Trial Outcomes & Findings for Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (NCT NCT05142722)

NCT ID: NCT05142722

Last Updated: 2025-09-19

Results Overview

LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2530 participants
• Primary outcome timeframe: 84 Days
• Results posted on: 2025-09-19

Participant Flow

4214 patients were screened: out of 4214, 2530 participants were randomized (2:1) (obicetrapib: placebo): 1686 participants to the obicetrapib 10 mg group and 844 participants to the placebo group

Participant milestones

Measure	Placebo one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Overall Study STARTED	844	1686
Overall Study COMPLETED	795	1600
Overall Study NOT COMPLETED	49	86

Reasons for withdrawal

Measure	Placebo one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Overall Study Lost to Follow-up	16	38
Overall Study Withdrawal by Subject	20	27
Overall Study Death	11	17
Overall Study Physician Decision	0	1
Overall Study Participant Moved Away	0	2
Overall Study Adverse Event	2	1

Baseline Characteristics

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Baseline characteristics by cohort

Measure	Placebo n=844 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1686 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet	Total n=2530 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 9.61 • n=5 Participants	65.4 years STANDARD_DEVIATION 9.90 • n=7 Participants	65.4 years STANDARD_DEVIATION 9.80 • n=5 Participants
Sex: Female, Male Female	280 Participants n=5 Participants	573 Participants n=7 Participants	853 Participants n=5 Participants
Sex: Female, Male Male	564 Participants n=5 Participants	1113 Participants n=7 Participants	1677 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants	80 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	798 Participants n=5 Participants	1605 Participants n=7 Participants	2403 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	150 Participants n=5 Participants	312 Participants n=7 Participants	462 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	39 Participants n=5 Participants	112 Participants n=7 Participants	151 Participants n=5 Participants
Race (NIH/OMB) White	647 Participants n=5 Participants	1241 Participants n=7 Participants	1888 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)	98.4 mg/dL STANDARD_DEVIATION 37.94 • n=5 Participants	98.1 mg/dL STANDARD_DEVIATION 37.05 • n=7 Participants	98.25 mg/dL STANDARD_DEVIATION 37.5 • n=5 Participants

PRIMARY outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).

Outcome measures

Measure	Placebo n=842 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1679 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]	2.70 percent change from baseline Standard Error 1.571	-29.94 percent change from baseline Standard Error 1.104

SECONDARY outcome

Timeframe: 180 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [Martin/Hopkins]. LDL-C value was calculated using the Martin/Hopkins equation unless TG >= 400 mg/dL or LDL-C <= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]	4.68 percent change from baseline Standard Error 1.625	-29.09 percent change from baseline Standard Error 1.176

SECONDARY outcome

Timeframe: 365 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).

Outcome measures

Measure	Placebo n=842 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1679 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]	-1.27 percent change from baseline Standard Error 1.798	-25.25 percent change from baseline Standard Error 1.480

SECONDARY outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84	1.08 percent change from baseline Standard Error 0.911	-17.84 percent change from baseline Standard Error 0.669

SECONDARY outcome

Timeframe: 180 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180	2.23 percent change from baseline Standard Error 1.033	-16.07 percent change from baseline Standard Error 0.742

SECONDARY outcome

Timeframe: 365 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365	-1.77 percent change from baseline Standard Error 1.165	-15.57 percent change from baseline Standard Error 0.914

SECONDARY outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Non-HDL-C From Baseline to Day 84	2.81 percent change from baseline Standard Error 1.212	-26.64 percent change from baseline Standard Error 0.892

SECONDARY outcome

Timeframe: 180 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Non-HDL-C From Baseline to Day 180	3.68 percent change from baseline Standard Error 1.302	-24.63 percent change from baseline Standard Error 0.972

SECONDARY outcome

Timeframe: 365 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Non-HDL-C From Baseline to Day 365	0.63 percent change from baseline Standard Error 1.480	-22.38 percent change from baseline Standard Error 1.186

SECONDARY outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in HDL-C From Baseline to Day 84	0.61 percent change from baseline Standard Error 1.391	136.87 percent change from baseline Standard Error 1.857

SECONDARY outcome

Timeframe: 180 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in HDL-C From Baseline to Day 180	1.18 percent change from baseline Standard Error 1.897	135.61 percent change from baseline Standard Error 2.192

SECONDARY outcome

Timeframe: 365 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in HDL-C From Baseline to Day 365	3.36 percent change from baseline Standard Error 1.651	125.40 percent change from baseline Standard Error 2.193

SECONDARY outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 84 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Lp(a) From Baseline to Day 84	13.65 percent change from baseline Standard Error 8.240	-0.48 percent change from baseline Standard Error 19.855

SECONDARY outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 84 in Apolipoprotein A1 (ApoA1) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Apolipoprotein A1 (ApoA1) From Baseline to Day 84	0.26 percent change from baseline Standard Error 0.597	43.44 percent change from baseline Standard Error 0.686

SECONDARY outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Total Cholesterol From Baseline to Day 84	-0.02 percent change from baseline Standard Error 0.757	17.66 percent change from baseline Standard Error 0.702

SECONDARY outcome

Timeframe: 180 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Total Cholesterol From Baseline to Day 180	0.85 percent change from baseline Standard Error 0.893	18.68 percent change from baseline Standard Error 0.769

SECONDARY outcome

Timeframe: 365 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Total Cholesterol From Baseline to Day 365	-0.58 percent change from baseline Standard Error 1.030	17.96 percent change from baseline Standard Error 0.886

SECONDARY outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Triglycerides From Baseline to Day 84	7.66 percent change from baseline Standard Error 1.814	-0.17 percent change from baseline Standard Error 1.445

SECONDARY outcome

Timeframe: 180 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Triglycerides From Baseline to Day 180	8.22 percent change from baseline Standard Error 2.061	0.25 percent change from baseline Standard Error 1.584

SECONDARY outcome

Timeframe: 365 days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Triglycerides From Baseline to Day 365	6.33 percent change from baseline Standard Error 2.135	0.60 percent change from baseline Standard Error 1.781

POST_HOC outcome

Timeframe: 84 Days

Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.

Median percent change from baseline to Day 84 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group.

Outcome measures

Measure	Placebo n=843 Participants one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 Participants one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Percent Change in Lp(a) From Baseline to Day 84 (Hodges-Lehman)	-0.9 percent change from baseline Interval -15.7 to 13.0	-32.3 percent change from baseline Interval -62.8 to -4.7

Adverse Events

Placebo

Serious events: 117 serious events

Other events: 241 other events

Deaths: 12 deaths

Obicetrapib 10mg

Serious events: 211 serious events

Other events: 459 other events

Deaths: 19 deaths

Serious adverse events

Measure	Placebo n=843 participants at risk one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 participants at risk one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Cardiac disorders Acute myocardial infarction	1.2% 10/843 • Number of events 10 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	1.0% 17/1685 • Number of events 18 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Angina unstable	0.95% 8/843 • Number of events 9 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	1.0% 17/1685 • Number of events 17 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Coronary artery disease	0.47% 4/843 • Number of events 5 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.42% 7/1685 • Number of events 8 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Myocardial infarction	0.83% 7/843 • Number of events 8 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac failure	0.47% 4/843 • Number of events 4 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.30% 5/1685 • Number of events 5 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Angina pectoris	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.42% 7/1685 • Number of events 7 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Acute left ventricular failure	0.47% 4/843 • Number of events 4 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.36% 6/1685 • Number of events 6 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Arteriosclerosis coronary artery	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.24% 4/1685 • Number of events 4 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Atrial fibrillation	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.24% 4/1685 • Number of events 5 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Bradycardia	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Myocardial ischaemia	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Acute coronary syndrome	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Atrial flutter	0.36% 3/843 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac arrest	0.24% 2/843 • Number of events 4 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac failure chronic	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Chronic coronary syndrome	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Coronary artery stenosis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac failure acute	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Ventricular extrasystoles	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Ventricular fibrillation	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Atrioventricular block complete	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Atrioventricular block second degree	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiogenic shock	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiovascular disorder	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Left ventricular failure	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Microvascular coronary artery disease	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Sinus node dysfunction	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Ventricular arrhythmia	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Ventricular tachycardia	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia	0.71% 6/843 • Number of events 6 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.53% 9/1685 • Number of events 9 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Urinary tract infection	0.36% 3/843 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.24% 4/1685 • Number of events 4 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Cellulitis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.24% 4/1685 • Number of events 5 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations COVID-19	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Influenza	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Osteomyelitis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Osteomyelitis acute	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia bacterial	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Sepsis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Upper respiratory tract infection	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Abscess oral	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Bronchiolitis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Chronic sinusitis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Diverticulitis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Endocarditis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Gastroenteritis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Herpes zoster	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Klebsiella infection	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Localised infection	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Neutropenic sepsis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Parainfluenzae virus infection	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia influenzal	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia viral	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Post procedural cellulitis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Pyelonephritis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Rhinitis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Septic shock	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Superinfection bacterial	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Wound infection	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebral infarction	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.42% 7/1685 • Number of events 7 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Transient ischaemic attack	0.36% 3/843 • Number of events 4 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.36% 6/1685 • Number of events 7 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebrovascular accident	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.42% 7/1685 • Number of events 7 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Ischaemic stroke	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.24% 4/1685 • Number of events 4 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Syncope	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Carotid artery stenosis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Diabetic neuropathy	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Embolic cerebral infarction	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Ataxia	0.12% 1/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Brain stem haemorrhage	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dysarthria	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Facial nerve disorder	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Haemorrhage intracranial	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Hemiparesis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Lacunar infarction	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Migraine with aura	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Presyncope	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Tension headache	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Toxic encephalopathy	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Chest pain	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Non-cardiac chest pain	0.36% 3/843 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Death	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Sudden cardiac death	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Asthenia	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Exercise tolerance decreased	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Cardiac death	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Chest discomfort	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Fat necrosis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Fatigue	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Pyrexia	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Sudden death	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Vascular stent stenosis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.24% 4/1685 • Number of events 5 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Vocal cord thickening	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Rectal polyp	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Colitis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Colitis ischaemic	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Enteritis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Faecaloma	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastritis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Ileus paralytic	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Mesenteric artery thrombosis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Rectal fissure	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Small intestinal obstruction	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage IV	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Joint injury	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Concussion	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Craniofacial injury	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Delayed recovery from anaesthesia	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Femur fracture	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Limb traumatic amputation	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Sternal fracture	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Thermal burn	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertension	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypotension	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Aortic stenosis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Peripheral artery occlusion	0.12% 1/843 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Aortic aneurysm	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Deep vein thrombosis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertensive emergency	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Iliac artery stenosis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Intermittent claudication	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Peripheral vascular disorder	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Peripheral venous disease	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Shock	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Varicose vein	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.24% 4/1685 • Number of events 4 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Back pain	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Chest wall haematoma	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Acute kidney injury	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.30% 5/1685 • Number of events 5 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Urinary retention	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Chronic kidney disease	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Renal failure	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Ureterolithiasis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyponatraemia	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Dehydration	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Diabetic complication	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholecystitis	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Bile duct stone	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Biliary obstruction	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Liver injury	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Anaemia	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.18% 3/1685 • Number of events 3 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations International normalised ratio increased	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations Troponin increased	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations White blood cell count increased	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.24% 2/843 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Eye disorders Cataract	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Eye disorders Cataract nuclear	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Eye disorders Diabetic retinopathy	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Alcoholism	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Cardiovascular somatic symptom disorder	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Mental status changes	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.12% 2/1685 • Number of events 2 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Endocrine disorders Goitre	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Endocrine disorders Primary hyperaldosteronism	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Ear and labyrinth disorders Vertigo	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Immune system disorders Seasonal allergy	0.00% 0/843 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.06% 1/1685 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Product Issues Device malfunction	0.12% 1/843 • Number of events 1 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/1685 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.

Other adverse events

Measure	Placebo n=843 participants at risk one placebo tablet once daily Placebo: placebo tablet made to resemble active	Obicetrapib 10mg n=1685 participants at risk one 10mg obicetrapib tablet once daily Obicetrapib: 10mg obicetrapib tablet
Infections and infestations COVID-19	5.7% 48/843 • Number of events 49 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	4.8% 81/1685 • Number of events 81 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Upper respiratory tract infection	3.9% 33/843 • Number of events 35 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	2.9% 49/1685 • Number of events 54 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Nasopharyngitis	2.6% 22/843 • Number of events 26 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	2.6% 43/1685 • Number of events 55 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Urinary tract infection	2.5% 21/843 • Number of events 25 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	2.3% 39/1685 • Number of events 41 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 24/843 • Number of events 28 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	2.3% 38/1685 • Number of events 40 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperglycaemia	3.3% 28/843 • Number of events 33 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	2.6% 44/1685 • Number of events 46 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Headache	2.0% 17/843 • Number of events 18 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	2.6% 43/1685 • Number of events 45 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	1.8% 15/843 • Number of events 15 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	2.4% 40/1685 • Number of events 44 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertension	3.9% 33/843 • Number of events 33 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.	4.9% 82/1685 • Number of events 89 • From first dose of study drug up to Week 54 Safety Population included all participants who received at least 1 dose of any study drug.

Additional Information

Study Director

NewAmsterdam Pharma

Phone: +1(305) 627-3081

Email: study.director@newamsterdampharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee After the multicenter publication or 12 months after completion of the study, whichever occurs first, Institution may publish the results of its study data. Institution and PI shall provide sponsor with an advance copy of any proposed communications at least 60 days prior and Sponsor shall have 60 days to review. Sponsor may request (a) the deletion of any Confidential Information, (b) reasonable changes, or (c) a delay for an additional period, not to exceed 90 days.
• Publication restrictions are in place

Restriction type: OTHER