Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor (NCT NCT01974206)

NCT ID: NCT01974206

Last Updated: 2024-10-24

Results Overview

CMV viremia was defined as presence of cytomegalovirus as measured in plasma viral load of ≥ 1000 IU/mL by central laboratory assay. A participant who discontinued the study without a positive CMV viral load was imputed as having a CMV viremia. A participant who had more than one viral load ≥ 1000 IU/mL by central assay was counted once in this summary. CMV viral loads after first injection (Day 1) through Day 380 (scheduled or unscheduled) were included in the analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 150 participants
• Primary outcome timeframe: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
• Results posted on: 2024-10-24

Participant Flow

A total of 150 participants were enrolled into the study from 6 countries. Eligible participants were ≥18 years of age, CMV-seronegative at the time of the transplant and had a kidney allograft from a CMV-seropositive living or deceased donor. After the primary period completion, 149 participants entered the long-term follow-up period.

Screening assessments were performed from 14-30 days after the transplant. Participants were randomized at day 30 in relation to the day of the transplant, in a 1:1 ratio to ASP0113 or placebo. Participants were stratified by the use of antithymocyte globulin (ATG) prior to randomization and by the receipt of a kidney from a living or deceased donor.

Participant milestones

Measure	Placebo Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 5mg Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Overall Study STARTED	74	76
Overall Study Received Treatment	74	75
Overall Study COMPLETED	68	75
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Measure	Placebo Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 5mg Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Overall Study Did Not Take Study Drug	0	1
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	3	0
Overall Study Lost to Follow-up	1	0
Overall Study Death	1	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

Baseline characteristics by cohort

Measure	Placebo n=74 Participants Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 n=76 Participants Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	Total n=150 Participants Total of all reporting groups
Age, Continuous	47.9 Years STANDARD_DEVIATION 13.3 • n=5 Participants	50.8 Years STANDARD_DEVIATION 13.6 • n=7 Participants	49.4 Years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	55 Participants n=7 Participants	110 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	70 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants	6 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	61 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Use of ATG No	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Use of ATG Yes	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Randomization Strata Living Donor & ATG Use = No	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Randomization Strata Living Donor & ATG Use = Yes	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Randomization Strata Deceased Donor & ATG Use = Yes	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Randomization Strata Deceased Donor & ATG Use = No	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Randomization Strata Not Recorded	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Source of Current Transplant LIVING UNRELATED DONOR	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Source of Current Transplant LIVING RELATED DONOR	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Source of Current Transplant DECEASED DONOR	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Source of Current Transplant Not Recorded	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Population: The Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of randomized study drug and who had at least 1 post dose viral load assessment within 1 year post first injection by central laboratory.

CMV viremia was defined as presence of cytomegalovirus as measured in plasma viral load of ≥ 1000 IU/mL by central laboratory assay. A participant who discontinued the study without a positive CMV viral load was imputed as having a CMV viremia. A participant who had more than one viral load ≥ 1000 IU/mL by central assay was counted once in this summary. CMV viral loads after first injection (Day 1) through Day 380 (scheduled or unscheduled) were included in the analysis.

Outcome measures

Measure	Placebo n=73 Participants Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 5mg n=73 Participants Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection Known CMV viremia	35.6 Percentage of Paticipants	35.6 Percentage of Paticipants
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection Imputed CMV viremia due to discontinuation	5.5 Percentage of Paticipants	0 Percentage of Paticipants

SECONDARY outcome

Timeframe: From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection

Population: The analysis population was the FAS.

An independent panel of medical experts reviewed/adjudicated events of CMV-associated disease including CMV syndrome and tissue invasive disease, which were defined according to the American Society of Transplantation Recommendations for Screening, Monitoring and Reporting of Infectious Complications in Immunosuppression Trials in Recipients of Organ Transplantation 2006.

Outcome measures

Measure	Placebo n=73 Participants Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 5mg n=73 Participants Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)	19.18 Percentage of Participants	19.18 Percentage of Participants

SECONDARY outcome

Timeframe: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Population: The analysis population was the FAS.

The central laboratory had the LLOQ level for CMV viral load assessment. When the viral load was below the LLOQ the actual reading was not possible and was denoted as ≤LLOQ. If the participant had any CMV viral load assessments greater than the LLOQ, set up by the central laboratory, participant was classified as viremic and was included in the analysis.

Outcome measures

Measure	Placebo n=73 Participants Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 5mg n=73 Participants Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)	49.32 Percentage of Participants	46.58 Percentage of Participants

SECONDARY outcome

Timeframe: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Population: The analysis population was the FAS.

An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.

Outcome measures

Measure	Placebo n=73 Participants Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 5mg n=73 Participants Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)	45.21 Percentage of Participants	42.47 Percentage of Participants

SECONDARY outcome

Timeframe: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Population: The analysis population was the FAS, with data available.

Graft survival was defined for any participant that did not fit the definition of graft loss. Graft loss was defined as participant death, re-transplant, nephrectomy, or return to permanent dialysis (i.e., for > 30 days). Missing values for graft survival were not included in the denominator when making the proportion. The analysis population was the FAS.

Outcome measures

Measure	Placebo n=68 Participants Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 5mg n=71 Participants Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Percentage of Participants With Graft Survival (Primary Study Period)	98.53 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: Month 18, 30, 42, 54, and 66

Population: All participants who entered long-term follow-up.

Graft survival was defined for any participant that did not fit the definition of graft loss. Graft loss was defined as participant death, re-transplant, nephrectomy, or return to permanent dialysis (i.e., for > 30 days). Missing values for graft survival were not included in the denominator when making the proportion.

Outcome measures

Measure	Placebo n=74 Participants Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 5mg n=76 Participants Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Percentage of Participants With Graft Survival (Long-term Follow up) Long Term Follow Up Month 42	85.1 Percentage of Participants	80.3 Percentage of Participants
Percentage of Participants With Graft Survival (Long-term Follow up) Long Term Follow Up Month 54	78.4 Percentage of Participants	77.6 Percentage of Participants
Percentage of Participants With Graft Survival (Long-term Follow up) Long Term Follow Up Month 18	91.9 Percentage of Participants	94.7 Percentage of Participants
Percentage of Participants With Graft Survival (Long-term Follow up) Long Term Follow Up Month 30	83.8 Percentage of Participants	81.6 Percentage of Participants
Percentage of Participants With Graft Survival (Long-term Follow up) Long Term Follow Up Month 66	82.4 Percentage of Participants	84.2 Percentage of Participants

Adverse Events

Placebo

Serious events: 36 serious events

Other events: 72 other events

Deaths: 5 deaths

ASP0113

Serious events: 44 serious events

Other events: 75 other events

Deaths: 7 deaths

Serious adverse events

Measure	Placebo n=74 participants at risk Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 n=75 participants at risk Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Infections and infestations Viral infection	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Bone fissure	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Graft haemorrhage	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Graft thrombosis	1.4% 1/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Perinephric collection	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Blood and lymphatic system disorders Anaemia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Blood and lymphatic system disorders Febrile neutropenia	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Blood and lymphatic system disorders Leukopenia	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Blood and lymphatic system disorders Neutropenia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Cardiac disorders Acute myocardial infarction	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Cardiac disorders Atrial fibrillation	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Cardiac disorders Bradycardia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Cardiac disorders Coronary artery disease	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Endocrine disorders Hyperparathyroidism tertiary	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Eye disorders Angle closure glaucoma	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Abdominal pain	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Constipation	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Diarrhoea	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Subileus	1.4% 1/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Umbilical hernia	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Malaise	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Pyrexia	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Hepatobiliary disorders Bile duct stone	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Hepatobiliary disorders Cholelithiasis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Immune system disorders Drug hypersensitivity	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Immune system disorders Kidney transplant rejection	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Abscess soft tissue	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations BK virus infection	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Bacterial pyelonephritis	1.4% 1/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Clostridium difficile colitis	1.4% 1/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus colitis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus infection	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	9.3% 7/75 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus mucocutaneous ulcer	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus oesophagitis	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus syndrome	6.8% 5/74 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus viraemia	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Enterococcal bacteraemia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Enterocolitis bacterial	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Epstein-Barr viraemia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Escherichia bacteraemia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Escherichia sepsis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Escherichia urinary tract infection	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Gastroenteritis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Gastroenteritis clostridial	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Gastroenteritis norovirus	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Gastroenteritis viral	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Gastrointestinal infection	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Haematoma infection	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Infected lymphocele	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Nasopharyngitis	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Orchitis	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Peritonitis	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Pneumonia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Pneumonia necrotising	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Polyomavirus-associated nephropathy	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Pyelonephritis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Pyelonephritis acute	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Staphylococcal bacteraemia	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Staphylococcal sepsis	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Streptococcal bacteraemia	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Urinary tract infection	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Urinary tract infection bacterial	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Urinary tract infection enterococcal	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Urosepsis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Seroma	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Wound	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Investigations Blood creatinine increased	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Investigations Blood glucose increased	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Investigations HLA marker study positive	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Investigations Immunosuppressant drug level increased	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Dehydration	1.4% 1/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Diabetes mellitus	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Failure to thrive	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Fluid overload	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Nervous system disorders Convulsion	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Nervous system disorders Neuropathy peripheral	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Psychiatric disorders Depression	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Psychiatric disorders Mental status changes	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Calculus urinary	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Haematuria	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Hydronephrosis	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Nephrolithiasis	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Nephropathy	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Renal artery stenosis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Renal cyst	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Renal failure acute	8.1% 6/74 • Number of events 10 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	13.3% 10/75 • Number of events 12 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Renal impairment	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Renal tubular necrosis	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Ureteric stenosis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Urinary bladder atrophy	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Urinary retention	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Urinary tract disorder	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Urinoma	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Surgical and medical procedures Nephrectomy	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Surgical and medical procedures Transurethral prostatectomy	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Surgical and medical procedures Ureteral stent removal	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Surgical and medical procedures Urostomy	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Aortic aneurysm	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Deep vein thrombosis	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Hypotension	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Jugular vein thrombosis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Lymphocele	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Thrombophlebitis superficial	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Thrombosis	0.00% 0/74 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.

Other adverse events

Measure	Placebo n=74 participants at risk Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	ASP0113 n=75 participants at risk Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Blood and lymphatic system disorders Anaemia	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	9.3% 7/75 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Blood and lymphatic system disorders Leukopenia	25.7% 19/74 • Number of events 23 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	38.7% 29/75 • Number of events 32 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Blood and lymphatic system disorders Neutropenia	8.1% 6/74 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	13.3% 10/75 • Number of events 11 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	6.8% 5/74 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Cardiac disorders Bradycardia	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Cardiac disorders Tachycardia	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Eye disorders Vision blurred	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Abdominal pain	8.1% 6/74 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	10.7% 8/75 • Number of events 9 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Abdominal pain upper	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Constipation	8.1% 6/74 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Diarrhoea	32.4% 24/74 • Number of events 38 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	30.7% 23/75 • Number of events 33 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Dyspepsia	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.1% 6/74 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Nausea	18.9% 14/74 • Number of events 19 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	17.3% 13/75 • Number of events 22 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Gastrointestinal disorders Vomiting	12.2% 9/74 • Number of events 13 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	12.0% 9/75 • Number of events 12 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Asthenia	10.8% 8/74 • Number of events 8 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Chills	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Fatigue	32.4% 24/74 • Number of events 38 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	36.0% 27/75 • Number of events 59 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Injection site erythema	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	10.7% 8/75 • Number of events 14 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Injection site pain	24.3% 18/74 • Number of events 46 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	62.7% 47/75 • Number of events 277 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Oedema	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Oedema peripheral	6.8% 5/74 • Number of events 8 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	12.0% 9/75 • Number of events 13 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
General disorders Pyrexia	17.6% 13/74 • Number of events 14 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	12.0% 9/75 • Number of events 11 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations BK virus infection	21.6% 16/74 • Number of events 18 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	21.3% 16/75 • Number of events 17 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus infection	6.8% 5/74 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus syndrome	8.1% 6/74 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	9.3% 7/75 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Cytomegalovirus viraemia	25.7% 19/74 • Number of events 22 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	29.3% 22/75 • Number of events 30 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Escherichia urinary tract infection	6.8% 5/74 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	8.0% 6/75 • Number of events 9 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Nasopharyngitis	10.8% 8/74 • Number of events 10 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	10.7% 8/75 • Number of events 10 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Upper respiratory tract infection	9.5% 7/74 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	10.7% 8/75 • Number of events 9 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Urinary tract infection	5.4% 4/74 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	13.3% 10/75 • Number of events 17 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Infections and infestations Urinary tract infection bacterial	4.1% 3/74 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	10.7% 8/75 • Number of events 11 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Complications of transplant surgery	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Complications of transplanted kidney	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Injury, poisoning and procedural complications Procedural pain	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	8.0% 6/75 • Number of events 10 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Investigations Blood creatinine increased	21.6% 16/74 • Number of events 19 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	14.7% 11/75 • Number of events 17 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Investigations Weight increased	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Investigations White blood cell count decreased	5.4% 4/74 • Number of events 12 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Decreased appetite	6.8% 5/74 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Diabetes mellitus	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hypercalcaemia	6.8% 5/74 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	6.8% 5/74 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	2.7% 2/75 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hyperkalaemia	10.8% 8/74 • Number of events 8 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	16.0% 12/75 • Number of events 16 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hyperlipidaemia	4.1% 3/74 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hypoglycaemia	8.1% 6/74 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hypomagnesaemia	8.1% 6/74 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	9.3% 7/75 • Number of events 13 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hyponatraemia	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Hypophosphataemia	9.5% 7/74 • Number of events 8 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	9.3% 7/75 • Number of events 8 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Metabolic acidosis	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	14.7% 11/75 • Number of events 12 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Metabolism and nutrition disorders Vitamin D deficiency	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	9.3% 7/75 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	10.8% 8/74 • Number of events 10 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Back pain	10.8% 8/74 • Number of events 9 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Muscle spasms	6.8% 5/74 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Muscular weakness	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	8.1% 6/74 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 11 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Myalgia	20.3% 15/74 • Number of events 22 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	28.0% 21/75 • Number of events 38 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	10.8% 8/74 • Number of events 9 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Nervous system disorders Dizziness	12.2% 9/74 • Number of events 12 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Nervous system disorders Headache	16.2% 12/74 • Number of events 14 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	17.3% 13/75 • Number of events 13 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Nervous system disorders Tremor	9.5% 7/74 • Number of events 9 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	13.3% 10/75 • Number of events 11 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Psychiatric disorders Insomnia	8.1% 6/74 • Number of events 8 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	10.7% 8/75 • Number of events 11 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Dysuria	8.1% 6/74 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Haematuria	9.5% 7/74 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	8.0% 6/75 • Number of events 8 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Renal and urinary disorders Kidney fibrosis	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	9.3% 7/75 • Number of events 7 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	5.4% 4/74 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	9.3% 7/75 • Number of events 8 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.8% 8/74 • Number of events 10 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	6.7% 5/75 • Number of events 9 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.8% 5/74 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Skin and subcutaneous tissue disorders Alopecia	10.8% 8/74 • Number of events 9 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	4.0% 3/75 • Number of events 3 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Skin and subcutaneous tissue disorders Rash	2.7% 2/74 • Number of events 2 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Surgical and medical procedures Ureteral stent removal	8.1% 6/74 • Number of events 6 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	1.3% 1/75 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Arteriosclerosis	1.4% 1/74 • Number of events 1 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	5.3% 4/75 • Number of events 4 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Hypertension	12.2% 9/74 • Number of events 14 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	16.0% 12/75 • Number of events 12 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Hypotension	10.8% 8/74 • Number of events 10 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	14.7% 11/75 • Number of events 16 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.
Vascular disorders Orthostatic hypotension	5.4% 4/74 • Number of events 5 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.	0.00% 0/75 • Day 1 to Day 380 Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first study drug injection Day 1 through Day 380. No AEs were collected / reported during the long-term follow-up period.

Additional Information

Clinical Trial Disclosure

Astellas Pharma Global Development, Inc.

Phone: 800-888-7704

Email: astellas.resultsdisclosure@astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
• Publication restrictions are in place

Restriction type: OTHER