Trial Outcomes & Findings for BIO|MASTER.Ilivia Family / Plexa (NCT NCT02774616)

Last Updated: 2019-05-22

Results Overview

This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device

Recruitment status

COMPLETED

Study phase

Target enrollment

292 participants

Primary outcome timeframe

3 months

Results posted on

2019-05-22

Participant Flow

292 patients completed the informed consent process and signed the informed consent sheet.

278 patients received one or more study devices implanted. 14 enrolled patients did not receive a study device and were excluded from the analysis. Reasons were implantation of other devices than the study devices (N = 8), no implantation of any device for different reasons (N = 5), or withdrawal of consent before implantation (N = 1).

Participant milestones

Participant milestones
Measure	Ilivia ICD Family Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule	Plexa ICD Lead Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting Plexa ICD lead: predefined follow-up schedule	Ilivia ICD and Plexa ICD Lead Implant of the new Ilivia ICD and the new Plexa ICD lead
Overall Study STARTED	95	167	16
Overall Study Died	6	3	1
Overall Study Withdrew Consent	3	3	0
Overall Study Lost to FU	2	0	0
Overall Study Device Explanted	2	1	1
Overall Study Other	2	4	1
Overall Study COMPLETED	80	156	13
Overall Study NOT COMPLETED	15	11	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ilivia ICD Family n=95 Participants Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule	Plexa ICD Lead n=167 Participants Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting Plexa ICD lead: predefined follow-up schedule	Ilivia ICD and Plexa ICD Lead n=16 Participants Implant of the new Ilivia ICD Family and the new Plexa ICD lead. Device measurements, pre-defined programming and Adverse Event Reporting Pre-defined device programming, measurements and follow-up schedule	Total n=278 Participants Total of all reporting groups
Age, Continuous	68 years n=95 Participants	64 years n=167 Participants	71 years n=16 Participants	65 years n=278 Participants
Sex: Female, Male Female	17 Participants n=95 Participants	29 Participants n=167 Participants	5 Participants n=16 Participants	51 Participants n=278 Participants
Sex: Female, Male Male	78 Participants n=95 Participants	138 Participants n=167 Participants	11 Participants n=16 Participants	227 Participants n=278 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 3 months

Population: These are all patients who either had a primary endpoint or who had reached 3 months of follow-up, or both.

This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device

Outcome measures

Outcome measures
Measure	Ilivia Arm n=92 Participants This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined	Ilivia ICD and Plexa ICD Lead n=12 Participants This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined
Ilivia Family Related SADE-free Rate Through 3 Months	91 Participants	12 Participants

PRIMARY outcome

Timeframe: 6 months

Population: These are all patients who either had an endpoint or who reached 6 months of follow-up.

This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead

Outcome measures

Outcome measures
Measure	Ilivia Arm n=136 Participants This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined	Ilivia ICD and Plexa ICD Lead n=13 Participants This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined
Plexa Related SADE-free Rate Through 6 Months	133 Participants	12 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Only 5 patients had spontaneous ventricular arrhythmia detected in the VF zone.

Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by "ATP-one-shot", the percentage of patients with at least one successful termination will be determined

Outcome measures

Outcome measures
Measure	Ilivia Arm n=5 Participants This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined	Ilivia ICD and Plexa ICD Lead This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up	1 Participants	—

SECONDARY outcome

Timeframe: 3 months

Population: Patients in whom this endpoint was not evaluated did not attend the 3-months follow-up or the data were not recorded

The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate

Outcome measures

Outcome measures
Measure	Ilivia Arm n=145 Participants This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined	Ilivia ICD and Plexa ICD Lead This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up	145 Participants	—

SECONDARY outcome

Timeframe: 3 months

Population: Patients in whom this endpoint was not evaluated did not attend the 3-months follow-up or the data were not recorded

The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate

Outcome measures

Outcome measures
Measure	Ilivia Arm n=150 Participants This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined	Ilivia ICD and Plexa ICD Lead This endpoint was evaluated in patients of the Iliva arm and the Ilivia and Plexa arm combined
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up	150 Participants	—

Adverse Events

Ilivia ICD Family

Serious events: 48 serious events

Other events: 52 other events

Deaths: 6 deaths

Plexa ICD Lead

Serious events: 56 serious events

Other events: 49 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Director Clinical Project Management

Biotronik SE & Co.KG

Phone: +49 30 68905

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Ilivia ICD Family n=111 participants at risk Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule	Plexa ICD Lead n=183 participants at risk Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting Plexa ICD lead: predefined follow-up schedule
Cardiac disorders Acute coronary syndrome	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Renal and urinary disorders Acute kidney injury	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Endocrine disorders Adrenal insufficiency	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders Adverse drug reaction	2.7% 3/111 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	3.3% 6/183 • Number of events 6 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Blood and lymphatic system disorders Anemia	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Aortic valve disease	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Atrial fibrillation	5.4% 6/111 • Number of events 7 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	2.7% 5/183 • Number of events 5 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Atrial flutter	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Immune system disorders Autoimmune disorder	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Infections and infestations Bronchial infection	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Cardiac arrest	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Vascular disorders Cardiogenic shock	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Cardiomyopathy	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Eye disorders Cataract	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Chest pain - cardiac	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Hepatobiliary disorders Cholelithiasis	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Respiratory, thoracic and mediastinal disorders COPD	2.7% 3/111 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.6% 3/183 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Coronary artery disorders	0.90% 1/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders Death NOS	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders decompensated heart failure/ cardiac decompensation	8.1% 9/111 • Number of events 11 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	3.3% 6/183 • Number of events 7 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Metabolism and nutrition disorders Dehydration	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Psychiatric disorders Delirium	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders Device issue	7.2% 8/111 • Number of events 8 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	4.9% 9/183 • Number of events 9 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Gastrointestinal disorders Diarrhea	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Investigations Ejection fraction decreased	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Nervous system disorders Encephalopathy	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Infections and infestations Endocarditis infective	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Eye disorders Eye disorders NEC	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Injury, poisoning and procedural complications Fall	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Gastrointestinal disorders Gastrointestinal disorders NEC	2.7% 3/111 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.6% 3/183 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders General disorders and administration site conditions NEC	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Heart failure	2.7% 3/111 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	3.8% 7/183 • Number of events 11 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Renal and urinary disorders Hematuria	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Hepatobiliary disorders Hepatic failure	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Vascular disorders Hypertensive crisis	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Endocrine disorders Hyperthyroidism	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Vascular disorders Hypotension	3.6% 4/111 • Number of events 4 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders Inappropriate phrenic nerve stimulation	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Infections and infestations Infections and infestations NEC	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.

Other adverse events
Measure	Ilivia ICD Family n=111 participants at risk Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting Ilivia ICD Family: pre-defined device programming, measurements and follow-up schedule	Plexa ICD Lead n=183 participants at risk Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting Plexa ICD lead: predefined follow-up schedule
General disorders Adverse drug reaction	3.6% 4/111 • Number of events 4 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	3.8% 7/183 • Number of events 7 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Immune system disorders Allergic reaction	3.6% 4/111 • Number of events 4 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Blood and lymphatic system disorders Anemia	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Gastrointestinal disorders Ascites	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Atrial fibrillation	2.7% 3/111 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.6% 3/183 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Respiratory, thoracic and mediastinal disorders COPD	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Respiratory, thoracic and mediastinal disorders Cough	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders decompensated heart failure/ cardiac decompensation	1.8% 2/111 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders Device issue	7.2% 8/111 • Number of events 9 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	2.7% 5/183 • Number of events 5 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Gastrointestinal disorders Diarrhea	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Nervous system disorders Dizziness	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.6% 3/183 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Eye disorders Eye disorders NEC	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Injury, poisoning and procedural complications Fall	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Gastrointestinal disorders Gastroesophageal reflux disease	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Gastrointestinal disorders Gastrointestinal disorders NEC	0.90% 1/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders General disorders and administration site conditions NEC	2.7% 3/111 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Nervous system disorders Headache	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Heart failure	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Vascular disorders Hematoma	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Hepatobiliary disorders Hepatobiliary disorders NEC	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Metabolism and nutrition disorders Hyperglycemia	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Endocrine disorders Hyperthyroidism	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Metabolism and nutrition disorders Hypokalemia	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Vascular disorders Hypotension	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Endocrine disorders Hypothyroidism	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders Inappropriate phrenic nerve stimulation	10.8% 12/111 • Number of events 18 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	3.8% 7/183 • Number of events 12 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Infections and infestations Infections and infestations NEC	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Injury, poisoning and procedural complications Intraoperative venous injury	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Investigations Investigations NEC	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Metabolism and nutrition disorders Metabolism and nutrition disorders NEC	0.00% 0/111 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder NEC	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.6% 3/183 • Number of events 4 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Gastrointestinal disorders Nausea	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.00% 0/183 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEC	2.7% 3/111 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Nervous system disorders Nervous system disorders NEC	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders Non-cardiac chest pain	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
General disorders Pain	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	0.55% 1/183 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.90% 1/111 • Number of events 1 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.1% 2/183 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.
Cardiac disorders Palpitations	1.8% 2/111 • Number of events 2 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.	1.6% 3/183 • Number of events 3 • Patients of the Ilivia group were followed for 3 months. Patients of the Plexa group were followed for 6 months.