Trial Outcomes & Findings for Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection (NCT NCT02651428)

NCT ID: NCT02651428

Last Updated: 2025-02-25

Results Overview

CRBSI was defined as the same organism grown from at least one positive blood culture from a peripheral site or bloodline sample, or either the arterial or venous catheter hub. The final assessment of CRBSI was determined by a Clinical Adjudication Committee (CAC) who used both clinical documentation and blood culture results in their assessment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 806 participants
• Primary outcome timeframe: The event time was the number of days from randomization until the occurrence of a CAC-Adjudicated CRBSI or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).
• Results posted on: 2025-02-25

Participant Flow

Participant milestones

Measure	Neutrolin Arm Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session	Heparin Arm Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session
Overall Study STARTED	403	403
Overall Study COMPLETED	359	359
Overall Study NOT COMPLETED	44	44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection

Baseline characteristics by cohort

Measure	Neutrolin Arm n=403 Participants Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session	Heparin Arm n=403 Participants Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session	Total n=806 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 14.22 • n=5 Participants	60.9 years STANDARD_DEVIATION 14.39 • n=7 Participants	60.9 years STANDARD_DEVIATION 14.30 • n=5 Participants
Sex: Female, Male Female	184 Participants n=5 Participants	154 Participants n=7 Participants	338 Participants n=5 Participants
Sex: Female, Male Male	219 Participants n=5 Participants	249 Participants n=7 Participants	468 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Black or African American	126 Participants n=5 Participants	112 Participants n=7 Participants	238 Participants n=5 Participants
Race (NIH/OMB) White	248 Participants n=5 Participants	262 Participants n=7 Participants	510 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	403 participants n=5 Participants	403 participants n=7 Participants	806 participants n=5 Participants

PRIMARY outcome

Timeframe: The event time was the number of days from randomization until the occurrence of a CAC-Adjudicated CRBSI or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).

Population: Full Analysis Population - all subjects randomized and receiving one or more doses of study medication.

CRBSI was defined as the same organism grown from at least one positive blood culture from a peripheral site or bloodline sample, or either the arterial or venous catheter hub. The final assessment of CRBSI was determined by a Clinical Adjudication Committee (CAC) who used both clinical documentation and blood culture results in their assessment.

Outcome measures

Measure	Neutrolin Arm n=397 Participants Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session	Heparin Arm n=398 Participants Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session
Presence of a CAC-Adjudicated Catheter-Related Bloodstream Infection (CRBSI) in Subjects Receiving Hemodialysis for the Treatment of End Stage Renal Disease (ESRD): Final Analysis	9 Participants	32 Participants

SECONDARY outcome

Timeframe: The event time was the number of days from randomization until catheter removal for any reason or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).

Population: Full Analysis Population - all subjects randomized and receiving one or more doses of study medication.

Analysis of all catheter removals during the study or until the catheter was removed

Outcome measures

Measure	Neutrolin Arm n=397 Participants Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session	Heparin Arm n=398 Participants Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session
Participants With a Study Catheter Removal for Any Reason	236 Participants	225 Participants

Adverse Events

Neutrolin Arm

Serious events: 159 serious events

Other events: 314 other events

Deaths: 18 deaths

Heparin Arm

Serious events: 167 serious events

Other events: 315 other events

Deaths: 21 deaths

Serious adverse events

Measure	Neutrolin Arm n=398 participants at risk Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session	Heparin Arm n=399 participants at risk Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session
Infections and infestations Urinary tract infection	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Abdominal abscess	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Abscess neck	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Appendicitis perforated	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Arteriovenous fistula site infection	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Arteriovenous graft site infection	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Bacteremia	1.3% 5/398 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.8% 7/399 • Number of events 7 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Bacterial sepsis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Bronchitis	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Bronchitis bacterial	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Carbuncle	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Catheter site cellulitis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Cellulitis	1.8% 7/398 • Number of events 7 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Clostridium difficile colitis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Clostridium difficile infection	1.0% 4/398 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Device related infection	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.0% 8/399 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Device related sepsis	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Diabetic foot infection	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Endocarditis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Endocarditis staphylococcal	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Endophthalmitis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Enterococcal bacteremia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Enterococcal infection	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Escherichia urinary tract infection	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Gangrene	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Gastritis viral	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Gastroenteritis	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Gastroenteritis viral	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Histoplasmosis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Infected skin ulcer	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Infectious pleural effusion	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Influenza	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Intervertebral discitis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Klebsiella bacteremia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Localized infection	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Necrotizing soft tissue infection	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Oral candidiasis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Orchitis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Oropharyngeal candidiasis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Osteomyelitis	1.0% 4/398 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Osteomyelitis acute	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Pancreatic abscess	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Pneumococcal sepsis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Pneumonia	3.0% 12/398 • Number of events 12 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	5.3% 21/399 • Number of events 21 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Pneumonia haemophilus	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Pneumonia staphylococcal	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Postoperative wound infection	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Psoas abscess	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Pyelonephritis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Pyelonephritis acute	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Respiratory tract infection viral	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Sepsis	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.5% 14/399 • Number of events 14 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Septic shock	1.3% 5/398 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Serratia bacteremia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Sinusitis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Staphylococcal infection	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Staphylococcal sepsis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Stenotrophomanas infection	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Streptococcal bacteremia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Streptococcal sepsis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Subcutaneous abscess	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Tracheobronchitis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Tuberculosis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Upper respiratory tract infection	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Urinary tract infection bacterial	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Urosepsis	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Viral infection	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Viral sepsis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Acute coronary syndrome	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Acute myocardial infarction	1.3% 5/398 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.3% 13/399 • Number of events 13 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Angina pectoris	1.3% 5/398 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Angina unstable	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Atrial fibrillation	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.5% 6/399 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Atrial tachycardia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Bradycardia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardiac arrest	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardiac failure	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardiac failure acute	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardiac failure congestive	3.0% 12/398 • Number of events 12 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.8% 7/399 • Number of events 7 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardiac tamponade	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardiac valve disease	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardio-respiratory arrest	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardiomyopathy	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Coronary artery disease	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Coronary artery occlusion	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Ischemic cardiomyopathy	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Left ventricular failure	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Mitral valve incompetence	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Myocardial infarction	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Nodal arrhythmia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Pericardial effusion	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Pulseless electrical activity	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Supraventricular tachycardia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Tachycardia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Failure to thrive	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Fluid overload	3.5% 14/398 • Number of events 14 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.0% 12/399 • Number of events 12 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Gout	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyperkalemia	2.5% 10/398 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.0% 8/399 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyperosmolar state	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypoglycaemia	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.5% 6/399 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypovolemia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Lactic acidosis	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Metabolic acidosis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Accelerated hypertension	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Angiopathy	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Aortic dissection	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Aortic stenosis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Arterial hemorrhage	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Arteriosclerosis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Dry gangrene	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Haematoma	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Hypertension	1.0% 4/398 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.5% 10/399 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Hypertensive crisis	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.5% 6/399 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Hypertensive emergency	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Hypotension	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Iliac artery occlusion	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Jugular vein thrombosis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Orthostatic hypotension	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Peripheral artery occlusive disease	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Peripheral artery occlusion	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Peripheral ischemia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Peripheral vascular disorder	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Steal syndrome	1.0% 4/398 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Superior vena cava occlusion	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Thrombosis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Vasculitis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Vasoconstriction	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Venous stenosis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.0% 4/398 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Asthma	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.3% 5/398 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.8% 7/398 • Number of events 7 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.3% 9/399 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Abdominal pain	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Ascites	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Colitis ischemic	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Constipation	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Diabetic gastroparesis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Diarrhea	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Dumping syndrome	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Duodenal ulcer	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Dysphagia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Gastric ulcer	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Gastric ulcer hemorrhage	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Gastritis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Gastrointestinal hemorrhage	1.0% 4/398 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.5% 6/399 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Hematemesis	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Incarcerated inguinal hernia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Intestinal infarction	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Intestinal ischemia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Intestinal obstruction	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Asthenia	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Large intestine perforation	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Mallory-Weiss syndrome	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Nausea	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Esophageal ulcer hemorrhage	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Esophageal varices hemorrhage	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Esophagitis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Esophagitis ulcerative	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Pancreatitis	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Pancreatitis acute	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Peptic ulcer	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Small intestinal obstruction	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Vomiting	1.3% 5/398 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Altered state of consciousness	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Carotid artery occlusion	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Cerebellar hemorrhage	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Cerebellar stroke	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Chest pain	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Cerebral hemorrhage	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Cerebral infarction	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Cerebral ischemia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Cerebrovascular accident	1.0% 4/398 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Dementia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Dizziness	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Dizziness postural	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Encephalopathy	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Hemorrhage intracranial	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Hemorrhagic stroke	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Headache	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Hepatic encephalopathy	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Hyperglycemic seizure	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Hypoxic-ischemic encephalopathy	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Loss of consciousness	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Metabolic encephalopathy	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Neuralgia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Paraesthesia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Seizure	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Somnolence	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Syncope	1.0% 4/398 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Toxic encephalopathy	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Transient ischemic attack	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Anemia postoperative	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Arteriovenous fistula site hematoma	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Arteriovenous graft thrombosis	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Eschar	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Fall	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Femur fracture	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Foot fracture	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Fractured coccyx	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Gastrostomy failure	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Head injury	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Incision site hemorrhage	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Limb surgery	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Post procedural complication	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Procedural hypotension	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Procedural pain	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Pubis fracture	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Subdural hematoma	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Transplant dysfunction	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Vascular graft complication	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Complication associated with device	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Death	1.3% 5/398 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.50% 2/399 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Drug withdrawal syndrome	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Impaired healing	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Multiple organ dysfunction syndrome	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Non-cardiac chest pain	1.3% 5/398 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Edema peripheral	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Pain	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Pyrexia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Anemia	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Hemorrhagic anemia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Nephrogenic anemia	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Normocytic anemia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Pancytopenia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Thrombocytopenia	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Arthritis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Costochondritis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Muscular weakness	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Myopathy	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Product Issues Device breakage	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Product Issues Device dislocation	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Product Issues Device malfunction	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Product Issues Thrombosis in device	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Biliary diskynesia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Cholangitis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Cholecystitis	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Cholecystitis acute	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Cholecystitis chronic	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Cholelithiasis	0.75% 3/398 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Hemobilia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Hepatic cirrhosis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Hepatic failure	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Hepatic cholestatic	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Jaundice	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Renal and urinary disorders Azotemia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Renal and urinary disorders End stage renal disease	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Renal and urinary disorders Nephrolithiasis	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Renal and urinary disorders Renal failure	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Renal and urinary disorders Renal hematoma	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Investigations Blood creatinine phosphokinase MB increased	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Investigations Blood culture positive	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Investigations Blood potassium increased	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Investigations Ejection fraction increased	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Investigations Hemoglobin decreased	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Investigations International normalized ration increased	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Psychiatric disorders Delirium	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Psychiatric disorders Mental status changes	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Psychiatric disorders Suicidal ideation	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Diabetic foot	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Skin ulcer	0.50% 2/398 • Number of events 2 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukemia	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urine leiomyoma	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Endocrine disorders Hyperthyroidism secondary	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Endocrine disorders Myxoedema	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Eye disorders Blindness cortical	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Eye disorders Visual impairment	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Congenital, familial and genetic disorders Protein C deficiency	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Immune system disorders Hypogammaglobulinemia	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.25% 1/398 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.00% 0/399 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Reproductive system and breast disorders Penile swelling	0.00% 0/398 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.25% 1/399 • Number of events 1 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.

Other adverse events

Measure	Neutrolin Arm n=398 participants at risk Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution Neutrolin: Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session	Heparin Arm n=399 participants at risk Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution Heparin: Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session
Infections and infestations Bacteremia	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.3% 9/399 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Bronchitis	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Cellulitis	3.3% 13/398 • Number of events 13 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.5% 14/399 • Number of events 14 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Device-related infection	2.5% 10/398 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.3% 17/399 • Number of events 17 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Nasopharyngitis	2.0% 8/398 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	0.75% 3/399 • Number of events 3 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Osteomyelitis	2.0% 8/398 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Pneumonia	4.5% 18/398 • Number of events 18 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	7.0% 28/399 • Number of events 28 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Sepsis	2.8% 11/398 • Number of events 11 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	5.3% 21/399 • Number of events 21 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Upper respiratory tract infection	2.0% 8/398 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.8% 15/399 • Number of events 15 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Infections and infestations Urinary tract infection	3.0% 12/398 • Number of events 12 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.8% 15/399 • Number of events 15 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Abdominal pain	5.0% 20/398 • Number of events 20 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	6.8% 27/399 • Number of events 27 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Constipation	4.5% 18/398 • Number of events 18 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.3% 17/399 • Number of events 17 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Diarrhea	9.5% 38/398 • Number of events 38 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	7.5% 30/399 • Number of events 30 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Gastrointestinal hemorrhage	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.0% 8/399 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Nausea	6.5% 26/398 • Number of events 26 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	10.8% 43/399 • Number of events 43 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Gastrointestinal disorders Vomiting	6.0% 24/398 • Number of events 24 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	7.8% 31/399 • Number of events 31 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Asthenia	3.8% 15/398 • Number of events 15 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.0% 12/399 • Number of events 12 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Catheter site erythema	1.8% 7/398 • Number of events 7 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.0% 8/399 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Non-cardiac chest pain	2.5% 10/398 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Edema peripheral	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.8% 19/399 • Number of events 19 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Pain	1.8% 7/398 • Number of events 7 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.5% 10/399 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Peripheral swelling	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.3% 9/399 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
General disorders Pyrexia	3.8% 15/398 • Number of events 15 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	6.0% 24/399 • Number of events 24 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	3.3% 13/398 • Number of events 13 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	5.0% 20/399 • Number of events 20 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Fall	4.3% 17/398 • Number of events 17 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.3% 17/399 • Number of events 17 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Injury, poisoning and procedural complications Procedural hypotension	4.5% 18/398 • Number of events 18 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.5% 18/399 • Number of events 18 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Hypertension	6.8% 27/398 • Number of events 27 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	9.8% 39/399 • Number of events 39 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Vascular disorders Hypotension	8.8% 35/398 • Number of events 35 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	6.8% 27/399 • Number of events 27 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Fluid overload	6.5% 26/398 • Number of events 26 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	5.3% 21/399 • Number of events 21 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyperkalemia	6.8% 27/398 • Number of events 27 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	6.5% 26/399 • Number of events 26 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypoglycemia	3.5% 14/398 • Number of events 14 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.5% 10/399 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Product Issues Device dislocation	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.3% 5/399 • Number of events 5 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Product Issues Device malfunction	17.1% 68/398 • Number of events 68 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	11.8% 47/399 • Number of events 47 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Product Issues Device occlusion	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.3% 9/399 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Product Issues Thrombosis in device	2.0% 8/398 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.0% 16/399 • Number of events 16 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 21/398 • Number of events 21 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	7.5% 30/399 • Number of events 30 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.8% 19/398 • Number of events 19 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	7.5% 30/399 • Number of events 30 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.5% 10/399 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.0% 8/399 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.3% 13/399 • Number of events 13 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Dizziness	5.5% 22/398 • Number of events 22 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.0% 16/399 • Number of events 16 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Headache	5.5% 22/398 • Number of events 22 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	5.5% 22/399 • Number of events 22 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Nervous system disorders Syncope	2.5% 10/398 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Back pain	3.8% 15/398 • Number of events 15 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.3% 17/399 • Number of events 17 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Muscle spasm	5.8% 23/398 • Number of events 23 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	9.0% 36/399 • Number of events 36 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 15/398 • Number of events 15 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	5.5% 22/399 • Number of events 22 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Acute myocardial infarction	1.5% 6/398 • Number of events 6 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.5% 14/399 • Number of events 14 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Angina pectoris	2.5% 10/398 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.0% 8/399 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Atrial fibrillation	1.8% 7/398 • Number of events 7 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.3% 13/399 • Number of events 13 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Bradycardia	3.0% 12/398 • Number of events 12 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.8% 11/399 • Number of events 11 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Cardiac failure congestive	4.0% 16/398 • Number of events 16 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.5% 10/399 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Cardiac disorders Tachycardia	2.8% 11/398 • Number of events 11 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	5.5% 22/399 • Number of events 22 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Skin ulcer	2.5% 10/398 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.0% 4/399 • Number of events 4 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Psychiatric disorders Insomnnia	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	1.8% 7/399 • Number of events 7 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Psychiatric disorders Mental status changes	2.3% 9/398 • Number of events 9 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	3.0% 12/399 • Number of events 12 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Anemia	2.0% 8/398 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	4.0% 16/399 • Number of events 16 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.
Blood and lymphatic system disorders Nephrogenic anemia	2.5% 10/398 • Number of events 10 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.	2.0% 8/399 • Number of events 8 • Through a participant's study completion. The mean participant duration of exposure to study drug was 174 days (range 4-884 days). Adverse events were collected for all participants who received study drug, the Full Analysis Population (n=398 Neutrolin, n=399 Heparin). Subjects who did not receive study medication are not included in the adverse event reporting.

Additional Information

Head of Clinical Operations

CorMedix Inc.

Phone: 908-517-9500

Email: lmasson@cormedix.com

Results disclosure agreements

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

Restriction type: GT60