An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol (ORION-3)

• ClinicalTrials.gov Identifier: NCT03060577
• Recruitment Status: Completed
• First Posted: February 23, 2017
• Results First Posted: March 24, 2023
• Last Update Posted: March 24, 2023
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Atherosclerotic Cardiovascular Disease; Symptomatic Atherosclerosis; Type2 Diabetes; Familial Hypercholesterolemia
• Interventions: Drug: Inclisiran; Drug: Evolocumab
• Enrollment: 382

Participant Flow

Recruitment Details	Participants were recruited from 51 sites in 5 countries.
Pre-assignment Details	After completion of study MDCO-PCS-15-01, participants were screened to fulfill all inclusion and exclusion criteria.

Arm/Group Title	Inclisiran-only	Switching
Arm/Group Description	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.	Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.
Period Title: Overall Study
Started [1]	290	92
Safety Analysis Set [2]	284	90
Completed	233	80
Not Completed	57	12
Reason Not Completed
Withdrawal by Subject	25	5
Physician Decision	4	3
Lost to Follow-up	3	0
Death	7	1
Adverse Event	9	1
Inclusion/Exclusion	1	0
Other	8	2
[1] All enrolled participants; [2] All enrolled participants who received at least one dose of study treatment

Baseline Characteristics

Arm/Group Title		Inclisiran-only	Switching	Total
Arm/Group Description		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.	Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.	Total of all reporting groups
Overall Number of Baseline Participants		290	92	382
Baseline Analysis Population Description		All enrolled participants
Age, Continuous; Mean (Standard Deviation); Unit of measure: Year
	Number Analyzed	290 participants	92 participants	382 participants
		63.3 (11.14)	61.9 (10.56)	63.0 (11.01)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	290 participants	92 participants	382 participants
	Female	102 35.2%	37 40.2%	139 36.4%
	Male	188 64.8%	55 59.8%	243 63.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	290 participants	92 participants	382 participants
	Hispanic or Latino	15 5.2%	7 7.6%	22 5.8%
	Not Hispanic or Latino	275 94.8%	85 92.4%	360 94.2%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Percentage Change in LDL-C From Baseline of the ORION-1 Study to Day 210 in ORION-3 (Inclisiran Arm)
Description	Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study to Day 210 in ORION-3. A negative percentage score represents a reduction in LDL-C. Change is relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Day 210 (ORION-3) (up to 570 days total)

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed includes all participants in the Safety Analysis Set of the Inclisiran-only arm with evaluable data for the endpoint.

Arm/Group Title	Inclisiran-only
Arm/Group Description:	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed	277
Mean (95% Confidence Interval); Unit of Measure: Percentage Change
	-47.48; (-50.69 to -44.27)

2. Secondary Outcome

Title	Percentage Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in LDL-C. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 360, 720, 1080 and 1440 (ORION-3) (up to 390, 720, 1080, 1440 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: Percentage Change
Day 30	Number Analyzed	277 participants
		-49.43; (-52.27 to -46.58)
Day 360	Number Analyzed	269 participants
		-37.14; (-40.95 to -33.32)
Day 720	Number Analyzed	253 participants
		-38.43; (-41.75 to -35.11)
Day 1080	Number Analyzed	225 participants
		-51.07; (-54.75 to -47.39)
Day 1440	Number Analyzed	232 participants
		-46.74; (-50.71 to -42.78)

3. Secondary Outcome

Title	Absolute Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Absolute Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in LDL-C. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 360, 720, 1080 and 1440 (ORION-3) (up to 390, 720, 1080, 1440 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: mg/dL
Day 30	Number Analyzed	277 participants
		-62.51; (-66.76 to -58.25)
Day 360	Number Analyzed	269 participants
		-47.96; (-52.56 to -43.35)
Day 720	Number Analyzed	253 participants
		-49.44; (-54.25 to -44.64)
Day 1080	Number Analyzed	225 participants
		-63.34; (-68.76 to -57.92)
Day 1440	Number Analyzed	232 participants
		-60.04; (-65.81 to -54.27)

4. Secondary Outcome

Title	Percentage Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Percent Change in PCSK9 from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in PCSK9. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: Percentage Change
Day 30	Number Analyzed	277 participants
		-71.80; (-73.17 to -70.44)
Day 360	Number Analyzed	271 participants
		-63.79; (-65.79 to -61.80)
Day 720	Number Analyzed	253 participants
		-62.17; (-64.46 to -59.88)
Day 1440	Number Analyzed	228 participants
		-69.54; (-71.19 to -67.89)

5. Secondary Outcome

Title	Absolute Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Absolute Change in PCSK9 from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in PCSK9. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: ug/L
Day 30	Number Analyzed	277 participants
		-314.07; (-328.69 to -299.45)
Day 360	Number Analyzed	271 participants
		-280.88; (-295.71 to -266.06)
Day 720	Number Analyzed	253 participants
		-275.78; (-291.91 to -259.64)
Day 1440	Number Analyzed	228 participants
		-314.34; (-331.22 to -297.46)

6. Secondary Outcome

Title	Percentage Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Percent Change in Triglycerides from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Triglycerides. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: Percentage Change
Day 30	Number Analyzed	277 participants
		-1.71; (-6.42 to 3.00)
Day 210	Number Analyzed	277 participants
		-3.35; (-9.12 to 2.41)
Day 1440	Number Analyzed	232 participants
		0.73; (-8.23 to 9.69)

7. Secondary Outcome

Title	Absolute Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Absolute Change in Triglycerides from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Triglycerides. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: mg/dL
Day 30	Number Analyzed	277 participants
		-14.61; (-22.15 to -7.08)
Day 210	Number Analyzed	277 participants
		-11.96; (-23.78 to -0.14)
Day 1440	Number Analyzed	232 participants
		-14.83; (-25.75 to -3.90)

8. Secondary Outcome

Title	Percentage Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Percent Change in Apolipoprotein B from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Apolipoprotein B. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: Percentage Change
Day 30	Number Analyzed	277 participants
		-40.43; (-42.57 to -38.29)
Day 210	Number Analyzed	277 participants
		-36.65; (-39.06 to -34.23)
Day 1440	Number Analyzed	226 participants
		-33.66; (-37.18 to -30.15)

9. Secondary Outcome

Title	Absolute Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Absolute Change in Apolipoprotein B from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Apolipoprotein B. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: mg/dL
Day 30	Number Analyzed	277 participants
		-42.63; (-45.22 to -40.04)
Day 210	Number Analyzed	277 participants
		-38.36; (-41.19 to -35.54)
Day 1440	Number Analyzed	226 participants
		-36.26; (-40.01 to -32.52)

10. Secondary Outcome

Title	Percentage Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Percent Change in Lipoprotein-a from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Lipoprotein-a. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: Percentage Change
Day 30	Number Analyzed	277 participants
		-15.88; (-19.48 to -12.28)
Day 210	Number Analyzed	277 participants
		9.29; (4.42 to 14.16)
Day 1440	Number Analyzed	225 participants
		-5.24; (-9.86 to -0.61)

11. Secondary Outcome

Title	Absolute Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Absolute Change in Lipoprotein-a from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Lipoprotein-a. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		277
Mean (95% Confidence Interval); Unit of Measure: nmol/L
Day 30	Number Analyzed	277 participants
		-8.52; (-12.25 to -4.79)
Day 210	Number Analyzed	277 participants
		-4.94; (-8.67 to -1.20)
Day 1440	Number Analyzed	225 participants
		-4.78; (-9.63 to 0.06)

12. Secondary Outcome

Title	Number of Participants With ≥50% LDL-C Reduction From Baseline of the ORION-1 Study (Inclisiran Arm)
Description	Number of Participants with ≥50% LDL-C (beta-quantification) Reduction from baseline of the ORION-1 Study overtime in ORION-3. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
Time Frame	Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed includes all participants in the Safety Analysis set of the Inclisiran-only arm. The number analyzed per row represents participants with evaluable data at each time point.

Arm/Group Title		Inclisiran-only
Arm/Group Description:		Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed		284
Measure Type: Count of Participants; Unit of Measure: Participants
Day 30	Number Analyzed	284 participants
		161 56.7%
Day 360	Number Analyzed	271 participants
		99 36.5%
Day 720	Number Analyzed	255 participants
		97 38.0%
Day 1440	Number Analyzed	234 participants
		122 52.1%

13. Secondary Outcome

Title	Number of Participants Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL (Inclisiran Arm)
Description	Individual responsiveness to inclisiran is defined as the number of Participants Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL at any time point.
Time Frame	From the start of treatment in ORION-3 to 90 days after end of treatment, assessed up to maximum duration of 4 years

Outcome Measure Data

Analysis Population Description

The overall number of participants and the number analyzed includes all participants in the Safety Analysis set of the Inclisiran-only arm.

Arm/Group Title	Inclisiran-only
Arm/Group Description:	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
Overall Number of Participants Analyzed	284
Measure Type: Count of Participants; Unit of Measure: Participants
LDL-C level <25 mg/dL	82 28.9%
LDL-C level <50 mg/dL	175 61.6%
LDL-C level <70 mg/dL	225 79.2%
LDL-C level <100 mg/dL	265 93.3%

Adverse Events

Time Frame	Adverse events were reported from first dose of study treatment in ORION-3 up to end of study visit, assessed up to maximum duration of 4 years.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Inclisiran Only Arm	Switching Arm up to Day 360 Visit	Switching Arm After Day 360 Visit
Arm/Group Description	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.	Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336.	Participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.
All-Cause Mortality
	Inclisiran Only Arm	Switching Arm up to Day 360 Visit	Switching Arm After Day 360 Visit
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	7/284 (2.46%)	0/90 (0.00%)	1/87 (1.15%)
Serious Adverse Events
	Inclisiran Only Arm	Switching Arm up to Day 360 Visit	Switching Arm After Day 360 Visit
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	104/284 (36.62%)	16/90 (17.78%)	30/87 (34.48%)
Blood and lymphatic system disorders
Anaemia † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Cardiac disorders
Acute coronary syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Acute myocardial infarction † 1	4/284 (1.41%)	1/90 (1.11%)	2/87 (2.30%)
Angina pectoris † 1	7/284 (2.46%)	0/90 (0.00%)	1/87 (1.15%)
Angina unstable † 1	5/284 (1.76%)	1/90 (1.11%)	0/87 (0.00%)
Aortic valve stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Atrial fibrillation † 1	4/284 (1.41%)	1/90 (1.11%)	1/87 (1.15%)
Atrial flutter † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Atrial tachycardia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bradycardia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cardiac arrest † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Cardiac failure † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Cardiac failure congestive † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Coronary artery disease † 1	4/284 (1.41%)	1/90 (1.11%)	3/87 (3.45%)
Coronary artery occlusion † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Coronary artery stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Mitral valve disease † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Myocardial infarction † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Myocardial ischaemia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sinus node dysfunction † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sinus tachycardia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tricuspid valve incompetence † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Ventricular extrasystoles † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Ventricular tachycardia † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Ear and labyrinth disorders
Vertigo † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Eye disorders
Optic ischaemic neuropathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gastrointestinal disorders
Abdominal pain upper † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Diarrhoea † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Epiploic appendagitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Haemorrhoidal haemorrhage † 1	0/284 (0.00%)	2/90 (2.22%)	0/87 (0.00%)
Haemorrhoids † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Ileus † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Incarcerated umbilical hernia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Obstructive pancreatitis † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Pancreatitis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Pancreatitis acute † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Small intestinal obstruction † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Swollen tongue † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
General disorders
Chest pain † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
General physical health deterioration † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Non-cardiac chest pain † 1	3/284 (1.06%)	1/90 (1.11%)	1/87 (1.15%)
Vascular stent restenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hepatobiliary disorders
Cholecystitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cholecystitis acute † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Cholelithiasis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hepatic fibrosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Infections and infestations
Appendicitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bacterial infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
COVID-19 † 1	6/284 (2.11%)	0/90 (0.00%)	1/87 (1.15%)
Cellulitis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Diverticulitis † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Escherichia sepsis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gastrointestinal infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Infected bite † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Localised infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pneumonia † 1	4/284 (1.41%)	0/90 (0.00%)	1/87 (1.15%)
Pneumonia pneumococcal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sepsis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Staphylococcal sepsis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tooth abscess † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Urinary tract infection † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Urosepsis † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Injury, poisoning and procedural complications
Alcohol poisoning † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Anaesthetic complication cardiac † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Concussion † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Fall † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Femoral neck fracture † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Humerus fracture † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Incisional hernia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Meniscus injury † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Multiple injuries † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Post procedural haemorrhage † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Postoperative wound complication † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Procedural pain † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Rib fracture † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Road traffic accident † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tendon rupture † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Investigations
Hepatic enzyme increased † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Pulse abnormal † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Metabolism and nutrition disorders
Dehydration † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Diabetes mellitus inadequate control † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Failure to thrive † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hypokalaemia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hyponatraemia † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Lactic acidosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Back pain † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bone pain † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Intervertebral disc protrusion † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lumbar spinal stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Osteoarthritis † 1	6/284 (2.11%)	0/90 (0.00%)	0/87 (0.00%)
Osteoporosis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Rotator cuff syndrome † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Spinal stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tendon disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Bladder transitional cell carcinoma recurrent † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Breast cancer † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Colon cancer † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Follicular lymphoma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Glottis carcinoma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hodgkin's disease stage IV † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Invasive ductal breast carcinoma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lipoma † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Malignant melanoma † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Ovarian fibroma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Plasma cell myeloma † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Prostate cancer † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Squamous cell carcinoma of skin † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Squamous cell carcinoma of the tongue † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Testicular seminoma (pure) stage I † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Testis cancer † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nervous system disorders
Carotid artery stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Cerebral haemorrhage † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cerebral infarction † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Encephalopathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Ischaemic stroke † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Nervous system disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Presyncope † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Sciatica † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Subarachnoid haemorrhage † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Syncope † 1	1/284 (0.35%)	1/90 (1.11%)	1/87 (1.15%)
Transient ischaemic attack † 1	4/284 (1.41%)	0/90 (0.00%)	2/87 (2.30%)
Psychiatric disorders
Alcohol withdrawal syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Delirium † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Post-traumatic stress disorder † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Nephrolithiasis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Urethral perforation † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Reproductive system and breast disorders
Benign prostatic hyperplasia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Postmenopausal haemorrhage † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Prostatitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Uterine polyp † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Epistaxis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Interstitial lung disease † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pleural effusion † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pulmonary embolism † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pulmonary fibrosis † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Respiratory failure † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Skin and subcutaneous tissue disorders
Diabetic foot † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Vascular disorders
Aortic aneurysm † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Aortic aneurysm rupture † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Aortic stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Circulatory collapse † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Giant cell arteritis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Hypertensive urgency † 1	0/284 (0.00%)	0/90 (0.00%)	2/87 (2.30%)
Intermittent claudication † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Peripheral arterial occlusive disease † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
1 Term from vocabulary, MedDRA (18.1); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Inclisiran Only Arm	Switching Arm up to Day 360 Visit	Switching Arm After Day 360 Visit
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	271/284 (95.42%)	78/90 (86.67%)	77/87 (88.51%)
Blood and lymphatic system disorders
Anaemia † 1	6/284 (2.11%)	4/90 (4.44%)	2/87 (2.30%)
Eosinophilia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Increased tendency to bruise † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Iron deficiency anaemia † 1	4/284 (1.41%)	1/90 (1.11%)	2/87 (2.30%)
Lymphadenopathy † 1	1/284 (0.35%)	0/90 (0.00%)	2/87 (2.30%)
Microcytic anaemia † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Neutropenia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Thrombocytopenia † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
White blood cell disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cardiac disorders
Angina pectoris † 1	17/284 (5.99%)	4/90 (4.44%)	5/87 (5.75%)
Aortic valve incompetence † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Aortic valve stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Arrhythmia † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Atrial fibrillation † 1	10/284 (3.52%)	0/90 (0.00%)	2/87 (2.30%)
Atrial flutter † 1	2/284 (0.70%)	0/90 (0.00%)	2/87 (2.30%)
Atrial thrombosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Atrioventricular block first degree † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Bradycardia † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Bundle branch block left † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Bundle branch block right † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Cardiac failure † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cardiac failure congestive † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Coronary artery aneurysm † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Coronary artery disease † 1	4/284 (1.41%)	1/90 (1.11%)	1/87 (1.15%)
Coronary artery occlusion † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Coronary artery stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Dilatation atrial † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Extrasystoles † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Ischaemic cardiomyopathy † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Left ventricular dysfunction † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Mitral valve incompetence † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Mitral valve prolapse † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Myocardial ischaemia † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Palpitations † 1	7/284 (2.46%)	1/90 (1.11%)	1/87 (1.15%)
Pericardial effusion † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Right ventricular dilatation † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Sinus bradycardia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Supraventricular tachycardia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tachycardia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Tricuspid valve incompetence † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Ventricular extrasystoles † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Ventricular hypokinesia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Ventricular tachycardia † 1	0/284 (0.00%)	1/90 (1.11%)	1/87 (1.15%)
Congenital, familial and genetic disorders
Corneal dystrophy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hydrocele † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Phimosis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Ear and labyrinth disorders
Deafness bilateral † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Deafness neurosensory † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Deafness unilateral † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Ear pain † 1	4/284 (1.41%)	1/90 (1.11%)	0/87 (0.00%)
Ear swelling † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Excessive cerumen production † 1	2/284 (0.70%)	1/90 (1.11%)	3/87 (3.45%)
Hypoacusis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tinnitus † 1	2/284 (0.70%)	1/90 (1.11%)	2/87 (2.30%)
Vertigo † 1	9/284 (3.17%)	1/90 (1.11%)	3/87 (3.45%)
Vertigo positional † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Vestibular disorder † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Endocrine disorders
Goitre † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Hyperthyroidism † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hypothyroidism † 1	4/284 (1.41%)	1/90 (1.11%)	2/87 (2.30%)
Thyroid cyst † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Thyroid mass † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Eye disorders
Blepharitis † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Cataract † 1	15/284 (5.28%)	0/90 (0.00%)	3/87 (3.45%)
Chalazion † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Conjunctival haemorrhage † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Corneal erosion † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Dacryostenosis acquired † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Diplopia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Dry eye † 1	4/284 (1.41%)	0/90 (0.00%)	3/87 (3.45%)
Entropion † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Epiretinal membrane † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Eye swelling † 1	0/284 (0.00%)	1/90 (1.11%)	1/87 (1.15%)
Glaucoma † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Iritis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lacrimal mucocoele † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lacrimation decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Macular degeneration † 1	4/284 (1.41%)	1/90 (1.11%)	1/87 (1.15%)
Macular hole † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Meibomian gland dysfunction † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Meibomianitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Metamorphopsia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Ocular hyperaemia † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Ocular hypertension † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Photophobia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Retinal artery embolism † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Retinal haemorrhage † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Retinal vein occlusion † 1	0/284 (0.00%)	1/90 (1.11%)	1/87 (1.15%)
Retinopathy hypertensive † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Vision blurred † 1	1/284 (0.35%)	1/90 (1.11%)	2/87 (2.30%)
Visual impairment † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Vitreous detachment † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Vitreous floaters † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Gastrointestinal disorders
Abdominal discomfort † 1	10/284 (3.52%)	0/90 (0.00%)	0/87 (0.00%)
Abdominal distension † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Abdominal hernia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Abdominal pain † 1	13/284 (4.58%)	4/90 (4.44%)	3/87 (3.45%)
Abdominal pain lower † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Abdominal pain upper † 1	5/284 (1.76%)	3/90 (3.33%)	2/87 (2.30%)
Anal haemorrhage † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Aphthous ulcer † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Barrett's oesophagus † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Buccal polyp † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Chronic gastritis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Colitis ulcerative † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Constipation † 1	15/284 (5.28%)	5/90 (5.56%)	5/87 (5.75%)
Defaecation urgency † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Dental caries † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Diarrhoea † 1	17/284 (5.99%)	3/90 (3.33%)	9/87 (10.34%)
Diverticulum † 1	5/284 (1.76%)	1/90 (1.11%)	4/87 (4.60%)
Diverticulum intestinal † 1	2/284 (0.70%)	0/90 (0.00%)	2/87 (2.30%)
Dry mouth † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Dyspepsia † 1	7/284 (2.46%)	0/90 (0.00%)	2/87 (2.30%)
Dysphagia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Enteritis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Faeces discoloured † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Flatulence † 1	1/284 (0.35%)	1/90 (1.11%)	1/87 (1.15%)
Food poisoning † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gastric disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gastric ulcer † 1	0/284 (0.00%)	1/90 (1.11%)	1/87 (1.15%)
Gastritis † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Gastritis erosive † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Gastrointestinal disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gastrointestinal motility disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gastrointestinal scarring † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gastrooesophageal reflux disease † 1	6/284 (2.11%)	2/90 (2.22%)	5/87 (5.75%)
Haematochezia † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Haemorrhoidal haemorrhage † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Haemorrhoids † 1	5/284 (1.76%)	2/90 (2.22%)	1/87 (1.15%)
Hiatus hernia † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Impaired gastric emptying † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Incarcerated umbilical hernia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Inguinal hernia † 1	6/284 (2.11%)	0/90 (0.00%)	1/87 (1.15%)
Intestinal polyp † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Irritable bowel syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Large intestine polyp † 1	9/284 (3.17%)	1/90 (1.11%)	3/87 (3.45%)
Levator syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Malpositioned teeth † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Melaena † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Mouth ulceration † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nausea † 1	18/284 (6.34%)	3/90 (3.33%)	6/87 (6.90%)
Oesophageal obstruction † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Oesophageal spasm † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Oesophagitis † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Pancreatic failure † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pancreatic steatosis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Rectal haemorrhage † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Rectal polyp † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Salivary gland disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Salivary gland enlargement † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Swollen tongue † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Tooth disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Toothache † 1	8/284 (2.82%)	0/90 (0.00%)	0/87 (0.00%)
Umbilical hernia † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Vomiting † 1	6/284 (2.11%)	2/90 (2.22%)	1/87 (1.15%)
General disorders
Adverse drug reaction † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Asthenia † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Chest discomfort † 1	5/284 (1.76%)	0/90 (0.00%)	1/87 (1.15%)
Chest pain † 1	6/284 (2.11%)	1/90 (1.11%)	1/87 (1.15%)
Chills † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Complication of device insertion † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Crepitations † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cyst † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Discomfort † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Drug intolerance † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Face oedema † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Fatigue † 1	23/284 (8.10%)	3/90 (3.33%)	10/87 (11.49%)
Feeling abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gait disturbance † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hernia † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Influenza like illness † 1	15/284 (5.28%)	2/90 (2.22%)	3/87 (3.45%)
Injection site bruising † 1	4/284 (1.41%)	4/90 (4.44%)	3/87 (3.45%)
Injection site discolouration † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Injection site erythema † 1	12/284 (4.23%)	0/90 (0.00%)	3/87 (3.45%)
Injection site haematoma † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Injection site haemorrhage † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Injection site oedema † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Injection site pain † 1	12/284 (4.23%)	0/90 (0.00%)	4/87 (4.60%)
Injection site paraesthesia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Injection site pruritus † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Injection site rash † 1	8/284 (2.82%)	0/90 (0.00%)	1/87 (1.15%)
Injection site reaction † 1	16/284 (5.63%)	2/90 (2.22%)	4/87 (4.60%)
Injection site urticaria † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Injection site vesicles † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Injection site warmth † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Malaise † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Medical device complication † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Multiple organ dysfunction syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nodule † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Non-cardiac chest pain † 1	13/284 (4.58%)	1/90 (1.11%)	4/87 (4.60%)
Oedema peripheral † 1	11/284 (3.87%)	2/90 (2.22%)	6/87 (6.90%)
Pain † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Peripheral swelling † 1	4/284 (1.41%)	1/90 (1.11%)	1/87 (1.15%)
Polyp † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pyrexia † 1	4/284 (1.41%)	1/90 (1.11%)	0/87 (0.00%)
Vessel puncture site bruise † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Vessel puncture site induration † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hepatobiliary disorders
Cholecystitis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Cholelithiasis † 1	7/284 (2.46%)	0/90 (0.00%)	0/87 (0.00%)
Hepatic cyst † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Hepatic fibrosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hepatic function abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hepatic steatosis † 1	5/284 (1.76%)	0/90 (0.00%)	2/87 (2.30%)
Immune system disorders
Allergy to animal † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Allergy to arthropod bite † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Allergy to arthropod sting † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Drug hypersensitivity † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Food allergy † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Hypersensitivity † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Mite allergy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Rubber sensitivity † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Seasonal allergy † 1	3/284 (1.06%)	2/90 (2.22%)	2/87 (2.30%)
Infections and infestations
Abscess † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Abscess of eyelid † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Acarodermatitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Acute sinusitis † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Asymptomatic bacteriuria † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bacterial infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bacteriuria † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Balanitis candida † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bronchitis † 1	15/284 (5.28%)	3/90 (3.33%)	4/87 (4.60%)
COVID-19 † 1	3/284 (1.06%)	0/90 (0.00%)	2/87 (2.30%)
Candida infection † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Cellulitis † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Chlamydial infection † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Clostridium difficile infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Conjunctivitis † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Corneal infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Coronavirus infection † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Cystitis † 1	5/284 (1.76%)	2/90 (2.22%)	6/87 (6.90%)
Diarrhoea infectious † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Diverticulitis † 1	5/284 (1.76%)	2/90 (2.22%)	2/87 (2.30%)
Ear infection † 1	1/284 (0.35%)	1/90 (1.11%)	5/87 (5.75%)
Ear lobe infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Erysipelas † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Escherichia bacteraemia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
External ear cellulitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Eye infection † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Folliculitis † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Fungal infection † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Fungal skin infection † 1	3/284 (1.06%)	1/90 (1.11%)	0/87 (0.00%)
Furuncle † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Gastroenteritis † 1	12/284 (4.23%)	1/90 (1.11%)	0/87 (0.00%)
Gastroenteritis bacterial † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Gastroenteritis viral † 1	8/284 (2.82%)	2/90 (2.22%)	2/87 (2.30%)
Genital herpes simplex † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Genital infection fungal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gingivitis † 1	0/284 (0.00%)	0/90 (0.00%)	3/87 (3.45%)
Helicobacter infection † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Hepatitis C † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Herpes simplex † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Herpes zoster † 1	12/284 (4.23%)	1/90 (1.11%)	3/87 (3.45%)
Hordeolum † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Impetigo † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Infective exacerbation of bronchiectasis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Infective exacerbation of chronic obstructive airways disease † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Influenza † 1	36/284 (12.68%)	6/90 (6.67%)	10/87 (11.49%)
Kidney infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Klebsiella infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Labyrinthitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Localised infection † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Lower respiratory tract infection † 1	11/284 (3.87%)	1/90 (1.11%)	1/87 (1.15%)
Mastitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nail infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nasopharyngitis † 1	55/284 (19.37%)	6/90 (6.67%)	13/87 (14.94%)
Onychomycosis † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Ophthalmic herpes zoster † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Oral candidiasis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Oral fungal infection † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Oral herpes † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Oral infection † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Orchitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Otitis externa † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Otitis media † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Paronychia † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Perichondritis † 1	0/284 (0.00%)	1/90 (1.11%)	1/87 (1.15%)
Pharyngitis † 1	3/284 (1.06%)	0/90 (0.00%)	3/87 (3.45%)
Pneumonia † 1	2/284 (0.70%)	2/90 (2.22%)	1/87 (1.15%)
Pneumonia viral † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Postoperative wound infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pulpitis dental † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Pyelonephritis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Rash pustular † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Respiratory syncytial virus infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Respiratory tract infection † 1	2/284 (0.70%)	0/90 (0.00%)	2/87 (2.30%)
Respiratory tract infection viral † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Retinitis † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Rhinitis † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Root canal infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sebaceous gland infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sinusitis † 1	10/284 (3.52%)	3/90 (3.33%)	3/87 (3.45%)
Skin infection † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Staphylococcal infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Suspected COVID-19 † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tinea cruris † 1	0/284 (0.00%)	0/90 (0.00%)	2/87 (2.30%)
Tooth abscess † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Tooth infection † 1	3/284 (1.06%)	2/90 (2.22%)	0/87 (0.00%)
Upper respiratory tract infection † 1	24/284 (8.45%)	1/90 (1.11%)	5/87 (5.75%)
Urethritis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Urinary tract infection † 1	37/284 (13.03%)	6/90 (6.67%)	7/87 (8.05%)
Urinary tract infection bacterial † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Vaginal infection † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Varicella zoster virus infection † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Vestibular neuronitis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Viral diarrhoea † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Viral infection † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Viral upper respiratory tract infection † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Vulvovaginal candidiasis † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Vulvovaginal mycotic infection † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Wound infection † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Injury, poisoning and procedural complications
Anaemia postoperative † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Animal bite † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Ankle fracture † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Arthropod bite † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Back injury † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Bone contusion † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Burns second degree † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cervical vertebral fracture † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Chest injury † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Concussion † 1	2/284 (0.70%)	3/90 (3.33%)	0/87 (0.00%)
Contusion † 1	15/284 (5.28%)	2/90 (2.22%)	3/87 (3.45%)
Epicondylitis † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Eye contusion † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Facial bones fracture † 1	0/284 (0.00%)	1/90 (1.11%)	1/87 (1.15%)
Fall † 1	24/284 (8.45%)	1/90 (1.11%)	2/87 (2.30%)
Fibula fracture † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Foot fracture † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Forearm fracture † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Foreign body † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hand fracture † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Head injury † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Hip fracture † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Incisional hernia † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Incorrect dose administered † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Inflammation of wound † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Injection related reaction † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Injury † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Joint dislocation † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Joint injury † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Ligament rupture † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Ligament sprain † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Limb injury † 1	2/284 (0.70%)	3/90 (3.33%)	1/87 (1.15%)
Lip injury † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lower limb fracture † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Lumbar vertebral fracture † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Medication error † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Meniscus injury † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Muscle rupture † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Muscle strain † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Musculoskeletal injury † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Overdose † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Patella fracture † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Periorbital haematoma † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Post procedural complication † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Post procedural oedema † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Post procedural swelling † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Post-traumatic neck syndrome † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Post-traumatic pain † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Postoperative ileus † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Procedural pain † 1	3/284 (1.06%)	1/90 (1.11%)	1/87 (1.15%)
Product dispensing error † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Radius fracture † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Reactive gastropathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Rib fracture † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Road traffic accident † 1	3/284 (1.06%)	2/90 (2.22%)	1/87 (1.15%)
Skin abrasion † 1	6/284 (2.11%)	1/90 (1.11%)	0/87 (0.00%)
Skin laceration † 1	2/284 (0.70%)	0/90 (0.00%)	3/87 (3.45%)
Sunburn † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tendon injury † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Tendon rupture † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Thermal burn † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Tibia fracture † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tooth fracture † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Traumatic haematoma † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Traumatic liver injury † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Traumatic shock † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Ulna fracture † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Ulnar nerve injury † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Upper limb fracture † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Vaccination complication † 1	6/284 (2.11%)	0/90 (0.00%)	0/87 (0.00%)
Wound † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Wound haemorrhage † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Wrist fracture † 1	1/284 (0.35%)	2/90 (2.22%)	0/87 (0.00%)
Wrong dose † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Investigations
Activated partial thromboplastin time prolonged † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Alanine aminotransferase increased † 1	3/284 (1.06%)	1/90 (1.11%)	1/87 (1.15%)
Aspartate aminotransferase increased † 1	2/284 (0.70%)	1/90 (1.11%)	1/87 (1.15%)
Blood alkaline phosphatase increased † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Blood bilirubin increased † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Blood calcium increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Blood creatine phosphokinase increased † 1	10/284 (3.52%)	2/90 (2.22%)	0/87 (0.00%)
Blood creatinine increased † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Blood folate decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Blood glucose abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Blood glucose increased † 1	5/284 (1.76%)	1/90 (1.11%)	1/87 (1.15%)
Blood potassium decreased † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Blood potassium increased † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Blood pressure increased † 1	1/284 (0.35%)	1/90 (1.11%)	1/87 (1.15%)
Blood sodium decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Blood urea increased † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Blood uric acid decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Blood uric acid increased † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Blood urine present † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Body temperature increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
C-reactive protein increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Carbohydrate antigen 19-9 increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Carcinoembryonic antigen increased † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Cardiac murmur † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Carotid bruit † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Electrocardiogram abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Gamma-glutamyltransferase abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gamma-glutamyltransferase increased † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Glomerular filtration rate decreased † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Glycosylated haemoglobin increased † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Haematocrit decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Haemoglobin decreased † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Heart rate decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Heart rate irregular † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Hepatic enzyme increased † 1	9/284 (3.17%)	0/90 (0.00%)	2/87 (2.30%)
International normalised ratio increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Intraocular pressure increased † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Lipoprotein (a) increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lipoprotein increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Liver function test abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Liver function test increased † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Low density lipoprotein increased † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Mean cell volume increased † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Neutrophil count increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Platelet count decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Platelet count increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Prostatic specific antigen increased † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Pulmonary function test decreased † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Pulse absent † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
QRS axis abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
SARS-CoV-2 test positive † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Sinus rhythm † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Spirometry abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Streptococcus test positive † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Thyroid function test abnormal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Troponin T increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Urine analysis abnormal † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Vitamin B12 decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Vitamin D decreased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Weight decreased † 1	1/284 (0.35%)	0/90 (0.00%)	2/87 (2.30%)
Weight increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
White blood cell count increased † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Metabolism and nutrition disorders
Decreased appetite † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Dehydration † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Diabetes mellitus † 1	32/284 (11.27%)	0/90 (0.00%)	6/87 (6.90%)
Diabetes mellitus inadequate control † 1	8/284 (2.82%)	0/90 (0.00%)	6/87 (6.90%)
Dyslipidaemia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Fluid retention † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Glucose tolerance impaired † 1	2/284 (0.70%)	2/90 (2.22%)	0/87 (0.00%)
Gout † 1	12/284 (4.23%)	1/90 (1.11%)	5/87 (5.75%)
Haemochromatosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hypercholesterolaemia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hyperglycaemia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Hypertriglyceridaemia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Hyperuricaemia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Hypoglycaemia † 1	2/284 (0.70%)	0/90 (0.00%)	2/87 (2.30%)
Hypokalaemia † 1	3/284 (1.06%)	0/90 (0.00%)	2/87 (2.30%)
Hypomagnesaemia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hyponatraemia † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Impaired fasting glucose † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Increased appetite † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Iron deficiency † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Type 2 diabetes mellitus † 1	7/284 (2.46%)	0/90 (0.00%)	2/87 (2.30%)
Vitamin B12 deficiency † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Vitamin D deficiency † 1	3/284 (1.06%)	0/90 (0.00%)	2/87 (2.30%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	40/284 (14.08%)	10/90 (11.11%)	10/87 (11.49%)
Arthritis † 1	5/284 (1.76%)	1/90 (1.11%)	3/87 (3.45%)
Arthritis reactive † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Axillary mass † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Back pain † 1	28/284 (9.86%)	1/90 (1.11%)	13/87 (14.94%)
Bone atrophy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bone pain † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Bursitis † 1	9/284 (3.17%)	0/90 (0.00%)	0/87 (0.00%)
Cervical spinal stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Chondropathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Coccydynia † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Costochondritis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Dupuytren's contracture † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Enthesopathy † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Exostosis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Exostosis of jaw † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Femoroacetabular impingement † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Fibromyalgia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Finger deformity † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Foot deformity † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Groin pain † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Intervertebral disc degeneration † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Intervertebral disc disorder † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Intervertebral disc protrusion † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Joint stiffness † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Joint swelling † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Limb discomfort † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Loose body in joint † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Lumbar spinal stenosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Muscle spasms † 1	15/284 (5.28%)	6/90 (6.67%)	2/87 (2.30%)
Muscle tightness † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Muscular weakness † 1	5/284 (1.76%)	2/90 (2.22%)	1/87 (1.15%)
Musculoskeletal chest pain † 1	5/284 (1.76%)	0/90 (0.00%)	1/87 (1.15%)
Musculoskeletal pain † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Musculoskeletal stiffness † 1	2/284 (0.70%)	0/90 (0.00%)	2/87 (2.30%)
Myalgia † 1	24/284 (8.45%)	7/90 (7.78%)	3/87 (3.45%)
Neck pain † 1	4/284 (1.41%)	1/90 (1.11%)	2/87 (2.30%)
Osteitis † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Osteoarthritis † 1	16/284 (5.63%)	2/90 (2.22%)	6/87 (6.90%)
Osteochondrosis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Osteopenia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Osteoporosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pain in extremity † 1	25/284 (8.80%)	1/90 (1.11%)	6/87 (6.90%)
Periarthritis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Plantar fasciitis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Polyarthritis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Polymyalgia rheumatica † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Rheumatoid arthritis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Rotator cuff syndrome † 1	3/284 (1.06%)	1/90 (1.11%)	1/87 (1.15%)
Shoulder deformity † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sjogren's syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Spinal deformity † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Spinal osteoarthritis † 1	6/284 (2.11%)	0/90 (0.00%)	0/87 (0.00%)
Spinal pain † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Spinal stenosis † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Spondyloarthropathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Spondylolisthesis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Synovial cyst † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Synovitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tendon pain † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Tendonitis † 1	3/284 (1.06%)	1/90 (1.11%)	4/87 (4.60%)
Tenosynovitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Trigger finger † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † 1	11/284 (3.87%)	0/90 (0.00%)	3/87 (3.45%)
Blepharal papilloma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bowen's disease † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Colon adenoma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Fibroma † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Haemangioma of liver † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Hypergammaglobulinaemia benign monoclonal † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Intraductal papillary mucinous neoplasm † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lipoma † 1	2/284 (0.70%)	2/90 (2.22%)	1/87 (1.15%)
Malignant melanoma † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Melanocytic naevus † 1	0/284 (0.00%)	0/90 (0.00%)	2/87 (2.30%)
Meningioma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Oral papilloma † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Ovarian fibroma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Papilloma † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Phaeochromocytoma † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Plasma cell myeloma † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Prostatic adenoma † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Seborrhoeic keratosis † 1	0/284 (0.00%)	0/90 (0.00%)	2/87 (2.30%)
Squamous cell carcinoma of skin † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nervous system disorders
Ageusia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Altered state of consciousness † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Amnesia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Anosmia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Balance disorder † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Burning sensation † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Carotid arteriosclerosis † 1	0/284 (0.00%)	0/90 (0.00%)	2/87 (2.30%)
Carotid artery stenosis † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Carpal tunnel syndrome † 1	3/284 (1.06%)	1/90 (1.11%)	2/87 (2.30%)
Cerebral haemorrhage † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cerebral infarction † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cerebrovascular accident † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Cervical radiculopathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cluster headache † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cognitive disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cubital tunnel syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Diabetic neuropathy † 1	3/284 (1.06%)	1/90 (1.11%)	0/87 (0.00%)
Disturbance in attention † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Dizziness † 1	24/284 (8.45%)	4/90 (4.44%)	5/87 (5.75%)
Dizziness postural † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Dysarthria † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Dysgeusia † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Epilepsy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Head discomfort † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Headache † 1	21/284 (7.39%)	8/90 (8.89%)	7/87 (8.05%)
Hypoaesthesia † 1	4/284 (1.41%)	2/90 (2.22%)	2/87 (2.30%)
Loss of consciousness † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lumbosacral radiculopathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Memory impairment † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Migraine † 1	2/284 (0.70%)	1/90 (1.11%)	2/87 (2.30%)
Migraine with aura † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Muscle tension dysphonia † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Nerve compression † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Nervous system disorder † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Neuropathy peripheral † 1	2/284 (0.70%)	0/90 (0.00%)	2/87 (2.30%)
Occipital neuralgia † 1	0/284 (0.00%)	1/90 (1.11%)	1/87 (1.15%)
Ophthalmic migraine † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Paraesthesia † 1	7/284 (2.46%)	1/90 (1.11%)	3/87 (3.45%)
Parkinson's disease † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Parkinsonism † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Piriformis syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Polyneuropathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Post herpetic neuralgia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Presyncope † 1	5/284 (1.76%)	1/90 (1.11%)	1/87 (1.15%)
Restless legs syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	2/87 (2.30%)
Sciatica † 1	3/284 (1.06%)	1/90 (1.11%)	3/87 (3.45%)
Sensory loss † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Somnolence † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Syncope † 1	4/284 (1.41%)	0/90 (0.00%)	2/87 (2.30%)
Taste disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Tremor † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Vascular dementia † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Product Issues
Device dislocation † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Prosthetic cardiac valve failure † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Psychiatric disorders
Acute stress disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Adjustment disorder with depressed mood † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Agitation † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Alcoholism † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Anxiety † 1	4/284 (1.41%)	2/90 (2.22%)	1/87 (1.15%)
Anxiety disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Burnout syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Confusional state † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Delirium † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Depressed mood † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Depression † 1	12/284 (4.23%)	0/90 (0.00%)	0/87 (0.00%)
Disorientation † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Emotional disorder † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Emotional distress † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Fear † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Indifference † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Insomnia † 1	10/284 (3.52%)	1/90 (1.11%)	1/87 (1.15%)
Nightmare † 1	0/284 (0.00%)	1/90 (1.11%)	1/87 (1.15%)
Panic attack † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Seasonal affective disorder † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Stress † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Albuminuria † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Bladder cyst † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Calculus bladder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Chronic kidney disease † 1	1/284 (0.35%)	1/90 (1.11%)	1/87 (1.15%)
Cystitis noninfective † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Dysuria † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Glycosuria † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Haematuria † 1	9/284 (3.17%)	1/90 (1.11%)	3/87 (3.45%)
Hydronephrosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hypertonic bladder † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Incontinence † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Leukocyturia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lower urinary tract symptoms † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Microalbuminuria † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Micturition disorder † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Micturition urgency † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Myoglobinuria † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nephrolithiasis † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Nephropathy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nocturia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Pollakiuria † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Polyuria † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Proteinuria † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Renal artery stenosis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Renal colic † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Renal cyst † 1	4/284 (1.41%)	0/90 (0.00%)	2/87 (2.30%)
Renal failure † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Renal impairment † 1	3/284 (1.06%)	1/90 (1.11%)	1/87 (1.15%)
Ureteral disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Urinary incontinence † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Urinary retention † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Urinary tract discomfort † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Reproductive system and breast disorders
Abnormal uterine bleeding † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Atrophic vulvovaginitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Balanoposthitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Benign prostatic hyperplasia † 1	8/284 (2.82%)	0/90 (0.00%)	3/87 (3.45%)
Breast disorder female † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Breast pain † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Breast tenderness † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Cervix disorder † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Erectile dysfunction † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Genital rash † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Gynaecomastia † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Haematospermia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Heavy menstrual bleeding † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Menopausal symptoms † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Penile erythema † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Postmenopausal haemorrhage † 1	1/284 (0.35%)	1/90 (1.11%)	1/87 (1.15%)
Prostatitis † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Pruritus genital † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Scrotal pain † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Spermatocele † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Testicular swelling † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Uterine polyp † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Vaginal dysplasia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Vulvovaginal pain † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Vulvovaginal pruritus † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthma † 1	10/284 (3.52%)	1/90 (1.11%)	4/87 (4.60%)
Bronchospasm † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Chronic obstructive pulmonary disease † 1	7/284 (2.46%)	1/90 (1.11%)	2/87 (2.30%)
Cough † 1	22/284 (7.75%)	1/90 (1.11%)	5/87 (5.75%)
Dry throat † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Dysphonia † 1	3/284 (1.06%)	0/90 (0.00%)	2/87 (2.30%)
Dyspnoea † 1	22/284 (7.75%)	2/90 (2.22%)	5/87 (5.75%)
Dyspnoea exertional † 1	10/284 (3.52%)	0/90 (0.00%)	5/87 (5.75%)
Emphysema † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Epistaxis † 1	10/284 (3.52%)	1/90 (1.11%)	0/87 (0.00%)
Hiccups † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Hypoxia † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Lung infiltration † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nasal congestion † 1	1/284 (0.35%)	1/90 (1.11%)	1/87 (1.15%)
Nasal obstruction † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Nasal polyps † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nasal septum deviation † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Oropharyngeal pain † 1	8/284 (2.82%)	1/90 (1.11%)	1/87 (1.15%)
Pleural effusion † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Pneumothorax † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Pulmonary calcification † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pulmonary embolism † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Pulmonary hypertension † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Pulmonary mass † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Reflux laryngitis † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Respiratory disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Respiratory distress † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Respiratory tract congestion † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Rhinorrhoea † 1	1/284 (0.35%)	2/90 (2.22%)	0/87 (0.00%)
Sinonasal obstruction † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sinus congestion † 1	1/284 (0.35%)	1/90 (1.11%)	1/87 (1.15%)
Sinus disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sinus polyp † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Sleep apnoea syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Sneezing † 1	2/284 (0.70%)	1/90 (1.11%)	0/87 (0.00%)
Throat irritation † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Upper respiratory tract irritation † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Upper-airway cough syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Wheezing † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Skin and subcutaneous tissue disorders
Acne † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Actinic elastosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Actinic keratosis † 1	4/284 (1.41%)	1/90 (1.11%)	2/87 (2.30%)
Alopecia † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Blister † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Dermal cyst † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Dermatitis † 1	2/284 (0.70%)	1/90 (1.11%)	1/87 (1.15%)
Dry skin † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Ecchymosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Eczema † 1	4/284 (1.41%)	2/90 (2.22%)	2/87 (2.30%)
Eczema nummular † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Erythema † 1	4/284 (1.41%)	0/90 (0.00%)	0/87 (0.00%)
Hand dermatitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hidradenitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hyperhidrosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hyperkeratosis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Ingrowing nail † 1	2/284 (0.70%)	0/90 (0.00%)	1/87 (1.15%)
Keloid scar † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lichen planus † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Lichenoid keratosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nail discolouration † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Nail dystrophy † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Neurodermatitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Night sweats † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Penile ulceration † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Petechiae † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Precancerous skin lesion † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Pruritus † 1	11/284 (3.87%)	2/90 (2.22%)	3/87 (3.45%)
Psoriasis † 1	5/284 (1.76%)	0/90 (0.00%)	0/87 (0.00%)
Rash † 1	11/284 (3.87%)	2/90 (2.22%)	1/87 (1.15%)
Rash erythematous † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Rosacea † 1	1/284 (0.35%)	1/90 (1.11%)	1/87 (1.15%)
Scab † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Seborrhoeic dermatitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Skin depigmentation † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Skin discolouration † 1	0/284 (0.00%)	1/90 (1.11%)	0/87 (0.00%)
Skin fissures † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Skin induration † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Skin lesion † 1	6/284 (2.11%)	0/90 (0.00%)	1/87 (1.15%)
Skin ulcer † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Stasis dermatitis † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Vitiligo † 1	0/284 (0.00%)	0/90 (0.00%)	1/87 (1.15%)
Xanthoma † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Surgical and medical procedures
Abortion induced † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Vascular disorders
Aortic aneurysm † 1	2/284 (0.70%)	0/90 (0.00%)	2/87 (2.30%)
Aortic arteriosclerosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Aortic dilatation † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Aortic stenosis † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Circulatory collapse † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Deep vein thrombosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Extremity necrosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Flushing † 1	1/284 (0.35%)	1/90 (1.11%)	0/87 (0.00%)
Hot flush † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Hypertension † 1	42/284 (14.79%)	2/90 (2.22%)	17/87 (19.54%)
Hypertensive crisis † 1	1/284 (0.35%)	0/90 (0.00%)	1/87 (1.15%)
Hypertensive urgency † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Hypotension † 1	6/284 (2.11%)	0/90 (0.00%)	1/87 (1.15%)
Intermittent claudication † 1	3/284 (1.06%)	0/90 (0.00%)	0/87 (0.00%)
Lymphoedema † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Orthostatic hypotension † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Peripheral arterial occlusive disease † 1	3/284 (1.06%)	0/90 (0.00%)	1/87 (1.15%)
Peripheral coldness † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Peripheral vascular disorder † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Peripheral venous disease † 1	2/284 (0.70%)	0/90 (0.00%)	0/87 (0.00%)
Post thrombotic syndrome † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Thrombosis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Varicophlebitis † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
Varicose vein † 1	1/284 (0.35%)	0/90 (0.00%)	0/87 (0.00%)
1 Term from vocabulary, MedDRA (18.1); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Results Point of Contact

• Name/Title: Study Director
• Organization: Novartis Pharmaceuticals
• Phone: + 1 862 778 8300
• EMail: Novartis.email@Novartis.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• ClinicalTrials.gov Identifier: NCT03060577
• Other Study ID Numbers: MDCO-PCS-16-01; 2016-003815-37 ( EudraCT Number )
• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Results First Submitted: November 28, 2022
• Results First Posted: March 24, 2023
• Last Update Posted: March 24, 2023