Trial Outcomes & Findings for Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD (NCT NCT02586155)
NCT ID: NCT02586155
Last Updated: 2021-08-20
Results Overview
Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2425 participants
Primary outcome timeframe
120 weeks
Results posted on
2021-08-20
Participant Flow
Participant milestones
| Measure |
High-Intensity Statin Therapy+RVX000222
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Overall Study
STARTED
|
1215
|
1210
|
|
Overall Study
Final Number Randomized
|
1212
|
1206
|
|
Overall Study
COMPLETED
|
1088
|
1083
|
|
Overall Study
NOT COMPLETED
|
127
|
127
|
Reasons for withdrawal
| Measure |
High-Intensity Statin Therapy+RVX000222
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
31
|
24
|
|
Overall Study
Lost to Follow-up
|
7
|
13
|
|
Overall Study
Death
|
61
|
72
|
|
Overall Study
Other reasons
|
26
|
15
|
Baseline Characteristics
Body weight data is missing for some subjects
Baseline characteristics by cohort
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1206 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
Total
n=2418 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
n=1212 Participants
|
62.0 years
n=1206 Participants
|
62.0 years
n=2418 Participants
|
|
Age, Customized
≤65 years
|
816 Participants
n=1212 Participants
|
772 Participants
n=1206 Participants
|
1588 Participants
n=2418 Participants
|
|
Age, Customized
>65 years
|
396 Participants
n=1212 Participants
|
434 Participants
n=1206 Participants
|
830 Participants
n=2418 Participants
|
|
Sex: Female, Male
Female
|
305 Participants
n=1212 Participants
|
313 Participants
n=1206 Participants
|
618 Participants
n=2418 Participants
|
|
Sex: Female, Male
Male
|
907 Participants
n=1212 Participants
|
893 Participants
n=1206 Participants
|
1800 Participants
n=2418 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
27 Participants
n=1212 Participants
|
31 Participants
n=1206 Participants
|
58 Participants
n=2418 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=1212 Participants
|
19 Participants
n=1206 Participants
|
39 Participants
n=2418 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1212 Participants
|
0 Participants
n=1206 Participants
|
0 Participants
n=2418 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1212 Participants
|
0 Participants
n=1206 Participants
|
0 Participants
n=2418 Participants
|
|
Race (NIH/OMB)
White
|
1063 Participants
n=1212 Participants
|
1056 Participants
n=1206 Participants
|
2119 Participants
n=2418 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1212 Participants
|
0 Participants
n=1206 Participants
|
0 Participants
n=2418 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
102 Participants
n=1212 Participants
|
100 Participants
n=1206 Participants
|
202 Participants
n=2418 Participants
|
|
Body weight
|
85.75 kilograms (kg)
n=1210 Participants • Body weight data is missing for some subjects
|
85.90 kilograms (kg)
n=1206 Participants • Body weight data is missing for some subjects
|
85.90 kilograms (kg)
n=2416 Participants • Body weight data is missing for some subjects
|
|
Body-mass index (BMI)
|
29.589 kg/m2
n=1208 Participants • Body-mass index (BMI) data missing for some subjects
|
29.585 kg/m2
n=1206 Participants • Body-mass index (BMI) data missing for some subjects
|
29.585 kg/m2
n=2414 Participants • Body-mass index (BMI) data missing for some subjects
|
PRIMARY outcome
Timeframe: 120 weeksIncidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1206 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE
CV Death
|
34 events
|
42 events
|
|
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE
Non-fatal MI
|
76 events
|
92 events
|
|
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE
Stroke
|
15 events
|
15 events
|
SECONDARY outcome
Timeframe: 120 weeksFirst occurrence of MACE broadly defined as a single composite endpoint of Cardiovascular Death (CVD) (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI), Stroke, or Hospitalization for CVD events (including unstable angina and evidence of new or presumed new progressive obstructive coronary disease or emergency revascularization procedures at any time and urgent revascularization procedures ≥30 days after the index event as defined by Hicks et al., 2014) . If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1206 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
CV Death
|
33 events
|
42 events
|
|
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
Non-fatal MI
|
74 events
|
91 events
|
|
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
Hospitalization for CVD events
|
22 events
|
18 events
|
|
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
Stroke
|
15 events
|
15 events
|
SECONDARY outcome
Timeframe: 120 weeksOutcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1206 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Incidence of Hospitalization for Congestive Heart Failure (CHF)
|
29 events
|
48 events
|
SECONDARY outcome
Timeframe: 120 weeksOutcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1207 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Incidence of All-cause Mortality
|
61 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 120 weeksPopulation: A select subset of subjects were analyzed for ApoA-I, Subject data is missing across time points.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=243 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=238 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Baseline
|
119.0 mg/dL
Interval 110.0 to 130.0
|
117.5 mg/dL
Interval 108.0 to 128.0
|
|
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 11 (Week 24)
|
128.0 mg/dL
Interval 118.5 to 138.5
|
125.0 mg/dL
Interval 114.0 to 138.0
|
|
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 14 (Week 52)
|
129.0 mg/dL
Interval 118.0 to 141.0
|
124.0 mg/dL
Interval 114.0 to 136.0
|
|
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 16 (Week 76)
|
132.0 mg/dL
Interval 119.0 to 146.0
|
125.0 mg/dL
Interval 112.0 to 136.0
|
|
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 18 (Week 100)
|
131.0 mg/dL
Interval 119.0 to 142.5
|
125.0 mg/dL
Interval 115.0 to 138.0
|
|
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Last Visit on Treatment (LVT)
|
132.5 mg/dL
Interval 120.0 to 147.0
|
129.0 mg/dL
Interval 115.5 to 141.0
|
|
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
Follow-up
|
131.0 mg/dL
Interval 119.0 to 146.0
|
127.0 mg/dL
Interval 116.0 to 143.0
|
SECONDARY outcome
Timeframe: 120 weeksPopulation: A select subset of subjects were analyzed for ApoB, Subject data is missing across time points.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=243 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=238 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Baseline
|
66.0 mg/dL
Interval 54.0 to 80.0
|
66.0 mg/dL
Interval 53.0 to 80.0
|
|
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 11 (Week 24)
|
68.5 mg/dL
Interval 55.0 to 80.5
|
68.0 mg/dL
Interval 53.0 to 86.0
|
|
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 14 (Week 52)
|
70.0 mg/dL
Interval 59.0 to 84.0
|
68.0 mg/dL
Interval 56.0 to 85.0
|
|
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 16 (Week 76)
|
70.5 mg/dL
Interval 58.0 to 87.0
|
69.0 mg/dL
Interval 55.0 to 89.0
|
|
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 18 (Week 100)
|
70.5 mg/dL
Interval 59.0 to 85.0
|
72.0 mg/dL
Interval 58.0 to 89.0
|
|
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Last Visit on Treatment (LVT)
|
68.0 mg/dL
Interval 56.0 to 85.0
|
72.0 mg/dL
Interval 57.5 to 89.0
|
|
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
Follow-up
|
70.0 mg/dL
Interval 57.0 to 86.0
|
71.0 mg/dL
Interval 57.0 to 89.0
|
SECONDARY outcome
Timeframe: 120 weeksPopulation: All subjects were analyzed and contributed LDL-C data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms. Subject data is missing across time points.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1206 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Baseline
|
1.690 mmol/L
Interval 1.27 to 2.215
|
1.690 mmol/L
Interval 1.26 to 2.18
|
|
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 11 (Week 24)
|
1.530 mmol/L
Interval 1.16 to 2.01
|
1.530 mmol/L
Interval 1.14 to 1.97
|
|
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 14 (Week 52)
|
1.590 mmol/L
Interval 1.21 to 2.12
|
1.655 mmol/L
Interval 1.24 to 2.13
|
|
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 16 Week 76)
|
1.600 mmol/L
Interval 1.23 to 2.09
|
1.660 mmol/L
Interval 1.27 to 2.1
|
|
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 18 Week 100)
|
1.660 mmol/L
Interval 1.3 to 2.18
|
1.725 mmol/L
Interval 1.3 to 2.22
|
|
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Last Visit on Treatment (LVT)
|
1.700 mmol/L
Interval 1.24 to 2.24
|
1.745 mmol/L
Interval 1.29 to 2.28
|
|
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Follow-up
|
1.650 mmol/L
Interval 1.25 to 2.21
|
1.680 mmol/L
Interval 1.24 to 2.27
|
SECONDARY outcome
Timeframe: 120 weeksPopulation: All subjects were analyzed and contributed HDL-C data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms. Subject data is missing across time points.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1206 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Baseline
|
0.870 mmol/L
Interval 0.77 to 0.96
|
0.860 mmol/L
Interval 0.78 to 0.96
|
|
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 11 (Week 24)
|
0.970 mmol/L
Interval 0.84 to 1.1
|
0.940 mmol/L
Interval 0.81 to 1.06
|
|
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 14 (Week 52)
|
0.970 mmol/L
Interval 0.84 to 1.11
|
0.930 mmol/L
Interval 0.82 to 1.07
|
|
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 16 Week 76)
|
0.960 mmol/L
Interval 0.83 to 1.11
|
0.920 mmol/L
Interval 0.8 to 1.06
|
|
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 18 Week 100)
|
0.970 mmol/L
Interval 0.84 to 1.11
|
0.910 mmol/L
Interval 0.81 to 1.06
|
|
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Last Visit on Treatment (LVT)
|
0.990 mmol/L
Interval 0.87 to 1.145
|
0.960 mmol/L
Interval 0.83 to 1.1
|
|
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
Follow-up
|
1.010 mmol/L
Interval 0.87 to 1.15
|
0.950 mmol/L
Interval 0.85 to 1.1
|
SECONDARY outcome
Timeframe: 120 weeksPopulation: All subjects were analyzed and contributed TG data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms. Subject data is missing across time points.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1206 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Baseline
|
1.630 mmol/L
Interval 1.245 to 2.205
|
1.690 mmol/L
Interval 1.31 to 2.275
|
|
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 11 (Week 24)
|
1.660 mmol/L
Interval 1.26 to 2.26
|
1.670 mmol/L
Interval 1.2 to 2.27
|
|
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 14 (Week 52)
|
1.735 mmol/L
Interval 1.285 to 2.37
|
1.700 mmol/L
Interval 1.22 to 2.33
|
|
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 16 Week 76)
|
1.730 mmol/L
Interval 1.24 to 2.42
|
1.670 mmol/L
Interval 1.2 to 2.33
|
|
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 18 Week 100)
|
1.755 mmol/L
Interval 1.26 to 2.42
|
1.610 mmol/L
Interval 1.24 to 2.42
|
|
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Last Visit on Treatment (LVT)
|
1.700 mmol/L
Interval 1.23 to 2.36
|
1.650 mmol/L
Interval 1.21 to 2.33
|
|
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
Follow-up
|
1.650 mmol/L
Interval 1.2 to 2.3
|
1.720 mmol/L
Interval 1.27 to 2.38
|
SECONDARY outcome
Timeframe: 120 weeksPopulation: All subjects were analyzed and contributed HbA1c data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms Subject data is missing across time points
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1207 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Baseline
|
7.40 % of hemoglobin
Interval 6.4 to 8.7
|
7.30 % of hemoglobin
Interval 6.4 to 8.6
|
|
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Visit 11 (Week 24)
|
7.20 % of hemoglobin
Interval 6.4 to 8.5
|
7.20 % of hemoglobin
Interval 6.4 to 8.4
|
|
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Visit 14 (Week 52)
|
7.30 % of hemoglobin
Interval 6.4 to 8.6
|
7.30 % of hemoglobin
Interval 6.4 to 8.7
|
|
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Visit 16 (Week 76)
|
7.30 % of hemoglobin
Interval 6.5 to 8.65
|
7.40 % of hemoglobin
Interval 6.5 to 8.6
|
|
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Visit 18 (Week 100)
|
7.30 % of hemoglobin
Interval 6.4 to 8.7
|
7.30 % of hemoglobin
Interval 6.5 to 8.7
|
|
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
LVT
|
7.40 % of hemoglobin
Interval 6.4 to 8.9
|
7.30 % of hemoglobin
Interval 6.4 to 8.7
|
|
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
Follow-up
|
7.30 % of hemoglobin
Interval 6.4 to 8.7
|
7.20 % of hemoglobin
Interval 6.4 to 8.6
|
SECONDARY outcome
Timeframe: 120 weeksPopulation: All subjects were analyzed and contributed glucose data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms. Subject data is missing across time points
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1207 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Baseline
|
7.590 mmol/L
Interval 6.14 to 9.73
|
7.385 mmol/L
Interval 6.1 to 9.66
|
|
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Visit 11 (Week 24)
|
7.925 mmol/L
Interval 6.31 to 10.45
|
7.835 mmol/L
Interval 6.23 to 10.24
|
|
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Visit 14 (Week 52)
|
7.900 mmol/L
Interval 6.29 to 10.39
|
7.800 mmol/L
Interval 6.42 to 10.345
|
|
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Visit 16 (Week 76)
|
7.920 mmol/L
Interval 6.39 to 10.34
|
7.840 mmol/L
Interval 6.25 to 10.43
|
|
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Visit 18 (Week 100)
|
8.010 mmol/L
Interval 6.365 to 10.535
|
7.890 mmol/L
Interval 6.28 to 10.67
|
|
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
LVT
|
8.100 mmol/L
Interval 6.44 to 10.75
|
7.795 mmol/L
Interval 6.18 to 10.445
|
|
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
Follow-up
|
7.650 mmol/L
Interval 6.25 to 10.13
|
7.595 mmol/L
Interval 6.08 to 10.11
|
SECONDARY outcome
Timeframe: 172 weeksPopulation: Subject data is missing across time points
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1207 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Baseline
|
78.0 U/L
Interval 64.0 to 95.5
|
77.0 U/L
Interval 64.0 to 93.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 3 (Week 2)
|
71.0 U/L
Interval 58.0 to 88.0
|
76.0 U/L
Interval 62.0 to 91.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 4 (Week 4)
|
70.0 U/L
Interval 58.0 to 88.0
|
75.0 U/L
Interval 63.0 to 92.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 5 (Week 6)
|
70.0 U/L
Interval 56.0 to 87.0
|
75.0 U/L
Interval 61.0 to 93.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 6 (Week 8)
|
69.0 U/L
Interval 56.0 to 86.0
|
76.0 U/L
Interval 62.0 to 92.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 7 (Week 10)
|
69.0 U/L
Interval 56.0 to 86.0
|
75.0 U/L
Interval 62.0 to 92.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 8 (Week 12)
|
69.0 U/L
Interval 56.0 to 87.0
|
75.0 U/L
Interval 62.0 to 93.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 9 (Week 16)
|
68.0 U/L
Interval 55.0 to 85.0
|
75.0 U/L
Interval 61.0 to 92.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 10 (Week 20)
|
68.0 U/L
Interval 55.0 to 86.0
|
74.0 U/L
Interval 61.0 to 92.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 11 (Week 24)
|
68.0 U/L
Interval 55.0 to 84.0
|
75.0 U/L
Interval 60.0 to 92.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 12 (Week 28)
|
69.0 U/L
Interval 55.0 to 85.0
|
74.0 U/L
Interval 61.0 to 93.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 13 (Week 40)
|
69.0 U/L
Interval 56.0 to 87.0
|
74.0 U/L
Interval 61.0 to 93.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 14 (Week 52)
|
71.0 U/L
Interval 57.0 to 89.0
|
76.0 U/L
Interval 61.0 to 96.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 15 (Week 64)
|
71.0 U/L
Interval 57.0 to 87.0
|
74.5 U/L
Interval 62.0 to 95.5
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 16 (Week 76)
|
70.0 U/L
Interval 58.0 to 88.0
|
76.0 U/L
Interval 61.0 to 93.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 17 (Week 88)
|
72.0 U/L
Interval 58.0 to 91.0
|
76.0 U/L
Interval 62.0 to 95.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 18 (Week 100)
|
72.0 U/L
Interval 59.0 to 92.0
|
75.0 U/L
Interval 62.0 to 95.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 19 (Week 112)
|
71.0 U/L
Interval 58.0 to 90.0
|
75.0 U/L
Interval 62.0 to 96.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 20 (Week 124)
|
71.0 U/L
Interval 57.0 to 92.0
|
77.0 U/L
Interval 63.0 to 95.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 21 (Week 136)
|
69.5 U/L
Interval 56.0 to 92.0
|
77.0 U/L
Interval 62.0 to 93.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 22 (Week 148)
|
69.0 U/L
Interval 56.0 to 88.0
|
76.0 U/L
Interval 64.0 to 91.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 23 (Week 160)
|
68.0 U/L
Interval 57.5 to 87.5
|
78.0 U/L
Interval 55.0 to 89.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Visit 24 (Week 172)
|
75.5 U/L
Interval 62.0 to 89.0
|
83.0 U/L
Interval 64.0 to 112.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Last Visit on Treatment (LVT)
|
72.0 U/L
Interval 59.0 to 91.0
|
77.0 U/L
Interval 62.0 to 97.0
|
|
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
Follow-up
|
76.0 U/L
Interval 63.0 to 93.0
|
76.0 U/L
Interval 62.0 to 95.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: A select subset of subjects in two countries were analyzed for CRP, Subject data is missing across time points.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=244 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=239 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups
Baseline
|
2.875 mg/dL
Interval 1.245 to 5.915
|
2.740 mg/dL
Interval 1.13 to 6.15
|
|
Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 8 (Week 12)
|
1.755 mg/dL
Interval 0.875 to 3.895
|
1.805 mg/dL
Interval 1.0 to 4.3
|
|
Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups
Visit 14 (Week 52)
|
1.710 mg/dL
Interval 0.86 to 4.05
|
1.580 mg/dL
Interval 0.72 to 3.71
|
SECONDARY outcome
Timeframe: 120 weeksPopulation: Subject data is missing across time points
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=121 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=162 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
Baseline
|
51.4 ml/min
Interval 41.4 to 56.0
|
48.9 ml/min
Interval 40.6 to 55.9
|
|
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
Visit 11 (Week 24)
|
53.0 ml/min
Interval 41.5 to 63.7
|
53.3 ml/min
Interval 41.4 to 63.2
|
|
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
Visit 14 (Week 52)
|
52.4 ml/min
Interval 41.3 to 62.2
|
52.5 ml/min
Interval 41.8 to 63.0
|
|
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
Visit 16 (Week 76)
|
50.8 ml/min
Interval 37.5 to 63.6
|
54.8 ml/min
Interval 42.5 to 63.8
|
|
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
Visit 18 (Week 100)
|
46.5 ml/min
Interval 34.0 to 59.3
|
56.7 ml/min
Interval 42.4 to 66.0
|
|
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
LVT
|
52.5 ml/min
Interval 39.2 to 62.3
|
53.9 ml/min
Interval 43.3 to 61.1
|
POST_HOC outcome
Timeframe: 120 weeksFirst occurrence of four-point MACE defined as a single composite endpoint of cardiovascular (CV) death (including undetermined cause of death) or non-fatal myocardial infarction (MI), stroke or hospital admission for congestive heart failure.
Outcome measures
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 Participants
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1206 Participants
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Incidence of First Occurrence of Adjudication-Confirmed Four-Point MACE
First Hospitalization for CHF
|
29 events
|
48 events
|
|
Incidence of First Occurrence of Adjudication-Confirmed Four-Point MACE
CV Death (CVD)
|
45 events
|
55 events
|
|
Incidence of First Occurrence of Adjudication-Confirmed Four-Point MACE
Non-fatal MI
|
77 events
|
94 events
|
|
Incidence of First Occurrence of Adjudication-Confirmed Four-Point MACE
Stroke
|
17 events
|
17 events
|
Adverse Events
High-Intensity Statin Therapy+RVX000222
Serious events: 354 serious events
Other events: 830 other events
Deaths: 61 deaths
High-Intensity Statin Therapy+Placebo
Serious events: 339 serious events
Other events: 820 other events
Deaths: 72 deaths
Serious adverse events
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 participants at risk
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1207 participants at risk
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
4.7%
57/1212 • 120 weeks
|
3.2%
39/1207 • 120 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
3.5%
42/1212 • 120 weeks
|
4.1%
49/1207 • 120 weeks
|
|
Cardiac disorders
Angina pectoris
|
2.6%
32/1212 • 120 weeks
|
2.7%
32/1207 • 120 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.91%
11/1212 • 120 weeks
|
2.3%
28/1207 • 120 weeks
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
14/1212 • 120 weeks
|
0.91%
11/1207 • 120 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.83%
10/1212 • 120 weeks
|
0.83%
10/1207 • 120 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.50%
6/1212 • 120 weeks
|
0.75%
9/1207 • 120 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.74%
9/1212 • 120 weeks
|
0.50%
6/1207 • 120 weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
0.41%
5/1212 • 120 weeks
|
0.75%
9/1207 • 120 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.66%
8/1212 • 120 weeks
|
0.50%
6/1207 • 120 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.41%
5/1212 • 120 weeks
|
0.33%
4/1207 • 120 weeks
|
|
Cardiac disorders
Myocardial ischemia
|
0.41%
5/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Cardiac disorders
Cardiac failure chronic
|
0.17%
2/1212 • 120 weeks
|
0.41%
5/1207 • 120 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.08%
1/1212 • 120 weeks
|
0.41%
5/1207 • 120 weeks
|
|
Cardiac disorders
Cardiogenic shock
|
0.17%
2/1212 • 120 weeks
|
0.33%
4/1207 • 120 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.25%
3/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.25%
3/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Cardiac disorders
Ventricular fibrillation
|
0.08%
1/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Cardiac disorders
Left ventricular failure
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Cardiac disorders
Anginal equivalent
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Aortic valve incompetence
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Atrioventricular block
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Cardiac disorders
Intracardiac thrombus
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Cardiac disorders
Myocardial fibrosis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Cardiac disorders
Ventricular failure
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Pneumonia
|
1.2%
15/1212 • 120 weeks
|
1.4%
17/1207 • 120 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.50%
6/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Infections and infestations
Cellulitis
|
0.17%
2/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Infections and infestations
Bronchitis
|
0.17%
2/1212 • 120 weeks
|
0.33%
4/1207 • 120 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.25%
3/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Infections and infestations
Gangrene
|
0.25%
3/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Sepsis
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Infections and infestations
Septic shock
|
0.25%
3/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Infections and infestations
Viral infection
|
0.25%
3/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Diverticulitis
|
0.08%
1/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Infections and infestations
Ertsipelas
|
0.17%
2/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.17%
2/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Urosepsis
|
0.17%
2/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Diabetic gangrene
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Infections and infestations
Acute endocarditis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Anal abscess
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Appendicitis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Appendicitis perforated
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Brain abscess
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Cholecystitis infective
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Cystitis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Device related infection
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Gallbladder empyema
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Hepatitis E
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Hepatitis viral
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Lung infection
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Mediastinitis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Pneumonia necrotising
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Scrotal abscess
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.41%
5/1212 • 120 weeks
|
0.41%
5/1207 • 120 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
4/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Infections and infestations
Syncope
|
0.08%
1/1212 • 120 weeks
|
0.41%
5/1207 • 120 weeks
|
|
Infections and infestations
Transient ischaemic attack
|
0.25%
3/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Quadriparesis
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Cervical cord compression
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Dysarthria
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Febrile convulsion
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Intracranial aneurysm
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Nerve compression
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Parkinson's disease
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Seizure
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
33/1212 • 120 weeks
|
2.1%
25/1207 • 120 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.41%
5/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.25%
3/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.08%
1/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Gastric polyps
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.58%
7/1212 • 120 weeks
|
0.58%
7/1207 • 120 weeks
|
|
Vascular disorders
Hypertension
|
0.17%
2/1212 • 120 weeks
|
0.75%
9/1207 • 120 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.08%
1/1212 • 120 weeks
|
0.58%
7/1207 • 120 weeks
|
|
Vascular disorders
Hypertensive emergency
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.08%
1/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.17%
2/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Vascular disorders
Hypotension
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Vascular disorders
Hypovolaemic shock
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Vascular disorders
Ischaemia
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Vascular disorders
Peripheral artery stenosis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Vascular disorders
Subclavian artery occlusion
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
3/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.17%
2/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatic neoplasm
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage IV
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine neoplasm
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.83%
10/1212 • 120 weeks
|
0.99%
12/1207 • 120 weeks
|
|
General disorders
Sudden death
|
0.17%
2/1212 • 120 weeks
|
0.50%
6/1207 • 120 weeks
|
|
General disorders
Death
|
0.25%
3/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
General disorders
Sudden cardiac death
|
0.00%
0/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
General disorders
Pyrexia
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
General disorders
Vascular stent restenosis
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
General disorders
Chest pain
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
General disorders
Exercise tolerance decreased
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
General disorders
Oedema peripheral
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
General disorders
Vascular stent stenosis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
General disorders
Vascular stent thrombosis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.74%
9/1212 • 120 weeks
|
0.58%
7/1207 • 120 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.33%
4/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Renal and urinary disorders
Calculus ureteric
|
0.17%
2/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.08%
1/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Renal and urinary disorders
Bladder perforation
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Renal and urinary disorders
Calculus bladder
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Renal and urinary disorders
Nephropathy
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Renal and urinary disorders
Renal mass
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Renal and urinary disorders
Ureteric rupture
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.58%
7/1212 • 120 weeks
|
0.75%
9/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.50%
6/1212 • 120 weeks
|
0.41%
5/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
4/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
1/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.08%
1/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus haematoma
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord cyst
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Lumbosacral plexus injury
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Nerve root injury
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Radial head dislocation
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.50%
6/1212 • 120 weeks
|
0.41%
5/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.08%
1/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.08%
1/1212 • 120 weeks
|
0.41%
5/1207 • 120 weeks
|
|
Hepatobiliary disorders
Bile duct stone
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Eye disorders
Cataract
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Eye disorders
Glaucoma
|
0.00%
0/1212 • 120 weeks
|
0.25%
3/1207 • 120 weeks
|
|
Eye disorders
Diabetic retinopathy
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Eye disorders
Eye haemorrhage
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Eye disorders
Hypotony of eye
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Eye disorders
Iris bombe
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
4/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.25%
3/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.17%
2/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Investigations
Blood pressure abnormal
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Psychiatric disorders
Depression
|
0.08%
1/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Psychiatric disorders
Anxiety disorder
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Psychiatric disorders
Confusional state
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.17%
2/1212 • 120 weeks
|
0.17%
2/1207 • 120 weeks
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.17%
2/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.08%
1/1212 • 120 weeks
|
0.00%
0/1207 • 120 weeks
|
|
Immune system disorders
Amyloidosis
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/1212 • 120 weeks
|
0.08%
1/1207 • 120 weeks
|
Other adverse events
| Measure |
High-Intensity Statin Therapy+RVX000222
n=1212 participants at risk
Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Apabetalone: 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
High-Intensity Statin Therapy+Placebo
n=1207 participants at risk
Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin)
Placebo: Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatin: High-Intensity Statin
Rosuvastatin: High-Intensity Statin
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.8%
46/1212 • 120 weeks
|
4.6%
56/1207 • 120 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.8%
58/1212 • 120 weeks
|
3.3%
40/1207 • 120 weeks
|
|
Infections and infestations
Influenza
|
3.5%
43/1212 • 120 weeks
|
3.9%
47/1207 • 120 weeks
|
|
Infections and infestations
Bronchitis
|
2.1%
25/1212 • 120 weeks
|
2.7%
32/1207 • 120 weeks
|
|
Infections and infestations
Pneumonia
|
2.2%
27/1212 • 120 weeks
|
2.2%
26/1207 • 120 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
29/1212 • 120 weeks
|
2.0%
24/1207 • 120 weeks
|
|
Cardiac disorders
Angina
|
6.1%
74/1212 • 120 weeks
|
6.3%
76/1207 • 120 weeks
|
|
Cardiac disorders
Angina unstable
|
4.8%
58/1212 • 120 weeks
|
3.4%
41/1207 • 120 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
3.5%
42/1212 • 120 weeks
|
4.1%
50/1207 • 120 weeks
|
|
Cardiac disorders
Cardiac failure
|
1.8%
22/1212 • 120 weeks
|
3.1%
38/1207 • 120 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
43/1212 • 120 weeks
|
3.6%
44/1207 • 120 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
12/1212 • 120 weeks
|
2.0%
24/1207 • 120 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.1%
26/1212 • 120 weeks
|
0.58%
7/1207 • 120 weeks
|
|
Gastrointestinal disorders
Hepatobiliary
|
2.0%
24/1212 • 120 weeks
|
3.5%
42/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
37/1212 • 120 weeks
|
2.7%
33/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
27/1212 • 120 weeks
|
2.3%
28/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
15/1212 • 120 weeks
|
2.2%
26/1207 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.91%
11/1212 • 120 weeks
|
2.0%
24/1207 • 120 weeks
|
|
Metabolism and nutrition disorders
Worsening diabetes mellitus
|
7.7%
93/1212 • 120 weeks
|
7.7%
93/1207 • 120 weeks
|
|
Vascular disorders
Hypertension
|
5.9%
72/1212 • 120 weeks
|
6.0%
72/1207 • 120 weeks
|
|
Investigations
ALT increase
|
5.3%
64/1212 • 120 weeks
|
1.5%
18/1207 • 120 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.7%
33/1212 • 120 weeks
|
3.2%
39/1207 • 120 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
36/1212 • 120 weeks
|
3.3%
40/1207 • 120 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place