Trial Outcomes & Findings for A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis (NCT NCT02546323)
NCT ID: NCT02546323
Last Updated: 2019-12-11
Results Overview
CIMT measurements were made from ultrasound images of the common carotid artery (CCA), carotid bulb and internal carotid artery (ICA). The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. Twelve carotid artery sites were scanned at each visit and the 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for a specific segment. The annualized rate of change in the MeanMax CIMT measurements from each of the 12 sites, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
543 participants
Primary outcome timeframe
From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
Results posted on
2019-12-11
Participant Flow
Chinese patients with subclinical atherosclerosis and a 10-year ischemic cardiovascular disease (ICVD) risk of less than 10% (as assessed by the 2007 China Adult Dyslipidema Management Guidelines) were enrolled at 25 sites in China between 17 September 2015 and 29 January 2019.
Eligible patients with carotid intima-media thickness (CIMT) measurements of maximum CIMT ≥1.2 millimeters (mm) and \<3.5 mm were randomized to receive either rosuvastatin 20 milligrams (mg) or corresponding placebo once daily. Randomization was stratified by ICVD risk (\<5% or 5% to 10%).
Participant milestones
| Measure |
Rosuvastatin 20 mg
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
272
|
271
|
|
Overall Study
Received Treatment
|
272
|
268
|
|
Overall Study
COMPLETED
|
212
|
205
|
|
Overall Study
NOT COMPLETED
|
60
|
66
|
Reasons for withdrawal
| Measure |
Rosuvastatin 20 mg
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
36
|
33
|
|
Overall Study
Eligibility Criteria not Fulfilled
|
0
|
1
|
|
Overall Study
Adverse Event
|
17
|
11
|
|
Overall Study
Patient Specific Reasons
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Non-compliance with Study Drug
|
2
|
2
|
|
Overall Study
Met Withdrawal Criteria
|
2
|
14
|
Baseline Characteristics
A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
Baseline characteristics by cohort
| Measure |
Rosuvastatin 20 mg
n=272 Participants
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=271 Participants
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 5.23 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 4.96 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 5.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
272 Participants
n=5 Participants
|
271 Participants
n=7 Participants
|
543 Participants
n=5 Participants
|
|
10-year ICVD Risk
<5%
|
196 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
10-year ICVD Risk
≥5% - <10%
|
76 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).Population: The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.
CIMT measurements were made from ultrasound images of the common carotid artery (CCA), carotid bulb and internal carotid artery (ICA). The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. Twelve carotid artery sites were scanned at each visit and the 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for a specific segment. The annualized rate of change in the MeanMax CIMT measurements from each of the 12 sites, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.
Outcome measures
| Measure |
Rosuvastatin 20 mg
n=272 Participants
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=271 Participants
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period
|
0.0038 mm/year
Standard Error 0.00312
|
0.0142 mm/year
Standard Error 0.00317
|
SECONDARY outcome
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).Population: The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.
CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.
Outcome measures
| Measure |
Rosuvastatin 20 mg
n=272 Participants
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=271 Participants
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA
|
-0.0031 mm/year
Standard Error 0.00310
|
0.0079 mm/year
Standard Error 0.00315
|
SECONDARY outcome
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).Population: The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.
CIMT measurements were made from ultrasound images of the near and far walls of the right and left carotid bulb. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.
Outcome measures
| Measure |
Rosuvastatin 20 mg
n=272 Participants
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=271 Participants
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb
|
0.0067 mm/year
Standard Error 0.00634
|
0.0228 mm/year
Standard Error 0.00643
|
SECONDARY outcome
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).Population: The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.
CIMT measurements were made from ultrasound images of the near and far walls of the right and left ICA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.
Outcome measures
| Measure |
Rosuvastatin 20 mg
n=272 Participants
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=271 Participants
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA
|
0.0077 mm/year
Standard Error 0.00502
|
0.0120 mm/year
Standard Error 0.00511
|
SECONDARY outcome
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).Population: The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.
CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the mean of the CIMT for this segment. The annualized rate of change in the MeanMean CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.
Outcome measures
| Measure |
Rosuvastatin 20 mg
n=272 Participants
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=271 Participants
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA
|
-0.0011 mm/year
Standard Error 0.00191
|
0.0075 mm/year
Standard Error 0.00194
|
SECONDARY outcome
Timeframe: From baseline (Week 0) to end-of-study (Week 104).Population: The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.
The percent change from baseline at final visit for lipid and lipoprotein measurements (low-density lipoprotein cholesterol \[LDL-C\], total cholesterol, high-density lipoprotein cholesterol \[HDL-C\], triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) and apolipoprotein measurements (apolipoprotein A-I \[ApoA-I\], apolipoprotein B \[ApoB\] and ApoB/ApoA-I ratio) was determined by analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0) to the final visit at Week 104, any missing observations were imputed by LOCF.
Outcome measures
| Measure |
Rosuvastatin 20 mg
n=272 Participants
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=271 Participants
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
LDL-C
|
-26.47 Percent change
Standard Error 1.700
|
8.99 Percent change
Standard Error 1.727
|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
Total Cholesterol
|
-20.56 Percent change
Standard Error 1.010
|
1.29 Percent change
Standard Error 1.026
|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
HDL-C
|
5.47 Percent change
Standard Error 0.944
|
0.48 Percent change
Standard Error 0.959
|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
Triglycerides
|
-7.26 Percent change
Standard Error 2.575
|
12.38 Percent change
Standard Error 2.616
|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
Non-HDL-C
|
-27.67 Percent change
Standard Error 1.344
|
1.82 Percent change
Standard Error 1.365
|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
Non-HDL-C/HDL-C
|
-28.52 Percent change
Standard Error 1.637
|
3.23 Percent change
Standard Error 1.663
|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
ApoB
|
-24.20 Percent change
Standard Error 1.307
|
1.91 Percent change
Standard Error 1.295
|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
ApoA-I
|
3.16 Percent change
Standard Error 0.784
|
0.96 Percent change
Standard Error 0.777
|
|
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
ApoB/ApoA-I
|
-25.14 Percent change
Standard Error 1.450
|
1.63 Percent change
Standard Error 1.436
|
SECONDARY outcome
Timeframe: From baseline (Week 0) to end-of-study (Week 104).Population: The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.
The percent change from baseline at final visit for lipid and lipoprotein measurements (LDL-C, total cholesterol, HDL-C, triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) was determined by ANCOVA with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0), the time-weighted average value was calculated as the value multiplied by the number of days since the last assessment, summed for all observations, and divided by the sum of days between all visits.
Outcome measures
| Measure |
Rosuvastatin 20 mg
n=272 Participants
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=271 Participants
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
LDL-C
|
-34.89 Percent change
Standard Error 1.275
|
4.62 Percent change
Standard Error 1.295
|
|
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
Total Cholesterol
|
-23.98 Percent change
Standard Error 0.798
|
1.49 Percent change
Standard Error 0.811
|
|
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
HDL-C
|
7.07 Percent change
Standard Error 0.737
|
3.41 Percent change
Standard Error 0.748
|
|
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
Triglycerides
|
-9.05 Percent change
Standard Error 2.091
|
9.36 Percent change
Standard Error 2.124
|
|
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
Non-HDL-C
|
-32.59 Percent change
Standard Error 1.072
|
1.19 Percent change
Standard Error 1.089
|
|
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
Non-HDL-C/HDL-C
|
-34.31 Percent change
Standard Error 1.288
|
-0.38 Percent change
Standard Error 1.308
|
Adverse Events
Rosuvastatin 20 mg
Serious events: 38 serious events
Other events: 144 other events
Deaths: 0 deaths
Placebo
Serious events: 34 serious events
Other events: 142 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Rosuvastatin 20 mg
n=272 participants at risk
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=268 participants at risk
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.75%
2/268 • Number of events 2 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Cardiac disorders
Arrhythmia
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.75%
2/268 • Number of events 2 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Endocrine disorders
Goitre
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Endocrine disorders
Thyroid mass
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Eye disorders
Cataract
|
0.74%
2/272 • Number of events 3 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Eye disorders
Iridocyclitis
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Eye disorders
Pathologic myopia
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Eye disorders
Pterygium
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Eye disorders
Retinal detachment
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Anal fistula
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Gastritis
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
General disorders
Pyrexia
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Herpes zoster
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Infection
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Pneumonia
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.75%
2/268 • Number of events 2 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Investigations
Investigation
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.75%
2/268 • Number of events 2 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.74%
2/272 • Number of events 4 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Nervous system disorders
Cerebral infarction
|
0.74%
2/272 • Number of events 2 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Nervous system disorders
Dizziness
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.00%
0/268 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/272 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Vascular disorders
Hypertension
|
0.37%
1/272 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
0.37%
1/268 • Number of events 1 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
Other adverse events
| Measure |
Rosuvastatin 20 mg
n=272 participants at risk
Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
Placebo
n=268 participants at risk
Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Toothache
|
8.5%
23/272 • Number of events 39 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
5.6%
15/268 • Number of events 23 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Nasopharyngitis
|
19.1%
52/272 • Number of events 79 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
20.9%
56/268 • Number of events 77 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.0%
49/272 • Number of events 74 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
20.1%
54/268 • Number of events 71 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Investigations
Blood glucose increased
|
8.8%
24/272 • Number of events 24 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
6.7%
18/268 • Number of events 18 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Investigations
Protein urine present
|
5.9%
16/272 • Number of events 16 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
3.4%
9/268 • Number of events 10 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Nervous system disorders
Dizziness
|
5.1%
14/272 • Number of events 17 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
6.0%
16/268 • Number of events 24 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
14/272 • Number of events 18 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
5.6%
15/268 • Number of events 19 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
|
Vascular disorders
Hypertension
|
7.0%
19/272 • Number of events 19 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
7.8%
21/268 • Number of events 27 • Treatment Emergent Adverse Events were collected from day of first dose in Week 0 up to and including 10 days following the date of last dose of investigational product or placebo (up to Week 104).
The safety analysis set consisted of all patients who took at least 1 dose of investigational product or placebo. Patients were analyzed according to treatment actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place