Trial Outcomes & Findings for Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting (NCT NCT02565615)

NCT ID: NCT02565615

Last Updated: 2021-02-21

Results Overview

Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.

• Recruitment status: COMPLETED
• Target enrollment: 5115 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-02-21

Participant Flow

Participant milestones

Measure	Atorvastatin <=10 mg Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Overall Study STARTED	291	3080	21	101	1622
Overall Study Treated	291	3080	21	101	1055
Overall Study COMPLETED	288	3044	21	98	21
Overall Study NOT COMPLETED	3	36	0	3	1601

Reasons for withdrawal

Measure	Atorvastatin <=10 mg Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Overall Study Death	0	1	0	0	4
Overall Study Not willing to participate in study	2	21	0	1	169
Overall Study Lost to Follow-up	0	4	0	1	765
Overall Study Not meeting eligibility criteria	0	7	0	0	25
Overall Study Reason not defined	0	2	0	1	62
Overall Study Adverse Event	1	1	0	0	9
Overall Study Untreated	0	0	0	0	567

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.	Total n=4548 Participants Total of all reporting groups
Age, Continuous	64.2 Years STANDARD_DEVIATION 12.0 • n=291 Participants	61.3 Years STANDARD_DEVIATION 11.6 • n=3080 Participants	59.5 Years STANDARD_DEVIATION 8.4 • n=21 Participants	63.2 Years STANDARD_DEVIATION 11.3 • n=101 Participants	62.2 Years STANDARD_DEVIATION 12.3 • n=1055 Participants	61.7 Years STANDARD_DEVIATION 11.8 • n=4548 Participants
Sex: Female, Male Female	144 Participants n=291 Participants	1390 Participants n=3080 Participants	11 Participants n=21 Participants	39 Participants n=101 Participants	483 Participants n=1055 Participants	2067 Participants n=4548 Participants
Sex: Female, Male Male	147 Participants n=291 Participants	1690 Participants n=3080 Participants	10 Participants n=21 Participants	62 Participants n=101 Participants	572 Participants n=1055 Participants	2481 Participants n=4548 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weight	64.9 kg STANDARD_DEVIATION 11.0 • n=282 Participants • Included participants with non-missing values	67.9 kg STANDARD_DEVIATION 11.8 • n=3029 Participants • Included participants with non-missing values	68.6 kg STANDARD_DEVIATION 8.2 • n=21 Participants • Included participants with non-missing values	67.5 kg STANDARD_DEVIATION 11.4 • n=98 Participants • Included participants with non-missing values	66.0 kg STANDARD_DEVIATION 12.2 • n=1026 Participants • Included participants with non-missing values	67.3 kg STANDARD_DEVIATION 11.9 • n=4456 Participants • Included participants with non-missing values
Height	163.3 cm STANDARD_DEVIATION 7.8 • n=282 Participants • Included participants with non-missing values	164.6 cm STANDARD_DEVIATION 7.8 • n=3035 Participants • Included participants with non-missing values	166.0 cm STANDARD_DEVIATION 6.9 • n=21 Participants • Included participants with non-missing values	163.8 cm STANDARD_DEVIATION 8.4 • n=98 Participants • Included participants with non-missing values	164.1 cm STANDARD_DEVIATION 7.7 • n=1024 Participants • Included participants with non-missing values	164.4 cm STANDARD_DEVIATION 7.8 • n=4460 Participants • Included participants with non-missing values

PRIMARY outcome

Timeframe: 12 weeks

Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. "Atorvastatin Unknown Dosage" arm did not meet FAS criteria.

Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.

Outcome measures

Measure	Atorvastatin <=10 mg n=141 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=1445 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=6 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=58 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall	0.79 Ratio Interval 0.716 to 0.857	0.67 Ratio Interval 0.64 to 0.69	0.83 Ratio Interval 0.359 to 0.996	0.57 Ratio Interval 0.432 to 0.698	—

PRIMARY outcome

Timeframe: 12 weeks

Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. "Atorvastatin Unknown Dosage" arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.

Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=141 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=1445 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=6 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=58 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level Low risk	1.00 Ratio Interval 0.735 to 1.0	0.93 Ratio Interval 0.87 to 0.967	—	1.00 Ratio Interval 0.158 to 1.0	—
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level Moderate risk	1.00 Ratio Interval 0.839 to 1.0	0.89 Ratio Interval 0.827 to 0.936	—	0.78 Ratio Interval 0.4 to 0.972	—
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level High risk	0.77 Ratio Interval 0.671 to 0.855	0.68 Ratio Interval 0.649 to 0.718	0.83 Ratio Interval 0.359 to 0.996	0.56 Ratio Interval 0.349 to 0.756	—
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level Very High risk	0.53 Ratio Interval 0.289 to 0.756	0.48 Ratio Interval 0.432 to 0.529	—	0.45 Ratio Interval 0.244 to 0.678	—

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. "Atorvastatin Unknown Dosage" arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.

Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline data was reported.

Outcome measures

Measure	Atorvastatin <=10 mg n=141 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=1445 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=6 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=58 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Change From Baseline for Lipid Parameters at Week 12 for Overall Cholesterol	-24.81 milligram/deciliter (mg/dL) Standard Deviation 43.971	-45.12 milligram/deciliter (mg/dL) Standard Deviation 394.177	-40.35 milligram/deciliter (mg/dL) Standard Deviation 44.527	-36.98 milligram/deciliter (mg/dL) Standard Deviation 54.175	—
Change From Baseline for Lipid Parameters at Week 12 for Overall Cholesterol (HDL)	0.55 milligram/deciliter (mg/dL) Standard Deviation 10.619	0.44 milligram/deciliter (mg/dL) Standard Deviation 13.643	0.13 milligram/deciliter (mg/dL) Standard Deviation 7.421	-0.17 milligram/deciliter (mg/dL) Standard Deviation 8.493	—
Change From Baseline for Lipid Parameters at Week 12 for Overall Cholesterol (LDL)	-25.26 milligram/deciliter (mg/dL) Standard Deviation 35.375	-31.47 milligram/deciliter (mg/dL) Standard Deviation 38.285	-31.40 milligram/deciliter (mg/dL) Standard Deviation 34.152	-36.00 milligram/deciliter (mg/dL) Standard Deviation 40.783	—
Change From Baseline for Lipid Parameters at Week 12 for Overall Triglycerides	-2.69 milligram/deciliter (mg/dL) Standard Deviation 94.228	-27.55 milligram/deciliter (mg/dL) Standard Deviation 107.785	-83.19 milligram/deciliter (mg/dL) Standard Deviation 151.512	-20.97 milligram/deciliter (mg/dL) Standard Deviation 160.296	—

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. "Atorvastatin Unknown Dosage" arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.

Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.

Outcome measures

Measure	Atorvastatin <=10 mg n=141 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=1445 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=6 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=58 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall Cholesterol	-9.96 Percent Change (%) Standard Deviation 24.219	-13.66 Percent Change (%) Standard Deviation 34.091	-17.33 Percent Change (%) Standard Deviation 19.989	-3.07 Percent Change (%) Standard Deviation 104.388	—
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall Cholesterol (HDL)	3.68 Percent Change (%) Standard Deviation 26.013	4.18 Percent Change (%) Standard Deviation 25.386	1.52 Percent Change (%) Standard Deviation 15.985	0.91 Percent Change (%) Standard Deviation 15.835	—
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall Cholesterol (LDL)	-17.40 Percent Change (%) Standard Deviation 32.437	-20.11 Percent Change (%) Standard Deviation 50.643	-22.57 Percent Change (%) Standard Deviation 26.524	-23.68 Percent Change (%) Standard Deviation 25.476	—
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall Triglycerides	12.03 Percent Change (%) Standard Deviation 82.582	-4.04 Percent Change (%) Standard Deviation 52.636	-27.55 Percent Change (%) Standard Deviation 33.921	-12.33 Percent Change (%) Standard Deviation 34.679	—

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. "Atorvastatin Unknown Dosage" arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.

Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline data was reported.

Outcome measures

Measure	Atorvastatin <=10 mg n=141 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=1445 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=6 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=58 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol-Low risk	-51.42 mg/dL Standard Deviation 42.967	-47.99 mg/dL Standard Deviation 56.938	—	-94.98 mg/dL Standard Deviation 71.530	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol-Moderate risk	-26.97 mg/dL Standard Deviation 42.807	-43.23 mg/dL Standard Deviation 49.231	—	-5.28 mg/dL Standard Deviation 61.380	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol- High risk	-27.04 mg/dL Standard Deviation 43.996	-56.59 mg/dL Standard Deviation 552.696	-40.35 mg/dL Standard Deviation 44.527	-38.43 mg/dL Standard Deviation 49.029	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol- Very high risk	4.63 mg/dL Standard Deviation 31.528	-25.78 mg/dL Standard Deviation 49.060	—	-43.16 mg/dL Standard Deviation 51.923	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol (HDL)- Low risk	-0.29 mg/dL Standard Deviation 8.445	-1.80 mg/dL Standard Deviation 9.943	—	-8.30 mg/dL Standard Deviation 24.298	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol (HDL)- Moderate risk	1.27 mg/dL Standard Deviation 10.964	-0.92 mg/dL Standard Deviation 10.398	—	5.06 mg/dL Standard Deviation 10.908	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol (HDL)- High risk	0.18 mg/dL Standard Deviation 11.112	0.64 mg/dL Standard Deviation 14.169	0.13 mg/dL Standard Deviation 7.421	1.21 mg/dL Standard Deviation 5.473	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol (HDL)- Very high risk	1.99 mg/dL Standard Deviation 9.675	1.25 mg/dL Standard Deviation 14.585	—	-3.02 mg/dL Standard Deviation 7.447	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol (LDL)- Low risk	-49.29 mg/dL Standard Deviation 37.689	-42.37 mg/dL Standard Deviation 37.719	—	-74.71 mg/dL Standard Deviation 53.238	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol (LDL)- Moderate risk	-26.07 mg/dL Standard Deviation 33.338	-37.50 mg/dL Standard Deviation 37.162	—	-25.91 mg/dL Standard Deviation 32.562	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol (LDL)- High risk	-26.61 mg/dL Standard Deviation 35.093	-33.10 mg/dL Standard Deviation 39.149	-31.40 mg/dL Standard Deviation 34.152	-34.61 mg/dL Standard Deviation 44.918	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Cholesterol (LDL)- Very high risk	-2.99 mg/dL Standard Deviation 26.243	-23.41 mg/dL Standard Deviation 35.895	—	-38.05 mg/dL Standard Deviation 38.867	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Triglycerides- Low risk	-42.92 mg/dL Standard Deviation 48.340	-28.67 mg/dL Standard Deviation 110.490	—	-14.16 mg/dL Standard Deviation 35.044	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Triglycerides- Moderate risk	1.52 mg/dL Standard Deviation 43.420	-22.32 mg/dL Standard Deviation 70.978	—	-18.19 mg/dL Standard Deviation 61.094	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Triglycerides- High risk	-3.85 mg/dL Standard Deviation 102.165	-29.73 mg/dL Standard Deviation 116.182	-83.19 mg/dL Standard Deviation 151.512	-46.98 mg/dL Standard Deviation 127.625	—
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group Triglycerides- Very high risk	23.34 mg/dL Standard Deviation 113.398	-25.34 mg/dL Standard Deviation 102.889	—	4.47 mg/dL Standard Deviation 217.543	—

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. "Atorvastatin Unknown Dosage" arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.

Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.

Outcome measures

Measure	Atorvastatin <=10 mg n=141 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=1445 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=6 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=58 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Triglycerides- high risk	13.35 Percent Change Standard Deviation 92.014	-3.77 Percent Change Standard Deviation 50.582	-27.55 Percent Change Standard Deviation 33.921	-14.81 Percent Change Standard Deviation 34.606	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Triglycerides- very high risk	36.01 Percent Change Standard Deviation 89.326	-1.17 Percent Change Standard Deviation 62.412	—	-10.55 Percent Change Standard Deviation 36.114	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol- low risk	-21.06 Percent Change Standard Deviation 18.145	-15.39 Percent Change Standard Deviation 53.309	—	-36.33 Percent Change Standard Deviation 23.292	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol- moderate risk	-11.66 Percent Change Standard Deviation 23.157	-18.50 Percent Change Standard Deviation 24.651	—	73.60 Percent Change Standard Deviation 253.741	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol- high risk	-11.53 Percent Change Standard Deviation 24.302	-13.91 Percent Change Standard Deviation 34.085	-17.33 Percent Change Standard Deviation 19.989	-15.34 Percent Change Standard Deviation 18.104	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol- very high risk	6.09 Percent Change Standard Deviation 22.562	-11.07 Percent Change Standard Deviation 29.007	—	-18.58 Percent Change Standard Deviation 24.524	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol (HDL) - low risk	1.21 Percent Change Standard Deviation 15.236	-1.55 Percent Change Standard Deviation 17.047	—	-7.03 Percent Change Standard Deviation 35.153	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol (HDL)- moderate risk	4.08 Percent Change Standard Deviation 20.094	0.29 Percent Change Standard Deviation 18.265	—	12.12 Percent Change Standard Deviation 22.325	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol (HDL)- high risk	3.41 Percent Change Standard Deviation 29.176	4.59 Percent Change Standard Deviation 25.053	1.52 Percent Change Standard Deviation 15.985	2.42 Percent Change Standard Deviation 11.126	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol (HDL)- very high risk	6.02 Percent Change Standard Deviation 22.796	6.55 Percent Change Standard Deviation 29.457	—	-4.53 Percent Change Standard Deviation 13.600	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol (LDL)- low risk	-31.33 Percent Change Standard Deviation 26.408	-27.43 Percent Change Standard Deviation 22.633	—	-47.37 Percent Change Standard Deviation 30.298	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol (LDL)- moderate risk	-18.59 Percent Change Standard Deviation 29.052	-27.12 Percent Change Standard Deviation 27.917	—	-20.86 Percent Change Standard Deviation 24.354	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol (LDL)- high risk	-19.16 Percent Change Standard Deviation 32.501	-21.81 Percent Change Standard Deviation 31.964	-22.57 Percent Change Standard Deviation 26.524	-20.59 Percent Change Standard Deviation 26.181	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Cholesterol (LDL)- very high risk	0.78 Percent Change Standard Deviation 34.076	-12.68 Percent Change Standard Deviation 79.286	—	-25.92 Percent Change Standard Deviation 25.288	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Triglycerides- low risk	-21.40 Percent Change Standard Deviation 32.030	-9.65 Percent Change Standard Deviation 39.610	—	-9.63 Percent Change Standard Deviation 32.475	—
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level Triglycerides- moderate risk	3.98 Percent Change Standard Deviation 40.156	-8.81 Percent Change Standard Deviation 39.316	—	-10.93 Percent Change Standard Deviation 37.268	—

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: The analysis set included all participants who received at least 1 dose of atorvastatin. "Atorvastatin Unknown Dosage" did not have Week 12 dose. Number analyzed refers to number of participants evaluable for specified category.

Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Study Drug Exposure for Overall - Total Dose and Week 12 Dose Total dose	958.90 mg Standard Deviation 240.812	1816.63 mg Standard Deviation 376.664	2506.19 mg Standard Deviation 314.555	3326.93 mg Standard Deviation 631.053	178.90 mg Standard Deviation 136.33
Study Drug Exposure for Overall - Total Dose and Week 12 Dose Week 12 dose	9.96 mg Standard Deviation 0.422	20.00 mg Standard Deviation 0.000	30.00 mg Standard Deviation 0.000	40.00 mg Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: The analysis set included all participants who received at least 1 dose of atorvastatin and evaluable for specified category (daily dose).

Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=845 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Study Drug Exposure for Overall - Daily Dose	10.43 mg/day Standard Deviation 1.633	20.00 mg/day Standard Deviation 0.423	29.00 mg/day Standard Deviation 2.646	39.96 mg/day Standard Deviation 0.314	20.09 mg/day Standard Deviation 3.74

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: The analysis set included all participants who received at least 1 dose of atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose; Week 12 dose: dose taken at Week 12 according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Total dose (Low risk)	975.00 mg Standard Deviation 312.567	1760.84 mg Standard Deviation 449.801	2790.00 mg Standard Deviation NA 1 participant of number analyzed	3456.00 mg Standard Deviation 1245.986	—
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Total dose (Moderate risk)	914.47 mg Standard Deviation 224.965	1781.18 mg Standard Deviation 415.197	2542.50 mg Standard Deviation 261.964	3524.44 mg Standard Deviation 464.519	—
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Total dose (High risk)	964.63 mg Standard Deviation 254.036	1842.03 mg Standard Deviation 383.312	2419.23 mg Standard Deviation 342.332	3525.95 mg Standard Deviation 373.954	—
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Total dose (Very high risk)	964.04 mg Standard Deviation 152.396	1804.61 mg Standard Deviation 328.691	2740.00 mg Standard Deviation 96.437	3131.20 mg Standard Deviation 685.669	—
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Week 12 dose (Low risk)	10.00 mg Standard Deviation 0.000	20.00 mg Standard Deviation 0.000	30.00 mg Standard Deviation NA 1 participant of number analyzed	40.00 mg Standard Deviation 0.000	—
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Week 12 dose(Moderate risk)	10.00 mg Standard Deviation 0.000	20.00 mg Standard Deviation 0.000	30.00 mg Standard Deviation 0.000	40.00 mg Standard Deviation 0.000	—
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Week 12 dose (High risk)	10.39 mg Standard Deviation 1.678	20.00 mg Standard Deviation 0.508	28.38 mg Standard Deviation 3.254	39.97 mg Standard Deviation 0.164	—
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose Week 12 dose (Very high risk)	10.00 mg Standard Deviation 0.000	20.00 mg Standard Deviation 0.000	30.00 mg Standard Deviation 0.000	40.00 mg Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: The analysis set included all participants who received at least 1 dose of atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

Daily dose was calculated by total dose divided by the total days of receiving atorvastatin according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Study Drug Exposure Within Each CVD Risk Group -Daily Dose Daily dose (High risk)	10.39 mg/day Standard Deviation 1.678	20.00 mg/day Standard Deviation 0.508	28.38 mg/day Standard Deviation 3.254	39.97 mg/day Standard Deviation 0.164	—
Study Drug Exposure Within Each CVD Risk Group -Daily Dose Daily dose (Low risk)	10.81 mg/day Standard Deviation 1.721	20.00 mg/day Standard Deviation 0.000	30.00 mg/day Standard Deviation NA 1 participant of number analyzed	40.00 mg/day Standard Deviation 0.000	—
Study Drug Exposure Within Each CVD Risk Group -Daily Dose Daily dose (Moderate risk)	10.53 mg/day Standard Deviation 1.572	20.03 mg/day Standard Deviation 0.719	30.00 mg/day Standard Deviation 0.000	40.00 mg/day Standard Deviation 0.000	—
Study Drug Exposure Within Each CVD Risk Group -Daily Dose Daily dose (Very high risk)	10.29 mg/day Standard Deviation 1.486	20.00 mg/day Standard Deviation 0.136	30.00 mg/day Standard Deviation 0.000	39.94 mg/day Standard Deviation 0.424	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.

All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall All causalities	36 Participants	241 Participants	1 Participants	7 Participants	19 Participants
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall Treatment-related	17 Participants	107 Participants	1 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. The AEs were categorized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level All causalities (Low risk)	1 Participants	18 Participants	0 Participants	1 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level All causalities (Moderate risk)	8 Participants	27 Participants	0 Participants	1 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level All causalities (High risk)	22 Participants	126 Participants	1 Participants	1 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level All causalities (Very high risk)	5 Participants	70 Participants	0 Participants	4 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level Treatment-related (Low risk)	0 Participants	7 Participants	0 Participants	0 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level Treatment-related (Moderate risk)	3 Participants	9 Participants	0 Participants	1 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level Treatment-related (High risk)	10 Participants	66 Participants	1 Participants	0 Participants	—
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level Treatment-related (Very high risk)	4 Participants	25 Participants	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin.

AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Number of Participants With Adverse Events of Special Interest (AESI) for Overall	18 Participants	146 Participants	1 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level Low risk	1 Participants	9 Participants	0 Participants	0 Participants	—
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level Moderate risk	3 Participants	11 Participants	0 Participants	1 Participants	—
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level High risk	11 Participants	81 Participants	1 Participants	1 Participants	—
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level Very high risk	3 Participants	45 Participants	0 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.

The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall ALT>3*ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall AST>3*ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall CK >= 10*ULN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk ALT>3*ULN (Low risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk ALT>3*ULN (Moderate risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk ALT>3*ULN (High risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk ALT>3*ULN (Very high risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk AST>3*ULN (Low risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk AST>3*ULN (Moderate risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk AST>3*ULN (High risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk AST>3*ULN (Very high risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk CK >= 10*ULN (Low risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk CK >= 10*ULN (Moderate risk)	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk CK >= 10*ULN (High risk)	0 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk CK >= 10*ULN (Very high risk)	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Change From Baseline for Clinical Laboratory Overall- ALT and AST ALT-Week 12	0.39 IU/L Standard Deviation 25.362	1.60 IU/L Standard Deviation 27.048	1.40 IU/L Standard Deviation 8.414	-0.25 IU/L Standard Deviation 14.079	-1.00 IU/L Standard Deviation 21.058
Change From Baseline for Clinical Laboratory Overall- ALT and AST ALT-Unplanned	-0.04 IU/L Standard Deviation 11.639	2.25 IU/L Standard Deviation 17.861	5.00 IU/L Standard Deviation NA 1 participant of number analyzed	-20.70 IU/L Standard Deviation 30.772	1.22 IU/L Standard Deviation 13.000
Change From Baseline for Clinical Laboratory Overall- ALT and AST AST- week 12	-1.50 IU/L Standard Deviation 18.833	-5.54 IU/L Standard Deviation 47.298	3.60 IU/L Standard Deviation 2.966	-37.78 IU/L Standard Deviation 87.382	-17.48 IU/L Standard Deviation 61.362
Change From Baseline for Clinical Laboratory Overall- ALT and AST AST- unplanned	-0.38 IU/L Standard Deviation 6.605	-8.43 IU/L Standard Deviation 58.715	9.00 IU/L Standard Deviation NA 1 participant of number analyzed	-125.5 IU/L Standard Deviation 184.247	2.22 IU/L Standard Deviation 10.169

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin-Week 12	0.02 mg/dL Standard Deviation 0.248	0.02 mg/dL Standard Deviation 0.323	-0.01 mg/dL Standard Deviation 0.132	0.00 mg/dL Standard Deviation 0.301	-0.08 mg/dL Standard Deviation 0.380
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin-Unplanned	-0.01 mg/dL Standard Deviation 0.301	0.04 mg/dL Standard Deviation 0.293	0.08 mg/dL Standard Deviation NA 1 participant of number analyzed	-0.36 mg/dL Standard Deviation 0.190	0.09 mg/dL Standard Deviation 0.387
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen-Week 12	0.16 mg/dL Standard Deviation 5.238	0.10 mg/dL Standard Deviation 5.001	-1.18 mg/dL Standard Deviation 2.989	-0.29 mg/dL Standard Deviation 4.417	-0.86 mg/dL Standard Deviation 9.287
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen- unplanned visit	-1.18 mg/dL Standard Deviation 3.495	-0.08 mg/dL Standard Deviation 5.326	3.11 mg/dL Standard Deviation NA 1 participant of number analyzed	4.66 mg/dL Standard Deviation 7.005	-1.16 mg/dL Standard Deviation 3.911
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Cholesterol- week 12	-26.13 mg/dL Standard Deviation 44.751	-45.15 mg/dL Standard Deviation 393.221	-40.35 mg/dL Standard Deviation 44.527	-36.98 mg/dL Standard Deviation 54.175	-27.20 mg/dL Standard Deviation 38.056
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Cholesterol- unplanned visit	-43.38 mg/dL Standard Deviation 31.472	-55.38 mg/dL Standard Deviation 41.996	-37.84 mg/dL Standard Deviation NA 1 participant of number analyzed	-75.98 mg/dL Standard Deviation 56.967	-24.23 mg/dL Standard Deviation 22.633
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Creatinine- Week 12	0.01 mg/dL Standard Deviation 0.202	0.01 mg/dL Standard Deviation 0.224	-0.09 mg/dL Standard Deviation 0.158	0.00 mg/dL Standard Deviation 0.106	0.01 mg/dL Standard Deviation 0.165
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Creatinine- unplanned	0.00 mg/dL Standard Deviation 0.087	0.01 mg/dL Standard Deviation 0.130	0.01 mg/dL Standard Deviation NA 1 participant of number analyzed	0.09 mg/dL Standard Deviation 0.060	-0.05 mg/dL Standard Deviation 0.131
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Triglycerides- Week 12	-3.95 mg/dL Standard Deviation 93.668	-27.88 mg/dL Standard Deviation 108.151	-83.19 mg/dL Standard Deviation 151.512	-20.97 mg/dL Standard Deviation 160.296	8.22 mg/dL Standard Deviation 49.616
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Triglycerides- unplanned	-36.84 mg/dL Standard Deviation 67.068	-46.19 mg/dL Standard Deviation 144.402	-100.9 mg/dL Standard Deviation NA 1 participant of number analyzed	-75.93 mg/dL Standard Deviation 88.578	-25.67 mg/dL Standard Deviation 39.725
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Uric acid- Week 12	-52.83 mg/dL Standard Deviation 621.039	-0.08 mg/dL Standard Deviation 1.438	-0.07 mg/dL Standard Deviation 0.795	-0.20 mg/dL Standard Deviation 1.468	-0.04 mg/dL Standard Deviation 1.781
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Uric acid- unplanned visit	-0.29 mg/dL Standard Deviation 0.859	0.12 mg/dL Standard Deviation 1.159	-0.30 mg/dL Standard Deviation NA 1 participant of number analyzed	0.68 mg/dL Standard Deviation 1.526	-0.28 mg/dL Standard Deviation 0.957

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Change From Baseline for Clinical Laboratory Overall- Creatine Kinase Week 12	-12.77 U/L Standard Deviation 168.370	-30.49 U/L Standard Deviation 388.838	-7.60 U/L Standard Deviation 24.572	-300.8 U/L Standard Deviation 698.733	-139.0 U/L Standard Deviation 431.288
Change From Baseline for Clinical Laboratory Overall- Creatine Kinase Unplanned visit	12.65 U/L Standard Deviation 59.880	-26.74 U/L Standard Deviation 256.628	22.00 U/L Standard Deviation NA 1 participant of number analyzed	-335.2 U/L Standard Deviation 469.795	23.67 U/L Standard Deviation 27.609

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST ALT (Low risk)- Week 12	-0.28 IU/L Standard Deviation 14.557	1.68 IU/L Standard Deviation 11.964	—	4.00 IU/L Standard Deviation 15.556	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST ALT (Low risk)- unplanned visit	-2.80 IU/L Standard Deviation 7.463	2.21 IU/L Standard Deviation 15.514	—	-29.23 IU/L Standard Deviation NA 1 participant of number analyzed	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST ALT (moderate risk)- Week 12	-3.68 IU/L Standard Deviation 15.438	0.83 IU/L Standard Deviation 19.970	—	0.77 IU/L Standard Deviation 6.612	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST ALT (moderate risk)- unplanned visit	0.00 IU/L Standard Deviation 17.146	-2.40 IU/L Standard Deviation 16.196	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST ALT (high risk)- Week 12	5.27 IU/L Standard Deviation 14.774	3.10 IU/L Standard Deviation 31.018	1.40 IU/L Standard Deviation 8.414	5.79 IU/L Standard Deviation 11.825	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST ALT (high risk)- unplanned visit	0.99 IU/L Standard Deviation 12.118	4.02 IU/L Standard Deviation 12.412	5.00 IU/L Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST ALT(very high risk)- Week 12	-17.98 IU/L Standard Deviation 56.864	-0.66 IU/L Standard Deviation 25.035	—	-7.36 IU/L Standard Deviation 15.789	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST ALT(very high risk)- unplanned visit	-1.75 IU/L Standard Deviation 8.382	1.14 IU/L Standard Deviation 24.172	—	-17.86 IU/L Standard Deviation 37.039	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST AST (low risk)-Week 12	-0.76 IU/L Standard Deviation 9.684	0.76 IU/L Standard Deviation 7.857	—	2.50 IU/L Standard Deviation 7.778	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST AST (low risk)- unplanned visit	-1.00 IU/L Standard Deviation 2.915	-0.28 IU/L Standard Deviation 6.874	—	-8.56 IU/L Standard Deviation NA 1 participant of number analyzed	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST AST (moderate risk)-Week 12	-5.36 IU/L Standard Deviation 16.276	-1.49 IU/L Standard Deviation 20.569	—	-30.51 IU/L Standard Deviation 92.532	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST AST (moderate risk)-unplanned visit	2.80 IU/L Standard Deviation 13.828	-1.66 IU/L Standard Deviation 5.743	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST AST (high risk)-Week 12	1.89 IU/L Standard Deviation 13.031	-0.21 IU/L Standard Deviation 21.587	3.60 IU/L Standard Deviation 2.966	1.38 IU/L Standard Deviation 7.432	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST AST (high risk)-unplanned visit	-0.75 IU/L Standard Deviation 5.299	0.79 IU/L Standard Deviation 12.214	9.00 IU/L Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST AST (very high risk)-Week 12	-14.62 IU/L Standard Deviation 38.588	-17.79 IU/L Standard Deviation 79.278	—	-85.34 IU/L Standard Deviation 111.577	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST AST (very high risk)-unplanned visit	-1.75 IU/L Standard Deviation 3.862	-30.13 IU/L Standard Deviation 106.059	—	-164.5 IU/L Standard Deviation 204.461	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin (low risk)- Week 12	-0.01 mg/dL Standard Deviation 0.237	-0.03 mg/dL Standard Deviation 0.270	—	0.07 mg/dL Standard Deviation 0.167	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin (low risk)- unplanned visit	-0.07 mg/dL Standard Deviation 0.236	0.08 mg/dL Standard Deviation 0.225	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin (moderate risk)- Week 12	0.02 mg/dL Standard Deviation 0.191	0.01 mg/dL Standard Deviation 0.305	—	-0.09 mg/dL Standard Deviation 0.245	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin (moderate risk)- unplanned visit	-0.21 mg/dL Standard Deviation 0.237	0.01 mg/dL Standard Deviation 0.219	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin (high risk)- Week 12	0.02 mg/dL Standard Deviation 0.271	0.03 mg/dL Standard Deviation 0.333	-0.01 mg/dL Standard Deviation 0.132	-0.04 mg/dL Standard Deviation 0.310	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin (high risk)- unplanned visit	0.03 mg/dL Standard Deviation 0.294	-0.01 mg/dL Standard Deviation 0.273	0.08 mg/dL Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin (very high risk)- Week 12	0.06 mg/dL Standard Deviation 0.209	0.02 mg/dL Standard Deviation 0.324	—	0.06 mg/dL Standard Deviation 0.324	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Bilirubin (very high risk)- unplanned visit	0.07 mg/dL Standard Deviation 0.457	0.09 mg/dL Standard Deviation 0.350	—	-0.36 mg/dL Standard Deviation 0.190	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen(low risk)-Week 12	-1.08 mg/dL Standard Deviation 3.499	0.24 mg/dL Standard Deviation 2.990	—	-2.38 mg/dL Standard Deviation 3.366	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen(low risk)-unplanned visit	-0.80 mg/dL Standard Deviation 0.783	-0.98 mg/dL Standard Deviation 4.594	—	-3.67 mg/dL Standard Deviation NA 1 participant of number analyzed	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen(moderate risk)-Week 12	1.18 mg/dL Standard Deviation 6.721	-0.14 mg/dL Standard Deviation 3.887	—	1.56 mg/dL Standard Deviation 4.723	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen(moderate risk)-unplanned	-0.83 mg/dL Standard Deviation 2.386	1.91 mg/dL Standard Deviation 2.925	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen(high risk)-Week 12	0.10 mg/dL Standard Deviation 5.191	0.20 mg/dL Standard Deviation 4.841	-1.18 mg/dL Standard Deviation 2.989	-0.99 mg/dL Standard Deviation 3.190	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen(high risk)-unplanned	-1.38 mg/dL Standard Deviation 4.248	-0.36 mg/dL Standard Deviation 5.678	3.11 mg/dL Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid cholesterol (low risk)-Week 12	-57.68 mg/dL Standard Deviation 46.926	-47.63 mg/dL Standard Deviation 56.296	—	-94.98 mg/dL Standard Deviation 71.530	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid cholesterol (low risk)-unplanned	-47.41 mg/dL Standard Deviation 28.986	-70.43 mg/dL Standard Deviation 46.727	—	-122.8 mg/dL Standard Deviation NA 1 participant of number analyzed	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid cholesterol (moderate risk)-Week 12	-27.71 mg/dL Standard Deviation 41.919	-43.23 mg/dL Standard Deviation 49.231	—	-5.28 mg/dL Standard Deviation 61.380	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid cholesterol (moderate risk)-unplanned	-44.59 mg/dL Standard Deviation 48.524	-81.23 mg/dL Standard Deviation 42.498	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid cholesterol (high risk)-week 12	-27.72 mg/dL Standard Deviation 44.199	-56.65 mg/dL Standard Deviation 551.937	-40.35 mg/dL Standard Deviation 44.527	-38.43 mg/dL Standard Deviation 49.029	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid cholesterol (high risk)-unplanned	-42.78 mg/dL Standard Deviation 32.877	-56.26 mg/dL Standard Deviation 39.587	-37.84 mg/dL Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid cholesterol (very high risk)-week 12	4.63 mg/dL Standard Deviation 31.528	-25.78 mg/dL Standard Deviation 49.060	—	-43.16 mg/dL Standard Deviation 51.923	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid cholesterol (very high risk)-unplanned	-39.96 mg/dL Standard Deviation 15.081	-40.75 mg/dL Standard Deviation 37.827	—	-64.29 mg/dL Standard Deviation 58.435	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid creatinine (low risk)-Week 12	0.01 mg/dL Standard Deviation 0.119	-0.01 mg/dL Standard Deviation 0.306	—	0.01 mg/dL Standard Deviation 0.007	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid creatinine (low risk)-unplanned	0.01 mg/dL Standard Deviation 0.067	0.01 mg/dL Standard Deviation 0.146	—	0.14 mg/dL Standard Deviation NA 1 participant of number analyzed	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid creatinine (moderate risk)-Week 12	-0.10 mg/dL Standard Deviation 0.299	0.00 mg/dL Standard Deviation 0.108	—	-0.05 mg/dL Standard Deviation 0.081	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid creatinine (moderate risk)-unplanned	-0.07 mg/dL Standard Deviation 0.089	-0.01 mg/dL Standard Deviation 0.101	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid creatinine (high risk)-Week 12	0.02 mg/dL Standard Deviation 0.175	0.01 mg/dL Standard Deviation 0.201	-0.09 mg/dL Standard Deviation 0.158	0.00 mg/dL Standard Deviation 0.120	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid creatinine (high risk)- unplanned	0.00 mg/dL Standard Deviation 0.091	-0.01 mg/dL Standard Deviation 0.137	0.01 mg/dL Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid creatinine (very high risk)- Week 12	0.09 mg/dL Standard Deviation 0.200	0.01 mg/dL Standard Deviation 0.258	—	0.02 mg/dL Standard Deviation 0.102	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid creatinine (very high risk)-unplanned	0.04 mg/dL Standard Deviation 0.053	0.03 mg/dL Standard Deviation 0.119	—	0.08 mg/dL Standard Deviation 0.062	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid triglycerides (low risk)- week 12	-45.48 mg/dL Standard Deviation 47.189	-31.41 mg/dL Standard Deviation 114.297	—	-14.16 mg/dL Standard Deviation 35.044	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid triglycerides (low risk)- unplanned	21.42 mg/dL Standard Deviation 28.999	-75.82 mg/dL Standard Deviation 101.162	—	-188.5 mg/dL Standard Deviation NA 1 participant of number analyzed	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid triglycerides (moderate risk)- week 12	0.00 mg/dL Standard Deviation 42.967	-22.32 mg/dL Standard Deviation 70.978	—	-18.19 mg/dL Standard Deviation 61.094	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid triglycerides (moderate risk)- unplanned	-32.08 mg/dL Standard Deviation 14.674	-53.27 mg/dL Standard Deviation 61.766	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid triglycerides (high risk)- week 12	-4.70 mg/dL Standard Deviation 101.889	-29.87 mg/dL Standard Deviation 116.122	-83.19 mg/dL Standard Deviation 151.512	-46.98 mg/dL Standard Deviation 127.625	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid triglycerides (high risk)- unplanned	-47.56 mg/dL Standard Deviation 70.510	-54.85 mg/dL Standard Deviation 189.895	-100.9 mg/dL Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid triglycerides (very high risk)- week 12	23.34 mg/dL Standard Deviation 113.398	-25.34 mg/dL Standard Deviation 102.889	—	4.47 mg/dL Standard Deviation 217.543	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid triglycerides (very high risk)- unplanned	-63.50 mg/dL Standard Deviation 89.174	-19.08 mg/dL Standard Deviation 85.039	—	-47.79 mg/dL Standard Deviation 71.981	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid uric acid (low risk)-Week 12	-0.33 mg/dL Standard Deviation 0.838	-0.06 mg/dL Standard Deviation 0.980	—	0.32 mg/dL Standard Deviation 0.933	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid uric acid (low risk)-unplanned	-0.13 mg/dL Standard Deviation 0.337	0.23 mg/dL Standard Deviation 1.139	—	0.00 mg/dL Standard Deviation NA 1 participant of number analyzed	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid uric acid (moderate risk)-Week12	-0.84 mg/dL Standard Deviation 2.753	-0.16 mg/dL Standard Deviation 1.335	—	-0.61 mg/dL Standard Deviation 1.285	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid uric acid (moderate risk)-unplanned	-0.87 mg/dL Standard Deviation 0.833	-0.47 mg/dL Standard Deviation 1.493	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid uric acid (high risk)-week 12	-0.38 mg/dL Standard Deviation 1.875	-0.07 mg/dL Standard Deviation 1.447	-0.07 mg/dL Standard Deviation 0.795	-0.58 mg/dL Standard Deviation 1.664	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid uric acid (high risk)-unplanned	-0.13 mg/dL Standard Deviation 0.879	-0.16 mg/dL Standard Deviation 1.047	-0.30 mg/dL Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid uric acid (very high risk)-week 12	-407.9 mg/dL Standard Deviation 1732.170	-0.05 mg/dL Standard Deviation 1.568	—	0.32 mg/dL Standard Deviation 1.237	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid uric acid (very high risk)-unplanned	-0.55 mg/dL Standard Deviation 1.039	0.60 mg/dL Standard Deviation 1.051	—	0.90 mg/dL Standard Deviation 1.786	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen (Very high risk)- Week 12	0.21 mg/dL Standard Deviation 4.794	-0.03 mg/dL Standard Deviation 5.975	—	-0.09 mg/dL Standard Deviation 5.417	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid Blood urea nitrogen (Very high risk)- unplanned	-0.89 mg/dL Standard Deviation 1.766	0.12 mg/dL Standard Deviation 5.484	—	7.43 mg/dL Standard Deviation 5.237	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5%~10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10%~15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Creatine Kinase(Low risk-Week 12	15.40 U/L Standard Deviation 47.148	22.89 U/L Standard Deviation 135.208	—	15.75 U/L Standard Deviation 22.274	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Creatine Kinase(Low risk-unplanned visit	3.00 U/L Standard Deviation 16.793	29.41 U/L Standard Deviation 112.521	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Creatine Kinase(moderate risk)-Week 12	0.45 U/L Standard Deviation 46.688	0.03 U/L Standard Deviation 73.412	—	-363.4 U/L Standard Deviation 1078.110	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Creatine Kinase(moderate risk)-unplanned visit	8.00 U/L Standard Deviation NA 1 participant of number analyzed	6.76 U/L Standard Deviation 30.302	—	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Creatine Kinase(high risk)-Week 12	-1.99 U/L Standard Deviation 118.333	14.49 U/L Standard Deviation 209.095	-7.60 U/L Standard Deviation 24.572	-0.25 U/L Standard Deviation 18.669	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Creatine Kinase(high risk)-unplanned visit	10.96 U/L Standard Deviation 62.211	3.17 U/L Standard Deviation 87.977	22.00 U/L Standard Deviation NA 1 participant of number analyzed	—	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Creatine Kinase(very high risk)-Week 12	-102.0 U/L Standard Deviation 387.028	-132.5 U/L Standard Deviation 637.616	—	-607.2 U/L Standard Deviation 800.209	—
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase Creatine Kinase(very high risk)-unplanned visit	31.50 U/L Standard Deviation 90.246	-134.0 U/L Standard Deviation 479.298	—	-335.2 U/L Standard Deviation 469.795	—

SECONDARY outcome

Timeframe: 12 weeks of follow-up

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.

Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 Participants Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Precentage of Participants With Discontinuation From the Study for Overall AE Related to study drug	0 Percent	0.03 Percent	0 Percent	0 Percent	0.47 Percent
Precentage of Participants With Discontinuation From the Study for Overall Death	0 Percent	0.03 Percent	0 Percent	0 Percent	0.37 Percent
Precentage of Participants With Discontinuation From the Study for Overall Relation to study drug not defined	0.68 Percent	1.10 Percent	0 Percent	2.97 Percent	96.77 Percent
Precentage of Participants With Discontinuation From the Study for Overall AE Not related to study drug	0.34 Percent	0 Percent	0 Percent	0 Percent	0.37 Percent

SECONDARY outcome

Timeframe: 12 weeks of follow-up

Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. "Atorvastatin Unknown Dosage" arm within each CVD risk level was exclude since incomplete information on medication.

Percentage of participants who dropped out of the study and reasons for discontinuation were summarized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Outcome measures

Measure	Atorvastatin <=10 mg n=291 Participants Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 Participants Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 Participants Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 Participants Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Death (Low risk)	0 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Relation to study drug not defined (Low risk)	0 Percent	0.36 Percent	0 Percent	20.0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Related to study drug (Low risk)	0 Percent	0.36 Percent	0 Percent	0.32 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Not related to study drug (Low risk)	0 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Death (Moderate risk)	0 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Relation to study drug not defined (Moderate risk)	0 Percent	2.43 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Related to study drug (Moderate risk)	0 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Not related to study drug (Moderate risk)	0 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Death (High risk)	0 Percent	0.06 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Relation to study drug not defined (High risk)	1.14 Percent	1.07 Percent	0 Percent	2.70 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Related to study drug (High risk)	0 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Not related to study drug (High risk)	0.57 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Death (Very high risk)	0 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Relation to study drug not defined(Very high risk)	0 Percent	0.97 Percent	0 Percent	2.00 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Related to study drug (Very high risk)	0 Percent	0 Percent	0 Percent	0 Percent	—
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level Not related to study drug (Very high risk)	0 Percent	0 Percent	0 Percent	0 Percent	—

Adverse Events

Atorvastatin <=10 mg

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Atorvastatin 20 mg

Serious events: 68 serious events

Other events: 0 other events

Deaths: 2 deaths

Atorvastatin 30 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atorvastatin 40 mg

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Atorvastatin Unknown Dosage

Serious events: 9 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Measure	Atorvastatin <=10 mg n=291 participants at risk Participants received Atorvastatin \<=10 mg daily according to doctor's prescription.	Atorvastatin 20 mg n=3080 participants at risk Participants received Atorvastatin 20 mg daily according to doctor's prescription.	Atorvastatin 30 mg n=21 participants at risk Participants received Atorvastatin 30 mg daily according to doctor's prescription.	Atorvastatin 40 mg n=101 participants at risk Participants received Atorvastatin 40 mg daily according to doctor's prescription.	Atorvastatin Unknown Dosage n=1055 participants at risk Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing.
Cardiac disorders Acute coronary syndrome	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Acute myocardial infarction	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Angina pectoris	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Angina unstable	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.19% 6/3080 • Number of events 6 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.99% 1/101 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.09% 1/1055 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Arrhythmia	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.06% 2/3080 • Number of events 2 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Arteriosclerosis coronary artery	0.34% 1/291 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.23% 7/3080 • Number of events 7 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Atrial fibrillation	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Cardiac amyloidosis	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.09% 1/1055 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Cardiac failure	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.13% 4/3080 • Number of events 4 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Cardiac failure chronic	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Congestive cardiomyopathy	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Coronary artery disease	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.10% 3/3080 • Number of events 3 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Left ventricular failure	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.06% 2/3080 • Number of events 2 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Myocardial infarction	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Myocardial ischaemia	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.10% 3/3080 • Number of events 3 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Cardiac disorders Sinus arrhythmia	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Ear and labyrinth disorders Vertigo	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.09% 1/1055 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Gastrointestinal disorders Gastritis erosive	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.06% 2/3080 • Number of events 2 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Gastrointestinal disorders Large intestine polyp	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
General disorders Death	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.28% 3/1055 • Number of events 3 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
General disorders Pelvic mass	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.09% 1/1055 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Hepatobiliary disorders Hepatic cyst	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Infections and infestations Gastroenteritis	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Infections and infestations Infection	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Infections and infestations Lung infection	0.34% 1/291 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.06% 2/3080 • Number of events 2 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Infections and infestations Pneumonia	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.06% 2/3080 • Number of events 2 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Infections and infestations Septic shock	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.09% 1/1055 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.99% 1/101 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.09% 1/1055 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.34% 1/291 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Nervous system disorders Cerebral arteriosclerosis	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Nervous system disorders Cerebral infarction	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Nervous system disorders Cerebral ischaemia	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.99% 1/101 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Nervous system disorders Cubital tunnel syndrome	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Nervous system disorders Syncope	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Renal and urinary disorders Hypertensive nephropathy	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.06% 2/3080 • Number of events 2 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Renal and urinary disorders Ureterolithiasis	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.06% 2/3080 • Number of events 2 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.34% 1/291 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.06% 2/3080 • Number of events 2 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Vascular disorders Arteriosclerosis	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.03% 1/3080 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Vascular disorders Hypertension	0.34% 1/291 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.16% 5/3080 • Number of events 5 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/1055 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Vascular disorders Peripheral artery occlusion	0.00% 0/291 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/3080 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/21 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.00% 0/101 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)	0.09% 1/1055 • Number of events 1 • Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Other adverse events

Adverse event data not reported

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER