Trial Outcomes & Findings for A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia (NCT NCT00491530)
NCT ID: NCT00491530
Last Updated: 2012-01-20
Results Overview
All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
310 participants
Primary outcome timeframe
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.
Results posted on
2012-01-20
Participant Flow
Subjects who had completed ABT-335/statin therapy in the preceding open-label year 1 study at a subset of sites were eligible for recruitment in this open-label year 2 extension study. Subjects continued to receive the treatment they had received in the preceding open-label year 1 study.
Participant milestones
| Measure |
ABT-335 + 20 mg Rosuvastatin
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Overall Study
STARTED
|
174
|
50
|
86
|
|
Overall Study
COMPLETED
|
162
|
44
|
81
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
5
|
Reasons for withdrawal
| Measure |
ABT-335 + 20 mg Rosuvastatin
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Investigator Discretion
|
0
|
1
|
0
|
|
Overall Study
Patient Request
|
0
|
1
|
0
|
|
Overall Study
Use of Prohibited Medication
|
0
|
0
|
1
|
Baseline Characteristics
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
Baseline characteristics by cohort
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=174 Participants
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=50 Participants
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=86 Participants
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
138 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
246 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Age Continuous
|
56.1 years
STANDARD_DEVIATION 10.71 • n=93 Participants
|
55.3 years
STANDARD_DEVIATION 10.55 • n=4 Participants
|
55.4 years
STANDARD_DEVIATION 10.94 • n=27 Participants
|
55.8 years
STANDARD_DEVIATION 10.72 • n=483 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
148 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
162 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
174 participants
n=93 Participants
|
50 participants
n=4 Participants
|
86 participants
n=27 Participants
|
310 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.Population: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.
All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=174 Participants
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=50 Participants
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=86 Participants
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study
|
94.8 percentage of participants
|
90.0 percentage of participants
|
97.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)Population: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.
\[(Week 104 triglycerides minus baseline triglycerides)/baseline triglycerides\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=162 Participants
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=43 Participants
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=80 Participants
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study
|
-36.9 percent change
Full Range 34.91 • Interval -84.8 to 124.4
|
-29.6 percent change
Full Range 36.61 • Interval -73.1 to 53.0
|
-38.7 percent change
Full Range 32.31 • Interval -80.8 to 80.2
|
SECONDARY outcome
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)Population: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at week 104 are included.
\[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=162 Participants
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=43 Participants
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=80 Participants
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
|
13.7 percent change
Standard Deviation 22.15
|
11.2 percent change
Standard Deviation 22.53
|
5.2 percent change
Standard Deviation 17.53
|
SECONDARY outcome
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)Population: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.
\[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=161 Participants
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=43 Participants
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=80 Participants
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
|
-19.2 percent change
Standard Deviation 30.87
|
-20.2 percent change
Standard Deviation 22.56
|
-20.5 percent change
Standard Deviation 30.04
|
SECONDARY outcome
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)Population: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.
\[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=162 Participants
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=43 Participants
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=80 Participants
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
|
-26.9 percent change
Standard Deviation 26.12
|
-23.8 percent change
Standard Deviation 21.99
|
-25.1 percent change
Standard Deviation 27.83
|
SECONDARY outcome
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)Population: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.
\[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=158 Participants
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=42 Participants
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=79 Participants
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
|
-33.7 percent change
Standard Deviation 42.50
|
-18.7 percent change
Standard Deviation 58.37
|
-26.6 percent change
Standard Deviation 65.88
|
SECONDARY outcome
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)Population: Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.
\[(Week 104 Total-C minus baseline Total-C)/baseline Total-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Outcome measures
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=162 Participants
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=43 Participants
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=80 Participants
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study
|
-20.1 percent change
Standard Deviation 21.41
|
-17.9 percent change
Standard Deviation 18.54
|
-20.4 percent change
Standard Deviation 21.57
|
Adverse Events
ABT-335 + 20 mg Rosuvastatin
Serious events: 26 serious events
Other events: 153 other events
Deaths: 0 deaths
ABT-335 + 40 mg Simvastatin
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
ABT-335 + 40 mg Atorvastatin
Serious events: 5 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=174 participants at risk
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=50 participants at risk
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=86 participants at risk
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Nervous system disorders
Headache
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Nervous system disorders
Syncope
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Renal and urinary disorders
Dysuria
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Renal and urinary disorders
Haematuria
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Reproductive system and breast disorders
Rectocele
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Cardiac disorders
Coronary artery disease
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Endocrine disorders
Goitre
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Enterocele
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
General disorders
Chest pain
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
2/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Diverticulitis
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Gastroenteritis viral
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Postoperative wound infection
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Subcutaneous abscess
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.7%
3/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc protrusion
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
3/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
Other adverse events
| Measure |
ABT-335 + 20 mg Rosuvastatin
n=174 participants at risk
Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Simvastatin
n=50 participants at risk
Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
ABT-335 + 40 mg Atorvastatin
n=86 participants at risk
Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.3%
2/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
9/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
6/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.3%
2/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
10/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
9.3%
8/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
14/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
10.0%
5/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
4.7%
4/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
6/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
7.0%
6/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.6%
8/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
4.7%
4/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
18/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
12.0%
6/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
11.6%
10/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Toothache
|
5.7%
10/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
3.5%
3/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
9/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
4.7%
4/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
General disorders
Chest discomfort
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
General disorders
Fatigue
|
6.9%
12/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
5.8%
5/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
General disorders
Oedema peripheral
|
1.1%
2/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.1%
7/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
General disorders
Pain
|
6.3%
11/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
5.8%
5/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
General disorders
Pyrexia
|
2.9%
5/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
7.0%
6/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Immune system disorders
Seasonal allergy
|
1.1%
2/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
5.8%
5/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Bronchitis
|
13.8%
24/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
16.0%
8/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
23.3%
20/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Gastroenteritis
|
5.7%
10/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
7.0%
6/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Gastroenteritis viral
|
2.9%
5/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.0%
1/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
5.8%
5/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Influenza
|
4.6%
8/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
12.8%
11/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Nasopharyngitis
|
15.5%
27/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
14.0%
7/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
11.6%
10/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Sinusitis
|
13.8%
24/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
10.0%
5/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
11.6%
10/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.2%
49/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
34.0%
17/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
27.9%
24/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Urinary tract infection
|
10.9%
19/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
5.8%
5/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Infections and infestations
Viral infection
|
1.7%
3/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
3.5%
3/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.57%
1/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.9%
5/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
10.0%
5/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
3.5%
3/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.2%
9/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.3%
2/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.9%
5/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.4%
6/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
3.5%
3/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.1%
21/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
12.0%
6/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
16.3%
14/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.8%
31/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
14.0%
7/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
17.4%
15/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
3.4%
6/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.3%
11/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
14.0%
7/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
11.6%
10/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.7%
10/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
12.0%
6/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
3.5%
3/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
14/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
3.5%
3/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
18/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
12.0%
6/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
11.6%
10/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Nervous system disorders
Dizziness
|
8.6%
15/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
12.0%
6/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
5.8%
5/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Nervous system disorders
Headache
|
21.3%
37/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
24.0%
12/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
23.3%
20/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Nervous system disorders
Paraesthesia
|
4.0%
7/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Psychiatric disorders
Depression
|
3.4%
6/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
5.8%
5/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Psychiatric disorders
Insomnia
|
9.2%
16/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
4.0%
2/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
7.0%
6/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.3%
4/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
11/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
17.4%
15/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
7/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
8.0%
4/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
2.3%
2/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
5/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
5.8%
5/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.2%
9/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
0.00%
0/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
1.2%
1/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
|
Vascular disorders
Hypertension
|
6.9%
12/174 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
6.0%
3/50 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
4.7%
4/86 • Up to 116 weeks
Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) to within 30 days after the last dose of combination therapy.
|
Additional Information
Medical Information Specialist
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Provide ABBOTT at least sixty (60) days prior to submission for review, ABBOTT shall return comments within sixty (60) days of receipt of draft. Proposed draft shall be delayed an additional sixty (60) days in addition to the Review Period.
- Publication restrictions are in place
Restriction type: OTHER