Trial Outcomes & Findings for RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial (NCT NCT00358215)

NCT ID: NCT00358215

Last Updated: 2022-11-08

Results Overview

Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2278 participants
• Primary outcome timeframe: From randomization to the end of study; maximum time on study was 73 months
• Results posted on: 2022-11-08

Participant Flow

First patient enrolled 13 June 2006; Last patient enrolled 4 May 2012

Participant milestones

Measure	Placebo Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Overall Study STARTED	1142	1136
Overall Study Received Investigational Product	1140	1133
Overall Study COMPLETED	463	484
Overall Study NOT COMPLETED	679	652

Reasons for withdrawal

Measure	Placebo Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Overall Study Ineligibility determined	4	3
Overall Study Adverse Event	83	65
Overall Study Withdrawal by Subject	111	102
Overall Study Participant request	65	64
Overall Study Physician Decision	47	39
Overall Study Lost to Follow-up	16	22
Overall Study Death	265	281
Overall Study Protocol Violation	64	59
Overall Study Pregnancy	1	0
Overall Study Other	21	14
Overall Study Did not receive investigational product	2	3

Baseline Characteristics

RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

Baseline characteristics by cohort

Measure	Placebo n=1142 Participants Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa n=1136 Participants Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.	Total n=2278 Participants Total of all reporting groups
Age, Continuous	69.6 years STANDARD_DEVIATION 11.3 • n=5 Participants	70.0 years STANDARD_DEVIATION 11.6 • n=7 Participants	69.8 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	486 Participants n=5 Participants	458 Participants n=7 Participants	944 Participants n=5 Participants
Sex: Female, Male Male	656 Participants n=5 Participants	678 Participants n=7 Participants	1334 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	768 participants n=5 Participants	781 participants n=7 Participants	1549 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	113 participants n=5 Participants	89 participants n=7 Participants	202 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	84 participants n=5 Participants	98 participants n=7 Participants	182 participants n=5 Participants
Race/Ethnicity, Customized Asian	162 participants n=5 Participants	162 participants n=7 Participants	324 participants n=5 Participants
Race/Ethnicity, Customized Japanese	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	12 participants n=5 Participants	3 participants n=7 Participants	15 participants n=5 Participants
Region North America	323 participants n=5 Participants	321 participants n=7 Participants	644 participants n=5 Participants
Region Latin America and Asia	286 participants n=5 Participants	285 participants n=7 Participants	571 participants n=5 Participants
Region Western Europe, Israel, South Africa, Australia	306 participants n=5 Participants	303 participants n=7 Participants	609 participants n=5 Participants
Region Eastern Europe and Russia	227 participants n=5 Participants	227 participants n=7 Participants	454 participants n=5 Participants
Device Usage CRT with or without ICD	143 participants n=5 Participants	143 participants n=7 Participants	286 participants n=5 Participants
Device Usage ICD without CRT	124 participants n=5 Participants	122 participants n=7 Participants	246 participants n=5 Participants
Device Usage None	875 participants n=5 Participants	871 participants n=7 Participants	1746 participants n=5 Participants
Kansas City Cardiomyopathy Questionnaire: Overall Summary Score	56.5 units on a scale STANDARD_DEVIATION 22.5 • n=5 Participants	55.8 units on a scale STANDARD_DEVIATION 22.6 • n=7 Participants	56.2 units on a scale STANDARD_DEVIATION 22.5 • n=5 Participants
Study Specific Characteristic [Kansas City Cardiomyopathy Questionnaire: Symptom Frequency Scale	63.3 units on a scale STANDARD_DEVIATION 25.2 • n=5 Participants	63.1 units on a scale STANDARD_DEVIATION 25.6 • n=7 Participants	63.2 units on a scale STANDARD_DEVIATION 25.4 • n=5 Participants

PRIMARY outcome

Timeframe: From randomization to the end of study; maximum time on study was 73 months

Population: Intent-to-treat (ITT) analysis set, defined as all randomized participants

Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.

Outcome measures

Measure	Placebo n=1142 Participants Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa n=1136 Participants Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Time to All Cause Death or First Hospitalization for Worsening Heart Failure	1260.0 days Interval 387.0 to 2176.0	1184.0 days Interval 445.0 to 2074.0

SECONDARY outcome

Timeframe: From randomization to the end of study; maximum time on study was 73 months

Population: Intent-to-treat

Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.

Outcome measures

Measure	Placebo n=1142 Participants Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa n=1136 Participants Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Time to Death From Any Cause	1637.0 days Interval 766.0 to 2229.0	1629.0 days Interval 682.0 to 2117.0

SECONDARY outcome

Timeframe: From randomization to the end of study; maximum time on study was 73 months

Population: Intent-to-treat

Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.

Outcome measures

Measure	Placebo n=1142 Participants Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa n=1136 Participants Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure	1414.0 days Interval 429.0 to Could not be calculated due to the low number of events.	1395.0 days Interval 483.0 to Could not be calculated due to the low number of events.

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.

The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.

Outcome measures

Measure	Placebo n=929 Participants Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa n=928 Participants Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	4.48 units on a scale Standard Error 0.68	6.68 units on a scale Standard Error 0.68

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.

The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.

Outcome measures

Measure	Placebo n=927 Participants Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa n=925 Participants Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Change From Baseline to Month 6 in KCCQ Symptom Frequency Score	3.91 units on a scale Standard Error 0.76	6.20 units on a scale Standard Error 0.76

Adverse Events

Placebo

Serious events: 741 serious events

Other events: 741 other events

Deaths: 0 deaths

Darbepoetin Alfa

Serious events: 781 serious events

Other events: 710 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=1140 participants at risk Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa n=1133 participants at risk Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Blood and lymphatic system disorders Sideroblastic anaemia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute coronary syndrome	1.1% 13/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute left ventricular failure	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute myocardial infarction	1.8% 21/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 21/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Adams-Stokes syndrome	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina pectoris	2.4% 27/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 26/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina unstable	2.3% 26/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 24/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Aortic valve incompetence	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Azotaemia	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Dysuria	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Haematuria	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Hydronephrosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Ischaemic nephropathy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Oliguria	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Pollakiuria	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Aortic valve stenosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arrhythmia	0.88% 10/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femoral neck fracture	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arrhythmia supraventricular	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arteriosclerosis coronary artery	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	2.6% 30/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.8% 32/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial flutter	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial tachycardia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrioventricular block	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrioventricular block complete	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bradyarrhythmia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bradycardia	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bundle branch block left	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac arrest	1.9% 22/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.7% 31/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac asthma	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac discomfort	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac disorder	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure	23.9% 273/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	23.3% 264/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure acute	1.4% 16/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 21/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure chronic	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.79% 9/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure congestive	12.7% 145/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 126/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Anaemia	4.3% 49/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.0% 23/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Coagulopathy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Haemolytic anaemia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Iron deficiency anaemia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukocytosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Lymphadenopathy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Pancytopenia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac valve disease	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardio-respiratory arrest	0.88% 10/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 14/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiogenic shock	0.96% 11/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.5% 17/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiomyopathy	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiopulmonary failure	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiorenal syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Congestive cardiomyopathy	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery disease	0.88% 10/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery occlusion	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery stenosis	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery thrombosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Hypertensive heart disease	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Intracardiac thrombus	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ischaemic cardiomyopathy	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Left ventricular dysfunction	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Left ventricular failure	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Mitral valve disease	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Mitral valve incompetence	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Mitral valve stenosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial fibrosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	3.1% 35/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.2% 36/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial ischaemia	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Palpitations	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Pericardial effusion	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Pericarditis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Pulseless electrical activity	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Right ventricular failure	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sick sinus syndrome	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sinoatrial block	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sinus arrhythmia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sinus bradycardia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Supraventricular tachycardia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tachyarrhythmia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tachycardia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tricuspid valve incompetence	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ventricular arrhythmia	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ventricular extrasystoles	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ventricular fibrillation	0.88% 10/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.88% 10/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ventricular tachycardia	2.1% 24/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 22/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Arteriovenous malformation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Ichthyosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Vertigo	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Adrenal insufficiency	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Hyperparathyroidism	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Hyperthyroidism	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Hypothyroidism	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Cataract	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Cataract diabetic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Diabetic retinopathy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Macular fibrosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Optic ischaemic neuropathy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Retinal artery occlusion	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Retinal detachment	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Retinal vein occlusion	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Retinopathy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Scleral haemorrhage	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Vision blurred	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Visual acuity reduced	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Vitreous haemorrhage	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal adhesions	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal distension	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal hernia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	0.53% 6/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.1% 13/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal wall haemorrhage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Anal polyp	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Ascites	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Coeliac disease	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colitis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colitis ischaemic	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colonic polyp	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colonic stenosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.79% 9/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Crohn's disease	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diabetic gastroparesis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diaphragmatic hernia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	1.1% 12/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.1% 12/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diverticular perforation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diverticulum	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Duodenal ulcer	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Duodenitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dyspepsia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dysphagia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Enterocolitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Epigastric discomfort	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Erosive oesophagitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Faecaloma	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastric haemorrhage	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastric ulcer	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastric ulcer perforation	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis atrophic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis erosive	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis haemorrhagic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.0% 23/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.6% 18/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal inflammation	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gingival bleeding	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Haematemesis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Hiatus hernia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Ileus	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Inflammatory bowel disease	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Inguinal hernia	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal haemorrhage	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal infarction	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal ischaemia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal mass	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal obstruction	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal polyp	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Irritable bowel syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Large intestinal ulcer	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Mallory-Weiss syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Melaena	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophageal food impaction	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophageal motility disorder	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophagitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis acute	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Peptic ulcer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Poor dental condition	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Proctalgia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Rectal haemorrhage	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Rectal polyp	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Small intestinal obstruction	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Subileus	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Toothache	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Umbilical hernia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Umbilical hernia, obstructive	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Varices oesophageal	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Volvulus	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	0.79% 9/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.79% 9/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Adverse drug reaction	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	0.88% 10/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Cardiac death	2.5% 29/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.0% 34/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Catheter site haemorrhage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest discomfort	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest pain	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Death	2.1% 24/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.6% 18/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Device breakage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Device dislocation	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Device lead damage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Device malfunction	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.88% 10/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Device misuse	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Device stimulation issue	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Drowning	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders General physical health deterioration	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Generalised oedema	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Hernia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Hyperpyrexia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Hypothermia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Impaired healing	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Implant site haematoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Implant site pain	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Implant site ulcer	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Inflammation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Malaise	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Medical device complication	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Medical device pain	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Medical device site reaction	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Multi-organ disorder	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Multi-organ failure	1.1% 13/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Necrobiosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Non-cardiac chest pain	2.4% 27/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 22/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Polyp	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Sudden cardiac death	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 21/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Sudden death	1.7% 19/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.97% 11/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Systemic inflammatory response syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Thrombosis in device	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Bile duct stone	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Biliary colic	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cardiac cirrhosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholangitis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis acute	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis chronic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholelithiasis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.79% 9/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Gallbladder non-functioning	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic congestion	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic failure	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic lesion	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatomegaly	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatorenal failure	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Liver disorder	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Heart transplant rejection	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Sarcoidosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abdominal abscess	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abdominal infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abscess limb	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abscess neck	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Appendicitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Arthritis bacterial	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Arthritis infective	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacteraemia	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacterial infection	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacterial sepsis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bone tuberculosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis	1.9% 22/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.1% 12/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis bacterial	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchopneumonia	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Campylobacter infection	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Catheter site infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	1.4% 16/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.6% 18/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridial infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridium difficile colitis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridium difficile sepsis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cystitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Device related infection	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diabetic foot infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diabetic gangrene	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diarrhoea infectious	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diverticulitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Endocarditis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Enterococcal sepsis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Erysipelas	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia bacteraemia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia urinary tract infection	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations External ear cellulitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Fungaemia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gangrene	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.3% 15/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis clostridial	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis viral	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations H1N1 influenza	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Helicobacter gastritis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Herpes zoster	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Implant site infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Incision site infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Infected skin ulcer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Influenza	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lobar pneumonia	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Localised infection	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lower respiratory tract infection	0.53% 6/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lung infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lung infection pseudomonal	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Malaria	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Neutropenic sepsis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nosocomial infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Oropharyngitis fungal	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Osteomyelitis	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Osteomyelitis chronic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Otitis externa	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pelvic abscess	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Peritonitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumococcal bacteraemia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	6.2% 71/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.6% 86/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia bacterial	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia escherichia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia influenzal	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia klebsiella	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia staphylococcal	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Post procedural infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Postoperative wound infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pseudomonal sepsis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pulmonary sepsis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pyelonephritis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pyelonephritis chronic	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Rectal abscess	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Respiratory tract infection	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.88% 10/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Respiratory tract infection viral	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sepsis	1.9% 22/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 19/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Septic shock	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 21/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Soft tissue infection	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Staphylococcal sepsis	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Streptococcal infection	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Subcutaneous abscess	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Superinfection	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Tracheobronchitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Tuberculous pleurisy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	1.8% 20/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.6% 29/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urosepsis	0.79% 9/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Viral infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Wound infection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Wound sepsis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Accidental overdose	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Acetabulum fracture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Alcohol poisoning	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Ankle fracture	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Burns third degree	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Chest injury	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Concussion	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Confusion postoperative	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Contusion	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Drug administered at inappropriate site	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Eschar	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.4% 16/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femur fracture	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fibula fracture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Foot fracture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Head injury	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Hip fracture	1.6% 18/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 14/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Humerus fracture	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Incisional hernia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Injury	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Intentional overdose	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Laceration	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Multiple fractures	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Multiple injuries	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Overdose	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Pelvic fracture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Poisoning	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Post procedural complication	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Radius fracture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Rib fracture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Road traffic accident	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Shunt occlusion	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Soft tissue injury	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Spinal compression fracture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Spinal fracture	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Subdural haematoma	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Subdural haemorrhage	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Tendon rupture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Toxicity to various agents	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Ulna fracture	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Upper limb fracture	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Wound	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Wound necrosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Wrist fracture	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Arteriogram coronary	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood glucose decreased	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood glucose increased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood potassium increased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood uric acid increased	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations C-reactive protein abnormal	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations C-reactive protein increased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Cardiac output decreased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Coagulation time prolonged	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Drug level increased	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Ejection fraction decreased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Glycosylated haemoglobin increased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Haemodynamic test abnormal	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Haemoglobin decreased	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations International normalised ratio abnormal	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations International normalised ratio increased	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Liver function test abnormal	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Occult blood	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Occult blood positive	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Platelet count decreased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Renal function test abnormal	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Transaminases increased	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Transferrin saturation decreased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Waist circumference increased	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Weight decreased	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Weight increased	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Cachexia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Calciphylaxis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Decreased appetite	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	1.9% 22/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 19/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetes mellitus	0.79% 9/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 14/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetic complication	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Failure to thrive	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Fluid overload	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Gout	0.88% 10/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypercalcaemia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperglycaemia	1.1% 13/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperkalaemia	1.3% 15/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.1% 13/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypoglycaemia	1.6% 18/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.4% 16/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypokalaemia	0.53% 6/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.79% 9/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.96% 11/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypovolaemia	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Lactic acidosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthritis	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Bone infarction	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Exostosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Foot deformity	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Fracture pain	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Joint effusion	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Lordosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Neck pain	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.53% 6/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myelomonocytic leukaemia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage II	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour pulmonary	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial sarcoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic leukaemia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant anorectal neoplasm	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of Vater	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.53% 6/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsillar neoplasm	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Altered state of consciousness	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Balance disorder	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Brain compression	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Brain oedema	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Carotid artery occlusion	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Carotid artery stenosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral haematoma	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral haemorrhage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral infarction	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral ischaemia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebrovascular accident	1.2% 14/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 27/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cervicobrachial syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Convulsion	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dementia	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Diabetic hyperosmolar coma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Diabetic neuropathy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	1.1% 13/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.88% 10/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dysarthria	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Encephalopathy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Epilepsy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Extrapyramidal disorder	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Haemorrhage intracranial	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Haemorrhagic stroke	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hemiparesis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hemiplegia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hepatic encephalopathy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hypoglycaemic coma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hypoglycaemic unconsciousness	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Intercostal neuralgia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Ischaemic stroke	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Lethargy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Loss of consciousness	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Lumbar radiculopathy	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Mental impairment	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Metabolic encephalopathy	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Nerve compression	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Neuropathy peripheral	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Paraesthesia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Presyncope	0.79% 9/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Radiculopathy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Somnolence	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Spinal cord compression	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Subarachnoid haemorrhage	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Syncope	2.5% 29/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 19/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Toxic encephalopathy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Transient ischaemic attack	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders VIIth nerve paralysis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Vocal cord paralysis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Anxiety	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Confusional state	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Delirium	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Depression	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Disorientation	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Insomnia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Major depression	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Mental status changes	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Psychiatric symptom	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Restlessness	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Sopor	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Suicidal ideation	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Suicide attempt	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Acute prerenal failure	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Anuria	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Polyuria	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal artery stenosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure	3.2% 37/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.6% 41/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure acute	5.4% 62/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.1% 58/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure chronic	1.8% 20/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.97% 11/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal impairment	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.79% 9/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal injury	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal mass	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Urethral disorder	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Urethral stenosis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Urinary retention	0.61% 7/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.79% 9/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Breast haematoma	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Epididymitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Menorrhagia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Pelvic floor muscle weakness	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Prostatic disorder	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Prostatitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.70% 8/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.53% 6/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Choking sensation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.7% 42/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 22/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 29/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 27/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.79% 9/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.97% 11/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleural fibrosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Productive cough	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.53% 6/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.88% 10/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.79% 9/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.97% 11/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.7% 19/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.1% 13/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory tract inflammation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Angioedema	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Blister	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Diabetic foot	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dry gangrene	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Ecchymosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Pruritus	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin disorder	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin maceration	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin necrosis	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin ulcer	1.1% 12/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Urticaria	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Cardiac pacemaker insertion	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Cardiac resynchronisation therapy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Cardioversion	0.26% 3/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Coronary arterial stent insertion	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Gastrostomy	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Haemodialysis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Implantable defibrillator insertion	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Percutaneous coronary intervention	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Resuscitation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Therapy regimen changed	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Accelerated hypertension	0.18% 2/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Aortic aneurysm rupture	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Aortic arteriosclerosis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Arterial insufficiency	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Arteriosclerosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Artery dissection	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Circulatory collapse	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Deep vein thrombosis	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Embolism	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Essential hypertension	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Extremity necrosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Femoral artery aneurysm	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Haematoma	0.53% 6/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.35% 4/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	0.53% 6/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.71% 8/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertensive crisis	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertensive emergency	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	2.1% 24/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 22/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypovolaemic shock	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Intermittent claudication	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.26% 3/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Intra-abdominal haematoma	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Ischaemia	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Lymphoedema	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Orthostatic hypotension	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral arterial occlusive disease	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 7/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral artery aneurysm	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral artery stenosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral artery thrombosis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral embolism	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral ischaemia	0.44% 5/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.44% 5/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral vascular disorder	0.35% 4/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Phlebitis	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Phlebitis superficial	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Poor peripheral circulation	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Poor venous access	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Shock	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Shock haemorrhagic	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Steal syndrome	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.09% 1/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Thrombophlebitis	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Varicose vein	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Venous insufficiency	0.00% 0/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.18% 2/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Venous thrombosis limb	0.09% 1/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Measure	Placebo n=1140 participants at risk Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.	Darbepoetin Alfa n=1133 participants at risk Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Cardiac disorders Angina pectoris	5.3% 60/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.6% 52/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure	8.1% 92/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.1% 69/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	6.0% 68/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 81/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	11.8% 135/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.1% 148/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	6.6% 75/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.3% 71/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	9.8% 112/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.8% 88/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	7.4% 84/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.6% 86/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	10.4% 118/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.2% 115/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis	7.7% 88/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 99/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Influenza	6.2% 71/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.4% 61/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	9.7% 111/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.3% 117/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	6.4% 73/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.4% 95/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	6.2% 71/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.2% 82/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	6.0% 68/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 80/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Gout	6.6% 75/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.3% 71/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	6.8% 78/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.9% 101/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	7.6% 87/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.2% 93/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	8.2% 93/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.3% 94/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	12.5% 143/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 138/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	6.1% 69/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.9% 67/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	11.6% 132/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 126/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.3% 174/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.9% 157/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	7.3% 83/1140 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 73/1133 • Informed consent to 30 days post treatment. Max time 72 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

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