Trial Outcomes & Findings for Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia (NCT NCT00504829)
NCT ID: NCT00504829
Last Updated: 2020-02-17
Results Overview
Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
220 participants
Primary outcome timeframe
baseline(randomization) to 12 weeks
Results posted on
2020-02-17
Participant Flow
Subjects will be recruited from a combination of sources: advertising, clinical databases, clinical referrals, and the general subject population.
The washout period for subjects on lipid-lowering therapy will be 4 to 8 weeks, depending on their regimen.
Participant milestones
| Measure |
LCP-AtorFen 40/100mg
study drug arm Atorvastatin 40mg and fenofibrate 100mg
|
Atorvastatin 40mg
active control arm atorvastatin 40mg
|
Fenofibrate 145mg
active control arm fenofibrate 145mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
74
|
73
|
|
Overall Study
COMPLETED
|
67
|
70
|
63
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
10
|
Reasons for withdrawal
| Measure |
LCP-AtorFen 40/100mg
study drug arm Atorvastatin 40mg and fenofibrate 100mg
|
Atorvastatin 40mg
active control arm atorvastatin 40mg
|
Fenofibrate 145mg
active control arm fenofibrate 145mg
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
4
|
10
|
Baseline Characteristics
Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
Baseline characteristics by cohort
| Measure |
LCP-AtorFen 40/100mg
n=73 Participants
study drug arm Atorvastatin 40mg and fenofibrate 100mg
|
Atorvastatin 40mg
n=74 Participants
active control arm atorvastatin 40mg
|
Fenofibrate 145mg
n=73 Participants
active control arm fenofibrate 145mg
|
Total
n=220 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
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 10.74 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 9.88 • n=7 Participants
|
56.4 years
STANDARD_DEVIATION 10.58 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 10.38 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
74 participants
n=7 Participants
|
73 participants
n=5 Participants
|
220 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline(randomization) to 12 weeksPopulation: Modified intent-to-treat population consisted of all subjects randomized who had at least one dose of study drug and one post-baseline (randomization) assessment
Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet.
Outcome measures
| Measure |
LCP-AtorFen 40/100mg
n=71 Participants
study drug arm Atorvastatin 40mg and fenofibrate 100mg
|
Atorvastatin 40mg
n=73 Participants
active control arm atorvastatin 40mg
|
|---|---|---|
|
Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy
non-HDL
|
-44.8 percent change from baseline
Standard Deviation 16.2
|
-40.2 percent change from baseline
Standard Deviation 17.3
|
|
Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy
triglycerides
|
-49.1 percent change from baseline
Standard Deviation 24.46
|
-28.9 percent change from baseline
Standard Deviation 32.25
|
|
Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy
HDL
|
19.7 percent change from baseline
Standard Deviation 21.38
|
6.5 percent change from baseline
Standard Deviation 18.77
|
SECONDARY outcome
Timeframe: baseline (week 0) to 12 weeksPopulation: Modified intent-to-treat population consisted of all subjects randomized who had at least one dose of study drug and one post-baseline (randomization) assessment
Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy
Outcome measures
| Measure |
LCP-AtorFen 40/100mg
n=71 Participants
study drug arm Atorvastatin 40mg and fenofibrate 100mg
|
Atorvastatin 40mg
n=73 Participants
active control arm atorvastatin 40mg
|
|---|---|---|
|
Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy
LDL
|
-42.3 percent change from baseline
Standard Deviation 20.01
|
-13.9 percent change from baseline
Standard Deviation 18.31
|
|
Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy
HDL
|
19.7 percent change from baseline
Standard Deviation 21.38
|
18.2 percent change from baseline
Standard Deviation 17.81
|
|
Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy
non-HDL
|
-44.8 percent change from baseline
Standard Deviation 16.2
|
-16.1 percent change from baseline
Standard Deviation 17.5
|
Adverse Events
LCP-AtorFen 40/100mg
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Atorvastatin 40mg
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Fenofibrate 145mg
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCP-AtorFen 40/100mg
n=73 participants at risk
study drug arm Atorvastatin 40mg and fenofibrate 100mg
|
Atorvastatin 40mg
n=74 participants at risk
active control arm atorvastatin 40mg
|
Fenofibrate 145mg
n=73 participants at risk
active control arm fenofibrate 145mg
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
Other adverse events
| Measure |
LCP-AtorFen 40/100mg
n=73 participants at risk
study drug arm Atorvastatin 40mg and fenofibrate 100mg
|
Atorvastatin 40mg
n=74 participants at risk
active control arm atorvastatin 40mg
|
Fenofibrate 145mg
n=73 participants at risk
active control arm fenofibrate 145mg
|
|---|---|---|---|
|
Endocrine disorders
Endocrine Disorders (any)
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders (any)
|
17.8%
13/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
12.2%
9/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
13.7%
10/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Gastrointestinal disorders
Flatulence
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Gastrointestinal disorders
Gastro esophageal reflux diseases
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
General disorders
General Disorders and Administration Site Conditions
|
6.8%
5/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
6.8%
5/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
General disorders
Fatigue
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Infections and infestations
Infections and Infestations (any)
|
13.7%
10/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
24.3%
18/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
17.8%
13/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
4/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
10.8%
8/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications (any)
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Investigations (any)
|
17.8%
13/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
14.9%
11/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
17.8%
13/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Alanine aminotransferase increased
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
6.8%
5/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Aspartate aminotransferase increased
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.5%
4/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Blood glucose increased
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Creatinine renal clearance decreased
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
6.8%
5/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Gamma- glutamyltransferase increased
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Investigations
Liver function test abnormal
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition (any)
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders (any)
|
11.0%
8/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
12.2%
9/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
12.3%
9/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and Unspecified (any)
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Nervous system disorders
Nervous System Disorders (any)
|
6.8%
5/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
6.8%
5/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Nervous system disorders
Headache
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Psychiatric disorders
Psychiatric Disorders (any)
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Renal and urinary disorders
Renal and Urinary Disorders (any)
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders (any)
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders (any)
|
5.5%
4/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
9.5%
7/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders (any)
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
1.4%
1/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
5.5%
4/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Vascular disorders
Vascular Disorders (any)
|
4.1%
3/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
|
Vascular disorders
Hypertension
|
1.4%
1/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
2.7%
2/74
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
0.00%
0/73
For certain "Other (Not Including Serious) Adverse Events" some adverse events were monitored/assessed without regard to a specific adverse event term, and were therefore listed only by organ class.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Individual investigators may publish data arising from their own subjects. The Principal Investigator will provide the Sponsor with copies of written publications (including abstracts and posters) at least 60 days in advance of submission.
- Publication restrictions are in place
Restriction type: OTHER