Trial Outcomes & Findings for Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001) (NCT NCT02137772)
NCT ID: NCT02137772
Last Updated: 2019-09-11
Results Overview
Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with clinically-significant CMV infection was assessed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
570 participants
Primary outcome timeframe
Up to Week 24 post-transplant
Results posted on
2019-09-11
Participant Flow
A total of 738 participants were screened, 570 were randomized 2:1 letermovir:placebo, and 565 received at least one dose of study medication.
Screening could occur up to 15 days before Hematopoietic Stem Cell Transplant (HSCT) and no more than Day 28 post-transplant. From the time of screening to randomization, participants were tested weekly for Cytomegalovirus (CMV) viremia; a positive test resulted in exclusion from the study.
Participant milestones
| Measure |
Letermovir
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
376
|
194
|
|
Overall Study
Treated Participants
|
373
|
192
|
|
Overall Study
COMPLETED
|
244
|
119
|
|
Overall Study
NOT COMPLETED
|
132
|
75
|
Reasons for withdrawal
| Measure |
Letermovir
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Death
|
71
|
44
|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
|
Overall Study
Physician Decision
|
15
|
5
|
|
Overall Study
Withdrawal by Subject
|
28
|
17
|
|
Overall Study
Non-compliance with study drug
|
1
|
0
|
|
Overall Study
Not treated
|
3
|
2
|
Baseline Characteristics
Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001)
Baseline characteristics by cohort
| Measure |
Letermovir
n=376 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=194 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Total
n=570 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
50.8 Years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
50.8 Years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
214 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
|
Risk Stratum for CMV Reactivation
High risk
|
122 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Risk Stratum for CMV Reactivation
Low risk
|
254 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
394 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24 post-transplantPopulation: The Full Analysis Set (FAS) was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1 (randomization). Participants who prematurely discontinued or had a missing outcome through the 24-week visit window were considered treatment failure (i.e. Non-completers equal failure \[NC=F\] approach was used).
Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with clinically-significant CMV infection was assessed.
Outcome measures
| Measure |
Letermovir
n=325 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=170 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Percentage of Participants With Clinically-significant CMV Infection up to Week 24 Post-transplant
|
37.5 Percentage of participants
|
60.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24 post-transplantPopulation: All randomized participants who received at least one dose of study drug and had no detectable CMV viral DNA on the day treatment was initiated.
Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. Time to onset of clinically-significant CMV infection was defined from the day of transplantation to the day the participant developed clinically-significant CMV infection, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not develop clinically-significant CMV infection.
Outcome measures
| Measure |
Letermovir
n=325 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=170 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Time to Onset of Clinically-significant CMV Infection (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)
|
18.9 Percentage of participants
Interval 14.4 to 23.5
|
44.3 Percentage of participants
Interval 36.4 to 52.1
|
SECONDARY outcome
Timeframe: Up to Week 14 post-transplantPopulation: The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 14-week visit window were considered treatment failure (i.e. NC=F approach was used).
Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with clinically-significant CMV infection was assessed.
Outcome measures
| Measure |
Letermovir
n=325 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=170 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Percentage of Participants With Clinically-significant CMV Infection up to Week 14 Post-transplant
|
19.1 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24 post-transplantPopulation: The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. A participant with a missing value up to Week 24 was excluded from the analysis (i.e., Data as observed \[DAO\] approach was used).
CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.
Outcome measures
| Measure |
Letermovir
n=254 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=123 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Percentage of Participants With CMV End-organ Disease up to Week 24 Post-transplant
|
2.0 Percentage of participants
|
2.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 14 post-transplantPopulation: The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. A participant with a missing value up to Week 14 was excluded from the analysis (i.e., Data as observed \[DAO\] approach was used).
CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.
Outcome measures
| Measure |
Letermovir
n=285 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=145 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Percentage of Participants With CMV End-organ Disease up to Week 14 Post-transplant
|
0.4 Percentage of participants
|
1.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 14 post-transplantPopulation: The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 14-week visit window were considered treatment failure (i.e. NC=F approach was used).
Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.
Outcome measures
| Measure |
Letermovir
n=325 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=170 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 14 Post-transplant
|
18.8 Percentage of participants
|
49.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24 post-transplantPopulation: The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 24-week visit window were considered treatment failure (i.e. NC=F approach was used).
Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.
Outcome measures
| Measure |
Letermovir
n=325 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=170 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 24 Post-transplant
|
36.6 Percentage of participants
|
59.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24 post-transplantPopulation: All randomized participants who received at least one dose of study drug and had no detectable CMV viral DNA on the day treatment was initiated.
The need for anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The outcome was calculated from the day of transplantation to the start of anti-CMV pre-emptive therapy, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not initiate pre-emptive therapy.
Outcome measures
| Measure |
Letermovir
n=325 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=170 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Time to Initiation of Pre-emptive Therapy for CMV Viremia (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)
|
17.2 Percentage of participants
Interval 12.8 to 21.6
|
42.4 Percentage of participants
Interval 34.7 to 50.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 48 post-transplantPopulation: All randomized participants who received at least one dose of study medication
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can 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, is also an adverse event.
Outcome measures
| Measure |
Letermovir
n=373 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=192 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Percentage of Participants With One or More Adverse Events up to Week 48 Post-transplant
|
98.4 Percentage of participants
|
100.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 14 post-transplantPopulation: All randomized participants who received at least one dose of study medication
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can 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, is also an adverse event.
Outcome measures
| Measure |
Letermovir
n=373 Participants
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=192 Participants
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Percentage of Participants Discontinued From Study Medication Due to an Adverse Event
|
19.6 Percentage of participants
|
51.6 Percentage of participants
|
Adverse Events
Letermovir
Serious events: 202 serious events
Other events: 360 other events
Deaths: 0 deaths
Placebo
Serious events: 115 serious events
Other events: 186 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Letermovir
n=373 participants at risk
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=192 participants at risk
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Metabolism and nutrition disorders
Gout
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/373 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Tetany
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.27%
1/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
1.6%
6/373 • Number of events 6 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.9%
7/373 • Number of events 7 • Up to Week 48 post-transplant
|
2.1%
4/192 • Number of events 4 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
6.2%
23/373 • Number of events 23 • Up to Week 48 post-transplant
|
8.9%
17/192 • Number of events 17 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma recurrent
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia recurrent
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma recurrent
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma recurrent
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides recurrent
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
1.6%
3/192 • Number of events 3 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Natural killer-cell leukaemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.00%
0/373 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma recurrent
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary myelofibrosis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Encephalopathy
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Headache
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Migraine
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Neurotoxicity
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Anaemia
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
7/373 • Number of events 10 • Up to Week 48 post-transplant
|
1.6%
3/192 • Number of events 3 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
4/373 • Number of events 4 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Cardiac disorders
Arrhythmia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Cardiac disorders
Atrial flutter
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Cardiac disorders
Cardiac failure
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Cardiac disorders
Pericarditis
|
0.27%
1/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Cardiac disorders
Sinus node dysfunction
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Colitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Constipation
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Diarrhoea
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
2.6%
5/192 • Number of events 5 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Food poisoning
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Nausea
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Pancreatitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Stomatitis haemorrhagic
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
General disorders
Chest pain
|
0.27%
1/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
General disorders
Gait disturbance
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
General disorders
Generalised oedema
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
General disorders
Malaise
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
General disorders
Mucosal inflammation
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
2.1%
4/192 • Number of events 4 • Up to Week 48 post-transplant
|
|
General disorders
Pyrexia
|
2.7%
10/373 • Number of events 12 • Up to Week 48 post-transplant
|
2.1%
4/192 • Number of events 4 • Up to Week 48 post-transplant
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
1.6%
3/192 • Number of events 3 • Up to Week 48 post-transplant
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Immune system disorders
Drug hypersensitivity
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Immune system disorders
Graft versus host disease
|
12.1%
45/373 • Number of events 49 • Up to Week 48 post-transplant
|
15.1%
29/192 • Number of events 31 • Up to Week 48 post-transplant
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Acute sinusitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Adenoviral haemorrhagic cystitis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Aspergillus infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Infections and infestations
Atypical pneumonia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Bacteraemia
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
BK virus infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Bronchiolitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Bronchitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
1.1%
4/373 • Number of events 4 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Cellulitis
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Cellulitis orbital
|
0.27%
1/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Clostridium bacteraemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Clostridium difficile colitis
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/373 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Infections and infestations
Cystitis viral
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Infections and infestations
Cytomegalovirus infection
|
3.8%
14/373 • Number of events 15 • Up to Week 48 post-transplant
|
7.8%
15/192 • Number of events 15 • Up to Week 48 post-transplant
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Diverticulitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Epstein-Barr viraemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Escherichia bacteraemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Fusarium infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Gastroenteritis
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Gastroenteritis viral
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Herpes zoster
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Implant site cellulitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Klebsiella infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Klebsiella sepsis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Meningitis aseptic
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Meningitis bacterial
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Meningoencephalitis viral
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Mucormycosis
|
0.27%
1/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Nasopharyngitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Neutropenic sepsis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Oesophageal candidiasis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Otitis media acute
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Periorbital cellulitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pharyngitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pilonidal cyst
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pneumonia
|
4.0%
15/373 • Number of events 15 • Up to Week 48 post-transplant
|
3.1%
6/192 • Number of events 6 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pneumonia adenoviral
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pneumonia bacterial
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pneumonia viral
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pseudomonas bronchitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Respiratory tract infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Respiratory tract infection viral
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Retinitis viral
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Rhinovirus infection
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Sepsis
|
2.1%
8/373 • Number of events 8 • Up to Week 48 post-transplant
|
2.1%
4/192 • Number of events 4 • Up to Week 48 post-transplant
|
|
Infections and infestations
Septic shock
|
1.3%
5/373 • Number of events 5 • Up to Week 48 post-transplant
|
3.6%
7/192 • Number of events 7 • Up to Week 48 post-transplant
|
|
Infections and infestations
Sinusitis
|
1.1%
4/373 • Number of events 4 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.1%
4/373 • Number of events 4 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Infections and infestations
Staphylococcal infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Systemic candida
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Tonsillitis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Tooth infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Urinary tract infection
|
1.1%
4/373 • Number of events 4 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Viraemia
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
1.6%
3/192 • Number of events 3 • Up to Week 48 post-transplant
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Viral infection
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Delayed engraftment
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Laceration
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/373 • Up to Week 48 post-transplant
|
1.6%
3/192 • Number of events 3 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Transfusion-related acute lung injury
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
1.6%
3/192 • Number of events 3 • Up to Week 48 post-transplant
|
|
Investigations
Blood creatinine increased
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Investigations
Platelet count decreased
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Sciatica
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Syncope
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Psychiatric disorders
Delirium
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/373 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
7/373 • Number of events 7 • Up to Week 48 post-transplant
|
4.7%
9/192 • Number of events 11 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Renal failure
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Renal impairment
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar damage
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/373 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.54%
2/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/373 • Up to Week 48 post-transplant
|
1.0%
2/192 • Number of events 2 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
7/373 • Number of events 7 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Vascular disorders
Hypertension
|
0.00%
0/373 • Up to Week 48 post-transplant
|
0.52%
1/192 • Number of events 1 • Up to Week 48 post-transplant
|
|
Vascular disorders
Hypertensive crisis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Vascular disorders
Hypotension
|
0.54%
2/373 • Number of events 2 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Vascular disorders
Hypovolaemic shock
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Vascular disorders
Orthostatic hypotension
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Vascular disorders
Thrombosis
|
0.27%
1/373 • Number of events 1 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
|
Vascular disorders
Venoocclusive disease
|
0.80%
3/373 • Number of events 3 • Up to Week 48 post-transplant
|
0.00%
0/192 • Up to Week 48 post-transplant
|
Other adverse events
| Measure |
Letermovir
n=373 participants at risk
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
Placebo
n=192 participants at risk
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
24/373 • Number of events 39 • Up to Week 48 post-transplant
|
6.2%
12/192 • Number of events 13 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.5%
28/373 • Number of events 28 • Up to Week 48 post-transplant
|
9.9%
19/192 • Number of events 20 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
18/373 • Number of events 20 • Up to Week 48 post-transplant
|
5.7%
11/192 • Number of events 12 • Up to Week 48 post-transplant
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.2%
27/373 • Number of events 32 • Up to Week 48 post-transplant
|
6.8%
13/192 • Number of events 13 • Up to Week 48 post-transplant
|
|
Eye disorders
Dry eye
|
6.4%
24/373 • Number of events 24 • Up to Week 48 post-transplant
|
6.2%
12/192 • Number of events 12 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Abdominal pain
|
13.1%
49/373 • Number of events 53 • Up to Week 48 post-transplant
|
9.9%
19/192 • Number of events 21 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
23/373 • Number of events 30 • Up to Week 48 post-transplant
|
8.9%
17/192 • Number of events 20 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Constipation
|
8.0%
30/373 • Number of events 30 • Up to Week 48 post-transplant
|
11.5%
22/192 • Number of events 24 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Diarrhoea
|
29.0%
108/373 • Number of events 139 • Up to Week 48 post-transplant
|
26.6%
51/192 • Number of events 64 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
21/373 • Number of events 22 • Up to Week 48 post-transplant
|
5.7%
11/192 • Number of events 11 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
21/373 • Number of events 22 • Up to Week 48 post-transplant
|
3.1%
6/192 • Number of events 8 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.6%
6/373 • Number of events 6 • Up to Week 48 post-transplant
|
5.7%
11/192 • Number of events 11 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Nausea
|
28.4%
106/373 • Number of events 141 • Up to Week 48 post-transplant
|
27.6%
53/192 • Number of events 64 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
24/373 • Number of events 25 • Up to Week 48 post-transplant
|
7.3%
14/192 • Number of events 14 • Up to Week 48 post-transplant
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
79/373 • Number of events 93 • Up to Week 48 post-transplant
|
18.2%
35/192 • Number of events 40 • Up to Week 48 post-transplant
|
|
General disorders
Asthenia
|
7.8%
29/373 • Number of events 36 • Up to Week 48 post-transplant
|
4.7%
9/192 • Number of events 13 • Up to Week 48 post-transplant
|
|
General disorders
Chest pain
|
5.4%
20/373 • Number of events 21 • Up to Week 48 post-transplant
|
2.6%
5/192 • Number of events 5 • Up to Week 48 post-transplant
|
|
General disorders
Fatigue
|
14.7%
55/373 • Number of events 63 • Up to Week 48 post-transplant
|
13.5%
26/192 • Number of events 30 • Up to Week 48 post-transplant
|
|
General disorders
Mucosal inflammation
|
12.1%
45/373 • Number of events 47 • Up to Week 48 post-transplant
|
12.5%
24/192 • Number of events 24 • Up to Week 48 post-transplant
|
|
General disorders
Oedema peripheral
|
16.1%
60/373 • Number of events 74 • Up to Week 48 post-transplant
|
12.0%
23/192 • Number of events 27 • Up to Week 48 post-transplant
|
|
General disorders
Pyrexia
|
22.8%
85/373 • Number of events 112 • Up to Week 48 post-transplant
|
26.0%
50/192 • Number of events 60 • Up to Week 48 post-transplant
|
|
Immune system disorders
Graft versus host disease
|
39.4%
147/373 • Number of events 173 • Up to Week 48 post-transplant
|
38.5%
74/192 • Number of events 91 • Up to Week 48 post-transplant
|
|
Infections and infestations
Bacteraemia
|
5.6%
21/373 • Number of events 24 • Up to Week 48 post-transplant
|
2.1%
4/192 • Number of events 5 • Up to Week 48 post-transplant
|
|
Infections and infestations
Cytomegalovirus infection
|
14.7%
55/373 • Number of events 65 • Up to Week 48 post-transplant
|
40.1%
77/192 • Number of events 93 • Up to Week 48 post-transplant
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
19/373 • Number of events 22 • Up to Week 48 post-transplant
|
4.2%
8/192 • Number of events 8 • Up to Week 48 post-transplant
|
|
Infections and infestations
Viraemia
|
3.2%
12/373 • Number of events 12 • Up to Week 48 post-transplant
|
6.2%
12/192 • Number of events 12 • Up to Week 48 post-transplant
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
26/373 • Number of events 31 • Up to Week 48 post-transplant
|
8.9%
17/192 • Number of events 20 • Up to Week 48 post-transplant
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
21/373 • Number of events 24 • Up to Week 48 post-transplant
|
6.8%
13/192 • Number of events 16 • Up to Week 48 post-transplant
|
|
Investigations
Blood creatinine increased
|
10.5%
39/373 • Number of events 43 • Up to Week 48 post-transplant
|
7.3%
14/192 • Number of events 17 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.5%
43/373 • Number of events 48 • Up to Week 48 post-transplant
|
13.5%
26/192 • Number of events 26 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
31/373 • Number of events 31 • Up to Week 48 post-transplant
|
6.8%
13/192 • Number of events 14 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.5%
28/373 • Number of events 29 • Up to Week 48 post-transplant
|
2.6%
5/192 • Number of events 5 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
23/373 • Number of events 25 • Up to Week 48 post-transplant
|
6.2%
12/192 • Number of events 13 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.4%
24/373 • Number of events 24 • Up to Week 48 post-transplant
|
7.8%
15/192 • Number of events 16 • Up to Week 48 post-transplant
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
23/373 • Number of events 24 • Up to Week 48 post-transplant
|
5.2%
10/192 • Number of events 10 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
30/373 • Number of events 31 • Up to Week 48 post-transplant
|
7.8%
15/192 • Number of events 18 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
24/373 • Number of events 26 • Up to Week 48 post-transplant
|
10.4%
20/192 • Number of events 22 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
12/373 • Number of events 13 • Up to Week 48 post-transplant
|
5.2%
10/192 • Number of events 12 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
21/373 • Number of events 21 • Up to Week 48 post-transplant
|
2.1%
4/192 • Number of events 4 • Up to Week 48 post-transplant
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
20/373 • Number of events 24 • Up to Week 48 post-transplant
|
8.3%
16/192 • Number of events 17 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Dizziness
|
7.8%
29/373 • Number of events 30 • Up to Week 48 post-transplant
|
8.3%
16/192 • Number of events 16 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Dysgeusia
|
5.1%
19/373 • Number of events 19 • Up to Week 48 post-transplant
|
5.2%
10/192 • Number of events 10 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Headache
|
15.5%
58/373 • Number of events 68 • Up to Week 48 post-transplant
|
12.5%
24/192 • Number of events 26 • Up to Week 48 post-transplant
|
|
Nervous system disorders
Tremor
|
7.8%
29/373 • Number of events 30 • Up to Week 48 post-transplant
|
6.8%
13/192 • Number of events 14 • Up to Week 48 post-transplant
|
|
Psychiatric disorders
Anxiety
|
6.2%
23/373 • Number of events 23 • Up to Week 48 post-transplant
|
2.6%
5/192 • Number of events 5 • Up to Week 48 post-transplant
|
|
Psychiatric disorders
Insomnia
|
9.4%
35/373 • Number of events 37 • Up to Week 48 post-transplant
|
6.2%
12/192 • Number of events 12 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Acute kidney injury
|
9.4%
35/373 • Number of events 37 • Up to Week 48 post-transplant
|
11.5%
22/192 • Number of events 25 • Up to Week 48 post-transplant
|
|
Renal and urinary disorders
Dysuria
|
4.6%
17/373 • Number of events 17 • Up to Week 48 post-transplant
|
5.7%
11/192 • Number of events 11 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.6%
62/373 • Number of events 70 • Up to Week 48 post-transplant
|
14.1%
27/192 • Number of events 28 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.7%
36/373 • Number of events 38 • Up to Week 48 post-transplant
|
4.7%
9/192 • Number of events 10 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
25/373 • Number of events 29 • Up to Week 48 post-transplant
|
6.8%
13/192 • Number of events 13 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.6%
32/373 • Number of events 34 • Up to Week 48 post-transplant
|
9.9%
19/192 • Number of events 20 • Up to Week 48 post-transplant
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.0%
15/373 • Number of events 18 • Up to Week 48 post-transplant
|
5.2%
10/192 • Number of events 11 • Up to Week 48 post-transplant
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
31/373 • Number of events 32 • Up to Week 48 post-transplant
|
8.3%
16/192 • Number of events 19 • Up to Week 48 post-transplant
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
34/373 • Number of events 37 • Up to Week 48 post-transplant
|
6.2%
12/192 • Number of events 13 • Up to Week 48 post-transplant
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
31/373 • Number of events 35 • Up to Week 48 post-transplant
|
6.2%
12/192 • Number of events 14 • Up to Week 48 post-transplant
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.1%
90/373 • Number of events 109 • Up to Week 48 post-transplant
|
26.6%
51/192 • Number of events 62 • Up to Week 48 post-transplant
|
|
Vascular disorders
Hypertension
|
9.1%
34/373 • Number of events 38 • Up to Week 48 post-transplant
|
12.0%
23/192 • Number of events 24 • Up to Week 48 post-transplant
|
|
Vascular disorders
Hypotension
|
4.3%
16/373 • Number of events 16 • Up to Week 48 post-transplant
|
5.7%
11/192 • Number of events 13 • Up to Week 48 post-transplant
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER