Trial Outcomes & Findings for Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002) (NCT NCT03443869)

NCT ID: NCT03443869

Last Updated: 2023-07-28

Results Overview

CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded Clinical Adjudication Committee (CAC). Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 601 participants
• Primary outcome timeframe: Up to 52 weeks
• Results posted on: 2023-07-28

Participant Flow

Male/Female participants of at least 18 years of age with receipt of a kidney transplant were enrolled in this trial.

Participant milestones

Measure	Letermovir Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks	Valganciclovir 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Overall Study STARTED	301	300
Overall Study Treated	292	297
Overall Study COMPLETED	256	266
Overall Study NOT COMPLETED	45	34

Reasons for withdrawal

Measure	Letermovir Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks	Valganciclovir 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Overall Study Death	3	3
Overall Study Withdrawal by Subject	34	22
Overall Study Lost to Follow-up	1	2
Overall Study Physician Decision	3	3
Overall Study Other	4	4

Baseline Characteristics

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Baseline characteristics by cohort

Measure	Letermovir n=301 Participants Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks	Valganciclovir n=300 Participants 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks	Total n=601 Participants Total of all reporting groups
Age, Continuous	49.6 Years STANDARD_DEVIATION 14.8 • n=5 Participants	49.5 Years STANDARD_DEVIATION 15.1 • n=7 Participants	49.6 Years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	90 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Male	217 Participants n=5 Participants	210 Participants n=7 Participants	427 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=5 Participants	45 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	230 Participants n=5 Participants	240 Participants n=7 Participants	470 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	10 Participants n=7 Participants	15 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	22 Participants n=5 Participants	33 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) White	259 Participants n=5 Participants	246 Participants n=7 Participants	505 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All randomized participants who received at least one dose of study treatment, were CMV seropositive organ donor/CMV seronegative organ recipient (D+/R-), and had no detectable CMV viral DNA (measured by central laboratory) on Day 1.

CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded Clinical Adjudication Committee (CAC). Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.

Outcome measures

Measure	Letermovir n=289 Participants Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks	Valganciclovir n=297 Participants 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant	10.4 Percentage of Participants	11.8 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 28 weeks

Population: All randomized participants who received at least one dose of study treatment, were D+/R-, and had no detectable CMV viral DNA (measured by central laboratory) on Day 1.

CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded CAC. Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.

Outcome measures

Measure	Letermovir n=289 Participants Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks	Valganciclovir n=297 Participants 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Percentage of Participants With Adjudicated CMV Disease Through 28 Weeks Post-transplant	0.0 Percentage of Participants	1.7 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: All randomized participants who received at least one dose of study treatment, were D+/R-, and had no detectable CMV viral DNA (measured by central laboratory) on Day 1.

The time to onset of adjudicated CMV disease was calculated in days, from the day of randomization to the day of onset of CMV disease as determined by the CAC.

Outcome measures

Measure	Letermovir n=289 Participants Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks	Valganciclovir n=297 Participants 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Time to Onset of Adjudicated CMV Disease Through 52 Weeks Post-transplant	NA Days NA=The median time to event was not reached as fewer than half the participants reached this endpoint.	NA Days NA=The median time to event was not reached as fewer than half the participants reached this endpoint.

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: All randomized participants who received at least one dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE.

Outcome measures

Measure	Letermovir n=292 Participants Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks	Valganciclovir n=297 Participants 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Percentage of Participants With Any AE	92.8 Percentage of Participants	92.9 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: All randomized participants who received at least one dose of study treatment.

An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. SAEs that the investigator determined the relationship of the AE to the treatment as at least possibly related were reported.

Outcome measures

Measure	Letermovir n=292 Participants Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks	Valganciclovir n=297 Participants 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Percentage of Participants With Any Drug-related Serious Adverse Event (SAE)	1.4 Percentage of Participants	5.1 Percentage of Participants

Adverse Events

Letermovir

Serious events: 118 serious events

Other events: 239 other events

Deaths: 5 deaths

Valganciclovir

Serious events: 129 serious events

Other events: 243 other events

Deaths: 3 deaths

Serious adverse events

Measure	Letermovir n=292 participants at risk LET 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to VGCV tablet orally once daily; and 400-mg capsule of ACV orally every 12 hours for 28 weeks	Valganciclovir n=297 participants at risk 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Blood and lymphatic system disorders Anaemia	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.7% 5/297 • Number of events 5 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Hypoplastic anaemia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Leukocytosis	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Leukopenia	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	3.0% 9/297 • Number of events 9 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	1.4% 4/292 • Number of events 4 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Pancytopenia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	0.34% 1/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.3% 4/297 • Number of events 4 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Atrial fibrillation	1.4% 4/292 • Number of events 4 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Atrial flutter	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Cardiac arrest	0.34% 1/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Cardiogenic shock	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Coronary artery stenosis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Myocardial infarction	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Myocardial ischaemia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Palpitations	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Colitis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	2.7% 8/297 • Number of events 8 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Faecaloma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastritis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Gingivitis ulcerative	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Ileus	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Inguinal hernia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Oesophagitis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Overflow diarrhoea	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Retroperitoneal haematoma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Dehiscence	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Discomfort	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders General physical health deterioration	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Generalised oedema	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Impaired healing	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Implant site extravasation	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Implant site necrosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Malacoplakia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Malaise	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Puncture site pain	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Pyrexia	3.1% 9/292 • Number of events 10 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Immune system disorders Kidney transplant rejection	1.7% 5/292 • Number of events 5 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Immune system disorders Transplant rejection	2.1% 6/292 • Number of events 6 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	3.0% 9/297 • Number of events 9 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Abdominal sepsis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Abdominal wall abscess	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Adenovirus infection	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Anal abscess	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Appendicitis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Bacteraemia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Bacterial pyelonephritis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Bacterial sepsis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Bronchopulmonary aspergillosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations COVID-19	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations COVID-19 pneumonia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Clostridium difficile colitis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Coronavirus infection	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Cytomegalovirus colitis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Cytomegalovirus gastritis	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Cytomegalovirus hepatitis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Cytomegalovirus infection	2.4% 7/292 • Number of events 7 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	2.7% 8/297 • Number of events 8 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Cytomegalovirus syndrome	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Cytomegalovirus viraemia	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.3% 4/297 • Number of events 5 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Endocarditis	0.34% 1/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Epstein-Barr virus infection	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Escherichia bacteraemia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Escherichia sepsis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis viral	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Infected urinoma	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Influenza	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Kidney infection	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Lymph node tuberculosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Norovirus infection	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Orchitis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Parvovirus B19 infection	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Parvovirus infection	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Penile gangrene	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumonia klebsiella	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumonia parainfluenzae viral	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Polyomavirus-associated nephropathy	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Postoperative wound infection	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Pseudomembranous colitis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Pyelonephritis	1.4% 4/292 • Number of events 6 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Pyelonephritis acute	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Renal graft infection	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Respiratory tract infection	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Sepsis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Septic shock	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	2.7% 8/292 • Number of events 10 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	2.7% 8/297 • Number of events 10 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection bacterial	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 4 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection enterococcal	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Urosepsis	1.4% 4/292 • Number of events 5 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.3% 4/297 • Number of events 4 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Complications of transplanted kidney	1.0% 3/292 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Delayed graft function	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Femur fracture	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Foreign body	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Graft complication	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Graft haemorrhage	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Incision site discharge	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Incision site erythema	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Incision site pain	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Post procedural urine leak	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Postoperative ileus	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Renal lymphocele	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Renal transplant failure	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Seroma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Shunt thrombosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Transplant failure	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Urethral injury	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Investigations Blood creatinine increased	2.4% 7/292 • Number of events 7 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Investigations Neutrophil count decreased	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Investigations White blood cell count decreased	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 4 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.34% 1/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperlipidaemia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypervolaemia	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Malnutrition	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders New onset diabetes after transplantation	1.0% 3/292 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular lymphoma	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Amnesia	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Coma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Nervous system disorder	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Presyncope	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Tremor	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Product Issues Device dislocation	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Delirium	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Hallucination	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Suicide attempt	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	2.7% 8/292 • Number of events 8 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	3.0% 9/297 • Number of events 12 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Bladder tamponade	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Cystitis haemorrhagic	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders End stage renal disease	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Haematuria	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Hydronephrosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders IgA nephropathy	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Nephropathy toxic	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Pyelocaliectasis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Renal artery stenosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Renal cyst haemorrhage	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Renal failure	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Renal haematoma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Renal impairment	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Subcapsular renal haematoma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Ureteric stenosis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Urethral stenosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Urinary incontinence	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Urinary retention	0.68% 2/292 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Urinoma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 3/292 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Deep vein thrombosis	1.4% 4/292 • Number of events 4 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Extremity necrosis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Haematoma	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypertension	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypertensive crisis	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypertensive emergency	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypotension	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Iliac artery stenosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Lymphocele	2.7% 8/292 • Number of events 8 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	1.7% 5/297 • Number of events 5 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Peripheral artery thrombosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Peripheral ischaemia	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Shock	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/292 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Glomerulonephritis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Renal tubular necrosis	0.34% 1/292 • Number of events 1 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	0.00% 0/297 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.

Other adverse events

Measure	Letermovir n=292 participants at risk LET 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to VGCV tablet orally once daily; and 400-mg capsule of ACV orally every 12 hours for 28 weeks	Valganciclovir n=297 participants at risk 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Blood and lymphatic system disorders Anaemia	8.2% 24/292 • Number of events 25 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	11.4% 34/297 • Number of events 36 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Leukopenia	12.0% 35/292 • Number of events 46 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	35.4% 105/297 • Number of events 125 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	2.4% 7/292 • Number of events 9 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	16.8% 50/297 • Number of events 60 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	7.2% 21/292 • Number of events 22 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	5.7% 17/297 • Number of events 17 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	9.2% 27/292 • Number of events 28 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	10.4% 31/297 • Number of events 36 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	33.9% 99/292 • Number of events 130 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	28.6% 85/297 • Number of events 101 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	6.5% 19/292 • Number of events 20 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	5.1% 15/297 • Number of events 17 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	12.0% 35/292 • Number of events 40 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	12.5% 37/297 • Number of events 48 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	7.9% 23/292 • Number of events 31 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	8.8% 26/297 • Number of events 32 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Fatigue	7.2% 21/292 • Number of events 21 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	11.4% 34/297 • Number of events 38 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Oedema peripheral	15.1% 44/292 • Number of events 52 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	15.8% 47/297 • Number of events 61 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
General disorders Pyrexia	7.5% 22/292 • Number of events 24 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	8.1% 24/297 • Number of events 29 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Cytomegalovirus infection	2.7% 8/292 • Number of events 9 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	5.1% 15/297 • Number of events 15 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Polyomavirus viraemia	3.8% 11/292 • Number of events 11 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	5.4% 16/297 • Number of events 18 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	14.0% 41/292 • Number of events 51 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	15.2% 45/297 • Number of events 60 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Investigations Blood creatinine increased	8.9% 26/292 • Number of events 29 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	13.1% 39/297 • Number of events 46 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Investigations White blood cell count decreased	1.0% 3/292 • Number of events 4 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	5.1% 15/297 • Number of events 20 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	3.4% 10/292 • Number of events 12 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	7.1% 21/297 • Number of events 22 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	11.0% 32/292 • Number of events 36 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	12.8% 38/297 • Number of events 44 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	6.5% 19/292 • Number of events 22 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	3.4% 10/297 • Number of events 10 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	14.0% 41/292 • Number of events 44 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	13.5% 40/297 • Number of events 47 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	12.0% 35/292 • Number of events 38 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	12.1% 36/297 • Number of events 41 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	6.2% 18/292 • Number of events 19 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	5.7% 17/297 • Number of events 18 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	3.1% 9/292 • Number of events 9 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	5.7% 17/297 • Number of events 19 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	5.1% 15/292 • Number of events 17 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	3.7% 11/297 • Number of events 14 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Headache	7.9% 23/292 • Number of events 27 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	7.1% 21/297 • Number of events 27 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Nervous system disorders Tremor	18.2% 53/292 • Number of events 56 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	17.5% 52/297 • Number of events 52 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	5.1% 15/292 • Number of events 16 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	3.0% 9/297 • Number of events 10 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Dysuria	5.5% 16/292 • Number of events 17 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	4.7% 14/297 • Number of events 14 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 15/292 • Number of events 16 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	7.7% 23/297 • Number of events 26 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 5/292 • Number of events 5 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	7.4% 22/297 • Number of events 23 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypertension	13.0% 38/292 • Number of events 43 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	14.5% 43/297 • Number of events 46 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypotension	6.8% 20/292 • Number of events 21 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	4.4% 13/297 • Number of events 14 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Procedural pain	2.7% 8/292 • Number of events 9 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	6.4% 19/297 • Number of events 22 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Metabolic acidosis	5.5% 16/292 • Number of events 17 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.	4.7% 14/297 • Number of events 15 • Up to 52 weeks All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity was not directed by the sponsor, the investigator agreed to submit all manuscripts or abstracts to the sponsor before submission. This allowed the sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER