Trial Outcomes & Findings for E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events (NCT NCT00345839)

NCT ID: NCT00345839

Last Updated: 2022-11-07

Results Overview

Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3883 participants
• Primary outcome timeframe: From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years
• Results posted on: 2022-11-07

Participant Flow

Participants were recruited from dialysis clinics and hospitals between August 2006 to Jan 2008 from 22 countries.

Participants were screened over a 30 day period.

Participant milestones

Measure	Cinacalcet Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Study STARTED	1948	1935
Overall Study COMPLETED	1799	1776
Overall Study NOT COMPLETED	149	159

Reasons for withdrawal

Measure	Cinacalcet Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Study Withdrawal by Subject	91	98
Overall Study Lost to Follow-up	58	61

Baseline Characteristics

E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events

Baseline characteristics by cohort

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.	Total n=3883 Participants Total of all reporting groups
Age, Continuous	54.8 Years STANDARD_DEVIATION 14.5 • n=5 Participants	54.0 Years STANDARD_DEVIATION 14.2 • n=7 Participants	54.4 Years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	809 Participants n=5 Participants	769 Participants n=7 Participants	1578 Participants n=5 Participants
Sex: Female, Male Male	1139 Participants n=5 Participants	1166 Participants n=7 Participants	2305 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	1124 Participants n=5 Participants	1116 Participants n=7 Participants	2240 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	409 Participants n=5 Participants	428 Participants n=7 Participants	837 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	317 Participants n=5 Participants	310 Participants n=7 Participants	627 Participants n=5 Participants
Race/Ethnicity, Customized Asian	47 Participants n=5 Participants	38 Participants n=7 Participants	85 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Aborigine	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
History of Diabetes Stratification Factor Diabetes	619 Participants n=5 Participants	614 Participants n=7 Participants	1233 Participants n=5 Participants
History of Diabetes Stratification Factor No Diabetes	1329 Participants n=5 Participants	1321 Participants n=7 Participants	2650 Participants n=5 Participants
Country stratification factor Argentina	171 Participants n=5 Participants	170 Participants n=7 Participants	341 Participants n=5 Participants
Country stratification factor Australia	74 Participants n=5 Participants	75 Participants n=7 Participants	149 Participants n=5 Participants
Country stratification factor Austria	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Country stratification factor Belgium	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Country stratification factor Brazil	151 Participants n=5 Participants	150 Participants n=7 Participants	301 Participants n=5 Participants
Country stratification factor Canada	73 Participants n=5 Participants	73 Participants n=7 Participants	146 Participants n=5 Participants
Country stratification factor Denmark	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Country stratification factor France	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Country stratification factor Germany	81 Participants n=5 Participants	81 Participants n=7 Participants	162 Participants n=5 Participants
Country stratification factor Hungary	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Country stratification factor Ireland	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Country stratification factor Italy	69 Participants n=5 Participants	68 Participants n=7 Participants	137 Participants n=5 Participants
Country stratification factor Mexico	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Country stratification factor Netherlands	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Country stratification factor Poland	59 Participants n=5 Participants	57 Participants n=7 Participants	116 Participants n=5 Participants
Country stratification factor Portugal	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Country stratification factor Russia	143 Participants n=5 Participants	140 Participants n=7 Participants	283 Participants n=5 Participants
Country stratification factor Spain	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Country stratification factor Sweden	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Country stratification factor Switzerland	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Country stratification factor United Kingdom	81 Participants n=5 Participants	79 Participants n=7 Participants	160 Participants n=5 Participants
Country stratification factor United States	715 Participants n=5 Participants	715 Participants n=7 Participants	1430 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)	55.0 Months Interval 22.6 to NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	53.0 Months Interval 19.1 to NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to All-cause Mortality. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to All-cause Mortality	NA Months Interval 37.9 to NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months Interval 31.6 to NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Myocardial Infarction. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Myocardial Infarction	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Hospitalization for Unstable Angina	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Heart Failure. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Heart Failure	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Peripheral Vascular Event. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Peripheral Vascular Event	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Cardiovascular Mortality. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Cardiovascular Mortality	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Stroke. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Stroke	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Bone Fracture. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Bone Fracture	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

SECONDARY outcome

Timeframe: From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years

Population: Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Time to Parathyroidectomy. Stratified by history of diabetes and country.

Outcome measures

Measure	Cinacalcet n=1948 Participants Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.	Placebo n=1935 Participants Participants were given matching placebo tablets compared to the cinacalcet group.
Time to Parathyroidectomy	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.	NA Months NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Adverse Events

Placebo

Serious events: 1351 serious events

Other events: 1220 other events

Deaths: 0 deaths

Cinacalcet

Serious events: 1338 serious events

Other events: 1444 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=1923 participants at risk	Cinacalcet n=1938 participants at risk Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Anastomotic stenosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Animal bite	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Ankle fracture	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula aneurysm	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.67% 13/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	2.3% 44/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.9% 36/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula site haematoma	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	1.2% 23/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.88% 17/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	2.2% 43/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.5% 49/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Excoriation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Lupus pneumonitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pleural disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.94% 18/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.7% 32/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.78% 15/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.72% 14/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary necrosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.3% 44/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.0% 39/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 40/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.6% 31/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Acne	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Acute generalised exanthematous pustulosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Alopecia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Angiodermatitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Angioedema	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous graft aneurysm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous graft site haematoma	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous graft site haemorrhage	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Brain contusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Burns second degree	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Cardiac valve replacement complication	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Chest injury	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Clavicle fracture	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Complications of transplanted kidney	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Compression fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Concussion	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Contusion	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Craniocerebral injury	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Anaemia	1.8% 35/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.2% 42/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Coagulopathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Febrile neutropenia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Haemolysis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Leukopenia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Lymphadenitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Lymphadenopathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Lymphatic disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Nephrogenic anaemia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Pancytopenia	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Polycythaemia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Retroperitoneal lymphadenopathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Splenic infarction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Splenomegaly	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Thrombocytopenia	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Acute coronary syndrome	0.73% 14/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Acute left ventricular failure	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Acute myocardial infarction	1.8% 34/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.4% 47/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Angina pectoris	2.2% 42/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.9% 36/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Angina unstable	2.2% 42/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.7% 52/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Aortic valve incompetence	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Aortic valve stenosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Arrhythmia	0.88% 17/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Arrhythmia supraventricular	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Arteriosclerosis coronary artery	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Atrial fibrillation	3.5% 68/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.9% 56/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Atrial flutter	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Atrial tachycardia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Atrioventricular block	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Atrioventricular block complete	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Atrioventricular block first degree	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Atrioventricular block second degree	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Atrioventricular dissociation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Bradyarrhythmia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Bradycardia	0.47% 9/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Bundle branch block	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Bundle branch block right	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac arrest	3.0% 57/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	3.1% 60/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac failure	4.7% 90/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	3.8% 74/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac failure acute	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac failure chronic	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac failure congestive	4.5% 86/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	3.3% 64/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac flutter	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac tamponade	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiac valve disease	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardio-respiratory arrest	1.1% 21/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.4% 27/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiogenic shock	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiomyopathy	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiopulmonary failure	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiovascular disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Cardiovascular insufficiency	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Congestive cardiomyopathy	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Coronary artery disease	1.2% 23/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.4% 28/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Coronary artery insufficiency	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Coronary artery occlusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Coronary artery stenosis	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Diastolic dysfunction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Dilatation ventricular	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Gastrocardiac syndrome	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Heart valve stenosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Hypertensive heart disease	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Ischaemic cardiomyopathy	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Left ventricular dysfunction	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Left ventricular failure	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Left ventricular hypertrophy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Mitral valve calcification	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Mitral valve disease	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Mitral valve incompetence	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Mitral valve stenosis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Myocardial infarction	5.5% 105/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	5.6% 109/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Myocardial ischaemia	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.57% 11/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Myocarditis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Palpitations	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Pericardial effusion	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Pericardial haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Pericarditis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Pericarditis uraemic	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Pulseless electrical activity	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Right ventricular failure	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Sick sinus syndrome	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Sinus bradycardia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Crush injury	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Sinus tachycardia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Supraventricular tachyarrhythmia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Supraventricular tachycardia	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Tachyarrhythmia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Tachycardia	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Tricuspid valve incompetence	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Tricuspid valve stenosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Ventricular arrhythmia	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Ventricular extrasystoles	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Ventricular failure	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Ventricular fibrillation	0.47% 9/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Cardiac disorders Ventricular tachycardia	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Congenital, familial and genetic disorders Adenomatous polyposis coli	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Congenital, familial and genetic disorders Congenital cystic disease of liver	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Congenital, familial and genetic disorders Left ventricle outflow tract obstruction	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Ear and labyrinth disorders Aural polyp	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Ear and labyrinth disorders Deafness unilateral	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Ear and labyrinth disorders Meniere's disease	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Ear and labyrinth disorders Vertigo	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Ear and labyrinth disorders Vertigo positional	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Adrenal insufficiency	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Goitre	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Hyperparathyroidism	4.5% 86/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.2% 23/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Hyperparathyroidism secondary	2.1% 41/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Hyperparathyroidism tertiary	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Hyperthyroidism	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Parathyroid disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Parathyroid gland enlargement	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Parathyroid haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Secondary hyperthyroidism	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Thyroid cyst	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Endocrine disorders Thyroiditis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Age-related macular degeneration	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Cataract	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Cataract cortical	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Conjunctival haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Conjunctivitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Diabetic retinopathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Diplopia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Exophthalmos	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Eye haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Glaucoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Keratitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Optic atrophy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Optic ischaemic neuropathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Papilloedema	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Photopsia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Retinal artery occlusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Retinal detachment	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Retinal vein thrombosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Retinopathy hypertensive	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Vision blurred	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Visual impairment	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Eye disorders Vitreous haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal discomfort	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal distension	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal hernia	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal pain	2.2% 42/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.7% 33/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal pain lower	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal pain upper	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Anal fistula	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Ascites	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Colitis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Colitis ischaemic	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Colitis ulcerative	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Colonic polyp	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Colonic pseudo-obstruction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Constipation	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Dental caries	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Diarrhoea	1.2% 24/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.7% 32/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Dieulafoy's vascular malformation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Diverticular perforation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Diverticulum	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Diverticulum intestinal	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Duodenal perforation	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Duodenal ulcer	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Duodenitis	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Duodenitis haemorrhagic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Dyspepsia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Dysphagia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Enteritis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Enterocolitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Erosive duodenitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Faecaloma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Faeces discoloured	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastric antral vascular ectasia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastric haemorrhage	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastric hypermotility	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastric perforation	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastric polyps	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastric ulcer	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastritis	0.78% 15/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastritis erosive	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.8% 53/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.8% 54/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal hypomotility	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal inflammation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal necrosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal obstruction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal oedema	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal perforation	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Haematemesis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Haematochezia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Haemorrhoids	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Hernial eventration	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Hiatus hernia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Ileus	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Impaired gastric emptying	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Inguinal hernia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal infarction	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal ischaemia	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal mass	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal obstruction	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal perforation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal polyp	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal strangulation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intestinal ulcer	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Ischaemic gastritis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Large intestinal haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Large intestine perforation	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Lumbar hernia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Mechanical ileus	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Melaena	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Nausea	0.83% 16/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.0% 20/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Necrotising colitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophageal disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophageal food impaction	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophageal haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophageal perforation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophageal rupture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophageal ulcer	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophagitis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Oesophagitis haemorrhagic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Pancreatic mass	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Pancreatitis	0.57% 11/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Pancreatitis acute	0.47% 9/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Pancreatitis chronic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Peptic ulcer	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Peritoneal disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Portal hypertensive enteropathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Portal hypertensive gastropathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Proctitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Rectal haemorrhage	0.62% 12/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Rectal ulcer	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Rectal ulcer haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Retroperitoneal haematoma	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Retroperitoneal mass	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Short-bowel syndrome	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Sigmoiditis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Small intestinal obstruction	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Stomach mass	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Stress ulcer	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Subileus	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Tooth loss	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Tooth socket haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Toothache	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Umbilical hernia	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Umbilical hernia, obstructive	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.57% 11/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Uraemic gastropathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Varices oesophageal	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Vomiting	1.2% 23/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.7% 33/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Adverse drug reaction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Asthenia	1.0% 20/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.77% 15/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Calcinosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Catheter site haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Catheter site haemorrhage	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Catheter site pain	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Catheter site swelling	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Chest discomfort	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Chest pain	2.8% 53/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.6% 51/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Chills	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Condition aggravated	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Cyst	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Death	2.0% 38/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.0% 38/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Device breakage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Device dislocation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Device failure	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Device malfunction	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Device occlusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Drug intolerance	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Drug withdrawal syndrome	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Face oedema	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Fat necrosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Fatigue	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Feeling abnormal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Gait disturbance	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders General physical health deterioration	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Granuloma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Hernia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Hernia obstructive	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Hernia pain	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Hyperthermia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Hypothermia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Impaired healing	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Implant site effusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Implant site haematoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Inflammation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Influenza like illness	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Infusion site thrombosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Ischaemic ulcer	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Localised oedema	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Malaise	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Medical device complication	0.88% 17/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Multi-organ failure	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Necrosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Non-cardiac chest pain	1.2% 23/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.4% 27/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Oedema	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Oedema peripheral	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Organ failure	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Pain	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Pelvic mass	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Polyserositis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Precancerous mucosal lesion	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Pyrexia	1.8% 35/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.2% 42/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Spinal pain	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Sudden cardiac death	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Sudden death	1.4% 26/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.1% 22/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Systemic inflammatory response syndrome	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Thrombosis in device	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Ulcer	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Ulcer haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Bile duct obstruction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Bile duct stone	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Biliary colic	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Biliary dyskinesia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholangitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholangitis acute	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholecystitis	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholecystitis acute	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholelithiasis	0.62% 12/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.83% 16/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Cholestasis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Chronic hepatic failure	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Gallbladder perforation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Hepatic cirrhosis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Hepatic congestion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Hepatic cyst ruptured	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Hepatic failure	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Hepatic lesion	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Hepatitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Hepatitis toxic	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Jaundice cholestatic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Hepatobiliary disorders Liver disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Immune system disorders Amyloidosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Immune system disorders Anaphylactic reaction	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Immune system disorders Contrast media allergy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Immune system disorders Dialysis amyloidosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Immune system disorders Kidney transplant rejection	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Immune system disorders Transplant rejection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abdominal abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abdominal sepsis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abdominal wall abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abdominal wall infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abscess	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abscess intestinal	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abscess limb	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abscess neck	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abscess of eyelid	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Abscess oral	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Acute sinusitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Amoebic dysentery	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Appendicitis	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Appendicitis perforated	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Arteriosclerotic gangrene	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Arteriovenous fistula site infection	0.78% 15/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Arteriovenous graft site infection	0.73% 14/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.3% 25/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Arthritis bacterial	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Arthritis infective	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bacteraemia	1.2% 24/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.4% 27/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bacterial infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bacterial sepsis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bartholin's abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Biliary sepsis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Biliary tract infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Breast cellulitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bronchitis	1.3% 25/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.3% 26/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bronchitis bacterial	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bronchitis viral	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bronchopneumonia	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Carbuncle	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Catheter site cellulitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Catheter site infection	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Cellulitis	2.0% 38/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.5% 29/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Cellulitis gangrenous	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Cellulitis orbital	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Cellulitis staphylococcal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Chest wall abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Clostridial infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Clostridium colitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Clostridium difficile colitis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Cystitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Dengue fever	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Dermo-hypodermitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Device related infection	1.5% 28/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.5% 29/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Device related sepsis	0.94% 18/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.77% 15/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Diabetic foot infection	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Diabetic gangrene	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Disseminated tuberculosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Diverticulitis	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Ear infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Embolic pneumonia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Emphysematous cystitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Empyema	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Endocarditis	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.67% 13/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Endocarditis bacterial	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Endocarditis staphylococcal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Enteritis infectious	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Enterobacter bacteraemia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Enterobacter pneumonia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Enterobacter sepsis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Enterococcal bacteraemia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Enterococcal infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Enterocolitis bacterial	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Enterocolitis infectious	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Erysipelas	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Escherichia bacteraemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Escherichia infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Escherichia sepsis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Extradural abscess	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Eye infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Fungaemia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Fungal oesophagitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Furuncle	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Gangrene	2.2% 42/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.0% 38/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Gas gangrene	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Gastric infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Gastroenteritis	1.0% 20/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.2% 24/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Gastroenteritis clostridial	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Gastroenteritis norovirus	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Gastroenteritis salmonella	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Gastroenteritis viral	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Giardiasis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Graft infection	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Groin abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations H1N1 influenza	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Haematoma infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Haemophilus infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Helicobacter infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Hepatitis B	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Hepatitis C	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Herpes zoster	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Herpes zoster ophthalmic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Implant site infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Incision site infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Infected fistula	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Infected skin ulcer	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Infection	0.57% 11/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.57% 11/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Infectious peritonitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Infectious pleural effusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Infective aneurysm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Infective tenosynovitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Influenza	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Intervertebral discitis	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Joint abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Kidney infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Klebsiella bacteraemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Laryngitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Liver abscess	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Lobar pneumonia	0.88% 17/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.72% 14/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Localised infection	0.88% 17/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.57% 11/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Lower respiratory tract infection	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.57% 11/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Lower respiratory tract infection viral	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Lung infection	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Lymph gland infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Meningitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Meningitis bacterial	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Meningitis cryptococcal	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Meningitis viral	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Morganella infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Nasal abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Necrotising fasciitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Oesophageal candidiasis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Orchitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Osteomyelitis	1.4% 26/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.77% 15/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Osteomyelitis chronic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Otitis externa	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Otitis externa bacterial	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Parotitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Perineal abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Periorbital cellulitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Perirectal abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Peritoneal abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Peritonitis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Peritonitis bacterial	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Peritonsillar abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pharyngitis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pilonidal cyst	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pleural infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumococcal bacteraemia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia	8.9% 171/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	6.1% 118/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia bacterial	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia cytomegaloviral	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia escherichia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia fungal	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia pneumococcal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia primary atypical	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia staphylococcal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia streptococcal	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pneumonia viral	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Post procedural infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Post procedural pneumonia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Post procedural sepsis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Postoperative abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Postoperative wound infection	0.73% 14/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pseudomembranous colitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pseudomonas infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pulmonary sepsis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pulmonary tuberculosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Purulent discharge	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pyelocystitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pyelonephritis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pyelonephritis acute	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pyelonephritis chronic	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Pyonephrosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Rectal abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Renal abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Renal cyst infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Respiratory tract infection	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Respiratory tract infection bacterial	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Respiratory tract infection fungal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Respiratory tract infection viral	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Retroperitoneal abscess	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Scrotal abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Scrotal gangrene	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Sepsis	5.8% 111/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	6.3% 123/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Sepsis syndrome	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Septic shock	1.8% 35/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.8% 35/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Serratia bacteraemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Serratia sepsis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Shunt infection	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Sinusitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Skin infection	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Soft tissue infection	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Staphylococcal abscess	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Staphylococcal bacteraemia	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Staphylococcal infection	0.47% 9/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.72% 14/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Staphylococcal sepsis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Streptococcal bacteraemia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Streptococcal sepsis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Subcutaneous abscess	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Systemic candida	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Testicular abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Tooth abscess	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Tooth infection	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Tracheobronchitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Tuberculosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Upper respiratory tract infection	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Urethritis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Urinary tract infection	1.2% 23/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.93% 18/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Urinary tract infection enterococcal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Urinary tract infection fungal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Urosepsis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Vestibular neuronitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Viral infection	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Viral pharyngitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Wound infection	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Wound infection bacterial	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Wound infection staphylococcal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Zygomycosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Extradural haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Eye operation complication	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Face injury	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Facial bones fracture	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Fall	0.73% 14/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Femoral neck fracture	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Femur fracture	0.99% 19/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.67% 13/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Fibula fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Foot fracture	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Forearm fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Foreign body	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Fracture	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Fractured coccyx	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Fractured ischium	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Fractured sacrum	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Graft complication	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Graft haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Graft thrombosis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Haemodialysis-induced symptom	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Hand fracture	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Head injury	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Hip fracture	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Humerus fracture	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications In-stent coronary artery restenosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Incision site complication	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Incisional hernia	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Incisional hernia, obstructive	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Injury	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Joint dislocation	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Joint injury	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Kidney rupture	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Laceration	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Ligament injury	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Ligament rupture	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Ligament sprain	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Limb injury	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Lower limb fracture	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Meniscus lesion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Multiple fractures	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Muscle rupture	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Open fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Open wound	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Overdose	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Patella fracture	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Pelvic fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Periorbital haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Periprosthetic fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Perirenal haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Post procedural complication	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Post procedural haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Postoperative adhesion	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Postoperative wound complication	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Procedural haemorrhage	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Procedural hypotension	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Procedural pain	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Pubis fracture	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Radius fracture	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Renal haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Rib fracture	0.68% 13/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Road traffic accident	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Shunt aneurysm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Shunt malfunction	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Shunt occlusion	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Shunt stenosis	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Shunt thrombosis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Skull fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Spinal compression fracture	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Spinal fracture	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Sternal fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Subdural haematoma	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Subdural haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Suture rupture	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Tendon rupture	0.73% 14/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Thermal burn	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Tibia fracture	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Toxicity to various agents	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Transfusion reaction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Transplant failure	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Traumatic haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Traumatic lung injury	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Ulna fracture	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Upper limb fracture	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Vascular access complication	0.68% 13/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.77% 15/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Vascular graft complication	0.57% 11/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.67% 13/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Vascular graft occlusion	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Vascular graft thrombosis	1.4% 27/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.1% 21/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Vascular pseudoaneurysm ruptured	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Venous injury	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Wound	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Wound decomposition	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Wound dehiscence	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Wound haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Wound necrosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Wrist fracture	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Blood calcium decreased	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Blood culture positive	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Blood parathyroid hormone abnormal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Blood parathyroid hormone increased	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Blood potassium increased	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Blood pressure increased	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations C-reactive protein increased	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Cardioactive drug level increased	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Clostridium test positive	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Coagulation time prolonged	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Coagulation time shortened	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Ejection fraction decreased	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Electrocardiogram ST segment abnormal	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Electrocardiogram ST-T segment abnormal	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Electrocardiogram abnormal	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Electrocardiogram change	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Fibrin D dimer increased	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Haematocrit decreased	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Haemoglobin decreased	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Heart rate increased	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Heart rate irregular	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Influenza virus test positive	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations International normalised ratio abnormal	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations International normalised ratio decreased	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations International normalised ratio fluctuation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations International normalised ratio increased	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Liver function test abnormal	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Myocardial strain	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Pulse absent	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Transaminases increased	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Troponin increased	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Investigations Weight decreased	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Acidosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Cachexia	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Calciphylaxis	0.68% 13/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Dehydration	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Diabetes mellitus	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Dystrophic calcification	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Electrolyte imbalance	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Failure to thrive	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Fluid overload	2.7% 51/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.1% 40/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Fluid retention	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hypercalcaemia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hyperglycaemia	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hyperkalaemia	3.8% 74/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	5.0% 97/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hypervolaemia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hypocalcaemia	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.83% 16/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hypoglycaemia	1.4% 27/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.8% 34/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hypokalaemia	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hypophosphataemia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Malnutrition	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Shock hypoglycaemic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	0.47% 9/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.57% 11/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Arthritis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Arthropathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	0.62% 12/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Bone pain	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Bursitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Chondropathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Costochondritis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Flank pain	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Fracture delayed union	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders High turnover osteopathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Joint destruction	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Joint effusion	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Joint swelling	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Kyphosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Ligamentitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Limb deformity	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Muscle spasms	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Muscular weakness	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Myalgia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Neck deformity	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Neck pain	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Osteitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.78% 15/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Osteolysis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Osteoporosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	0.57% 11/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.67% 13/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Pathological fracture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Polyarthritis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Renal osteodystrophy	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Spinal disorder	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign bone neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder adenocarcinoma stage unspecified	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraocular melanoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna stage unspecified	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant urinary tract neoplasm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm recurrence	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraganglion neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary tract neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vocal cord neoplasm	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Altered state of consciousness	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Aphasia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Ataxia	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Autonomic neuropathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Balance disorder	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Basal ganglia haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Benign intracranial hypertension	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Brain oedema	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Brain stem infarction	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Carotid artery stenosis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Carpal tunnel syndrome	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebellar atrophy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebral artery stenosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebral atrophy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebral haemorrhage	0.47% 9/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebral hypoperfusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebral infarction	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebral ischaemia	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebrovascular accident	3.4% 66/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	3.1% 60/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cerebrovascular disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Clonus	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Cognitive disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Coma	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Convulsion	1.1% 21/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.5% 30/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Dementia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Demyelinating polyneuropathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Depressed level of consciousness	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Dizziness	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Dysarthria	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Dyskinesia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Encephalitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Encephalitis post varicella	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Encephalomalacia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Encephalopathy	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Epilepsy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Extrapyramidal disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Haemorrhage intracranial	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Haemorrhagic cerebral infarction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Haemorrhagic stroke	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Headache	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hemianopia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hemiparesis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hemiplegia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hepatic encephalopathy	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hydrocephalus	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hypertensive encephalopathy	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hypertonia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hypoaesthesia	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hypogeusia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hypoglycaemic coma	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hypoglycaemic encephalopathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hypotonia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Intracranial hypotension	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Intracranial pressure increased	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Ischaemic stroke	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Lacunar infarction	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Lethargy	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Loss of consciousness	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Mental impairment	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Metabolic encephalopathy	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Migraine	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Myelitis transverse	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Myelopathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Myoclonus	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Nerve compression	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Neuralgia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Neuropathy peripheral	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Optic neuritis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Paraesthesia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Paraplegia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Parkinson's disease	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Parkinsonism	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Partial seizures	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Polyneuropathy	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Post herpetic neuralgia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Presyncope	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Psychomotor hyperactivity	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Quadriplegia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Sciatica	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Simple partial seizures	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Somnolence	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Speech disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Spinal cord compression	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Spinal cord herniation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Status epilepticus	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Stupor	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Subarachnoid haemorrhage	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Subdural hygroma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Syncope	1.7% 32/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.7% 32/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Tardive dyskinesia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Thalamic infarction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Transient ischaemic attack	0.62% 12/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.77% 15/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Tremor	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Uraemic encephalopathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Uraemic neuropathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders VIIth nerve paralysis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Vascular dementia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Vascular encephalopathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Vertebral artery occlusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Vertebral artery stenosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Vertebrobasilar insufficiency	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Aggression	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Agitation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Anxiety	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Bipolar disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Borderline personality disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Completed suicide	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Confusional state	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Conversion disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Delirium	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Depression	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Disorientation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Drug abuse	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Hallucination	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Insomnia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Major depression	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Mental disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Mental disorder due to a general medical condition	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Mental status changes	1.2% 24/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.2% 23/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Mood swings	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Psychotic disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Restlessness	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Schizophrenia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Substance abuse	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Suicidal ideation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Psychiatric disorders Suicide attempt	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Azotaemia	0.47% 9/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Calculus ureteric	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Cystitis noninfective	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Haematuria	0.52% 10/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Nephrolithiasis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Obstructive uropathy	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Polyuria	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal artery stenosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal colic	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal cyst	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal cyst haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal cyst ruptured	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal failure	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal failure acute	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal failure chronic	1.6% 30/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.3% 25/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal impairment	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal injury	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal mass	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Urethral obstruction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Urethral prolapse	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Urethral stenosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Urinary tract pain	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Renal and urinary disorders Vesicoureteric reflux	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Breast haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Breast inflammation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Cervical dysplasia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Cystocele	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Dysmenorrhoea	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Epididymitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Productive cough	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Fibrocystic breast disease	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Menorrhagia	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Metrorrhagia	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Ovarian cyst	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Ovarian cyst ruptured	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Pelvic adhesions	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Priapism	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Prostatitis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Scrotal haematocoele	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Scrotal pain	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Testicular haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Uterine polyp	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Vaginal haemorrhage	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Vaginal laceration	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.2% 23/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.0% 20/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.62% 12/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Alveolitis fibrosing	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Aspiration	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Asthma	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.83% 16/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.0% 20/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Cough	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 44/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.4% 47/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.57% 11/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Laryngeal cyst	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Laryngeal ulceration	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Diabetic foot	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Drug eruption	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Dry gangrene	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Erythema	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Hair growth abnormal	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Leukocytoclastic vasculitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Neurodermatitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Purpura	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Rash	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Skin disorder	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Skin lesion	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Skin necrosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Skin ulcer	1.1% 21/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.0% 20/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Swelling face	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Social circumstances Activities of daily living impaired	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Social circumstances Homicide	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Social circumstances Refusal of treatment by patient	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Social circumstances Treatment noncompliance	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Surgical and medical procedures Incisional drainage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Surgical and medical procedures Intraocular lens implant	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Surgical and medical procedures Mechanical ventilation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Surgical and medical procedures Therapy cessation	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Accelerated hypertension	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Air embolism	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aneurysm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aneurysm arteriovenous	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aneurysm ruptured	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Angiopathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aortic aneurysm	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aortic aneurysm rupture	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aortic arteriosclerosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aortic dilatation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aortic dissection	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Aortic stenosis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arterial disorder	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arterial haemorrhage	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arterial insufficiency	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arterial occlusive disease	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arterial stenosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arterial stenosis limb	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arterial thrombosis limb	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arteriosclerosis	0.36% 7/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arteriovenous fistula	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Arteritis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Bleeding varicose vein	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Blood pressure inadequately controlled	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Circulatory collapse	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Deep vein thrombosis	0.31% 6/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Diabetic macroangiopathy	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Diabetic vascular disorder	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Embolism	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Embolism arterial	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Exsanguination	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Extremity necrosis	0.42% 8/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Femoral arterial stenosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.41% 8/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Femoral artery occlusion	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Haematoma	0.88% 17/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.52% 10/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Haemorrhage	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Haemorrhagic infarction	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Hypertension	2.3% 44/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.5% 49/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Hypertensive crisis	1.5% 28/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.5% 29/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Hypertensive emergency	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.62% 12/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Hypotension	2.7% 52/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	2.8% 54/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Hypovolaemic shock	0.26% 5/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Iliac artery occlusion	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Iliac artery stenosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Iliac artery thrombosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Inferior vena caval occlusion	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Intermittent claudication	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Intra-abdominal haematoma	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Ischaemia	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Ischaemic limb pain	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Jugular vein thrombosis	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Leriche syndrome	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Malignant hypertension	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.31% 6/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Necrosis ischaemic	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Neurogenic shock	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Orthostatic hypotension	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.26% 5/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Peripheral arterial occlusive disease	0.57% 11/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.67% 13/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Peripheral artery aneurysm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Peripheral embolism	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Peripheral ischaemia	1.4% 27/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.83% 16/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Peripheral vascular disorder	1.4% 27/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	1.5% 30/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Phlebitis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Poor peripheral circulation	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Shock	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Shock haemorrhagic	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Steal syndrome	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Subclavian artery aneurysm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Subclavian artery stenosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Superior vena cava syndrome	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.36% 7/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Systolic hypertension	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Thrombophlebitis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Thrombophlebitis superficial	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Thrombosis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Varicose ulceration	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Varicose vein	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Vascular calcification	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.10% 2/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Vascular occlusion	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Vascular stenosis	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.15% 3/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Vasculitis	0.10% 2/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Vena cava thrombosis	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Venous aneurysm	0.00% 0/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Venous insufficiency	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Venous occlusion	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.21% 4/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Venous stenosis	0.21% 4/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.46% 9/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Venous thrombosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Venous thrombosis limb	0.16% 3/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.05% 1/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Wegener's granulomatosis	0.05% 1/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	0.00% 0/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.

Other adverse events

Measure	Placebo n=1923 participants at risk	Cinacalcet n=1938 participants at risk Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Blood and lymphatic system disorders Anaemia	5.0% 96/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	5.6% 109/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal pain	8.0% 154/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	9.6% 187/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Abdominal pain upper	6.3% 121/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	7.9% 153/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Diarrhoea	18.1% 349/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	19.4% 376/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Dyspepsia	4.6% 89/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	7.2% 140/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Nausea	15.0% 288/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	28.5% 552/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Gastrointestinal disorders Vomiting	12.8% 247/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	24.9% 482/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Chest pain	6.2% 119/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	6.9% 134/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Oedema peripheral	5.0% 96/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	6.0% 117/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
General disorders Pyrexia	8.4% 161/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	6.5% 126/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Bronchitis	6.3% 121/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	7.1% 138/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Nasopharyngitis	7.2% 138/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	8.1% 157/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Upper respiratory tract infection	6.2% 119/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	7.4% 144/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Infections and infestations Urinary tract infection	4.9% 94/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	5.9% 114/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	5.6% 107/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	6.4% 124/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Decreased appetite	3.5% 67/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	5.8% 112/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Metabolism and nutrition disorders Hypocalcaemia	1.0% 20/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	10.6% 206/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	11.6% 224/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	8.2% 158/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	7.6% 146/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	8.2% 159/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Muscle spasms	9.0% 174/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	11.0% 213/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.5% 125/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	5.6% 109/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 193/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	10.4% 201/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Dizziness	4.5% 86/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	7.0% 135/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Nervous system disorders Headache	9.5% 182/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	11.3% 219/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Cough	9.6% 185/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	11.6% 225/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.8% 188/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	11.7% 226/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus	5.6% 107/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	5.3% 103/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Hypertension	8.3% 160/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	9.1% 176/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
Vascular disorders Hypotension	8.0% 154/1923 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.	9.4% 183/1938 • Average 24 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER