Trial Outcomes & Findings for EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection (NCT NCT00105183)

NCT ID: NCT00105183

Last Updated: 2012-06-11

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

223 participants

Primary outcome timeframe

12 months

Results posted on

2012-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	EZ-2053 9mg/kg Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo USP 0.9% sodium chloride solution	EZ-2053 5mg/kg Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Overall Study STARTED	82	79	62
Overall Study COMPLETED	60	60	39
Overall Study NOT COMPLETED	22	19	23

Reasons for withdrawal

Reasons for withdrawal
Measure	EZ-2053 9mg/kg Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo USP 0.9% sodium chloride solution	EZ-2053 5mg/kg Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Overall Study Death	19	13	15
Overall Study Withdrawal by Subject	1	1	4
Overall Study Physician Decision	1	2	3
Overall Study Lost to Follow-up	0	1	1
Overall Study Other reason	1	2	0

Baseline Characteristics

EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EZ-2053 9mg/kg n=82 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=79 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=62 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit	Total n=223 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants	68 Participants n=7 Participants	58 Participants n=5 Participants	204 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	36 Participants n=7 Participants	27 Participants n=5 Participants	99 Participants n=4 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	43 Participants n=7 Participants	35 Participants n=5 Participants	124 Participants n=4 Participants
Region of Enrollment United States	45 participants n=5 Participants	41 participants n=7 Participants	36 participants n=5 Participants	122 participants n=4 Participants
Region of Enrollment Canada	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	15 participants n=4 Participants
Region of Enrollment Austria	18 participants n=5 Participants	18 participants n=7 Participants	14 participants n=5 Participants	50 participants n=4 Participants
Region of Enrollment Australia	14 participants n=5 Participants	15 participants n=7 Participants	7 participants n=5 Participants	36 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: ITT. During the interim analysis the 5 mg/kg arm was dropped and it was showed that the study was insufficiently powered so the main focus of study shifted to safety endpoints. Data is based on local lung biopsy readings for efficacy failure instead of central readings

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=82 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=79 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=62 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)	33 participants	29 participants	30 participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=82 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=79 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=62 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Number of Participants With Death or Graft Loss Post-transplant	13 participants	8 participants	7 participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=82 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=79 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=62 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Number of Participants With Acute Rejection	22 participants	20 participants	22 participants

SECONDARY outcome

Timeframe: 12 months

Population: Safety population

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=82 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=78 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=61 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Number of Participants With Infections and Infestations	75 participants	70 participants	57 participants

SECONDARY outcome

Timeframe: 12 months

Population: Safety population

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=82 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=78 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=61 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Number of Participants With Severe Adverse Events	18 participants	14 participants	9 participants

SECONDARY outcome

Timeframe: 12 months

Population: Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=45 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=41 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=35 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test	457.0 Meters Interval 122.0 to 714.0	448.0 Meters Interval 278.0 to 674.2	427.0 Meters Interval 0.0 to 757.0

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=66 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=64 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=49 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Pulmonary Function Test, Forced Vital Capacity	3.0 Liters Interval 1.3 to 6.2	2.9 Liters Interval 1.0 to 5.1	3.3 Liters Interval 1.0 to 5.4

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=66 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=64 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=50 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Pulmonary Function Test, Forced Expiratory Volume in 1 Second	2.3 Liters Interval 0.8 to 4.9	2.3 Liters Interval 0.6 to 4.4	2.5 Liters Interval 0.8 to 5.1

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	EZ-2053 9mg/kg n=66 Participants Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=64 Participants USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=50 Participants Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Pulmonary Function Test, Forced Expiratory Flow 25-75	2.7 Liters/second Interval 0.3 to 7.4	2.2 Liters/second Interval 0.3 to 9.3	2.6 Liters/second Interval 0.5 to 8.0

Adverse Events

EZ-2053 9mg/kg

Serious events: 65 serious events

Other events: 82 other events

Deaths: 0 deaths

Placebo

Serious events: 52 serious events

Other events: 78 other events

Deaths: 0 deaths

EZ-2053 5mg/kg

Serious events: 44 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Regulatory Affairs

Fresenius Biotech

Phone: 781 699 4618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Protocol: The 1st publication of study results shall be a complete, joint multicenter publication or disclosure coordinated by sponsor. Later publications will reference 1st publication. Prior to submitting for publication, the Investigator shall allow sponsor at least 30 days to review the proposed Publication. Proposed Publications shall not include either Fresenius Biotech confidential information other than the study results or personal data on any patient, such as name or initials.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	EZ-2053 9mg/kg n=82 participants at risk Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=78 participants at risk USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=61 participants at risk Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Gastrointestinal disorders Colitis	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Gastric ulcer	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Immune system disorders Transplant rejection	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.3% 1/78 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Gastrointestinal motility disorder	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Haematemesis	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Haemorrhoidal haemorrhage	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Large intestine perforation	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Megacolon	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Peritonitis	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Retroperitoneal haemorrhage	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Immune system disorders Cytokine release syndrome	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Immune system disorders Anaphylactic reaction	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Injury, poisoning and procedural complications Drug toxicity	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Injury, poisoning and procedural complications Wound dehiscence	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Injury, poisoning and procedural complications Bronchial anastomosis complication	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.3% 2/61 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	2.6% 2/78 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Injury, poisoning and procedural complications Complications of transplant surgery	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Injury, poisoning and procedural complications Contusion	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Injury, poisoning and procedural complications Haemothorax	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.3% 1/78 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Umbilical hernia	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Abdominal pain upper	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.3% 1/78 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Diverticular perforation	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.3% 1/78 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Abdominal hematoma	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.3% 1/78 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.3% 1/78 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Ctytomegalovirus infection	2.4% 2/82 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Gastrointestinal disorders Proctitis ulcerative	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.3% 1/78 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Immune system disorders Lung transplant rejection	11.0% 9/82 • Number of events 9 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	14.1% 11/78 • Number of events 11 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	11.5% 7/61 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Pneumonia	4.9% 4/82 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	7.7% 6/78 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.8% 6/61 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Lung infection pseudomonal	4.9% 4/82 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	5.1% 4/78 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	8.2% 5/61 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Renal and urinary disorders Renal failure acute	4.9% 4/82 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.8% 3/78 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.3% 6/82 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	11.5% 7/61 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.5% 7/82 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	5.1% 4/78 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.3% 6/82 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.8% 3/78 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.1% 5/82 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.8% 3/78 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Vascular disorders Hypotension	8.5% 7/82 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	2.6% 2/78 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Staphylococcal infection	0.00% 0/82 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.8% 3/78 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Enterococcal infection	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/78 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.

Other adverse events
Measure	EZ-2053 9mg/kg n=82 participants at risk Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)	Placebo n=78 participants at risk USP 0.9% sodium chloride solution	EZ-2053 5mg/kg n=61 participants at risk Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Respiratory, thoracic and mediastinal disorders Pleural effusion	50.0% 41/82 • Number of events 41 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	46.2% 36/78 • Number of events 36 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	44.3% 27/61 • Number of events 27 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumothorax	46.3% 38/82 • Number of events 38 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	44.9% 35/78 • Number of events 35 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	37.7% 23/61 • Number of events 23 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	24.4% 20/82 • Number of events 20 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	30.8% 24/78 • Number of events 24 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	34.4% 21/61 • Number of events 21 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnoea	32.9% 27/82 • Number of events 27 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	29.5% 23/78 • Number of events 23 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	31.1% 19/61 • Number of events 19 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Lung infiltration	8.5% 7/82 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	12.8% 10/78 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	18.0% 11/61 • Number of events 11 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Atelectasis	7.3% 6/82 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	16.4% 10/61 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hypoxia	13.4% 11/82 • Number of events 11 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	7.7% 6/78 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory failure	12.2% 10/82 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	12.8% 10/78 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	11.5% 7/61 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Haemoptysis	12.2% 10/82 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	7.7% 6/78 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Productive cough	12.2% 10/82 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.8% 6/61 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	12.2% 10/82 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.4% 5/78 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	8.2% 5/61 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Emphysema	9.8% 8/82 • Number of events 8 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	11.5% 7/61 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Wheezing	8.5% 7/82 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.4% 5/78 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	11.5% 7/61 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Rales	11.0% 9/82 • Number of events 9 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.8% 3/78 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	10.3% 8/78 • Number of events 8 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	4.9% 3/61 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Bronchostenosis	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.3% 2/61 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hypercapnia	2.4% 2/82 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	4.9% 4/82 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	8.2% 5/61 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory distress	8.5% 7/82 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	7.7% 6/78 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	7.3% 6/82 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	2.6% 2/78 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.3% 2/61 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.4% 5/78 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.4% 5/78 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	4.9% 3/61 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Tachypnoea	6.1% 5/82 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.8% 3/78 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.3% 2/61 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.2% 1/82 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	5.1% 4/78 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Sleep apnoe syndrome	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	5.1% 4/78 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Respiratory moniliasis	24.4% 20/82 • Number of events 20 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	26.9% 21/78 • Number of events 21 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	32.8% 20/61 • Number of events 20 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Bronchopulmonary aspergillosis	15.9% 13/82 • Number of events 13 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	26.9% 21/78 • Number of events 21 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	31.1% 19/61 • Number of events 19 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Lung infection Pseudomonal	18.3% 15/82 • Number of events 15 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	28.2% 22/78 • Number of events 22 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	31.1% 19/61 • Number of events 19 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Staphylococcal infection	13.4% 11/82 • Number of events 11 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	24.4% 19/78 • Number of events 19 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	18.0% 11/61 • Number of events 11 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Pneumonia	11.0% 9/82 • Number of events 9 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	15.4% 12/78 • Number of events 12 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	14.8% 9/61 • Number of events 9 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Cytomegalovirus viraemia	12.2% 10/82 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	14.8% 9/61 • Number of events 9 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Cytomegalovirus infection	14.6% 12/82 • Number of events 12 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	10.3% 8/78 • Number of events 8 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	13.1% 8/61 • Number of events 8 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Enterococcal infection	12.2% 10/82 • Number of events 10 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	5.1% 4/78 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	8.2% 5/61 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Stenotrophomonas infection	7.3% 6/82 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	11.5% 7/61 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Oral Candidiasis	9.8% 8/82 • Number of events 8 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	5.1% 4/78 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.3% 2/61 • Number of events 2 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Aspergillosis	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	9.0% 7/78 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	0.00% 0/61 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Upper respiratory tract infection	8.5% 7/82 • Number of events 7 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.4% 5/78 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	6.6% 4/61 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Bronchitis	3.7% 3/82 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	3.8% 3/78 • Number of events 3 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	8.2% 5/61 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Respiratory tract infection fungal	4.9% 4/82 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	7.7% 6/78 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	8.2% 5/61 • Number of events 5 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.
Infections and infestations Nasopharyngitis	4.9% 4/82 • Number of events 4 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	7.7% 6/78 • Number of events 6 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.	1.6% 1/61 • Number of events 1 • 1 year Total number of randomized participants is 223. The total number of randomized and treated participants is 221. Two participants (1 from EZ-2053 5mg/kg group and 1 from placebo group) were randomized but were not treated and therefore not included in the adverse event reporting.