standard Error 2.2
|
44.8 mg/dl
Standard Error 2.1
|
PRIMARY outcome
Timeframe: Measured at 24 weeksPopulation: All those who underwent the 2-week (first follow-up) measurement and continued in the study.
Total cholesterol (mg/dL): Fasting lipid levels
Outcome measures
| Measure |
Group 1 - Usual Care
n=30 Participants
These subjects did not participate in the diet/exercise program and took placebos.
|
Group 2 - Diet/Exercise Only
n=38 Participants
These subjects participated in the diet/exercise program and took placebos.
|
Group 3 - Diet/Exercise + Fenofibrate
n=41 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
|
Group 4 - Diet/Exercise + Niacin
n=40 Participants
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
|
Group 5 - Diet/Exercise + Fenofibrate + Niacin
n=42 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
|
|---|---|---|---|---|---|
|
Total Cholesterol
|
195.6 mg/dL
Standard Error 7.7
|
200.1 mg/dL
Standard Error 8.3
|
184 mg/dL
Standard Error 6.9
|
190.8 mg/dL
Standard Error 8.2
|
178.4 mg/dL
Standard Error 7
|
PRIMARY outcome
Timeframe: Measured at 24 weeksPopulation: All those who underwent the 2-week (first follow-up) measurement and continued in the study.
Total cholesterol : HDL-C ratio: Fasting lipid levels
Outcome measures
| Measure |
Group 1 - Usual Care
n=30 Participants
These subjects did not participate in the diet/exercise program and took placebos.
|
Group 2 - Diet/Exercise Only
n=38 Participants
These subjects participated in the diet/exercise program and took placebos.
|
Group 3 - Diet/Exercise + Fenofibrate
n=41 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
|
Group 4 - Diet/Exercise + Niacin
n=40 Participants
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
|
Group 5 - Diet/Exercise + Fenofibrate + Niacin
n=42 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
|
|---|---|---|---|---|---|
|
Total Cholesterol : HDL-C Ratio
|
5.2 ratio
Standard Error 0.3
|
5.1 ratio
Standard Error 0.3
|
4.5 ratio
Standard Error 0.2
|
4.6 ratio
Standard Error 0.3
|
4 ratio
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Measured at 24 weeksPopulation: All subjects who completed 24 weeks.
Adiponectin (micrograms/ml)
Outcome measures
| Measure |
Group 1 - Usual Care
n=26 Participants
These subjects did not participate in the diet/exercise program and took placebos.
|
Group 2 - Diet/Exercise Only
n=24 Participants
These subjects participated in the diet/exercise program and took placebos.
|
Group 3 - Diet/Exercise + Fenofibrate
n=29 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
|
Group 4 - Diet/Exercise + Niacin
n=21 Participants
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
|
Group 5 - Diet/Exercise + Fenofibrate + Niacin
n=28 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
|
|---|---|---|---|---|---|
|
Insulin Sensitivity
Fasting insulin
|
8.7 micrograms/ml
Standard Error 2
|
6.7 micrograms/ml
Standard Error 1.6
|
9.5 micrograms/ml
Standard Error 1.6
|
11.9 micrograms/ml
Standard Error 3
|
10.3 micrograms/ml
Standard Error 2.5
|
|
Insulin Sensitivity
HOMA-IR
|
1.92 micrograms/ml
Standard Error 0.47
|
1.38 micrograms/ml
Standard Error 0.36
|
2.02 micrograms/ml
Standard Error 0.47
|
2.76 micrograms/ml
Standard Error 0.75
|
2.38 micrograms/ml
Standard Error 0.62
|
|
Insulin Sensitivity
Insulin sensitvity index
|
3.54 micrograms/ml
Standard Error 0.73
|
4.95 micrograms/ml
Standard Error 1.1
|
3.81 micrograms/ml
Standard Error 0.76
|
2.88 micrograms/ml
Standard Error 0.67
|
2.38 micrograms/ml
Standard Error 0.62
|
|
Insulin Sensitivity
Adiponectin
|
7.12 micrograms/ml
Standard Error 1.09
|
6.04 micrograms/ml
Standard Error 0.98
|
5.24 micrograms/ml
Standard Error 0.76
|
11.01 micrograms/ml
Standard Error 1.87
|
10.34 micrograms/ml
Standard Error 1.67
|
SECONDARY outcome
Timeframe: Measured at 24 weeksPopulation: The number corresponds to the number of subjects who completed the study (see Participant flow)
1. Body cell mass (kg) 2. Fat mass (kg)
Outcome measures
| Measure |
Group 1 - Usual Care
n=26 Participants
These subjects did not participate in the diet/exercise program and took placebos.
|
Group 2 - Diet/Exercise Only
n=24 Participants
These subjects participated in the diet/exercise program and took placebos.
|
Group 3 - Diet/Exercise + Fenofibrate
n=29 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
|
Group 4 - Diet/Exercise + Niacin
n=21 Participants
These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
|
Group 5 - Diet/Exercise + Fenofibrate + Niacin
n=28 Participants
These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
|
|---|---|---|---|---|---|
|
Body Composition
Body cell mass
|
59.6 kg
Standard Error 2.3
|
67.3 kg
Standard Error 2
|
66.6 kg
Standard Error 1.8
|
67.1 kg
Standard Error 2.1
|
68.2 kg
Standard Error 2
|
|
Body Composition
Fat mass
|
36.8 kg
Standard Error 1.9
|
37.5 kg
Standard Error 1.6
|
35.8 kg
Standard Error 1.5
|
37.7 kg
Standard Error 1.8
|
36.2 kg
Standard Error 1.7
|
Adverse Events
Group 1: Usual Care
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 2: Diet / Exercise
Serious events: 10 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 3: Diet / Exercise + Fenofibrate
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 4: Diet / Exercise + Niacin
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Group 5: Diet / Exercise + Niacin + Fenofibrate
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Usual Care
n=30 participants at risk
Subjects receive lifestyle advice and placebos for Niaspan and Tricor
|
Group 2: Diet / Exercise
n=38 participants at risk
Diet, exercise, and two placebos
|
Group 3: Diet / Exercise + Fenofibrate
n=41 participants at risk
Diet, exercise, Fenofibrate, and Niaspan placebo
|
Group 4: Diet / Exercise + Niacin
n=40 participants at risk
Diet, exercise, Fenofibrate placebo, and Niaspan
|
Group 5: Diet / Exercise + Niacin + Fenofibrate
n=42 participants at risk
Diet, exercise, Fenofibrate and Niaspan
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Transaminases elevated >3 times upper normal limit
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
4.8%
2/42 • Number of events 2 • Throughout duration of study (5 years)
|
|
Cardiac disorders
Chest pain / angina
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
2.4%
1/41 • Number of events 1 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Renal and urinary disorders
Serum creatining > 1.5 mg/dL
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
2.4%
1/41 • Number of events 1 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
2.4%
1/42 • Number of events 1 • Throughout duration of study (5 years)
|
|
Metabolism and nutrition disorders
Triglycerides > 1000mg/dl
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
7.9%
3/38 • Number of events 3 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Hepatobiliary disorders
Elevated Bilirubin
|
10.0%
3/30 • Number of events 3 • Throughout duration of study (5 years)
|
13.2%
5/38 • Number of events 5 • Throughout duration of study (5 years)
|
9.8%
4/41 • Number of events 4 • Throughout duration of study (5 years)
|
0.00%
0/40 • Throughout duration of study (5 years)
|
4.8%
2/42 • Number of events 2 • Throughout duration of study (5 years)
|
Other adverse events
| Measure |
Group 1: Usual Care
n=30 participants at risk
Subjects receive lifestyle advice and placebos for Niaspan and Tricor
|
Group 2: Diet / Exercise
n=38 participants at risk
Diet, exercise, and two placebos
|
Group 3: Diet / Exercise + Fenofibrate
n=41 participants at risk
Diet, exercise, Fenofibrate, and Niaspan placebo
|
Group 4: Diet / Exercise + Niacin
n=40 participants at risk
Diet, exercise, Fenofibrate placebo, and Niaspan
|
Group 5: Diet / Exercise + Niacin + Fenofibrate
n=42 participants at risk
Diet, exercise, Fenofibrate and Niaspan
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30 • Number of events 3 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
4.9%
2/41 • Number of events 2 • Throughout duration of study (5 years)
|
5.0%
2/40 • Number of events 2 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
6.7%
2/30 • Number of events 2 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
9.8%
4/41 • Number of events 4 • Throughout duration of study (5 years)
|
0.00%
0/40 • Throughout duration of study (5 years)
|
7.1%
3/42 • Number of events 3 • Throughout duration of study (5 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
5.3%
2/38 • Number of events 2 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/30 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/30 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
2.4%
1/41 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/40 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/30 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
0.00%
0/40 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/30 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/30 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Ear and labyrinth disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
2.4%
1/42 • Number of events 1 • Throughout duration of study (5 years)
|
|
Skin and subcutaneous tissue disorders
Rash/Itching
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
7.5%
3/40 • Number of events 3 • Throughout duration of study (5 years)
|
4.8%
2/42 • Number of events 2 • Throughout duration of study (5 years)
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
5.3%
2/38 • Number of events 2 • Throughout duration of study (5 years)
|
7.3%
3/41 • Number of events 3 • Throughout duration of study (5 years)
|
40.0%
16/40 • Number of events 16 • Throughout duration of study (5 years)
|
28.6%
12/42 • Number of events 12 • Throughout duration of study (5 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
5.0%
2/40 • Number of events 2 • Throughout duration of study (5 years)
|
2.4%
1/42 • Number of events 1 • Throughout duration of study (5 years)
|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 2 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
2.4%
1/41 • Number of events 1 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
4.8%
2/42 • Number of events 2 • Throughout duration of study (5 years)
|
|
Musculoskeletal and connective tissue disorders
Headache
|
16.7%
5/30 • Number of events 5 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
5.0%
2/40 • Number of events 2 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Musculoskeletal and connective tissue disorders
Body ache
|
0.00%
0/30 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
4.8%
2/42 • Number of events 2 • Throughout duration of study (5 years)
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/30 • Throughout duration of study (5 years)
|
0.00%
0/38 • Throughout duration of study (5 years)
|
2.4%
1/41 • Number of events 1 • Throughout duration of study (5 years)
|
2.5%
1/40 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/42 • Throughout duration of study (5 years)
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.00%
0/30 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
0.00%
0/40 • Throughout duration of study (5 years)
|
2.4%
1/42 • Number of events 1 • Throughout duration of study (5 years)
|
|
General disorders
Loss of appetite
|
3.3%
1/30 • Number of events 1 • Throughout duration of study (5 years)
|
2.6%
1/38 • Number of events 1 • Throughout duration of study (5 years)
|
0.00%
0/41 • Throughout duration of study (5 years)
|
0.00%
0/40 • Throughout duration of study (5 years)
|
2.4%
1/42 • Number of events 1 • Throughout duration of study (5 years)
|
Additional Information
Ashok Balasubramanyam, MD, Prinicipal Investigator
Baylor College of Medicine
Phone: 713-798-8654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place