Trial Outcomes & Findings for CardioMEMS HF System Post Approval Study (NCT NCT02279888)

NCT ID: NCT02279888

Last Updated: 2024-04-17

Results Overview

As defined in the study protocol, a DSRC is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

• Recruitment status: COMPLETED
• Target enrollment: 1214 participants
• Primary outcome timeframe: two years
• Results posted on: 2024-04-17

Participant Flow

All patients who were consented and had an attempted implant (n=1214) are included in all safety analyses. To be considered enrolled in the study, subjects must sign consent and have the CardioMEMS PA Sensor successfully implanted (n=1200).

Participant milestones

Measure	CardioMEMS HF System Group All patients who were consented and had an attempted implant (n=1214) are included in all safety analyses. To be considered enrolled in the study, subjects must sign consent and have the CardioMEMS PA Sensor successfully implanted (n=1200).
Overall Study STARTED	1214
Overall Study Successful Implant	1200
Overall Study 6 Months Follow Up Completed	1013
Overall Study 1 Year Follow Up Completed	875
Overall Study 18 Months Follow Up Completed	770
Overall Study COMPLETED	684
Overall Study NOT COMPLETED	530

Reasons for withdrawal

Measure	CardioMEMS HF System Group All patients who were consented and had an attempted implant (n=1214) are included in all safety analyses. To be considered enrolled in the study, subjects must sign consent and have the CardioMEMS PA Sensor successfully implanted (n=1200).
Overall Study Death	326
Overall Study Withdrawal by Subject	38
Overall Study Lost to Follow-up	21
Overall Study Physician Decision	62
Overall Study Subject Non-compliance	43
Overall Study Not implanted	14
Overall Study Visit not performed	26

Baseline Characteristics

CardioMEMS HF System Post Approval Study

Baseline characteristics by cohort

Measure	CardioMEMS HF System Group n=1214 Participants Patients who underwent a CardioMEMS HF System implant procedure CardioMEMS HF System: Pulmonary artery pressure sensor
Age, Continuous	69.4 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	457 Participants n=5 Participants
Sex: Female, Male Male	757 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	175 Participants n=5 Participants
Race (NIH/OMB) White	1004 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants
Region of Enrollment United States	1214 participants n=5 Participants
Body Mass Index (BMI)	31.7 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants
Left Ventricular Ejection Fraction (LVEF)	38.8 % ejected STANDARD_DEVIATION 17.4 • n=5 Participants

PRIMARY outcome

Timeframe: two years

As defined in the study protocol, a DSRC is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

Outcome measures

Measure	CardioMEMS HF System Safety Group n=1214 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population Subjects implanted in Community Hospitals
Freedom From Device and/or System Related Complication (DSRC)	1209 Participants	—

PRIMARY outcome

Timeframe: two year

Population: Subjects implanted with CardioMEMS device

A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

Outcome measures

Measure	CardioMEMS HF System Safety Group n=1200 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population Subjects implanted in Community Hospitals
Freedom From Pressure Sensor Failure	1199 Participants	—

PRIMARY outcome

Timeframe: one year

Population: Patients implanted with a CardioMEMS PA Sensor

Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met.

Outcome measures

Measure	CardioMEMS HF System Safety Group n=1200 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population Subjects implanted in Community Hospitals
Heart Failure Hospitalization (HFH) Rate 1 Year HFH Rate prior implant (Events per patient year)	1.249 hospitalization events per patient year Interval 1.192 to 1.308	—
Heart Failure Hospitalization (HFH) Rate 1 Year HFH Rate post implant (Events per patient year)	0.535 hospitalization events per patient year Interval 0.482 to 0.594	—

OTHER_PRE_SPECIFIED outcome

Timeframe: one and two years

Survival at 1 year and 24 years post-implant is reported using the Kaplan-Meier method.

Outcome measures

Measure	CardioMEMS HF System Safety Group n=1200 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population Subjects implanted in Community Hospitals
Overall Survival Survival at 1 year post implant	83.9 survival percentage Interval 81.7 to 85.9	—
Overall Survival Survival at 2 years post implant	71.0 survival percentage Interval 68.1 to 73.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: one year

The annualized HFH or death rate parameter at 1 year was compared to the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then this effectiveness endpoint was met.

Outcome measures

Measure	CardioMEMS HF System Safety Group n=1200 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population Subjects implanted in Community Hospitals
Heart Failure Hospitalization or Death Rate Annualized HFH + Death 1 Year prior implant (Events per patient year)	1.249 events per patient year Interval 1.192 to 1.308	—
Heart Failure Hospitalization or Death Rate Annualized HFH + Death 1 Year post implant (Events per patient year)	0.708 events per patient year Interval 0.646 to 0.777	—

OTHER_PRE_SPECIFIED outcome

Timeframe: One and Two Years

Total daily readings divided by total number possible for daily readings as well as total weekly readings divided by total possible weekly readings

Outcome measures

Measure	CardioMEMS HF System Safety Group n=1200 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population Subjects implanted in Community Hospitals
Patient Compliance Weekly Compliance at 1 Year	92.8 percentage of compliance Standard Deviation 15.8	—
Patient Compliance Weekly Compliance at 2 Years	90.0 percentage of compliance Standard Deviation 18.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Years

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

Outcome measures

Measure	CardioMEMS HF System Safety Group n=430 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population n=784 Participants Subjects implanted in Community Hospitals
Training Evaluation - Freedom From DRSC in Academic and Community Hospitals	428 Participants	781 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Years

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

Outcome measures

Measure	CardioMEMS HF System Safety Group n=425 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population n=775 Participants Subjects implanted in Community Hospitals
Training Evaluation - Freedom From Pressure Sensor Failure in Academic and Community Hospitals	425 Participants	774 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Years

To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

Outcome measures

Measure	CardioMEMS HF System Safety Group n=425 Participants Patients with an attempted CardioMEMS PA Sensor implant. CardioMEMS HF System: Pulmonary artery pressure sensor	Community Centers Population n=775 Participants Subjects implanted in Community Hospitals
Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals HF hospitalizations one year prior implant	588 HF hospitalizations	1012 HF hospitalizations
Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals HF hospitalizations one year prost implant	245 HF hospitalizations	383 HF hospitalizations

Adverse Events

CardioMEMS HF System Group

Serious events: 970 serious events

Other events: 62 other events

Deaths: 970 deaths

Serious adverse events

Measure	CardioMEMS HF System Group n=1214 participants at risk Patients who underwent a CardioMEMS HF System implant
Blood and lymphatic system disorders Anemia deficiencies	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Blood and lymphatic system disorders Anaemia NEC	4.3% 52/1214 • Number of events 68 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Blood and lymphatic system disorders Coagulopathies	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Blood and lymphatic system disorders Leukocytoses NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Blood and lymphatic system disorders Marrow Depression and Hypoplastic Anaemias	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Blood and lymphatic system disorders Neutropenias	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Blood and lymphatic system disorders Thrombocytopenias	0.66% 8/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Cardiac Disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Cardiac Signs and Symptoms NEC	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Cardiomyopathies	0.82% 10/1214 • Number of events 11 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Coronary Artery Disorders NEC	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Heart Failures NEC	38.6% 468/1214 • Number of events 884 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Ischaemic Coronary Artery Disorders	5.0% 61/1214 • Number of events 68 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Mitral Valvular Disorders	0.91% 11/1214 • Number of events 11 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Myocardial Disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Pericardial Disorders NEC	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Rate and Rhythm Disorders NEC	1.9% 23/1214 • Number of events 24 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Supraventricular Arrhythmias	5.8% 70/1214 • Number of events 85 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Cardiac disorders Ventricular Arrhythmias and Cardiac Arrest	7.7% 93/1214 • Number of events 110 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Ear and labyrinth disorders Inner Ear Signs and Symptoms	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Endocrine disorders Adrenal Cortical Hypofunctriuons	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Endocrine disorders Hyperparathyroid Disorders	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Eye disorders Partial Vision Loss	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Eye disorders Visual Disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Abdominal Hernias, site unspecified	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Abdominal Wall Conditions NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Acute and Chronic Pancreatitis	0.49% 6/1214 • Number of events 7 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Anal and Rectal Disorders NEC	0.08% 1/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Colitis (excl infective)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Diarrhoea (excl infective)	0.66% 8/1214 • Number of events 11 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Duodenal and Small Intestinal stenosis and obstruction	0.49% 6/1214 • Number of events 7 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Flatulence, bloating and Distension	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Gastric Ulcers and Perforation	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Gastritis (excl infective)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Gastrointestinal and Abdominal Pain (excl oral and throat)	2.6% 31/1214 • Number of events 35 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Gastrointestinal atonic and hypomobility disorders NEC	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Gastrointestinal disorders NEC	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Gastrointestinal signs and symptoms NEC	0.66% 8/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Gastrointestinal stenosis and obstruction NEC	0.74% 9/1214 • Number of events 9 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Gastrointestinal vascular occlusion and infarction	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Haemorrhoids and gastointestinal varices (excl oesophageal)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Intestinal Haemorrhages	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Intestinal ulcers and perforation NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Nausea and vomiting symptoms	0.58% 7/1214 • Number of events 9 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Non-site specific gastrointestinal haemorrhages	6.0% 73/1214 • Number of events 91 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Oesophageal stenosis and obstruction	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Oesophagitis (excl infective)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Pancreatic and retroperitoneal disorders	0.41% 5/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Pancreatic disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Peritoneal and retroperitoneal disorders	0.41% 5/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Gastrointestinal disorders Peritoneal and retroperitoneal fibrosis and adhesions	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Asthenic conditions	4.1% 50/1214 • Number of events 54 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Febrile disorders	1.2% 15/1214 • Number of events 15 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders General signs and symptoms NEC	0.74% 9/1214 • Number of events 9 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Hernias NEC	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Implant and catheter site reactions	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Mass conditions NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Oedema NEC	0.91% 11/1214 • Number of events 16 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Pain and discomfort NEC	7.9% 96/1214 • Number of events 131 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Hepatobiliary disorders Bile duct infections and inflammations	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Hepatobiliary disorders Cholecystitis and cholelithiasis	0.74% 9/1214 • Number of events 9 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Hepatobiliary disorders Hepatic and hepatobiliary disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Hepatobiliary disorders Hepatic failure and associated disorders	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Hepatobiliary disorders Hepatic fibrosis and cirrhosis	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Hepatobiliary disorders Hepatobiliary signs and symptoms	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Immune system disorders Allergic conditions NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Immune system disorders Allergies to food, food additives, drugs and other chemicals	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Immune system disorders Amyloidoses	0.25% 3/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Immune system disorders Transplant rejections	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Abdominal and gastrointestinal infections	1.1% 13/1214 • Number of events 15 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Bacterial infections NEC	3.6% 44/1214 • Number of events 52 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Bone and join infections NEC	0.49% 6/1214 • Number of events 6 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Breast infections	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Cardiac infections	0.41% 5/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Chlostridia infections	0.82% 10/1214 • Number of events 18 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Herpes viral infections	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Infections NEC	2.1% 25/1214 • Number of events 28 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Influenza viral infections	0.99% 12/1214 • Number of events 12 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Klebsiella infections	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Lower respiratory tract and lung infections	8.6% 104/1214 • Number of events 135 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Pseudomonal infections	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Sepsis, bacteraemia, viraemia and fungaemia NEC	7.2% 87/1214 • Number of events 102 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Skin structures and soft tissue infections	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Upper respiratory tract infections	0.74% 9/1214 • Number of events 10 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Urinary tract infections	3.5% 42/1214 • Number of events 51 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Viral infections NEC	0.49% 6/1214 • Number of events 6 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Cerebral injuries NEC	0.58% 7/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device malfunction events	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device related complications (pacemaker complications)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device related complications	0.58% 7/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Fractures and dislocations NEC	0.82% 10/1214 • Number of events 12 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Injuries NEC (head injury)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Limb injuries NEC (incl. traumatic amputation)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications lower limb fractures and dislocations	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Non-site specific injuries NEC (fall)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Non-site specific injuries NEC	3.1% 38/1214 • Number of events 41 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Non-site specific procedural complications	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Overdoses	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Pelvic fractures and dislocations	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Poisoning and toxicity	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Renal and urinary tract injuries NEC	1.2% 14/1214 • Number of events 15 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Site specific injuries NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Skin injuries NEC	0.33% 4/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Spinal fractures and dislocations	0.49% 6/1214 • Number of events 6 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Thoracic cage fractures and dislocations	0.25% 3/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Upper limb fractures and dislocations	0.41% 5/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Carbohydrate tolerance analysis (incl. diabetes)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Cardiac function diagnostic procedures	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Coagulation and bleeding analyses	0.74% 9/1214 • Number of events 9 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Investigations NEC	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Liver function analyses	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Physical examination procedures	0.25% 3/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Renal function analyses	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Therapeutic drug monitoring analyses	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Diabetes mellitus (incl. subtypes)	0.49% 6/1214 • Number of events 6 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Diabetic complications NEC	0.08% 1/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Electrolyte imbalance NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders General nutrition disorders NEC	0.66% 8/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Hyperglycaemic conditions NEC	1.2% 14/1214 • Number of events 14 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Hypoglicaemic conditions NEC	0.41% 5/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Iron deficiencies	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Magnesium metabolism disorders	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Metabolic acidoses (excl diabetic acidoses)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Potassium imbalance	3.0% 37/1214 • Number of events 42 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Purine metabolism disorders NEC	0.82% 10/1214 • Number of events 10 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Sodium imbalance	1.2% 14/1214 • Number of events 14 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Total fluid volume decreased	2.7% 33/1214 • Number of events 36 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Metabolism and nutrition disorders Total fluid volume increased	2.6% 32/1214 • Number of events 38 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Arthropaties NEC	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Bursal disorders	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Joint related disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Joint related signs and symptoms	0.49% 6/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Muscle related signs and symptoms NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Muscle weakness condition	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue signs and symptoms NEC	3.0% 37/1214 • Number of events 45 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Osteoarthropathies	0.74% 9/1214 • Number of events 9 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Spine and neck deformities	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast and nipple neoplasm malignant	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endocrine neoplasm benign NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasms malignant	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphomas unspecified NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign site unspecified NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms malignant site unspecified NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasms malignant (excl germ cell)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Respiratory tract and pleural neoplasms malignant cell type undisclosed NEC	0.41% 5/1214 • Number of events 6 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Central nervous system haemorrhages and cerebrovascular accidents	2.5% 30/1214 • Number of events 35 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Central nervous system vascular disorders NEC	0.49% 6/1214 • Number of events 7 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Cerebellar coordination and balance disturbances	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Dementia (excl Alzheimer's type)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Disturbances in consciousness NEC	7.0% 85/1214 • Number of events 98 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Encephalopaties NEC	1.3% 16/1214 • Number of events 17 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Encephalopaties toxic and metabolic	0.99% 12/1214 • Number of events 14 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Headaches NEC	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Neurological signs and symptoms	1.8% 22/1214 • Number of events 24 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Paralysis and paresis (excl. cranial nerve)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Peripheral neuropathies NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Seizures and seizure disorders NEC	0.49% 6/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Sensory abnormalities NEC	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Speech and languages abnormalities	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Spinal chord and nerve root disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Structural brain disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Transient cerebrovascular events	0.82% 10/1214 • Number of events 10 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Nervous system disorders Tremor (excl congenital)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device component findings (lead fracture)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device malfunctions (lead dislodgement)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Non-site specific procedural complications (seroma)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device malfunction events (sensor recalibration)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Implant procedure failure	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Non-site specific procedural complications (hematoma post-operative)	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Pacemaker complication (lead dislodgement)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Psychiatric disorders Anxiety symptoms	0.25% 3/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Psychiatric disorders Confusion and disorientation	0.82% 10/1214 • Number of events 10 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Psychiatric disorders Depressive disorders	0.08% 1/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Psychiatric disorders Mental disorders NEC	1.6% 19/1214 • Number of events 21 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Psychiatric disorders Substance-related disorders	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Psychiatric disorders Suicidal and self-injurious behaviour	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Renal and urinary disorders Bladder and urethral symptoms	0.41% 5/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Renal and urinary disorders Renal disorders NEC	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Renal and urinary disorders Renal failure and impairment	11.2% 136/1214 • Number of events 166 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Renal and urinary disorders Renal failure complications	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Renal and urinary disorders Renal lithiasis	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Renal and urinary disorders Renal vascular and ischaemic conditions	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Renal and urinary disorders Urinary abnormalitiues	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Reproductive system and breast disorders Prostate and seminal vesicles infections and inflammations	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Reproductive system and breast disorders Prostatic neoplasms and hypertrophy	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Reproductive system and breast disorders Scrotal disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Reproductive system and breast disorders Vulvovaginal disorders NEC	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Breathing abnormalities	13.0% 158/1214 • Number of events 215 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Bronchospasm and obstruction	3.8% 46/1214 • Number of events 66 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Conditions associated with abnormal gas exchange	1.2% 15/1214 • Number of events 16 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Coughing and associated symptoms	1.2% 14/1214 • Number of events 14 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Lower respiratory tract inflammatory and immunologic conditions	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Lower respiratory tract signs and symptoms	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Nasal disorders NEC	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Parenchymal lung disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Pleural infections and inflammations	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Pneumothorax and pleural effusions NEC	1.2% 15/1214 • Number of events 17 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Pulmonary hypertensions	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Pulmonary oedemas	0.58% 7/1214 • Number of events 7 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Pulmonary thrombotic and embolic conditions	0.91% 11/1214 • Number of events 11 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Respiratory failures (excl neonatal)	5.5% 67/1214 • Number of events 76 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Respiratory tract disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Skin and subcutaneous tissue disorders Angioedemas	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Skin and subcutaneous tissue disorders Bullous conditions	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Skin and subcutaneous tissue disorders Dermal and epidermal conditions NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue ulcerations	0.33% 4/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Biliary tract and gallbladder therapeutic procedures	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Bladder therapeutic procedures	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Cardiac device therapeutic procedures	2.2% 27/1214 • Number of events 27 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Cardiac therapeutic procedures NEC	1.1% 13/1214 • Number of events 15 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Cardiac valve therapeutic procedures	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Gastric therapeutic procedures	0.74% 9/1214 • Number of events 9 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Hernia repairs	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Joint therapeutic procedures	0.58% 7/1214 • Number of events 9 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Limb therapeutic procedures	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Therapeutic procedures NEC	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Tongue therapeutic procedures	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Ureteric therapeutic procedures	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Uterine therapeutic procedure	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Vascular therapeutic procedures NEC	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Accelerated and malignant hypertension	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Aortic aneurysm and dissections	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Aortic necrosis and vascular insufficiency	0.58% 7/1214 • Number of events 7 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Circulatory collapse an shock	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Haemorrhages NEC	1.8% 22/1214 • Number of events 25 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Non-site specific embolism and thrombosis	0.33% 4/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Non-site specific necrosis and vascular insufficiency NEC	0.25% 3/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Non-site specific vascular disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Peripheral embolism and thrombosis	0.58% 7/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Peripheral vascular disorders NEC	0.49% 6/1214 • Number of events 8 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Peripheral vasoconstriction, necrosis and vascular insufficiency	0.49% 6/1214 • Number of events 7 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Vascular hypertensive disorders NEC	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Vascular hypotensive disorders	4.3% 52/1214 • Number of events 60 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Vascular injuries NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition

Other adverse events

Measure	CardioMEMS HF System Group n=1214 participants at risk Patients who underwent a CardioMEMS HF System implant
Cardiac disorders Rate and rhythm disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Febrile disorders	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders General signs and symptoms NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
General disorders Pain and discomfort NEC	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Immune system disorders Allergic conditions NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Infections and infestations Skin structures and soft tissue infections	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device malfunctions events	1.2% 14/1214 • Number of events 17 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device related complications	0.25% 3/1214 • Number of events 3 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Non-site specific procedural complications	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Blood gas and acid base analyses	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Investigations Cardiac function diagnostic procedures	0.41% 5/1214 • Number of events 6 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue signs and symptoms NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Musculoskeletal and connective tissue disorders Soft tissue disorders NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device malfunctions events (sensor recalibration, repositioning, difficulty obtaining readings)	0.74% 9/1214 • Number of events 10 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Device-related complications (migration of implant)	0.41% 5/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Non-site specific procedural complications (hematoma, bleeding, incision site complications)	0.41% 5/1214 • Number of events 5 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Non-site specific injuries NEC (wound)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Injury, poisoning and procedural complications Skin injuries NEC (bruising)	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Renal and urinary disorders Renal failure and impairment	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Coughing and associated symptoms	0.16% 2/1214 • Number of events 2 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Therapeutic procedures NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Surgical and medical procedures Vascular therapeutic procedures NEC	0.08% 1/1214 • Number of events 1 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition
Vascular disorders Haemorrhages NEC	0.33% 4/1214 • Number of events 4 • Adverse event data were collected as they occur since the subject signed the Informed consent up to 24 months follow-up, unless the patient's participation was terminated earlier. The definition in adverse events matches the clinicaltrials.gov definition

Additional Information

Dr. Lynne Stevenson

Vanderbilt University Medical Center

Phone: 6159368187

Email: lynne.w.stevenson@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place