Trial Outcomes & Findings for Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood (NCT NCT00616772)
NCT ID: NCT00616772
Last Updated: 2018-07-02
Results Overview
Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
682 participants
Primary outcome timeframe
Baseline, 6 months, 12 months, 18 months, and 24 months
Results posted on
2018-07-02
Participant Flow
Participant milestones
| Measure |
ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
|---|---|---|
|
Overall Study
STARTED
|
340
|
342
|
|
Overall Study
Treated
|
337
|
339
|
|
Overall Study
COMPLETED
|
225
|
240
|
|
Overall Study
NOT COMPLETED
|
115
|
102
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood
Baseline characteristics by cohort
| Measure |
ABT-335 + Atorvastatin
n=337 Participants
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
n=339 Participants
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
Total
n=676 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 8.71 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 8.79 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
228 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Low-density Lipoprotein Cholesterol (LDL-C)
|
84.0 mg/dL
STANDARD_DEVIATION 21.30 • n=5 Participants
|
84.5 mg/dL
STANDARD_DEVIATION 20.47 • n=7 Participants
|
84.3 mg/dL
STANDARD_DEVIATION 20.88 • n=5 Participants
|
|
Triglycerides
|
226.3 mg/dL
STANDARD_DEVIATION 110.01 • n=5 Participants
|
228.7 mg/dL
STANDARD_DEVIATION 127.06 • n=7 Participants
|
227.5 mg/dL
STANDARD_DEVIATION 118.78 • n=5 Participants
|
|
Posterior-wall Carotid Intima-media (cIMT) Thickness
|
0.76 mm
STANDARD_DEVIATION 0.10 • n=5 Participants
|
0.78 mm
STANDARD_DEVIATION 0.12 • n=7 Participants
|
0.77 mm
STANDARD_DEVIATION 0.11 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, and 24 monthsPopulation: All randomized participants who had both a baseline value and at least 1 postbaseline value for that parameter.
Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Outcome measures
| Measure |
ABT-335 + Atorvastatin
n=281 Participants
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
n=291 Participants
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
|---|---|---|
|
Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)
|
-0.006 mm/year
Standard Error 0.0037
|
0.000 mm/year
Standard Error 0.0036
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, and 24 monthsPopulation: All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter.
Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Outcome measures
| Measure |
ABT-335 + Atorvastatin
n=281 Participants
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
n=291 Participants
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
|---|---|---|
|
Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)
|
-0.005 mm/year
Standard Error 0.0047
|
-0.003 mm/year
Standard Error 0.0046
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, and 24 monthsPopulation: All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.
Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Outcome measures
| Measure |
ABT-335 + Atorvastatin
n=138 Participants
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
n=133 Participants
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
|---|---|---|
|
Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)
|
-0.010 mm/year
Standard Error 0.0039
|
-0.004 mm/year
Standard Error 0.0041
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, and 24 monthsPopulation: All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.
Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Outcome measures
| Measure |
ABT-335 + Atorvastatin
n=138 Participants
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
n=133 Participants
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
|---|---|---|
|
Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)
|
-0.014 mm/year
Standard Error 0.0053
|
-0.008 mm/year
Standard Error 0.0056
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, and 24 monthsPopulation: All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 6 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 6 or more segments matched the segments at baseline and at 2 years.
Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Outcome measures
| Measure |
ABT-335 + Atorvastatin
n=67 Participants
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
n=66 Participants
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
|---|---|---|
|
Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)
|
-0.003 mm/year
Standard Error 0.0070
|
-0.019 mm/year
Standard Error 0.0067
|
Adverse Events
ABT-335 + Atorvastatin
Serious events: 58 serious events
Other events: 235 other events
Deaths: 0 deaths
Placebo + Atorvastatin
Serious events: 66 serious events
Other events: 241 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-335 + Atorvastatin
n=337 participants at risk
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
n=339 participants at risk
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
|---|---|---|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.8%
6/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
1.5%
5/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.59%
2/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
DIASTOLIC DYSFUNCTION
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
EXTRASYSTOLES
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
ISCHAEMIC CARDIOMYOPATHY
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.89%
3/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
TACHYARRHYTHMIA
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Cardiac disorders
WOLFF-PARKINSON-WHITE SYNDROME
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
NAUSEA
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
VOMITING
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
General disorders
CHEST PAIN
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
General disorders
MEDICAL DEVICE COMPLICATION
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.2%
4/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.88%
3/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
ABSCESS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
CELLULITIS
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
DIVERTICULITIS
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
PNEUMONIA
|
1.2%
4/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.88%
3/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
PYELONEPHRITIS
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
SIALOADENITIS
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.59%
2/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
JAW FRACTURE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.89%
3/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.59%
2/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
JOINT INSTABILITY
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN PANCREATIC NEOPLASM
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM BENIGN
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER IN SITU
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARCINOID TUMOUR PULMONARY
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE CARCINOMA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER STAGE III
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER STAGE II
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SARCOMA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.59%
2/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
COMPLICATED MIGRAINE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
DIABETIC NEUROPATHY
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
PRESYNCOPE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
RUPTURED CEREBRAL ANEURYSM
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
SYNCOPE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.88%
3/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.88%
3/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
UNRESPONSIVE TO STIMULI
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Psychiatric disorders
GENERALISED ANXIETY DISORDER
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.89%
3/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.59%
2/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
NASAL POLYPS
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Vascular disorders
ANEURYSM
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.59%
2/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Vascular disorders
AORTIC STENOSIS
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.00%
0/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.59%
2/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.30%
1/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Vascular disorders
SUBCLAVIAN ARTERY ANEURYSM
|
0.00%
0/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
0.29%
1/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
Other adverse events
| Measure |
ABT-335 + Atorvastatin
n=337 participants at risk
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
|
Placebo + Atorvastatin
n=339 participants at risk
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
|
|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
5.0%
17/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
4.1%
14/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.8%
23/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
7.4%
25/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Gastrointestinal disorders
NAUSEA
|
7.1%
24/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
5.9%
20/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
General disorders
FATIGUE
|
6.8%
23/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
5.0%
17/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
General disorders
OEDEMA PERIPHERAL
|
4.5%
15/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
5.6%
19/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
BRONCHITIS
|
7.1%
24/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
8.8%
30/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
NASOPHARYNGITIS
|
13.1%
44/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
11.2%
38/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
SINUSITIS
|
5.9%
20/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
8.8%
30/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
15.7%
53/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
17.1%
58/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.3%
18/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
4.1%
14/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Investigations
BLOOD CREATININE INCREASED
|
6.5%
22/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
1.8%
6/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
8.0%
27/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
3.2%
11/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
8.6%
29/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
10.6%
36/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.7%
36/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
12.7%
43/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.1%
24/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
6.8%
23/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
6.5%
22/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
4.4%
15/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.7%
26/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
9.4%
32/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
13.1%
44/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
7.7%
26/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
DIZZINESS
|
8.6%
29/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
5.9%
20/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Nervous system disorders
HEADACHE
|
11.3%
38/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
12.7%
43/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Psychiatric disorders
INSOMNIA
|
5.3%
18/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
5.9%
20/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.8%
23/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
5.3%
18/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
|
Vascular disorders
HYPERTENSION
|
5.0%
17/337 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
10.6%
36/339 • AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER