Trial Outcomes & Findings for Study to Evaluate Safety & Effectiveness of Vascular Sealant System (NCT NCT00439309)

Last Updated: 2017-09-07

Results Overview

The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.

Recruitment status

TERMINATED

Study phase

Target enrollment

69 participants

Primary outcome timeframe

Within 10 minutes following restoration of blood flow

Results posted on

2017-09-07

Participant Flow

Subjects enrolled between 6APR07 \& 20MAY08 at: U. Hospitals of Cleveland; Cleveland Clinic; Medical U. of Ohio Toledo; Boston Medical Center; OHSU; Southern Illinois U.; Washington Hospital Center; Penn State Heart \& Vascular Inst., Georgetown U.; Brigham \& Women's; Methodist Hospital; Vascular \& Transplant Specialists; St. Vincent's East

Participant milestones

Participant milestones
Measure	VascuSeal Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.	GELFOAM/THROMBIN GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
Treatment STARTED	54	15
Treatment COMPLETED	54	15
Treatment NOT COMPLETED	0	0
Follow-Up STARTED	54	15
Follow-Up COMPLETED	51	13
Follow-Up NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	VascuSeal Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.	GELFOAM/THROMBIN GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
Follow-Up Death	1	0
Follow-Up Lost to Follow-up	2	0
Follow-Up Withdrawal by Subject	0	1
Follow-Up Late response by subject	0	1

Baseline Characteristics

Study to Evaluate Safety & Effectiveness of Vascular Sealant System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VascuSeal n=54 Participants Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.	GELFOAM/THROMBIN n=15 Participants GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	11 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	4 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	63.45 years STANDARD_DEVIATION 11.773 • n=5 Participants	60.91 years STANDARD_DEVIATION 12.958 • n=7 Participants	62.51 years STANDARD_DEVIATION 11.904 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	8 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	7 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants	15 participants n=7 Participants	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 10 minutes following restoration of blood flow

Population: The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.

Outcome measures

Outcome measures
Measure	GELFOAM/THROMBIN n=15 Participants GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.	VascuSeal n=54 Participants Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
Sealing Success	86.7 percentage of participants Interval 59.5 to 98.3	90.7 percentage of participants Interval 79.7 to 96.9

SECONDARY outcome

Timeframe: 60 seconds post restoration of blood flow

A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow

Outcome measures

Outcome measures
Measure	GELFOAM/THROMBIN n=19 Anastomosis GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.	VascuSeal n=68 Anastomosis Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)	10.5 percentage of anastomotic sites	51.5 percentage of anastomotic sites

SECONDARY outcome

Timeframe: Within 10 minutes post restoration of blood flow

A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow.

Outcome measures

Outcome measures
Measure	GELFOAM/THROMBIN n=19 Anastomosis GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.	VascuSeal n=68 Anastomosis Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)	89.5 percentage of anastomitic sites	92.6 percentage of anastomitic sites

SECONDARY outcome

Timeframe: Within 10 minutes post restoration of blood flow

Time to hemostasis determined from time circulation restored after treatment application until bleeding stopped (assessed at intervals of immediate, 1, 3, 5, 7.5 and 10 min). For subject with two sites, time to hemostasis of both sites used for analysis. Subjects for whom bleeding had not stopped within 10 min considered censored observations.

Outcome measures

Outcome measures
Measure	GELFOAM/THROMBIN n=15 Participants GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.	VascuSeal n=54 Participants Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
Time to Hemostasis	5.0 Minutes Interval 3.0 to 7.5	1.0 Minutes Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: From initial clamp removal at the last anastomotic site until skin closure

Time to wound closure was defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. This endpoint was analyzed using the log-rank test to compare the two treatment groups. The Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group.

Outcome measures

Outcome measures
Measure	GELFOAM/THROMBIN n=15 Participants GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.	VascuSeal n=54 Participants Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
Time to Wound Closure	42.5 Minutes Interval 37.0 to 75.0	53.5 Minutes Interval 43.0 to 59.0

Adverse Events

VascuSeal

Serious events: 19 serious events

Other events: 37 other events

Deaths: 0 deaths

GELFOAM/THROMBIN

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	VascuSeal n=54 participants at risk Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.	GELFOAM/THROMBIN n=15 participants at risk GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
Blood and lymphatic system disorders Blood and Lymphatic System Disorder	5.6% 3/54 • Number of events 3 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Cardiac disorders Cardiac Disorder	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Gastrointestinal disorders Gastrointestinal Disorder	9.3% 5/54 • Number of events 5 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
General disorders General Disorder and Administration Site Conditions	14.8% 8/54 • Number of events 8 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	13.3% 2/15 • Number of events 2 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Infections and infestations Infection and Infestation	7.4% 4/54 • Number of events 4 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	14.8% 8/54 • Number of events 8 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Investigations Investigations	5.6% 3/54 • Number of events 3 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	20.0% 3/15 • Number of events 3 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Metabolism and nutrition disorders Metabolism and Nutrition	7.4% 4/54 • Number of events 4 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	5.6% 3/54 • Number of events 3 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Respiratory, thoracic and mediastinal disorders Respiratroy, Thoracic And mediastinal Disorders	11.1% 6/54 • Number of events 6 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Vascular disorders Vascular Disorders	9.3% 5/54 • Number of events 5 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Nervous system disorders Nervous System Disorders	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Surgical and medical procedures Surgical and medical Procedures	0.00% 0/54 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.

Additional Information

Director, Medical Affairs

Integra LifeSciences

Phone: 609-275-0500

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	VascuSeal n=54 participants at risk Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.	GELFOAM/THROMBIN n=15 participants at risk GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
Blood and lymphatic system disorders Coagulopathy	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Blood and lymphatic system disorders Leukocytosis	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Cardiac disorders Cardiac Failure Congestive	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Gastrointestinal disorders Gastrointestinal Haemorrhage	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
General disorders Pyrexia	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Infections and infestations Arteriovenous Graft Site Infection	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Infections and infestations Cellulitis	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Infections and infestations Incision Site Cellulitis	3.7% 2/54 • Number of events 2 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Infections and infestations Incision Site Infection	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Infections and infestations Septic Shock	3.7% 2/54 • Number of events 2 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Injury, poisoning and procedural complications Arteriovenous Graft Thrombosis	3.7% 2/54 • Number of events 2 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Injury, poisoning and procedural complications Graft Thrombosis	0.00% 0/54 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Investigations Laboratory test Abnormal	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential Thrombocythaemia	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Nervous system disorders Cerebrovascular Accident	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Psychiatric disorders Delirium	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Renal and urinary disorders Renal Failure Acute	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Vascular disorders Arterial Thrombosis Limb	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Vascular disorders Haematoma	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	6.7% 1/15 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.
Vascular disorders Haemorrhage	1.9% 1/54 • Number of events 1 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.	0.00% 0/15 • 30 days post randomization For other adverse events, adverse events were only collected with regard to the affected organ system.